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Study was terminated base on Sponsor's decision.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tibion Arm | Experimental | Arm of the study in which enrolled subacute post-stroke subjects undergo lower extremity physical therapy using the Tibion Bionic Leg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tibion Bionic Leg | Device | 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). |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurements of Gait | The secondary endpoints are obtained from the GAITRite analysis system:
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Browne, MD | Magee Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee Rehabilitation Hospital | Philadelphia | Pennsylvania | 19102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22082495 | Background | Wong CK, Bishop L, Stein J. A wearable robotic knee orthosis for gait training: a case-series of hemiparetic stroke survivors. Prosthet Orthot Int. 2012 Mar;36(1):113-20. doi: 10.1177/0309364611428235. Epub 2011 Nov 14. | |
| 19964374 | Background | Horst RW. A bio-robotic leg orthosis for rehabilitation and mobility enhancement. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:5030-3. doi: 10.1109/IEMBS.2009.5333581. |
| Label | URL |
|---|---|
| Tibion Bionic Leg | View source |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Measurements of Stride | Other secondary endpoints are obtained from the GAITRite analysis system:
| 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:
| 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. |
| 17946511 | Background | Horst RW, Marcus RR. FlexCVA: a continuously variable actuator for active orthotics. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:2425-8. doi: 10.1109/IEMBS.2006.259950. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |