Stroke
Conditions
Keywords
Stroke, Tibion, Bionics, Rehab, Therapy, Robotics, Intention
Brief summary
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
Samples text.
Interventions
DEVICETibion Bionic Leg
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).
Sponsors
Tibion Bionics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ambulation Speed | Baseline (prior to training); at conclusion of training regimen, an average of 2 weeks. | Walking speed (comfortable and fastest possible), in meters per second, as measured by the 10 Meter Walk Test (10 MWT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurements of Gait | 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. | 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. |
| Measurements of Stride | 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. | 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. |
| Measurements of Force, Stance, and 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. | 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. |
Countries
United States
Outcome results
None listed