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Ankle Robot to Reduce Foot Drop in Stroke

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ClinicalTrials.gov Identifier: NCT02483676
Recruitment Status : Completed
First Posted : June 29, 2015
Results First Posted : May 20, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Stroke
Foot Drop
Interventions Device: Treadmill plus anklebot
Behavioral: Treadmill only
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treadmill+Anklebot Treadmill Only
Hide Arm/Group Description

This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.

Treadmill plus anklebot: This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.

This group will receive gait training on a treadmill, without use of the anklebot.

Treadmill only: This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period

Period Title: Overall Study
Started 23 22
Completed 17 17
Not Completed 6 5
Arm/Group Title Treadmill+Anklebot Treadmill Only Total
Hide Arm/Group Description

This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.

Treadmill plus anklebot: This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.

This group will receive gait training on a treadmill, without use of the anklebot.

Treadmill only: This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period

Total of all reporting groups
Overall Number of Baseline Participants 23 22 45
Hide Baseline Analysis Population Description
45 patients were randomized.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 22 participants 45 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  34.8%
10
  45.5%
18
  40.0%
>=65 years
15
  65.2%
12
  54.5%
27
  60.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 23 participants 22 participants 45 participants
64
(30 to 75)
65
(30 to 75)
65
(30 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 22 participants 45 participants
Female
9
  39.1%
8
  36.4%
17
  37.8%
Male
14
  60.9%
14
  63.6%
28
  62.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 22 participants 45 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   8.7%
1
   4.5%
3
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
15
  65.2%
15
  68.2%
30
  66.7%
White
6
  26.1%
6
  27.3%
12
  26.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
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 23 participants 22 participants 45 participants
23
 100.0%
22
 100.0%
45
 100.0%
Years since stroke  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 22 participants 45 participants
<2
4
  17.4%
2
   9.1%
6
  13.3%
2-4
7
  30.4%
9
  40.9%
16
  35.6%
4-6
4
  17.4%
7
  31.8%
11
  24.4%
6+
8
  34.8%
4
  18.2%
12
  26.7%
1.Primary Outcome
Title Gait Velocity During Self-selected Overground Walking
Hide Description Gait velocity during self-selected overground walking measured in cm/sec
Time Frame Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
Hide Outcome Measure Data
Hide Analysis Population Description
Only 38 of patients were included in the intention-to-treat analysis, as we excluded patients who had no baseline or follow-up data on the primary outcomes.
Arm/Group Title Treadmill+Anklebot Treadmill Only
Hide Arm/Group Description:

This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.

Treadmill plus anklebot: This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.

This group will receive gait training on a treadmill, without use of the anklebot.

Treadmill only: This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period

Overall Number of Participants Analyzed 17 21
Mean (Standard Deviation)
Unit of Measure: CM/SEC
Baseline 0.48  (0.21) 0.48  (0.34)
Post 6-week training 0.54  (0.24) 0.56  (0.32)
6 weeks after completion 0.53  (0.24) 0.55  (0.33)
3 (or 6) months after completion 0.52  (0.23) 0.55  (0.33)
2.Primary Outcome
Title Anterior-posterior Propulsion Forces of Paretic Side During Gait
Hide Description Newtons: anterior-posterior force generated during push-off phase of the gait cycle
Time Frame Change from baseline to: Post 6-weeks training, 6 weeks after completion, and 3 (or 6) months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 38 are included in the intention-to-treat analysis, as we excluded patients with no baseline or follow-up data on the primary outcomes.
Arm/Group Title Treadmill+Anklebot Treadmill Only
Hide Arm/Group Description:

This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.

Treadmill plus anklebot: This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.

This group will receive gait training on a treadmill, without use of the anklebot.

Treadmill only: This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period

Overall Number of Participants Analyzed 17 21
Mean (Standard Deviation)
Unit of Measure: Force in Newtons
Baseline 2.22  (12.37) 2.22  (12.37)
Post 6-week training 4.92  (10.99) 3.03  (10.99)
6 weeks after completion 6.06  (8.92) 4.14  (8.92)
3 (or 6) months after completion 4.88  (10.74) 3.98  (10.74)
3.Primary Outcome
Title Peak Dorsiflexion Angle During Swing Phase of Gait
Hide Description Degrees; extent of ankle dorsiflexion to enable foot clearance
Time Frame Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
Hide Outcome Measure Data
Hide Analysis Population Description
Only 38 are included in the intention-to-treat analysis, as we excluded patients who had no baseline or follow-up data on the primary outcomes.
Arm/Group Title Treadmill+Anklebot Treadmill Only
Hide Arm/Group Description:

This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.

Treadmill plus anklebot: This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.

This group will receive gait training on a treadmill, without use of the anklebot.

Treadmill only: This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period

Overall Number of Participants Analyzed 17 21
Mean (Standard Deviation)
Unit of Measure: Degrees
Baseline 3.95  (6.83) 3.95  (6.83)
Post 6-week training 4.84  (6.83) 4.24  (6.83)
6 weeks after completion 4.34  (6.26) 3.27  (6.26)
3 (or 6) months after completion 3.33  (6.72) 3.43  (6.72)
4.Primary Outcome
Title Postural Sway Areas During Quiet Standing
Hide Description cm^2; extent of postural deviations to assess static postural control
Time Frame Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 38 are included in the intention-to-treat analysis, as we excluded patients who had no baseline or follow-up data on the primary outcomes.
Arm/Group Title Treadmill+Anklebot Treadmill Only
Hide Arm/Group Description:

This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.

