Robot Therapy for Rehabilitation of Hand Movement After Stroke

Study Overview
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Brief Summary
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A study will be performed where individuals with chronic stroke will be randomly assigned to receive 2 different dosages of robotic hand therapy. One group will receive 12 sessions of robot-assisted repetitive movement practice in the HEXORR robot over a 4-5 week period. A second group will receive 24 sessions of HEXORR therapy over a 8-10 week period.

Detailed Description
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The overall goal of the proposed work is to improve hand function after stroke. Adequate hand function is critical to a functional upper limb, and is often resistant to conventional therapeutic interventions. Many stroke survivors have residual ability to flex the fingers, but extension is often limited and impeded by increased passive stiffness in flexors, involuntary activation of flexors and inability to activate extensors. The rationale for this approach stems from the growing evidence that neuro-rehabilitation after stroke may be enhanced via the application of motor learning strategies within the context of repetitive movement practice. The key therapeutic aspects of these strategies are high repetition, volitional effort, and successful completion of tasks to prevent frustration. While these represent promising therapeutic strategies, they are limited to mildly impaired subjects who already have enough control of finger extension to tolerate high repetitions of grasp/release tasks without succumbing to fatigue and/or frustration. There is a very large population of stroke patients who don't fall into this category and often must rely on compensatory strategies. In these patients, repetitive task practice facilitated by a robotic device may be more effective than unassisted task practice.

Official Title
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Robot Therapy for Rehabilitation of Hand Movement After Stroke

Conditions
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Stroke, Movement Disorders, Hemiparesis

Intervention / Treatment
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* Device: HEXORR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a diagnosis of stroke more than 6 months prior to randomization presence of voluntary hand activity indicated by a score of at least 1 on the finger mass extension/grasp release item of the Fugl-Meyer Test of Motor Function adequate cognitive status, as determined by Mini-Mental Status Examination score >24 Exclusion Criteria: were under the influence of oral or injected antispasticity medications during the study had MCP and IP passive extension limit > 30 degrees from full extension had pain that interfered with daily activities had excessive tone in the fingers and thumb as determined by Ashworth scores >=3 had severe sensory loss or hemispatial neglect as determined by clinical exam.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Random assignment to two study groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low-dosage robot therapy<br>12 sessions of robotic therapy over 4-5 weeks | Device: HEXORR<br>* The subject receives robotic assistance from the HEXORR robot during finger and thumb movements. Several different video games are used to provide feedback of performance and motivate the training. The assistance level is adjusted automatically in some games and manually in other games to enable a target success rate of 67% when playing the games.<br>|
| Experimental: hi-dosage robot therapy<br>24 sessions of robotic therapy over 8-10 weeks | Device: HEXORR<br>* The subject receives robotic assistance from the HEXORR robot during finger and thumb movements. Several different video games are used to provide feedback of performance and motivate the training. The assistance level is adjusted automatically in some games and manually in other games to enable a target success rate of 67% when playing the games.<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 Motor Function | Measures motor impairment in the upper extremity after stroke | 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Action Research Arm Test | Measures functional limitations of the upper extremity | 6 month follow-up | 
| Change in finger extension range of motion (degrees) | Motion capture of finger and thumb movement will be used to assess extension ability in units of degrees. The task will be to open the hand as far as possible from a closed fist. Data from all digits will be averaged to provide a single metric for extension ability of the fingers and thumb. | 6 month follow-up | 
| Change in Modified Ashworth Test | Measures hypertonia in the flexors of the fingers, wrist and elbow joints | 6 month follow-up | 
| Change in Motor Activity Log | Measures the amount of use of the upper extremity in ADL | 6 month follow-up | 
| Change in Grip Strength | Jamar Dynamometer | 6 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robotic therapy, finger, hand