A Prospective Study to Evaluate Use of the Tibion Bionic Leg in Sub-Acute Post-stroke Patients (Acute Effects)
This study has been terminated.
(Study was terminated base on Sponsor's decision.)
Sponsor:
Tibion Bionics, Inc.
Information provided by (Responsible Party):
Tibion Bionics, Inc.
ClinicalTrials.gov Identifier:
NCT01558232
First received: March 6, 2012
Last updated: July 5, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Stroke |
Device: Tibion Bionic Leg |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Experimental ABA Study to Evaluate Use of the Tibion Bionic Leg in Subacute Post-stroke Patients Undergoing Physical Therapy |
Resource links provided by NLM:
Further study details as provided by Tibion Bionics, Inc.:
Primary Outcome Measures:
- Ambulation Speed [ Time Frame: Baseline (prior to training); at conclusion of training regimen, an average of 2 weeks. ] [ Designated as safety issue: Yes ]Walking speed (comfortable and fastest possible), in meters per second, as measured by the 10 Meter Walk Test (10 MWT).
Secondary Outcome Measures:
- Measurements of Gait [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
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.
| Enrollment: | 10 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tibion Arm
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
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).
|
Detailed Description:
Samples text.
Eligibility| Ages Eligible for Study: | 40 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558232
Locations
| United States, Pennsylvania | |
| Magee Rehabilitation Hospital | |
| Philadelphia, Pennsylvania, United States, 19102 | |
Sponsors and Collaborators
Tibion Bionics, Inc.
Investigators
| Principal Investigator: | Barbara Browne, MD | Magee Rehabilitation Hospital |
More Information
Additional Information:
Publications:
| Responsible Party: | Tibion Bionics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01558232 History of Changes |
| Other Study ID Numbers: | CP001 |
| Study First Received: | March 6, 2012 |
| Last Updated: | July 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Tibion Bionics, Inc.:
|
Stroke Tibion Bionics Rehab |
Therapy Robotics Intention |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 21, 2013