Evaluation of Transfer Kinematics and Kinetics in Patients Chronic Post-stroke Using the Tibion Bionic Leg
NCT ID: NCT01626417
Last Updated: 2012-11-14
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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COMPLETED
NA
20 participants
INTERVENTIONAL
2012-05-31
2012-11-30
Brief Summary
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Detailed Description
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The sit-to-stand and stand-to-sit transfers will be performed using a standard chair, with a seat height not less than 12" from the floor. The chair will be positioned such that, at sitting rest, each of the subject's feet are positioned on limb-specific force plates (left and right).
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Patient Population
Chronic post-stroke subjects with varied impairment level, who have completed routine rehabilitative physical therapy.
Tibion Bionic Leg
The device is a lightweight, wearable, portable, battery-powered, robotic leg orthosis that provides active assistance and resistance to lower limb movement according to the patient's intent to move.
Interventions
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Tibion Bionic Leg
The device is a lightweight, wearable, portable, battery-powered, robotic leg orthosis that provides active assistance and resistance to lower limb movement according to the patient's intent to move.
Eligibility Criteria
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Inclusion Criteria
* Chronic post-stroke (\>12 months since event)
* Eligible to participate to lower extremity physical therapy
* Age 30 years or greater
* Able to ambulate at least 10 meters without therapist assistance
* Able to ambulate without a leg brace
* Able to transfer from sitting to standing without physical assistance from a therapist
* Able to transfer from standing to sitting without physical assistance from a therapist
* 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 30 years
* Subacute post-stroke (\< 12 months since event)
* Status-post multiple strokes
* Status-post traumatic brain injury
* Not eligible to participate in lower extremity physical therapy
* Concomitant degenerative neurological conditions
* Not able to ambulate at least 10 meters without therapist assistance
* Unable to ambulate without a leg brace
* Unable to transfer from sitting to standing without physical assistance from a therapist
* Unable to transfer from standing to sitting without physical assistance from a therapist
* Unable to follow instructions, complete follow-up, or provide informed consent.
* Currently enrolled in another investigational device or drug trial
30 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Tibion Bionics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joshua G Vose, MD
Role: PRINCIPAL_INVESTIGATOR
Tibion Corporation
Locations
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UCSF Human Performance Center
San Francisco, California, United States
Tibion Corporation
Sunnyvale, California, 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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CP 007
Identifier Type: -
Identifier Source: org_study_id