Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- University of California, Irvine
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Action Research Arm Test
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to develop and assess the effectiveness of robot-assisted movement therapy in enhancing hand motor function in subjects with chronic hemiparetic stroke, and to identify predictors of treatment response.
Investigators
Steven C. Cramer, MD
Professor
University of California, Irvine
Eligibility Criteria
Inclusion Criteria
- •At least 18 years old
- •Had stroke between 11-26 weeks ago
- •Have some weakness in one of your wrists or hands due to stroke
- •Did not have too much disability prior to stroke
- •Do not have major depression
Exclusion Criteria
- •Non-English speaking
- •If you have trouble keeping good attention
- •Pregnant, advanced liver, kidney, heart, or lung disease
- •Terminal medical diagnosis or major neurological or psychiatric disease apart from stroke
- •Cannot undergo MRI scanning
- •Have history of brain surgery or seizures
Outcomes
Primary Outcomes
Action Research Arm Test
Time Frame: change from baseline to 1 month post-end treatment, Intention To Treat
The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. The test is used to determine upper limb function, 0-57 points with higher is better, 57 is the highest score indicating normal arm movement.
Arm Motor Fugl-Meyer Test
Time Frame: change from baseline to 1 month post-end treatment, Intention To Treat
The Arm Motor Fugl-Meyer test is an assessment of Sensorimotor Recovery After Stroke. It is a 33 item measure with 3 subgroups which are Proximal, Wrist/Hand, and Coordination/Speed. The scaling for each item works on a scale of 0-2 with 0 being not able to be done, 1 being partially done, and 2 being done normally. The scoring goes from 0-66, higher is better, 66 is considered a normal score with no noticable complications in movement.