Mobility Training Using a Bionic Knee Orthosis in Patients Chronic Post-Stroke: A Case Series

Study Overview
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Brief Summary
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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).

Official Title
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Discriminatory Neurosensory Stimulation Neurological H5394-11417-15

Conditions
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Stroke

Intervention / Treatment
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* Device: Tibion Bionic Leg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Aged 40 to 60 years One year status post-stroke Able to walk at least 10 meters Independence in self-care Exclusion Criteria: Medically unstable Major cardiopulmonary deficiency Major depression Significant cognitive deficit Currently receiving gait training Younger than 40 years of age Older than 60 years of age Unable to walk at least 10 meters

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tibion Arm<br>Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg. | Device: Tibion Bionic Leg<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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) | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Tibion, Bionics, Rehab, Therapy, Robotics, Intention