Trial Outcomes & Findings for Ankle Robot to Reduce Foot Drop in Stroke (NCT NCT02483676)
NCT ID: NCT02483676
Last Updated: 2020-05-20
Results Overview
Gait velocity during self-selected overground walking measured in cm/sec
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
Results posted on
2020-05-20
Participant Flow
Participant milestones
| Measure |
Treadmill+Anklebot
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.
|
Treadmill Only
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 Study
STARTED
|
23
|
22
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ankle Robot to Reduce Foot Drop in Stroke
Baseline characteristics by cohort
| Measure |
Treadmill+Anklebot
n=23 Participants
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.
|
Treadmill Only
n=22 Participants
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
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Continuous
|
64 years
n=5 Participants
|
65 years
n=7 Participants
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Years since stroke
<2
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Years since stroke
2-4
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Years since stroke
4-6
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Years since stroke
6+
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completionPopulation: 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.
Gait velocity during self-selected overground walking measured in cm/sec
Outcome measures
| Measure |
Treadmill+Anklebot
n=17 Participants
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.
|
Treadmill Only
n=21 Participants
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
|
|---|---|---|
|
Gait Velocity During Self-selected Overground Walking
Baseline
|
0.48 CM/SEC
Standard Deviation 0.21
|
0.48 CM/SEC
Standard Deviation 0.34
|
|
Gait Velocity During Self-selected Overground Walking
Post 6-week training
|
0.54 CM/SEC
Standard Deviation 0.24
|
0.56 CM/SEC
Standard Deviation 0.32
|
|
Gait Velocity During Self-selected Overground Walking
6 weeks after completion
|
0.53 CM/SEC
Standard Deviation 0.24
|
0.55 CM/SEC
Standard Deviation 0.33
|
|
Gait Velocity During Self-selected Overground Walking
3 (or 6) months after completion
|
0.52 CM/SEC
Standard Deviation 0.23
|
0.55 CM/SEC
Standard Deviation 0.33
|
PRIMARY outcome
Timeframe: Change from baseline to: Post 6-weeks training, 6 weeks after completion, and 3 (or 6) monthsPopulation: 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.
Newtons: anterior-posterior force generated during push-off phase of the gait cycle
Outcome measures
| Measure |
Treadmill+Anklebot
n=17 Participants
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.
|
Treadmill Only
n=21 Participants
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
|
|---|---|---|
|
Anterior-posterior Propulsion Forces of Paretic Side During Gait
Baseline
|
2.22 Force in Newtons
Standard Deviation 12.37
|
2.22 Force in Newtons
Standard Deviation 12.37
|
|
Anterior-posterior Propulsion Forces of Paretic Side During Gait
Post 6-week training
|
4.92 Force in Newtons
Standard Deviation 10.99
|
3.03 Force in Newtons
Standard Deviation 10.99
|
|
Anterior-posterior Propulsion Forces of Paretic Side During Gait
6 weeks after completion
|
6.06 Force in Newtons
Standard Deviation 8.92
|
4.14 Force in Newtons
Standard Deviation 8.92
|
|
Anterior-posterior Propulsion Forces of Paretic Side During Gait
3 (or 6) months after completion
|
4.88 Force in Newtons
Standard Deviation 10.74
|
3.98 Force in Newtons
Standard Deviation 10.74
|
PRIMARY outcome
Timeframe: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completionPopulation: 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.
Degrees; extent of ankle dorsiflexion to enable foot clearance
Outcome measures
| Measure |
Treadmill+Anklebot
n=17 Participants
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.
|
Treadmill Only
n=21 Participants
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
|
|---|---|---|
|
Peak Dorsiflexion Angle During Swing Phase of Gait
Baseline
|
3.95 Degrees
Standard Deviation 6.83
|
3.95 Degrees
Standard Deviation 6.83
|
|
Peak Dorsiflexion Angle During Swing Phase of Gait
Post 6-week training
|
4.84 Degrees
Standard Deviation 6.83
|
4.24 Degrees
Standard Deviation 6.83
|
|
Peak Dorsiflexion Angle During Swing Phase of Gait
6 weeks after completion
|
4.34 Degrees
Standard Deviation 6.26
|
3.27 Degrees
Standard Deviation 6.26
|
|
Peak Dorsiflexion Angle During Swing Phase of Gait
3 (or 6) months after completion
|
3.33 Degrees
Standard Deviation 6.72
|
3.43 Degrees
Standard Deviation 6.72
|
PRIMARY outcome
Timeframe: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) monthsPopulation: 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.
cm\^2; extent of postural deviations to assess static postural control
Outcome measures
| Measure |
Treadmill+Anklebot
n=17 Participants
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.
|
Treadmill Only
n=21 Participants
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
|
|---|---|---|
|
Postural Sway Areas During Quiet Standing
Baseline
|
1.16 CM^2
Standard Deviation 0.64
|
1.16 CM^2
Standard Deviation 0.64
|
|
Postural Sway Areas During Quiet Standing
Post 6-week training
|
1.51 CM^2
Standard Deviation 0.82
|
1.33 CM^2
Standard Deviation 0.82
|
|
Postural Sway Areas During Quiet Standing
6 weeks after completion
|
1.44 CM^2
Standard Deviation 0.57
|
1.13 CM^2
Standard Deviation 0.52
|
|
Postural Sway Areas During Quiet Standing
3 (or 6) months after completion
|
1.59 CM^2
Standard Deviation 0.52
|
1.14 CM^2
Standard Deviation 0.52
|
PRIMARY outcome
Timeframe: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) monthsPopulation: This data was not recorded during the study nor calculated as part of the analysis.
Ratio of Newtons of force per each leg (paretic/nonparetic) while standing quietly
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) monthsPopulation: 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.
Newtons; magnitude of forward ground reaction forces
Outcome measures
| Measure |
Treadmill+Anklebot
n=17 Participants
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.
|
Treadmill Only
n=21 Participants
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
|
|---|---|---|
|
Peak Paretic Push Off Forces During Gait Initiation
Baseline
|
64.7 Newtons
Standard Deviation 28.5
|
64.7 Newtons
Standard Deviation 28.5
|
|
Peak Paretic Push Off Forces During Gait Initiation
Post 6-week training
|
63.5 Newtons
Standard Deviation 27
|
62.8 Newtons
Standard Deviation 27
|
|
Peak Paretic Push Off Forces During Gait Initiation
6 weeks after completion
|
65.4 Newtons
Standard Deviation 30.6
|
69.8 Newtons
Standard Deviation 30.6
|
|
Peak Paretic Push Off Forces During Gait Initiation
3 (or 6) months after completion
|
66.1 Newtons
Standard Deviation 29.9
|
70.9 Newtons
Standard Deviation 29.9
|
POST_HOC outcome
Timeframe: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completionPopulation: 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.
Degrees, extent of ankle dorsiflexion at initial foot contact with the floor
Outcome measures
| Measure |
Treadmill+Anklebot
n=17 Participants
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.
|
Treadmill Only
n=21 Participants
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
|
|---|---|---|
|
Dorsiflexion Angle at Foot Strike
Baseline
|
-1.83 Degrees
Standard Deviation 5.03
|
-1.83 Degrees
Standard Deviation 7.31
|
|
Dorsiflexion Angle at Foot Strike
3 (or 6) months after completion
|
-2.99 Degrees
Standard Deviation 5.96
|
-1.58 Degrees
Standard Deviation 6.71
|
|
Dorsiflexion Angle at Foot Strike
Post 6-week training
|
-0.70 Degrees
Standard Deviation 6.55
|
-0.46 Degrees
Standard Deviation 5.7
|
|
Dorsiflexion Angle at Foot Strike
6 weeks after completion
|
-2.18 Degrees
Standard Deviation 6.27
|
-2.15 Degrees
Standard Deviation 6.16
|
Adverse Events
Treadmill+Anklebot
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Treadmill Only
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treadmill+Anklebot
n=23 participants at risk
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.
|
Treadmill Only
n=22 participants at risk
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
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pre-existing Medical Condition
|
8.7%
2/23 • Number of events 2 • 24 to 36 weeks for each subject; 6 week training + 6 weeks post training + 12 or 24 weeks follow up
|
0.00%
0/22 • 24 to 36 weeks for each subject; 6 week training + 6 weeks post training + 12 or 24 weeks follow up
|
|
Musculoskeletal and connective tissue disorders
Pain
|
8.7%
2/23 • Number of events 2 • 24 to 36 weeks for each subject; 6 week training + 6 weeks post training + 12 or 24 weeks follow up
|
0.00%
0/22 • 24 to 36 weeks for each subject; 6 week training + 6 weeks post training + 12 or 24 weeks follow up
|
|
Cardiac disorders
Weakness
|
0.00%
0/23 • 24 to 36 weeks for each subject; 6 week training + 6 weeks post training + 12 or 24 weeks follow up
|
9.1%
2/22 • Number of events 2 • 24 to 36 weeks for each subject; 6 week training + 6 weeks post training + 12 or 24 weeks follow up
|
Additional Information
Dr. Steven Kittner
Baltimore VA Medical Center VA Maryland Health Care System
Phone: 410-706-0414
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place