Efficacy of Robot-Assisted Rehabilitation of Hand Paralysis After Stroke

Study Overview
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Brief Summary
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Among robotic devices, Gloreha, with its compliant mechanical transmission, may represent an easily applied innovative solution to rehabilitation, because the hand can perform grasp and release activities wearing the device by mean of a flexible and light orthosis. Our objective on this research was to the robotic assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis.

Detailed Description
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The investigators evaluated the effectiveness of a robotic-assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis. A randomized controlled trial. The experimental group received a passive mobilization of the hand through the robotic device Gloreha and control group received a PT and OT for 3 consecutive weeks (3 days/week) in addition to traditional rehabilitation. Outcomes included the National Institutes of Health Stroke Scale (NIHSS), Modified Ashworth Scale (MAS), Barthel index (BI), Motricity index (MI), short version of the Disabilities of the Arm, Shoulder and Hand (quickDASH), and the Visual Analogue Scale (VAS) measurements. All measures were collected at baseline and end of the intervention (3 weeks).

Official Title
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Efficacy of Short-Term Robot-Assisted Rehabilitation in Patients With Hand Paralysis After Stroke: a Randomized Clinical Trial

Conditions
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Stroke

Intervention / Treatment
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* Device: Experimental group
* Device: Control group
* Device: traditional rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute phase of stroke first stroke episode. no history of peripheral nerve injury or musculoskeletal disease 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 prior to the start of this study. paralysis of the wrist and fingers Exclusion Criteria: unstable medical disorders, active Complex Regional Pain Syndrome (CRPS) severe spatial neglect, aphasia, or cognitive problems. scored greater than 4 points on the Beck Depression Inventory (BDI) more than 30 points in the State Trait Anxiety Inventory (STAI)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Robotic device Gloreha (Gloreha, Idrogenet, Italy) and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week). | Device: Experimental group<br>* Robotic assisted passive mobilization (Gloreha, Idrogenet, Italy) and traditional rehabilitation.<br>Device: traditional rehabilitation<br>* Assisted stretching, shoulder and arm exercises, and functional reaching tasks<br>|
| Active Comparator: Control group<br>Physiotherapy, occupational therapy and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week). | Device: Control group<br>* Physiotherapy and occupational therapy.<br>Device: traditional rehabilitation<br>* Assisted stretching, shoulder and arm exercises, and functional reaching tasks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from National Institutes of Health Stroke Scale (NIHSS) |  | baseline, immediately post-intervention (3 weeks). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Visual analogue scale (VAS) |  | baseline, immediately post-intervention (3 weeks). | 
| Change from Barthel Index (BI) |  | baseline, immediately post-intervention (3 weeks). | 
| Change from Modified Ashworth Scale (MAS) |  | baseline, immediately post-intervention | 
| Change from Disabilities of the Arm, Shoulder and Hand (quickDASH) |  | baseline, immediately post-intervention (3 weeks). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hand, Paralysis, Stroke