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Mechanisms of Manual Therapies in CAI Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03418051
Recruitment Status : Completed
First Posted : February 1, 2018
Results First Posted : August 27, 2021
Last Update Posted : August 27, 2021
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Basic Science
Conditions Ankle Inversion Sprain
Chronic Instability of Joint
Interventions Other: Joint Mobilization
Other: Massage
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description Control group that will receive no intervention throughout the duration of the study (2-weeks). Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion. Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Period Title: Overall Study
Started 20 20 20
Completed 14 18 17
Not Completed 6 2 3
Arm/Group Title Control Joint Mobilization Massage Total
Hide Arm/Group Description Control group that will receive no intervention throughout the duration of the study (2-weeks). Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion. Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface. Total of all reporting groups
Overall Number of Baseline Participants 20 20 20 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 20 participants 60 participants
19.5  (.8) 21.9  (3.9) 20.9  (3.2) 20.7  (3.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 participants
Female
5
  25.0%
3
  15.0%
12
  60.0%
20
  33.3%
Male
15
  75.0%
17
  85.0%
8
  40.0%
40
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 participants
Hispanic or Latino
2
  10.0%
3
  15.0%
2
  10.0%
7
  11.7%
Not Hispanic or Latino
18
  90.0%
17
  85.0%
18
  90.0%
53
  88.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.0%
2
  10.0%
3
  15.0%
6
  10.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  15.0%
1
   5.0%
1
   5.0%
5
   8.3%
White
15
  75.0%
17
  85.0%
14
  70.0%
46
  76.7%
More than one race
1
   5.0%
0
   0.0%
2
  10.0%
3
   5.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 20 participants 60 participants
20
 100.0%
20
 100.0%
20
 100.0%
60
 100.0%
Ankle Instability Instrument   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 20 participants 20 participants 60 participants
7.4  (1.35) 7.4  (1.46) 7.0  (1.23) 7.3  (1.34)
[1]
Measure Description:

The ankle instability instrument (AII) is a questionnaire used to capture self-reported data from the participant regarding history of ankle injury and perceived deficits in function. The outcome is the number of 'yes' responses to the questions asked.

Minimum = 0 Maximum = 9 Higher scores = greater perceived disability.

Number of ankle sprains  
Mean (Standard Deviation)
Unit of measure:  Sprains
Number Analyzed 20 participants 20 participants 20 participants 60 participants
4.5  (3.5) 4.25  (2.35) 5.1  (3.85) 4.6  (3.27)
Number of giving way episodes   [1] 
Mean (Standard Deviation)
Unit of measure:  Giving way episodes
Number Analyzed 20 participants 20 participants 20 participants 60 participants
7  (1.56) 10.4  (16.13) 9.15  (8.63) 8.85  (11.2)
[1]
Measure Description: A giving way episode is defined as an episode where the participant had the sensation that their ankle was about to give way but such an event did not result in a recurrent ankle sprain. The outcome is the number of giving way episodes within the past 6 months.
Outcome Expectations for Exercise Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 20 participants 20 participants 60 participants
2.8  (0.83) 2.8  (0.76) 2.9  (0.85) 2.83  (0.81)
[1]
Measure Description: The Outcome Expectations for Exercise Scale was used to determine if participants believe that receiving a manual therapy treatment would result in a positive outcome. This was captured via a single question using a Likert scale (range: 1 to 5). Higher scores indicate a higher perception that a manual therapy treatment would result in a positive outcome.
1.Primary Outcome
Title ML COP Velocity From Baseline to Post Intervention
Hide Description

% Modulation of ML COP velocity.

First, center of pressure (COP) is calculated in the mediolateral (ML) direction [side to side] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial.

Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the immediate post-treatment assessment.

Time Frame Baseline and 24-72 hours post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
All missing data was the result of participants being lost to follow-up.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 18 19 19
Mean (Standard Deviation)
Unit of Measure: % modulation
Baseline 119.91  (47.38) 118.91  (47.38) 121.07  (44.55)
Post Intervention 116.99  (36.16) 128.23  (40.10) 121.20  (42.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.824
Comments A priori alpha level was set to 0.05
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.426
Comments A priori alpha level was set to 0.05.
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title ML COP Velocity From Baseline to Follow-Up
Hide Description

% Modulation of ML COP velocity.

First, center of pressure (COP) is calculated in the mediolateral (ML) direction [side to side] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial.

Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the Follow-Up assessment.

