Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke

Study Overview
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Brief Summary
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The investigators evaluate the effectiveness of the application of continuous passive motion device for hand rehabilitation in two classes of patients: with a residual active motion and without a residual active motion.

Detailed Description
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We will conduct a double blind clinical trial. A sample size calculation were performed to determine the necessary number of subjects needed for this study and was based upon the results of a previous pilot study. All patients had functional impairments of their upper extremities after the stroke. We hypothesized that the hand-rehabilitation oriented with robotics assistance, would improve edema by paralysis of the upper limb even in patient without sensory pathway recovery.

Official Title
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Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: A-ROM Continuous Passive Rehabilitation
* Device: P-ROM Continuous Passive Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a history of acute phase of stroke (less than 12 months post onset), first stroke episode, no history of peripheral nerve injury or musculoskeletal disease in the affected upper extremity, no contracture of the affected wrist or fingers (Modified Ashworth<3), no history of any invasive procedure (Botulinum toxin type A) for the treatment of spasticity for at least 6 months before the start of this study, for P-ROM patients, the absence of active hand movements, for the A-ROM patients, the presence of active hand movements. Exclusion Criteria: unstable medical disorders, active Complex Regional Pain Syndrome (CRPS), severe spatial neglect, aphasia, cognitive problems.

Ages Eligible for Study
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Minimum Age: 45 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A-ROM Continuous Passive Rehabilitation<br>The group of patients with Active Range Of Motion (A-ROM) is subjected to two session per day in the morning and in the afternoon over a period of two weeks (5 days per week). Each session is composed by 30 min of continuous passive motion rehabilitation and 60 min of physical and occupational therapy. | Device: A-ROM Continuous Passive Rehabilitation<br>* Half an hour of treatment during the morning with the sequential program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the synchronous program (II-III-IV-V finger are mobilized simultaneously, the thumb individually).<br>* Other names: Continuous Passive Motion device for hand: Gloreha;|
| Experimental: P-ROM Continuous Passive Rehabilitation<br>The group of patients with Passive Range Of Motion (P-ROM), i.e. without active movements of the hand at the baseline, is subjected to two session per day in the morning and in the afternoon over a period of two weeks (5 days per week). Each session is composed by 30 min of continuous passive motion rehabilitation and 60 min of physical and occupational therapy. | Device: P-ROM Continuous Passive Rehabilitation<br>* Half an hour of treatment during the morning with the sequential program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the synchronous program (II-III-IV-V finger are mobilized simultaneously, the thumb individually).<br>* Other names: Continuous Passive Motion device for hand: Gloreha;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline of Perimeter edema |  | 1 day after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline of Visual analogue scale (VAS) |  | 1 day after the treatment | 
| Change from Baseline of Modified Ashworth Scale for Grading Spasticity (MAS) |  | 1 day after the treatment | 
| Change from Baseline of Range Of Motion (ROM) |  | 1 day after the treatment | 
| Clinical Global Impression (CGI) |  | 1 day after the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hand Edema, Exercise Therapy