FINGER Robot Therapy Study

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness of training hand movement using FINGER robot after stroke. FINGER is a robot that measures finger movements and allows users to play computer games using those movements.

Detailed Description
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Robotic devices can be used to retrain movement after stroke. However, it is unclear how best to assist in movement. Providing physical assistance may improve the flow of proprioceptive information to the nervous system, which may help a person relearn to move a limb. On the other hand, assisting movement with a robot may cause a person to slack, not trying as hard during therapy. This study will test the effect of different levels of assistance on recovery of finger function during robot-assisted therapy after stroke.

Official Title
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Study of Influence of Timing on Motor Learning

Conditions
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Cerebrovascular Accident

Intervention / Treatment
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* Device: FINGER I
* Device: FINGER II


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 80 years of age Have history of stroke affecting the arm, at least 6 months prior to enrollment have arm and/or hand weakness as measured on a standard clinical scale do not have active major psychological problems, or problems affecting the stroke-affected arm or hand besides the stroke do not have active major brain disease other than the stroke have absence of pain in the stroke-affected arm and hand Exclusion Criteria: severe stiffness of the arm or hand as measured on a standard clinical scale severe problems speaking or understanding speech as measured on a standard clinical scale severe reduced level of consciousness severe loss ability to sense movement of your limbs as measured on a standard clinical scale currently pregnant difficulty in understanding or complying with the instructions given by the researcher inability to perform the experimental task that will be studied increased pain with movement of the stroke-affected arm or hand Exclusion criteria that will prevent subjects from participating in the MRI: Subjects having any implanted metal such as metallic splinters, metallic surgical clips, prosthetic heart valves, pacemakers, neuro-stimulation devices, orthodontic work that contains ferromagnetic materials, Subjects whose occupation or activities may cause accidental lodging of ferromagnetic materials, or that may have imbedded metal fragments from military activities, unless cleared by a screening head CT scan Subjects with tattoo(s) presenting metallic or ferromagnetic color ingredients or with facial make-up Subjects who have claustrophobia Subjects who are currently pregnant or breastfeeding.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FINGER I<br>Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with first setting at a minimum of 3 days per week, 1 hour per day with the exercise program | Device: FINGER I<br>* FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I<br>Device: FINGER II<br>* FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II<br>|
| Experimental: FINGER II<br>Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with a second setting at a minimum of 3 days per week, 1 hour per day with the exercise program | Device: FINGER I<br>* FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I<br>Device: FINGER II<br>* FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor and Strength Outcome Measure Using Box and Block Test Measured in Units of Blocks Placed | The primary endpoint was the change in Box and Blocks score, which measures how many blocks a subject can pick up and place in a box in 60 seconds, from baseline to 1-month post-therapy. The higher the scores, the better arm and hand function indicated. | From baseline to 1-month post therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor and Strength Measure Using Action Research Arm Test Measured as a Score | We compared the change in Action Research Arm Test (ARAT) scores from the baseline evaluation to 1-month post-therapy evaluation. The ARAT is a 57-point scale, 0 being the minimum scoreand 57 being the maximum score, that measures upper extremity function, coordination, and dexterity. The higher scores indicate a better outcome. | From baseline to 1-month post therapy | 
| Motor, Strength and Sensory Using Fugl-Meyer Test Measured as a Score | The primary outcome measure was the change in Upper Extremity Fugl-Meyer score on a scale of 0 to 66 at one-month post-therapy. The higher the scores, the better arm and hand function indicated. | From baseline to 1-month post therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke