Home Therapy for Upper Limb Stroke Rehabilitation Using the HandSOME Exoskeleton
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- The Catholic University of America
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change in Action Research Arm Test
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This research will evaluate the potential for a novel hand orthosis (HandSOME) to help stroke victims regain functional use of their hand and regain independent living. Participants will use the HandSOME at home regularly for 8 weeks. Clinical evaluations will measure changes from the intervention after the 8 weeks and also at a 3 month followup.
Detailed Description
After stroke, individuals often have great difficulty with using the affected hand in functional tasks. The hand frequently suffers from finger flexor hypertonia as well as finger extensor weakness. This leads to increased difficulty in grasp and release of objects. HandSOME is a light weight wearable hand orthosis that increases range of motion and decreases effort during grasping tasks. The goal of this study is to evaluate the HandSOME device's effectiveness in the rehabilitation of stroke patients through an 8 week intervention. Eligible subjects will use the device daily at home for 8 weeks with one visit per week to the clinic to evaluate progress and troubleshoot problems with the device. The hypotheses are that the gains from the 8 weeks of training will be statistically significant and clinically important (defined as gains of greater than 10% of full scale) in the domains of impairment, function and amount of arm use.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of stroke more than six months prior to entry into the study
- •Impaired ability to open affected the hand
- •At least trace ability to extend the wrist and fingers
Exclusion Criteria
- •Have cognitive deficits that could negatively affect their ability to complete the protocols as evidenced by a score of 24 or less on the Folstein Mini-Mental State Examination
- •Have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols
- •Have serious uncontrolled medical problems as judged by the project therapist
- •Receiving oral or injected antispasticity medications during study treatment
- •MCP and IP passive extension limit \> 30 degrees from full extension
- •Excessive tone in the fingers and thumb as determined by Ashworth scores \>=3
Outcomes
Primary Outcomes
Change in Action Research Arm Test
Time Frame: Change from baseline Action Research Arm Test score at 2 months
clinical test of the functional limitations of the upper extremities
Change in Fugl-Meyer Test of Arm Function
Time Frame: Change from baseline Fugl-Meyer score at 2 months
clinical test of arm motor ability and impairment
Change in Motor Activity Log
Time Frame: Change from baseline Motor Activity Log score at 2 months
assess the amount and quality of limb use at home
Secondary Outcomes
- Change in Motor Activity Log at followup(Change from baseline Motor Activity Log score at 5 months)
- Change in Action Research Arm Test at followup(Change from baseline Action Research Arm Test score at 5 months)
- Change in Fugl-Meyer Test of Arm Function at followup(Change from baseline Fugl-Meyer score at 5 months)