A Prospective Study to Evaluate Use of the Tibion Bionic Leg in Sub-Acute Post-stroke Patients
NCT ID: NCT01558232
Last Updated: 2012-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2012-03-31
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tibion Arm
Arm of the study in which enrolled subacute post-stroke subjects undergo lower extremity physical therapy using the Tibion Bionic Leg.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
60 Years
ALL
No
Sponsors
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Tibion Bionics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Barbara Browne, MD
Role: PRINCIPAL_INVESTIGATOR
Magee Rehabilitation Hospital
Locations
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Magee Rehabilitation Hospital
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
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.
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.
Related Links
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Tibion Bionic Leg
Other Identifiers
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CP001
Identifier Type: -
Identifier Source: org_study_id