Status:
COMPLETED
Robot-Assisted Motivating Rehabilitation
Lead Sponsor:
Medical College of Wisconsin
Collaborating Sponsors:
American Heart Association
Conditions:
Stroke
Cerebrovascular Accident
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to examine how a novel robot technology designed for eventual use as a home therapy can improve arm function after stroke.
Detailed Description
Typically, after brain damage due to a stroke, the affected arm is weak and suffering from some of paralysis. As a result, adults with this condition are unable to move their impaired arm well during ...
Eligibility Criteria
Inclusion
- Subjects will be included in the study on the basis of the following criteria:
- They must be at least six months post-stroke.
- 18 years of age or older with a clinical diagnosis of hemiparesis (as verified by medical record and a medical expert).
- They have voluntary control with a low to medium range of motion function (UE-FT\<5) and a muscle tone.
- They are functionally stable (no significant changes in motor function over a week) and are able to tolerate being seated upright for 90 minutes.
- They report no excessive pain the impaired arm.
- If left neglect or spasticity is detected in the impaired arm, these levels must not interfere with the ability to cognitively complete the tasks or turn a wheel.
- They must not be participating in any experimental rehabilitation or drug therapies.
- If subjects are receiving chemical injections for spasticity, they must be at least 3-months away from their last treatment.
- They must have driven prior to stroke.
- They are not clinically depressed (as measured by the Geriatric Depression Scale (GDS) short form (Sheikh and Yesavage, 1986).
Exclusion
- Subjects will be excluded from the study if they voluntarily decide to withdraw from the study or if they do not meet the above inclusion criteria.
- Once informed consent is given twenty-four of these subjects will be randomized into two training groups (fun driving: fun and functional driving activities and rote tracking (12 subjects): rote and functional tracking activities). Two subjects will be randomized the case study group. The groups will be matched in initial motor function.
- Subjects will be excluded if they voluntarily decide to withdraw from the study or if they do not meet the above inclusion criteria.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00393926
Start Date
July 1 2006
End Date
June 1 2013
Last Update
February 4 2014
Active Locations (1)
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1
Clement J Zablocki VA - Rehabilitation Robotics R&D Lab
Milwaukee, Wisconsin, United States, 53295