Home Therapy for Stroke Rehabilitation Using the HandSOME Exoskeleton

Study Overview
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Brief Summary
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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
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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.

Official Title
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Home Therapy for Upper Limb Stroke Rehabilitation Using the HandSOME Exoskeleton

Conditions
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Stroke

Intervention / Treatment
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* Device: HandSOME


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HandSOME<br>The intervention is given to this group. | Device: HandSOME<br>* Participants use the HandSOME orthosis daily for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fugl-Meyer Test of Arm Function | clinical test of arm motor ability and impairment | Change from baseline Fugl-Meyer score at 2 months | 
| Change in Action Research Arm Test | clinical test of the functional limitations of the upper extremities | Change from baseline Action Research Arm Test score at 2 months | 
| Change in Motor Activity Log | assess the amount and quality of limb use at home | Change from baseline Motor Activity Log score at 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fugl-Meyer Test of Arm Function at followup | clinical test of arm motor ability and impairment | Change from baseline Fugl-Meyer score at 5 months | 
| Change in Action Research Arm Test at followup | clinical test of the functional limitations of the upper extremities | Change from baseline Action Research Arm Test score at 5 months | 
| Change in Motor Activity Log at followup | assess the amount and quality of limb use at home | Change from baseline Motor Activity Log score at 5 months |