Use of Repetitive Facilitative Exercise Program in Established Stroke

Study Overview
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Brief Summary
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The purpose of this study is to assess whether a novel therapy approach (repetitive facilitative exercise (RFE)) is more effective than conventional rehabilitation in facilitating the recovery of upper extremity function following stroke.

Official Title
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A Randomized Controlled Evaluation of a Repetitive Facilitative Exercise Program for Adults With an Established Stroke and Upper Extremity Impairment

Conditions
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Stroke

Intervention / Treatment
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* Other: Occupational therapy- Repetitive Facilitative Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 18 years Having a single ischemic or hemorrhagic hemispheric stroke of more than 6 months duration The ability to selectively demonstrate active extension of at least 10 degrees at the metacarpo-phalangeal joint and the interphalangeal joints and 20 degrees at the wrist Capable of effectively participating in the study Exclusion Criteria: Upper extremity contracture/pain that interfere with study technique Pre-existing upper extremity neurologic or orthopedic disorders Unstable medical condition BMI > 35 Active treatment of condition during 3 months prior to enrollment in study (botulinum toxin, therapy, tendon release, etc.) Language or cognitive/perceptual deficits or scheduling problems that would limit participation Inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Repetitive Facilitative Exercise<br>Occupational therapy program - Repetitive facilitative exercise therapy protocol including 40 min of RFE and 20 minutes of task-specific activity. 3 treatment sessions weekly for a total of 4 weeks. | Other: Occupational therapy- Repetitive Facilitative Exercise<br>* Occupational therapy program - Repetitive facilitative exercise therapy protocol including 40 min of RFE and 20 minutes of task-specific activity. 3 treatment sessions weekly for a total of 4 weeks.<br>|
| No Intervention: Conventional Therapy Program<br>Typical therapy excluding robotics, RFE | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Arm score |  | baseline, immediate post-intervention and 3 month post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Activity Log |  | baseline, immediate post-intervention and 3 month post-intervention | 
| 9-Hole Peg Test |  | baseline, immediate post-intervention and 3 month post-intervention | 
| Box and Block test |  | baseline, immediate post-intervention and 3 month post-intervention | 
| Grasp strength |  | baseline, immediate post-intervention and 3 month post-intervention | 
| Active Range of motion of shoulder flexion, wrist extension, and index finger extension |  | baseline, immediate post-intervention and 3 month post-intervention | 
| Overall patient satisfaction |  | baseline, immediate post-intervention and 3 month post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, weakness, rehabilitation, chronic stroke