Time Frame Baseline and 4-week Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
All missing data was the result of participants being lost to follow-up.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 14 18 17
Mean (Standard Deviation)
Unit of Measure: % modulation
Baseline 119.71  (48.70) 116.13  (41.37) 119.14  (46.66)
Follow-Up 118.86  (45.11) 110.80  (46.45) 111.06  (43.86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.722
Comments A priori alpha level was set to 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.843
Comments A priori alpha level was set to 0.05.
Method ANOVA
Comments [Not Specified]
3.Primary Outcome
Title AP COP Velocity From Baseline to Post Intervention
Hide Description

% Modulation of AP COP velocity.

First, center of pressure (COP) is calculated in the anterioposterior (AP) direction [front to back]. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial.

Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the immediate post-treatment assessment.

Time Frame Baseline and 24-72 hours post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
All missing data was the result of participants being lost to follow-up.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 18 19 19
Mean (Standard Deviation)
Unit of Measure: % modulation
Baseline 117.40  (31.73) 115.84  (47.32) 126.50  (37.95)
Post Intervention 120.91  (33.69) 122.51  (39.05) 100.91  (38.53)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments A priori alpha level was set to 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.845
Comments A priori alpha level was set to 0.05.
Method ANOVA
Comments [Not Specified]
4.Primary Outcome
Title AP COP Velocity From Baseline to Follow-up
Hide Description

% Modulation of AP COP velocity.

First, center of pressure (COP) is calculated in the anterioposterior (AP) direction [front to back] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial.

Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the follow-up assessment.

Time Frame Baseline and 4-week Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
All missing data was the result of participants being lost to follow-up.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 14 18 17
Mean (Standard Deviation)
Unit of Measure: % modulation
Baseline 119.48  (33.02) 116.69  (48.19) 123.93  (39.40)
Follow-Up 117.67  (40.04) 105.10  (48.54) 97.96  (35.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.138
Comments A priori alpha level was set to 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.523
Comments A priori alpha level was set to 0.05.
Method ANOVA
Comments [Not Specified]
5.Primary Outcome
Title ML TTB From Baseline to Post Intervention
Hide Description

% Modulation of ML Time-to-Boundary.

First, time-to-Boundary (TTB) is calculated in the mediolateral (ML) direction [side to side] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot.

Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as ML TTB decreased with eyes closed.

Time Frame Baseline and 24-72 hours post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
All missing data was the result of participants being lost to follow-up.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 18 19 19
Mean (Standard Deviation)
Unit of Measure: % modulation
Baseline -50.76  (13.41) -54.97  (8.98) -55.41  (10.81)
Post Intervention -55.99  (7.14) -56.61  (10.43) -52.28  (11.73)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.069
Comments A priori alpha level was set to 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.413
Comments A priori alpha level was set to 0.05.
Method ANOVA
Comments [Not Specified]
6.Primary Outcome
Title ML TTB From Baseline to Follow-Up
Hide Description

% Modulation of ML Time-to-Boundary.

First, time-to-Boundary (TTB) is calculated in the mediolateral (ML) direction [side to side] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot.

Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as ML TTB decreased with eyes closed.

Time Frame Baseline and 4-week Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data was due to participants lost to follow up.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 14 18 17
Mean (Standard Deviation)
Unit of Measure: % modulation
Baseline -48.98  (14.31) -54.18  (9.41) -51.12  (13.00)
Follow-Up -51.12  (13.00) -52.18  (12.69) -53.12  (10.91)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.604
Comments A priori alpha level was set to 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.499
Comments A priori alpha level was set to 0.05.
Method ANOVA
Comments [Not Specified]
7.Primary Outcome
Title AP TTB From Baseline to Post Intervention
Hide Description

% Modulation of AP Time-to-Boundary.

First, time-to-Boundary (TTB) is calculated in the anterioposterior (AP) direction [front to back] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot.

Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in AP TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as AP TTB decreased with eyes closed.

Time Frame Baseline and 24-72 hours post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
All missing data was the result of participants being lost to follow-up.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 18 18 19
Mean (Standard Deviation)
Unit of Measure: % modulation
Baseline -52.54  (9.67) -54.59  (8.81) -57.53  (8.24)
Post Intervention -52.97  (7.31) -54.39  (11.01) -48.81  (8.67)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments A priori threshold was set at 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.853
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
8.Primary Outcome
Title AP TTB From Baseline to Follow-Up
Hide Description

% Modulation of AP Time-to-Boundary.