Treadmill plus anklebot: This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.

This group will receive gait training on a treadmill, without use of the anklebot.

Treadmill only: This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period

Overall Number of Participants Analyzed 17 21
Mean (Standard Deviation)
Unit of Measure: CM^2
Baseline 1.16  (0.64) 1.16  (0.64)
Post 6-week training 1.51  (0.82) 1.33  (0.82)
6 weeks after completion 1.44  (0.57) 1.13  (0.52)
3 (or 6) months after completion 1.59  (0.52) 1.14  (0.52)
5.Primary Outcome
Title Ratio of Asymmetric Loading in Quiet Standing
Hide Description Ratio of Newtons of force per each leg (paretic/nonparetic) while standing quietly
Time Frame Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
Hide Outcome Measure Data
Hide Analysis Population Description
This data was not recorded during the study nor calculated as part of the analysis.
Arm/Group Title Treadmill+Anklebot Treadmill Only
Hide Arm/Group Description:

This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.

Treadmill plus anklebot: This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.

This group will receive gait training on a treadmill, without use of the anklebot.

Treadmill only: This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Primary Outcome
Title Peak Paretic Push Off Forces During Gait Initiation
Hide Description Newtons; magnitude of forward ground reaction forces
Time Frame Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
Hide Outcome Measure Data
Hide Analysis Population Description

Only 38 are included in the intention-to-treat analysis, as we excluded patients who had no baseline or follow-up data on the primary outcomes.

The results should be interpreted with extreme caution as there was inconsistent use of AFO's (ankle-foot orthosis) during evaluations and/or the training focus was on dorsiflexion assistance.

Arm/Group Title Treadmill+Anklebot Treadmill Only
Hide Arm/Group Description:

This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.

Treadmill plus anklebot: This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.

This group will receive gait training on a treadmill, without use of the anklebot.

Treadmill only: This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period

Overall Number of Participants Analyzed 17 21
Mean (Standard Deviation)
Unit of Measure: Newtons
Baseline 64.7  (28.5) 64.7  (28.5)
Post 6-week training 63.5  (27) 62.8  (27)
6 weeks after completion 65.4  (30.6) 69.8  (30.6)
3 (or 6) months after completion 66.1  (29.9) 70.9  (29.9)
7.Post-Hoc Outcome
Title Dorsiflexion Angle at Foot Strike
Hide Description Degrees, extent of ankle dorsiflexion at initial foot contact with the floor
Time Frame Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
Hide Outcome Measure Data
Hide Analysis Population Description
Only 38 are included in the intention-to-treat analysis, as we excluded patients who had no baseline or follow-up data on the primary outcomes.
Arm/Group Title Treadmill+Anklebot Treadmill Only
Hide Arm/Group Description:

This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.

Treadmill plus anklebot: This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.

This group will receive gait training on a treadmill, without use of the anklebot.

Treadmill only: This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period

Overall Number of Participants Analyzed 17 21
Mean (Standard Deviation)
Unit of Measure: Degrees
Baseline -1.83  (5.03) -1.83  (7.31)
Post 6-week training -0.70  (6.55) -0.46  (5.7)
6 weeks after completion -2.18  (6.27) -2.15  (6.16)
3 (or 6) months after completion -2.99  (5.96) -1.58  (6.71)
Time Frame 24 to 36 weeks for each subject; 6 week training + 6 weeks post training + 12 or 24 weeks follow up
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treadmill+Anklebot Treadmill Only
Hide Arm/Group Description

This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.

Treadmill plus anklebot: This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.

This group will receive gait training on a treadmill, without use of the anklebot.

Treadmill only: This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period

All-Cause Mortality
Treadmill+Anklebot Treadmill Only
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)      0/22 (0.00%)    
Hide Serious Adverse Events
Treadmill+Anklebot Treadmill Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/23 (0.00%)      0/22 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treadmill+Anklebot Treadmill Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/23 (17.39%)      2/22 (9.09%)    
Cardiac disorders     
Weakness * [1]  0/23 (0.00%)  0 2/22 (9.09%)  2
Musculoskeletal and connective tissue disorders     
Pre-existing Medical Condition * [2]  2/23 (8.70%)  2 0/22 (0.00%)  0
Pain * [3]  2/23 (8.70%)  2 0/22 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Dizziness, weakness
[2]
Knee pain
[3]
Leg soreness, foot swelling
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. Steven Kittner
Organization: Baltimore VA Medical Center VA Maryland Health Care System
Phone: 410-706-0414
EMail: skittner@som.umaryland.edu
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02483676    
Other Study ID Numbers: N1699-R
First Submitted: June 19, 2015
First Posted: June 29, 2015
Results First Submitted: April 23, 2020
Results First Posted: May 20, 2020
Last Update Posted: May 20, 2020