Study of Hand Therapy 3 to 24 Months After Stroke

Study Overview
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Brief Summary
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The primary aim of this study is to investigate the effectiveness of the use of a robotic hand therapy device in the home environment. We hypothesize that the therapy group will improve hand function more than a customary and usual care group.

Detailed Description
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Many stroke survivors have significant limitations of upper extremity function which impacts many important activities such as eating, dressing and personal care. Studies show that to be effective in increasing functional independence, therapy must involve active participation of the patient and repetitive training. Robotic therapy offers a means of transferring some of this essential, but time consuming, therapy into the home. Seventy subjects (3 to 12 months post stroke)are being randomized to a control group that utilizes an innovative robotic hand therapy device in the home for three months or a control group that receives no device treatment. Clinical motor function and quality of life measures will compare the groups before intervention, immediately after, and 3 months later. The control group will receive device treatment for 3 months following their final evaluation. The results will provide valuable data on the ability of monitored home therapy to provide effective treatment. This project has the potential to increase the availability of effective rehabilitation techniques to patients with stroke.

Official Title
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Clinical Assessment of a Massed Practice Therapy Device

Conditions
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Cerebrovascular Accident

Intervention / Treatment
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* Device: Hand Mentor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 3 to 24 months post stroke Able to extend wrist and fingers at least 10 degrees Functional hearing and vision Able to follow instructions Lives at home, not institution Stable medications for 3 months Exclusion Criteria: Excessive cognitive impairments Taking/Receiving medicines/shots to make arm/hand less stiff Severe pain in the impaired arm Stroke was more than 24 months ago

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Hand Mentor | Device: Hand Mentor<br>* Use of the Hand Mentor therapy device at home for 6 weeks. Therapy programs include spasticity reduction, motor control, and emg biofeedback for encouraging activity.<br>* Other names: Hand Mentor Home;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wolf Motor Function Test |  | Initial, 6 wks, 12 wks, 16 wks, 52 wks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with recommended use |  | 6 wks, 12 wks | 
| Fugl-Meyer Test |  | Initial, 6 wks, 12 wks, 16 wks, 52 wks | 
| Stoke Impact Scale |  | Initial, 6 wks, 12 wks, 16 wks, 52 wks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke rehabilitation, stroke therapy, hand therapy, stroke, cerebrovascular stroke, cerebral stroke