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Reduction of Risk Factors for ACL Re-injuries Using a Novel Biofeedback Approach

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ClinicalTrials.gov Identifier: NCT03273673
Recruitment Status : Completed
First Posted : September 6, 2017
Results First Posted : December 4, 2020
Last Update Posted : December 4, 2020
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Robin Queen, Virginia Polytechnic Institute and State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Anterior Cruciate Ligament Injury
Intervention Other: Biofeedback Intervention
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Biofeedback Intervention Control
Hide Arm/Group Description

The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.

Biofeedback Intervention: Visual and Tactile Biofeedback

The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.
Period Title: Overall Study
Started 18 22
Completed 14 22
Not Completed 4 0
Arm/Group Title Biofeedback Intervention Control Total
Hide Arm/Group Description

The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.

Biofeedback Intervention: Visual and Tactile Biofeedback

The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6. Total of all reporting groups
Overall Number of Baseline Participants 18 22 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 22 participants 40 participants
16.2  (1.6) 16.4  (2.2) 16.3  (1.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 22 participants 40 participants
Female
6
  33.3%
10
  45.5%
16
  40.0%
Male
12
  66.7%
12
  54.5%
24
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 22 participants 40 participants
Hispanic or Latino
1
   5.6%
1
   4.5%
2
   5.0%
Not Hispanic or Latino
17
  94.4%
19
  86.4%
36
  90.0%
Unknown or Not Reported
0
   0.0%
2
   9.1%
2
   5.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 22 participants 40 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   4.5%
1
   2.5%
White
14
  77.8%
21
  95.5%
35
  87.5%
More than one race
3
  16.7%
0
   0.0%
3
   7.5%
Unknown or Not Reported
1
   5.6%
0
   0.0%
1
   2.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 22 participants 40 participants
18 22 40
Peak Knee Extension Moment Symmetry  
Mean (Standard Deviation)
Unit of measure:  % Symmetry
Number Analyzed 18 participants 22 participants 40 participants
47.9  (28.4) 41.4  (16.3) 44.3  (22.5)
1.Primary Outcome
Title Change in Peak Knee Extension Moment Symmetry
Hide Description The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task
Time Frame Baseline (week 0) and Post-intervention (week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis completed with participants with >80% adherence
Arm/Group Title Biofeedback Intervention Control
Hide Arm/Group Description:

The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.

Biofeedback Intervention: Visual and Tactile Biofeedback

The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.
Overall Number of Participants Analyzed 11 19
Mean (Standard Deviation)
Unit of Measure: % Symmetry
Baseline 50.1  (33.8) 44.2  (26)
Post-intervention 44.6  (24.2) 40.6  (16.7)
2.Primary Outcome
Title Change in Peak Knee Extension Moment Symmetry
Hide Description The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task
Time Frame Post-intervention (week 6) and Retention (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis completed with participants with >80% adherence
Arm/Group Title Biofeedback Intervention Control
Hide Arm/Group Description:

The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.

Biofeedback Intervention: Visual and Tactile Biofeedback

The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.
Overall Number of Participants Analyzed 14 22
Mean (Standard Deviation)
Unit of Measure: % Symmetry
Post-intervention 44.6  (24.2) 40.6  (16.7)
Retention 38.7  (22.5) 33.3  (13.5)
3.Secondary Outcome
Title Change in Frontal Plane Knee Range of Motion
Hide Description The frontal plane knee range of motion will be assessed during the first landing of a stop-jump task
Time Frame Baseline (week 0) and Post-intervention (week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis completed with participants with >80% adherence
Arm/Group Title Biofeedback Intervention Control
Hide Arm/Group Description:

The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.

Biofeedback Intervention: Visual and Tactile Biofeedback

The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.
Overall Number of Participants Analyzed 11 19
Mean (Standard Deviation)
Unit of Measure: Degree
Baseline 6.4  (2.7) 10.1  (4.4)
Post-Intervention 7.5  (4.5) 9.1  (4.3)
4.Secondary Outcome
Title Change in Frontal Plane Knee Range of Motion
Hide Description The frontal plane knee range of motion will be assessed during the first landing of a stop-jump task
Time Frame Post-intervention (week 6) and Retention (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis completed with participants with >80% adherence
Arm/Group Title Biofeedback Intervention Control
Hide Arm/Group Description:

The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.

Biofeedback Intervention: Visual and Tactile Biofeedback

The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.
Overall Number of Participants Analyzed 11 19
Mean (Standard Deviation)
Unit of Measure: Degree
Post-intervention 7.5  (4.5) 9.1  (4.3)
Retention 7.9  (4.2) 10.1  (4.6)
5.Secondary Outcome
Title Change in Peak Vertical Ground Reaction Force Symmetry
Hide Description The peak vertical ground reaction force symmetry will be assessed during the first landing of a stop-jump task
Time Frame Baseline (week 0) and Post-intervention (week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis completed with participants with >80% adherence
Arm/Group Title Biofeedback Intervention Control
Hide Arm/Group Description:

The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.

Biofeedback Intervention: Visual and Tactile Biofeedback

The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.
Overall Number of Participants Analyzed 11 19
Mean (Standard Deviation)
Unit of Measure: % Symmetry
Baseline 34.1  (23) 28  (9.4)
Post-intervention 24.6  (14) 25.7  (12.9)
6.Secondary Outcome
Title Change in Peak Vertical Ground Reaction Force Symmetry
Hide Description The peak vertical ground reaction force symmetry will be assessed during the first landing of a stop-jump task
Time Frame Post-intervention (week 6) and Retention (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis completed with participants with >80% adherence
Arm/Group Title Biofeedback Intervention Control
Hide Arm/Group Description:

The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.

Biofeedback Intervention: Visual and Tactile Biofeedback

The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.
Overall Number of Participants Analyzed 11 19
Mean (Standard Deviation)
Unit of Measure: % Symmetry
Post-intervention 24.6  (14) 25.7  (12.9)
Retention 32.5  (14.5) 22.7  (9.2)
Time Frame Data was collected over the 12 weeks during which the participants were active on the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Biofeedback Intervention Control
Hide Arm/Group Description

The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.

Biofeedback Intervention: Visual and Tactile Biofeedback

The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.
All-Cause Mortality
Biofeedback Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/22 (0.00%) 
Hide Serious Adverse Events
Biofeedback Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/22 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Biofeedback Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/22 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Robin Queen
Organization: Virginia Tech
Phone: (540) 231-3134
EMail: rmqueen@vt.edu
Layout table for additonal information
Responsible Party: Robin Queen, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier: NCT03273673    
Other Study ID Numbers: 17-007
R21AR069865-01A1 ( U.S. NIH Grant/Contract )
First Submitted: September 1, 2017
First Posted: September 6, 2017
Results First Submitted: October 28, 2020
Results First Posted: December 4, 2020
Last Update Posted: December 4, 2020