First, time-to-Boundary is calculated in the anterioposterior (AP) direction [front to back] with eyes open and closed. Time-to-boundary represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot.

Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in AP TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as AP TTB decreased with eyes closed.

Time Frame Baseline and 4-week Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
All missing data was the result of participants being lost to follow-up.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 14 18 17
Mean (Standard Deviation)
Unit of Measure: % modulation
Baseline -52.95  (10.40) -55.09  (8.36) -53.98  (10.53)
Follow-Up -51.94  (11.40) -47.38  (12.05) -48.81  (9.92)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.142
Comments A priori threshold set to 0.05
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.167
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
9.Primary Outcome
Title 95% Confidence Ellipse From Baseline to Post Intervention
Hide Description

% Modulation of 95% Confidence Ellipse.

First, center of pressure (COP) excursion [movement] is calculated and the magnitude of an ellipse that contains 95% of all data points is calculated with eyes open and closed. The resulting outcome is calculated from a 10 second single limb stance trial.

Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as the variable increased when eyes were closed relative to the eyes open condition. A change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the immediate post-treatment assessment.

Time Frame Baseline and 24-72 hours post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
All missing data was the result of participants being lost to follow-up.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 18 18 19
Mean (Standard Deviation)
Unit of Measure: % modulation
Baseline 270.91  (168.28) 270.91  (168.28) 290.70  (128.07)
Post-Intervention 267.85  (127.60) 283.26  (111.89) 275.92  (142.78)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.849
Comments A priori alpha set at 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.993
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
10.Primary Outcome
Title 95% Confidence Ellipse From Baseline to Follow-Up
Hide Description

% Modulation of 95% Confidence Ellipse.

First, center of pressure (COP) excursion [movement] is calculated and the magnitude of an ellipse that contains 95% of all data points is calculated with eyes open and closed. The resulting outcome is calculated from a 10 second single limb stance trial.

Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as the variable increased when eyes were closed relative to the eyes open condition. A change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the immediate post-treatment assessment.

