A Prospective Study to Evaluate Use of the Tibion Bionic Leg in Sub-Acute Post-stroke Patients
- Conditions
- Stroke
- Interventions
- Device: Tibion Bionic Leg
- Registration Number
- NCT01558232
- Lead Sponsor
- Tibion Bionics, Inc.
- 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
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Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tibion Arm Tibion Bionic Leg Arm of the study in which enrolled subacute post-stroke subjects undergo lower extremity physical therapy using the Tibion Bionic Leg.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.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.
Trial Locations
- Locations (1)
Magee Rehabilitation Hospital
🇺🇸Philadelphia, Pennsylvania, United States