A Prospective Study to Evaluate Use of the Tibion Bionic Leg in Sub-Acute Post-stroke Patients

Study Overview
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Brief Summary
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The objective of this clinical study is to examine acute changes in stability, force allocation, work, and mobility from using a wearable, portable, battery-operated robotic orthosis (the Tibion Bionic Leg) in subacute post-stroke persons undergoing lower extremity physical therapy.

Detailed Description
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Samples text.

Official Title
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A Prospective, Experimental ABA Study to Evaluate Use of the Tibion Bionic Leg in Subacute Post-stroke Patients Undergoing Physical Therapy

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: Single stroke with residual unilateral lower-extremity weakness Subacute post-stroke period (>3 and <12 months) Eligible to participate to lower extremity physical therapy Age 40 years or greater Able to ambulate at least 10 meters Able to ambulate without a leg brace Ambulation speed less than 0.8 meters/second Minimum to moderate assist for transfer or ambulation by physical therapist evaluation Subject must understand the nature of the study and provide written informed consent prior to enrollment. Subject must be willing and able to attend all study sessions Exclusion Criteria: Medically unstable Age younger than 40 years Acute post-stroke (< 3 months) Chronic post-stroke (> 12 months) Status-post multiple strokes Status-post traumatic brain injury Ambulation speed greater than 0.8 meters/second Currently using a Knee-Ankle-Foot Orthosis (KAFO) Not eligible for lower extremity physical therapy Concomitant degenerative neurological conditions Not able to ambulate at least 10 meters without assistance Greater than moderate assist during transfer or ambulation by physical therapist evaluation Unable to ambulate without a leg brace Unable to follow instructions, complete follow-up, or provide informed consent. Currently enrolled in another investigational device or drug trial

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 subacute post-stroke subjects undergo lower extremity physical therapy using the Tibion Bionic Leg. | Device: Tibion Bionic Leg<br>* The Tibion Bionic Leg is used as an adjunct in post-stroke and post-operative rehabilitative physical therapy. The leg is a lightweight, wearable, portable, battery-powered, motorized leg orthosis that provides active assistance and resistance to lower limb movement during walking, stair ascent and descent, and transfers from sitting to standing (and standing to sitting).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulation Speed | Walking speed (comfortable and fastest possible), in meters per second, as measured by the 10 Meter Walk Test (10 MWT). | Baseline (prior to training); at conclusion of training regimen, an average of 2 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurements of Gait | The secondary endpoints are obtained from the GAITRite analysis system: Measurements of gait, such as the length and time of step, cycle, and stride, Heel to Heel base support, single/double limb support time, and stance and swing phase timing. | Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks. | 
| Measurements of Stride | Other secondary endpoints are obtained from the GAITRite analysis system: Measurements of Stride such as distance, ambulation time, velocity, normalized velocity, cadence, step time, step length, cycle time. | Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks. | 
| Measurements of Force, Stance, and Stability | Other secondary endpoints are obtained from Balance Master system: Limb parameters, including force in transfers from sitting to standing, standing to sitting, weight-bearing squats, and limits of stability. | Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks. | 

 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