Time Frame Baseline and 4-week Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
All missing data was the result of participants being lost to follow-up.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 14 18 17
Mean (Standard Deviation)
Unit of Measure: % modulation
Baseline 286.29  (173.43) 272.07  (142.18) 282.06  (129.60)
Follow-Up 317.46  (146.05) 254.06  (165.90) 267.92  (134.57)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.535
Comments A priori alpha level was set to 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.569
Comments A priori alpha level was set to 0.05.
Method ANOVA
Comments [Not Specified]
11.Secondary Outcome
Title Plantar Flexion Joint Position Sense From Baseline to Post Intervention
Hide Description Amount of error, measured in degrees, from a target angle of plantar flexion. Participants are shown a target ankle and asked to replicate that angle (i.e. joint position) with their eyes closed. The amount of error from the target angle is recorded as the joint position sense. Larger values (i.e. greater error) indicates worse joint position sense. This analysis focused on baseline to the immediate post-treatment assessment.
Time Frame Baseline and 24-72 hours post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
All missing data was the result of participants being lost to follow-up.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 19 20 19
Mean (Standard Deviation)
Unit of Measure: Degrees
Baseline 3.00  (1.82) 3.25  (1.60) 3.73  (2.54)
Post Intervention 2.22  (1.36) 1.97  (1.54) 2.42  (1.67)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.405
Comments A priori threshold was 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.229
Comments A priori threshold set to 0.05.
Method ANOVA
Comments [Not Specified]
12.Secondary Outcome
Title Plantar Flexion Joint Position Sense From Baseline to Follow-Up
Hide Description Amount of error, measured in degrees, from a target angle of plantar flexion. Participants are shown a target ankle and asked to replicate that angle (i.e. joint position) with their eyes closed. The amount of error from the target angle is recorded as the joint position sense. Larger values (i.e. greater error) indicates worse joint position sense. This analysis focused on baseline to the follow-up assessment.
Time Frame Baseline and 4-week Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data was due to participants being lost to follow up.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 14 18 18
Mean (Standard Deviation)
Unit of Measure: Degrees
Baseline 3.04  (1.78) 3.04  (1.78) 3.72  (2.61)
Follow-Up 2.35  (1.95) 1.51  (1.49) 2.62  (2.20)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.609
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments A priori threshold was set at 0.05.
Method ANOVA
Comments [Not Specified]
13.Secondary Outcome
Title 1st Metatarsal Light-touch Threshold From Baseline to Post Intervention
Hide Description Minimal amount of pressure that can be detected by an individual at the head of the 1st metatarsal. Semmes-Weinstein monofilaments, of different diameters (mm), are pressed against the skin using an established 4-2-1 stepping algorithm. Higher values (thresholds) indicate worse light touch sensation thresholds. his analysis focused on baseline to the immediate post-treatment assessment.
Time Frame Baseline and 24-72 hours post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data due to participants being lost at follow up.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 18 20 19
Median (Standard Deviation)
Unit of Measure: mm
Baseline 2.83  (0.62) 3.22  (0.55) 3.61  (0.76)
Post intervention 3.41  (0.57) 3.22  (0.73) 2.83  (0.54)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.613
Comments A priori alpha set at 0.05.
Method Independent sample Mann-Whitney U
Comments [Not Specified]
14.Secondary Outcome
Title 1st Metatarsal Light-touch Threshold From Baseline to Follow-Up
Hide Description Minimal amount of pressure that can be detected by an individual at the head of the 1st metatarsal. Semmes-Weinstein monofilaments, of different diameters (mm), are pressed against the skin using an established 4-2-1 stepping algorithm. Higher values (thresholds) indicate worse light touch sensation thresholds. This analysis focused on baseline to the follow-up assessment.
Time Frame Baseline and 4-week Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data due to participants being lost at follow up.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 14 18 18
Median (Standard Deviation)
Unit of Measure: mm
Baseline 2.95  (0.67) 3.22  (0.57) 3.41  (0.77)
Follow-Up 3.22  (0.67) 3.22  (0.58) 2.83  (0.81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.925
Comments A priori threshold set at 0.05.
Method Independent sample Mann-Whitney U
Comments [Not Specified]
15.Secondary Outcome
Title 5th Metatarsal Light-touch Threshold From Baseline to Post Intervention
Hide Description Minimal amount of pressure that can be detected by an individual at the base of the 5th metatarsal. Semmes-Weinstein monofilaments, of different diameters (mm), are pressed against the skin using an established 4-2-1 stepping algorithm. Higher values (thresholds) indicate worse light touch sensation thresholds. This analysis focused on baseline to the immediate post-treatment assessment.
Time Frame Baseline and 24-72 hours post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data due to participants being lost at follow up.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 18 20 19
Median (Standard Deviation)
Unit of Measure: mm
Baseline 3.22  (0.60) 3.22  (0.59) 3.84  (0.75)
Post Intervention 3.61  (0.69) 3.41  (0.23) 3.22  (0.69)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.641
Comments A priori threshold set at 0.05.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.897
Comments A priori threshold set at 0.05.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
16.Secondary Outcome
Title 5th Metatarsal Light-touch Threshold From Baseline to Follow-Up
Hide Description Minimal amount of pressure that can be detected by an individual at the base of the 5th metatarsal. Semmes-Weinstein monofilaments, of different diameters (mm), are pressed against the skin using an established 4-2-1 stepping algorithm. Higher values (thresholds) indicate worse light touch sensation thresholds. This analysis focused on baseline to the follow-up assessment.
Time Frame Baseline and 4-week Follow Up
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data due to participants being lost at follow up.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 14 18 18
Median (Standard Deviation)
Unit of Measure: mm
Baseline 3.22  (0.62) 3.22  (0.61) 3.84  (0.76)
Follow-Up 3.61  (0.50) 3.41  (0.85) 3.61  (0.91)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.561
Comments A priori threshold set at 0.05.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.925
Comments A priori threshold set at 0.05.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
17.Secondary Outcome
Title Soleus H:M Ratio From Baseline to Post Intervention
Hide Description

This measure shows the percentage of excited alpha motor neurons (H) within a muscle upon electrical stimulation, relative to the total number of alpha motor neurons in the same muscle (M). Higher scores represent a greater percentage of excitability (i.e. activation) and is thought to represent better function of the spinal motor pathway. This analysis focused on baseline to the immediate post-treatment assessment.

The test is performed using an electric stimulator and electromyography (EMG) to record muscle responses. Stimulation intensity is increased on sequential trials to capture both the H-wave and M-wave responses.

