Status:
TERMINATED
Bilateral Versus Unilateral Task Retraining Using the SaeboFlex Orthosis
Lead Sponsor:
University of Missouri-Columbia
Conditions:
Muscle Spasticity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A small, pilot study consisting of twelve participants with subacute (6-12 months post-stroke)and chronic stroke (1year+ post-stroke)living in and around Columbia area. The twelve participants will ra...
Detailed Description
The SaeboFlex device is a mechanical orthosis that promotes grasp and release and functional movement of an upper limb that has impaired movement due to a stroke. Many researchers have found that inco...
Eligibility Criteria
Inclusion
- at least 18 years of age
- \>6 months post stroke
- diagnosis of first stroke
- medically stable
- ability to follow multipart verbal directions
- score of \>26 on Mini-Mental Status Exam
- achieve 10 degrees elbow flexion
- 1/4 range volitional finger flexion when hand positioned in wrist and finger extension
- capable of standing for \>2 minutes without an assistive ambulatory device
- maintain independence in self-care or have a caretaker to provide assistance
- no concurrent skilled therapy treatment
- not participating in any experimental rehabilitation or drug studies.
Exclusion
- more than one stroke/multiple strokes
- receptive aphasia
- medically documented dementia
- score less than 26 on Mini Mental Status Exam
- contractures or joint deformities in the affected hand or wrist that impede the ability to use the device
- inability to transfer 12 balls crate right and 12 balls crate left, while using the Saeboflex device on the affected arm, by the end of a 5-day training session.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00893776
Start Date
June 1 2009
End Date
December 1 2014
Last Update
October 26 2017
Active Locations (1)
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1
University of Missouri, Lewis and Clark Hall
Columbia, Missouri, United States, 65211