Automatic Versus Intentional Movement Exercises to Enhance Arm Functions After Stroke

Study Overview
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Brief Summary
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Many patients retain upper-limb motor impairment following stroke. Most conventional rehabilitation techniques are aimed to improve motor intentional movement by repeated exercises. These techniques require attentional load and are responsible for significant fatigue that probably represents a limiting factor. Alternatively, the automatic control of action is now well documented. A rehabilitation method based on this principle could allow recovery of more natural movements. Hypothesis: Stimulating automatic motricity improves upper-limb motor skills compared with a rehabilitation technique based on intentional movements.

Official Title
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Automatic Versus Intentional Movement Exercises to Enhance Arm Functions After Stroke

Conditions
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Stroke, Upper-limb Paresis

Intervention / Treatment
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* Other: motor training
* Other: motor training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects must be between the ages of 18-80 and must not be pregnant Patients volunteer to participate in the study, with a written informed consent signed Affiliation to a national health insurance program Hemiplegia after stroke Stroke onset >6 weeks and <4 years prior to study enrollment Patients able to perform the exercises on the automated table Exclusion Criteria: Pregnancy Excessive pain in any joint of the paretic extremity (VAS>5) Coexistent major neurological or psychiatric disease as to decrease number of confounders Subjects with global aphasia and deficits of comprehension Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing

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:  AUTO  Group<br> | Other: motor training<br>* Subject will perform prehension exercises on an automated table. After the initiation of the arm movement, the target to be grasped is programmed to move in order to stimulate automatic motricity.<br>|
| Sham Comparator:  CONTROL  Group<br> | Other: motor training<br>* Subject will perform prehension exercises on an automated table. After the initiation of the arm movement, the target to be grasped will remain static in order to involve intentional motricity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl Meyer assessment (upper extremity) of motor recovery following stroke | we are looking for a change in scores between the baseline session score (Day 1), and those collected during this follow-up session (Day 26). | 2 weeks following the last day of the intervention (Day 26) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl Meyer assessment (upper extremity) of motor recovery following stroke | we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session | immediately following the last day of the intervention (Day 12) | 
| modified Ashworth scale | we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session. | immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26) | 
| Visual Analog Pain Scale | we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session. | immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26) | 
| Box and block test | we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session | immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26) | 
| Frenchey Arm Test | we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session. | immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26) | 
| Motor Activity Log (MAL | we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session. | immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26) | 
| Functional independence scale (MIF) | we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session | immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, hemiplegia, automatic pilot, upper-limb rehabilitation