Time Frame Baseline and 24-72 hours post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data due to participants being lost to follow up or technical issues with equipment.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 18 19 15
Mean (Standard Deviation)
Unit of Measure: H:M Ratio
Baseline 0.68  (.140) 0.65  (0.18) 0.63  (0.30)
Post-Intervention 0.67  (0.14) 0.62  (0.12) 0.64  (0.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.233
Comments A priori threshold set at 0.05
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.634
Comments A priori threshold set at 0.05
Method ANOVA
Comments [Not Specified]
18.Secondary Outcome
Title Soleus H:M Ratio From Baseline to Follow-Up
Hide Description

This measure shows the percentage of excited alpha motor neurons (H) within a muscle upon electrical stimulation, relative to the total number of alpha motor neurons in the same muscle (M). Higher scores represent a greater percentage of excitability (i.e. activation) and is thought to represent better function of the spinal motor pathway. This analysis focused on baseline to the immediate post-treatment assessment.

The test is performed using an electric stimulator and electromyography (EMG) to record muscle responses. Stimulation intensity is increased on sequential trials to capture both the H-wave and M-wave responses.

Time Frame Baseline and 4-week Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data due to participants being lost to follow up or technical issues with equipment.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 14 17 13
Mean (Standard Deviation)
Unit of Measure: H:M Ratio
Baseline 0.67  (0.15) 0.63  (0.18) 0.65  (0.25)
Follow-Up 0.64  (0.13) 0.62  (0.16) 0.67  (0.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.233
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.634
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
19.Secondary Outcome
Title Fibularis Longus H:M Ratio From Baseline to Post Intervention
Hide Description

This measure shows the percentage of excited alpha motor neurons (H) within a muscle upon electrical stimulation, relative to the total number of alpha motor neurons in the same muscle (M). Higher scores represent a greater percentage of excitability (i.e. activation) and is thought to represent better function of the spinal motor pathway. This analysis focused on baseline to the immediate post-treatment assessment.

The test is performed using an electric stimulator and electromyography (EMG) to record muscle responses. Stimulation intensity is increased on sequential trials to capture both the H-wave and M-wave responses.

Time Frame Baseline and 24-72 hours post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data due to participants being lost to follow up or technical issues with equipment.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 18 19 15
Mean (Standard Deviation)
Unit of Measure: H:M Ratio
Baseline 0.34  (0.13) 0.29  (0.20) 0.25  (0.20)
Post-Intervention 0.27  (0.08) 0.23  (0.12) 0.28  (0.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.618
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
20.Secondary Outcome
Title Fibularis Longus H:M Ratio From Baseline to Follow-Up
Hide Description

This measure shows the percentage of excited alpha motor neurons (H) within a muscle upon electrical stimulation, relative to the total number of alpha motor neurons in the same muscle (M). Higher scores represent a greater percentage of excitability (i.e. activation) and is thought to represent better function of the spinal motor pathway. This analysis focused on baseline to the immediate post-treatment assessment.

The test is performed using an electric stimulator and electromyography (EMG) to record muscle responses. Stimulation intensity is increased on sequential trials to capture both the H-wave and M-wave responses.

