Trial Outcomes & Findings for Mobility Training Using a Bionic Knee Orthosis in Patients Chronic Post-Stroke: A Case Series (NCT NCT01499862)
NCT ID: NCT01499862
Last Updated: 2013-08-02
Results Overview
Ambulation speed, in meters per second, as obtained by the Ten (10) Meter Walk Test (10 MWT). The 10 MWT measures the time required to walk 10 meters at the subject's comfortable walking pace.
COMPLETED
PHASE4
3 participants
Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.
2013-08-02
Participant Flow
Patients were part of the hospitals patient population.
Participant milestones
| Measure |
Tibion Arm Baseline Assessments
Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mobility Training Using a Bionic Knee Orthosis in Patients Chronic Post-Stroke: A Case Series
Baseline characteristics by cohort
| Measure |
All Participants
n=3 Participants
All subjects had reached plateau with conventional Bodyweight-Supported Treadmill Training (BWSTT, participated in task-oriented mobility therapy(1.5 hours, 2-4 times per week for 4 weeks) with Robotic Leg Orthosis (RLO) under the supervision of a physical therapist.
|
|---|---|
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Age Continuous
|
50 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Lower Left Extremity Strength
|
105 Pounds-Force
n=5 Participants
|
|
Right Lower Extremity Strength
|
105 Pounds-Force
n=5 Participants
|
|
Resting Extensor Tone (Modified Ashworth Scale)
Mean Ankle Score
|
2 Units on a Scale
n=5 Participants
|
|
Resting Extensor Tone (Modified Ashworth Scale)
Mean Knee Score
|
3 Units on a Scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.Population: Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.
Ambulation speed, in meters per second, as obtained by the Ten (10) Meter Walk Test (10 MWT). The 10 MWT measures the time required to walk 10 meters at the subject's comfortable walking pace.
Outcome measures
| Measure |
Patient 1
n=1 Participants
Six Minute Walk Test (meters)
|
Patient 2
n=1 Participants
Six Minute Walk Test (meters)
|
Patient 3
n=1 Participants
Six Minute Walk Test (meters)
|
|---|---|---|---|
|
Ambulation Speed
Baseline
|
0.60 meters per second (m/s)
|
0.29 meters per second (m/s)
|
0.83 meters per second (m/s)
|
|
Ambulation Speed
End of Training
|
0.81 meters per second (m/s)
|
0.43 meters per second (m/s)
|
1.03 meters per second (m/s)
|
|
Ambulation Speed
1 Month Post-Training
|
0.95 meters per second (m/s)
|
0.45 meters per second (m/s)
|
1.14 meters per second (m/s)
|
SECONDARY outcome
Timeframe: Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.Population: Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.
The total distance walked by the patient, in meters, as obtained by the Six (6) Minute Walk Test (6 MWT). The 6 MWT is performed over level ground, using any walking aids (canes, walkers, etc.) the patient requires for comfortable walking.
Outcome measures
| Measure |
Patient 1
n=1 Participants
Six Minute Walk Test (meters)
|
Patient 2
n=1 Participants
Six Minute Walk Test (meters)
|
Patient 3
n=1 Participants
Six Minute Walk Test (meters)
|
|---|---|---|---|
|
6 Minute Walk Test (6 MWT)
Baseline
|
170 Meters
|
93 Meters
|
271 Meters
|
|
6 Minute Walk Test (6 MWT)
End of Training
|
207 Meters
|
140 Meters
|
300 Meters
|
|
6 Minute Walk Test (6 MWT)
1 Month Post-Training
|
250 Meters
|
123 Meters
|
285 Meters
|
SECONDARY outcome
Timeframe: Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.Population: Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.
The time, in seconds, for the patient to rise from sitting in a standard arm chair, walk 3 meters, turn around, walk back to the chair, and sit down. This evaluation is called the Timed Up and Go test (TUG). The patient may wear their usual footwear and use any aids (canes, walkers, etc.) they typically employ for comfortable walking.
Outcome measures
| Measure |
Patient 1
n=1 Participants
Six Minute Walk Test (meters)
|
Patient 2
n=1 Participants
Six Minute Walk Test (meters)
|
Patient 3
n=1 Participants
Six Minute Walk Test (meters)
|
|---|---|---|---|
|
Timed Up and Go (TUG) Test
Baseline
|
21.4 Seconds
|
21.4 Seconds
|
9.14 Seconds
|
|
Timed Up and Go (TUG) Test
End of Training
|
14.5 Seconds
|
23.3 Seconds
|
8.94 Seconds
|
|
Timed Up and Go (TUG) Test
1 Month Post-Training
|
12.4 Seconds
|
24.0 Seconds
|
10.1 Seconds
|
SECONDARY outcome
Timeframe: Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.Population: Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.
The time, in seconds, for the patient to rise from a seated to full standing position and return to sitting five times in rapid succession. This evaluation is called the Five Times Sit to Stand Test (5 x STS)
Outcome measures
| Measure |
Patient 1
n=3 Participants
Six Minute Walk Test (meters)
|
Patient 2
n=3 Participants
Six Minute Walk Test (meters)
|
Patient 3
n=3 Participants
Six Minute Walk Test (meters)
|
|---|---|---|---|
|
Five Times Sit to Stand Test (5 x STS)
Baseline
|
12.1 Seconds
|
12.4 Seconds
|
11.4 Seconds
|
|
Five Times Sit to Stand Test (5 x STS)
End of Training
|
10.5 Seconds
|
13.0 Seconds
|
12.2 Seconds
|
|
Five Times Sit to Stand Test (5 x STS)
1 Month Post-Training
|
11.1 Seconds
|
13.2 Seconds
|
10.1 Seconds
|
SECONDARY outcome
Timeframe: Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.Population: Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.
The length of the patient's average step, in meters, as measured during comfortable walking.
Outcome measures
| Measure |
Patient 1
n=1 Participants
Six Minute Walk Test (meters)
|
Patient 2
n=1 Participants
Six Minute Walk Test (meters)
|
Patient 3
n=1 Participants
Six Minute Walk Test (meters)
|
|---|---|---|---|
|
Step Length
Baseline
|
0.49 Meters
|
0.29 Meters
|
0.54 Meters
|
|
Step Length
End of Training
|
0.56 Meters
|
0.40 Meters
|
0.59 Meters
|
|
Step Length
1 Month Post-Training
|
0.59 Meters
|
0.39 Meters
|
0.60 Meters
|
Adverse Events
Tibion Arm Baseline Assessments
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Nancy N. Byl
Department of Physical Therapy and Rehabilitation, University of California San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place