A Phase 4 interventional study of Tibion Bionic Leg in Stroke, sponsored by Tibion Bionics, Inc.. Completed at 1 site in United States. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-08-02.
Sponsored by Tibion Bionics, Inc. · Phase 4, Interventional, and Treatment
This pilot study examined the effect of task-oriented mobility training in three persons chronic post-stroke using a novel, wearable, mobile intention-based robotic orthosis (Tibion Bionic Leg).
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 3 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Tibion Bionics, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg.
Device: Tibion Bionic Leg
A programmable, carbon-fiber robotic leg orthosis (Tibion Bionic Leg, Tibion Corporation, Sunnyvale, CA) was used during therapy to actively supplement concentric and eccentric quadriceps function on the participant's impaired side. The device uses internal sensors at the foot and knee joint to detect intention of movement and, once a variable force threshold is passed, the devices provides appropriate assistive and resistive adjustments.
Ambulation Speed
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.
Time frame: 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.
6 Minute Walk Test (6 MWT)
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.
Time frame: 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.
Timed Up and Go (TUG) Test
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.
Time frame: 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.
Five Times Sit to Stand Test (5 x STS)
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)
Time frame: 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.
Step Length
The length of the patient's average step, in meters, as measured during comfortable walking.
Time frame: 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.
Patients were part of the hospitals patient population.
| Milestone | Tibion Arm Baseline Assessments |
|---|---|
| Started | 3 |
| Completed | 3 |
| Not completed | 0 |
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.
| Meters | Patient 1 | Patient 2 | Patient 3 |
|---|---|---|---|
| Baseline | 170 | 93 | 271 |
| End of Training | 207 | 140 | 300 |
| 1 Month Post-Training | 250 | 123 | 285 |
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.
| Seconds | Patient 1 | Patient 2 | Patient 3 |
|---|---|---|---|
| Baseline | 21.4 | 21.4 | 9.14 |
| End of Training | 14.5 | 23.3 | 8.94 |
| 1 Month Post-Training | 12.4 | 24.0 | 10.1 |
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)
| Seconds | Patient 1 | Patient 2 | Patient 3 |
|---|---|---|---|
| Baseline | 12.1 | 12.4 | 11.4 |
| End of Training | 10.5 | 13.0 | 12.2 |
| 1 Month Post-Training | 11.1 | 13.2 | 10.1 |
The length of the patient's average step, in meters, as measured during comfortable walking.
| Meters | Patient 1 | Patient 2 | Patient 3 |
|---|---|---|---|
| Baseline | 0.49 | 0.29 | 0.54 |
| End of Training | 0.56 | 0.40 | 0.59 |
| 1 Month Post-Training | 0.59 | 0.39 | 0.60 |
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.
| meters per second (m/s) | Patient 1 | Patient 2 | Patient 3 |
|---|---|---|---|
| Baseline | 0.60 | 0.29 | 0.83 |
| End of Training | 0.81 | 0.43 | 1.03 |
| 1 Month Post-Training | 0.95 | 0.45 | 1.14 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tibion Arm Baseline Assessments | — | 0/3 (0%) | 0/3 (0%) |
| Age Continuous(Years) | All Participants |
|---|---|
| Median | 50 (40 to 60) |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 2 |
| Male | 1 |
| Lower Left Extremity Strength(Pounds-Force) | All Participants |
|---|---|
| Median | 105 (90 to 169) |
| Right Lower Extremity Strength(Pounds-Force) | All Participants |
|---|---|
| Median | 105 (97 to 138) |
| Resting Extensor Tone (Modified Ashworth Scale)(Units on a Scale) | All Participants |
|---|---|
| Mean Ankle Score | 2 (1 to 4) |
| Mean Knee Score | 3 (1 to 4) |
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Tibion Bionics, Inc.