Time Frame Baseline and 4-week Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data due to participants being lost to follow up or technical issues with equipment.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 14 17 13
Mean (Standard Deviation)
Unit of Measure: H:M Ratio
Baseline 0.30  (0.08) 0.28  (0.20) 0.28  (0.20)
Follow-Up 0.29  (0.14) 0.23  (0.11) 0.32  (0.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.456
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.568
Comments A priori threshold set to 0.05.
Method ANOVA
Comments [Not Specified]
21.Secondary Outcome
Title Fibularis Longus Active Motor Threshold From Baseline to Post Intervention
Hide Description A measure of cortical excitability using transcranial electromagnetic stimulation. A higher active motor threshold (AMT) indicates decreased excitability, as a greater stimulus intensity is required to elicit a motor evoke potential (MEP). This analysis focused on baseline to the immediate post-treatment assessment.
Time Frame Baseline and 24-72 hours post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data due to participants being lost to follow up or technical issues with equipment.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 16 18 10
Mean (Standard Deviation)
Unit of Measure: % maximum intensity
Baseline 44  (9.87) 38.38  (8.60) 40.8  (42.2)
Post-Intervention 45.12  (8.37) 38.27  (6.75) 42.2  (8.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.919
Comments A priori alpha level was set to 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.558
Comments A priori alpha level was set to 0.05.
Method ANOVA
Comments [Not Specified]
22.Secondary Outcome
Title Fibularis Longus Active Motor Threshold From Baseline to Follow-Up
Hide Description A measure of cortical excitability using transcranial electromagnetic stimulation. A higher active motor threshold (AMT) indicates decreased excitability, as a greater stimulus intensity is required to elicit a motor evoke potential (MEP). This analysis focused on baseline to the immediate post-treatment assessment.
Time Frame Baseline and 4-week Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data due to participants lost to follow up or technical issues with equipment.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 12 15 9
Mean (Standard Deviation)
Unit of Measure: % maximum intensity
Baseline 44  (10.23) 39.6  (8.47) 41.22  (6.90)
Follow-Up 44.75  (9.16) 40.26  (9.26) 42.55  (43.80)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.796
Comments A priori alpha level was set to 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.558
Comments A priori alpha level was set to 0.05.
Method ANOVA
Comments [Not Specified]
23.Secondary Outcome
Title Cortical Silent Period From Baseline to Post Intervention
Hide Description A measure of corticospinal inhibition using transcranial electromagnetic stimulation. The cortical silent period (CSP) will be measured as the distance from the end of the motor evoked potential (MEP) to a return of the mean electromyographic (EMG) signal plus two times the standard deviation of the baseline (pre-stimulus) EMG signal. A longer CSP indicates a greater corticospinal inhibition. This analysis focused on baseline to the immediate post-treatment assessment.
Time Frame Baseline and 24-72 hours post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data due to participants lost to follow up or technical issues with equipment.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 16 18 10
Mean (Standard Deviation)
Unit of Measure: ms
Baseline 0.107  (0.077) 0.125  (0.084) 0.122  (0.027)
Post-Intervention 0.085  (0.036) 0.114  (0.038) 0.091  (0.024)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.701
Comments A priori alpha level was set to 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments A priori alpha level was set to 0.05.
Method ANOVA
Comments [Not Specified]
24.Secondary Outcome
Title Cortical Silent Period From Baseline to Follow-Up
Hide Description A measure of corticospinal inhibition using transcranial electromagnetic stimulation. The cortical silent period (CSP) will be measured as the distance from the end of the motor evoked potential (MEP) to a return of the mean electromyographic (EMG) signal plus two times the standard deviation of the baseline (pre-stimulus) EMG signal. A longer CSP indicates a greater corticospinal inhibition. This analysis focused on baseline to the follow-up assessment.
Time Frame Baseline and 4-week Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data due to participants lost to follow up or technical issues with equipment.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 12 15 9
Mean (Standard Deviation)
Unit of Measure: ms
Baseline 0.088  (0.037) 0.121  (0.087) 0.114  (0.032)
Follow Up 0.088  (0.024) 0.096  (0.024) 0.110  (0.046)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.883
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.401
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
25.Secondary Outcome
Title Corticomotor Map Area From Baseline to Post Intervention
Hide Description A measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation. Map area is the number of stimulus positions whose stimulation evoked an average motor evoked potential ≥ the motor evoked potential threshold. An increase would suggest an expansion of the cortical representation of a selected muscle. This analysis focused on baseline to the immediate post-treatment assessment.
Time Frame Baseline and 24-72 hours post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data due to participants lost to follow up or technical issues with equipment.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 16 18 10
Mean (Standard Deviation)
Unit of Measure: number of positions
Baseline 13.43  (10.6) 19.6  (12.0) 21.8  (15.3)
Post-Intervention 16.68  (11.47) 21.55  (11.4) 20.2  (12.14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.393
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.779
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
26.Secondary Outcome
Title Corticomotor Map Area From Baseline to Follow-Up
Hide Description A measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation. Map area is the number of stimulus positions whose stimulation evoked an average motor evoked potential ≥ the motor evoked potential threshold. An increase would suggest an expansion of the cortical representation of a selected muscle. This analysis focused on baseline to the follow-up assessment.
Time Frame Baseline and 4-week Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data due to participants lost at follow-up or technical issues with equipment.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 12 15 9
Mean (Standard Deviation)
Unit of Measure: number of positions
Baseline 14.3  (11.79) 16.73  (10.1) 20.0  (12.92)
Follow Up 9.08  (6.17) 16.73  (6.73) 20.66  (12.92)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.246
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.191
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
27.Secondary Outcome
Title Corticomotor Map Volume From Baseline to Post Intervention
Hide Description A measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation. Map volume will be calculated as the sum of the mean normalized MEPs recorded with an increase suggesting greater cortical excitability. This analysis focused on baseline to the immediate post-treatment assessment.
Time Frame Baseline and 24-72 hours post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data due to participants lost to follow up or technical issues with equipment.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 16 18 10
Mean (Standard Deviation)
Unit of Measure: number of positions
Baseline 0.89  (0.29) 1.2  (0.60) 1.07  (0.72)
Post-Intervention 0.80  (0.36) 0.93  (0.23) 1.05  (0.89)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.703
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.282
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
28.Secondary Outcome
Title Corticomotor Map Volume From Baseline to Follow-Up
Hide Description measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation. Map volume will be calculated as the sum of the mean normalized MEPs recorded with an increase suggesting greater cortical excitability. This analysis focused on baseline to the immediate post-treatment assessment.
Time Frame Baseline and 4-week Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data due to participants lost at follow-up or technical issues with equipment.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 12 15 9
Mean (Standard Deviation)
Unit of Measure: number of positions
Baseline 0.91  (0.32) 1.12  (0.62) 0.99  (0.50)
Follow-Up 0.66  (0.39) 0.74  (0.16) 0.72  (0.35)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.925
Comments A priori alpha level was set to 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.551
Comments A priori alpha level was set to 0.05.
Method ANOVA
Comments [Not Specified]
29.Secondary Outcome
Title Alpha Power Spectral Density From Baseline to Post Intervention
Hide Description A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the alpha bandwidth. This analysis focused on baseline to the immediate post-treatment assessment.
Time Frame Baseline and 24-72 hours post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data due to participants lost to follow up or technical issues with equipment.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 18 20 18
Mean (Standard Deviation)
Unit of Measure: mV
Baseline 0.739  (0.479) 0.911  (0.686) 0.755  (0.428)
Post Intervention 0.731  (0.477) 0.990  (0.887) 0.633  (0.272)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.506
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.753
Comments A priori threshold at 0.05.
Method ANOVA
Comments [Not Specified]
30.Secondary Outcome
Title Alpha Power Spectral Density From Baseline to Follow-Up
Hide Description A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the alpha bandwidth. This analysis focused on baseline to the immediate follow-up assessment.
Time Frame Baseline and 4-week Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data due to participants lost at follow up or technical issues with equipment.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 14 16 17
Mean (Standard Deviation)
Unit of Measure: mV
Baseline 0.669  (0.373) 0.896  (0.673) 0.707  (0.425)
Follow-Up 0.718  (0.398) 0.805  (0.471) 0.701  (0.441)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.777
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.475
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
31.Secondary Outcome
Title Beta Power Spectral Density From Baseline to Post Intervention
Hide Description A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the beta bandwidth. This analysis focused on baseline to the immediate post-treatment assessment.
Time Frame Baseline and 24-72 hours post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data due to participants lost to follow up or technical issues with equipment.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 18 20 18
Mean (Standard Deviation)
Unit of Measure: mV
Baseline 0.355  (0.147) 0.480  (0.285) 0.361  (0.200)
Post Intervention 0.336  (0.125) 0.600  (0.330) 0.354  (0.162)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.738
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
32.Secondary Outcome
Title Beta Power Spectral Density From Baseline to Follow-Up
Hide Description A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the beta bandwidth. This analysis focused on baseline to the follow-up assessment.
Time Frame Baseline and 4-week Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data due to participants lost at follow up or technical issues with equipment.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 14 16 17
Mean (Standard Deviation)
Unit of Measure: mV
Baseline 0.310  (0.104) 0.442  (0.169) 0.338  (0.206)
Follow-Up 0.309  (0.080) 0.429  (0.169) 0.311  (0.140)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.738
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.830
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
33.Secondary Outcome
Title Gamma Power Spectral Density From Baseline to Post Intervention
Hide Description A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the gamma bandwidth. This analysis focused on baseline to the immediate post-treatment assessment.
Time Frame Baseline and 24-72 hours post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data due to participants lost to follow up or technical issues with equipment.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 18 20 18
Mean (Standard Deviation)
Unit of Measure: mV
Baseline 0.116  (0.046) 0.155  (0.063) 0.123  (0.052)
Post Intervention 0.123  (0.041) 0.172  (0.097) 0.125  (0.047)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.700
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.492
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
34.Secondary Outcome
Title Gamma Power Spectral Density From Baseline to Follow-Up
Hide Description A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the gamma bandwidth. This analysis focused on baseline to the follow-up assessment.
Time Frame Baseline and 4-week Follow-Up
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data due to participants lost at follow up or technical issues with equipment.
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description:
Control group that will receive no intervention throughout the duration of the study (2-weeks).
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
Overall Number of Participants Analyzed 14 16 17
Mean (Standard Deviation)
Unit of Measure: mV
Baseline 0.109  (0.029) 0.149  (.062) 0.120  (0.048)
Follow-Up 0.116  (0.036) 0.166  (0.072) 0.123  (0.041)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Massage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.820
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Joint Mobilization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.526
Comments A priori threshold set at 0.05.
Method ANOVA
Comments [Not Specified]
35.Other Pre-specified Outcome
Title Walking Ankle Dorsiflexion at Baseline
Hide Description Dorsiflexion angle of the ankle at initial contact while walking.
Time Frame Baseline
Outcome Measure Data Not Reported
36.Other Pre-specified Outcome
Title Walking Ankle Dorsiflexion Immediately Post Intervention
Hide Description Dorsiflexion angle of the ankle at initial contact while walking.
Time Frame 24-72 hours post intervention
Outcome Measure Data Not Reported
37.Other Pre-specified Outcome
Title Walking Ankle Dorsiflexion at 4-weeks Post Intervention
Hide Description Dorsiflexion angle of the ankle at initial contact while walking.
Time Frame 4-weeks post intervention
Outcome Measure Data Not Reported
38.Other Pre-specified Outcome
Title Walking Loading Rate at Baseline
Hide Description Rate of weight acceptance while walking
Time Frame Baseline
Outcome Measure Data Not Reported
39.Other Pre-specified Outcome
Title Walking Loading Rate Immediately Post Intervention
Hide Description Rate of weight acceptance while walking
Time Frame 24-72 hours post intervention
Outcome Measure Data Not Reported
40.Other Pre-specified Outcome
Title Walking Loading Rate at 4-weeks Post Intervention
Hide Description Rate of weight acceptance while walking
Time Frame 4-weeks post intervention
Outcome Measure Data Not Reported
41.Other Pre-specified Outcome
Title Landing Ankle Dorsiflexion at Baseline
Hide Description Dorsiflexion angle of the ankle at initial contact while landing from a jump
Time Frame Baseline
Outcome Measure Data Not Reported
42.Other Pre-specified Outcome
Title Landing Ankle Dorsiflexion Immediately Post Intervention
Hide Description Dorsiflexion angle of the ankle at initial contact while landing from a jump
Time Frame 24-72 hours post intervention
Outcome Measure Data Not Reported
43.Other Pre-specified Outcome
Title Landing Ankle Dorsiflexion at 4-weeks Post Intervention
Hide Description Dorsiflexion angle of the ankle at initial contact while landing from a jump
Time Frame 4-weeks post intervention
Outcome Measure Data Not Reported
44.Other Pre-specified Outcome
Title Landing Loading Rate at Baseline
Hide Description Rate of weight acceptance while landing from a jump
Time Frame Baseline
Outcome Measure Data Not Reported
45.Other Pre-specified Outcome
Title Landing Loading Rate Immediately Post Intervention
Hide Description Rate of weight acceptance while landing from a jump
Time Frame 24-72 hours post intervention
Outcome Measure Data Not Reported
46.Other Pre-specified Outcome
Title Landing Loading Rate at 4-weeks Post Intervention
Hide Description Rate of weight acceptance while landing from a jump
Time Frame 4-weeks post intervention
Outcome Measure Data Not Reported
Time Frame From the Baseline assessment through the Follow-up visit, a total of up to approximately 6 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Joint Mobilization Massage
Hide Arm/Group Description Control group that will receive no intervention throughout the duration of the study (2-weeks). Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion. Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
All-Cause Mortality
Control Joint Mobilization Massage
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Hide Serious Adverse Events
Control Joint Mobilization Massage
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Joint Mobilization Massage
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
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Name/Title: Erik Wikstrom
Organization: University of North Carolina at Chapel Hill
Phone: 9199622260
EMail: wikstrom@unc.edu
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03418051    
Other Study ID Numbers: 17-2655
1R21AT009704-01 ( U.S. NIH Grant/Contract )
First Submitted: January 24, 2018
First Posted: February 1, 2018
Results First Submitted: July 24, 2021
Results First Posted: August 27, 2021
Last Update Posted: August 27, 2021