Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation

Study Overview
=================
Brief Summary
-----------------
This study aims to design and verify a multi-mode smart assistive device system for Stroke Rehabilitation by using EEG, fMRI, IMU and questioners

Official Title
-----------------
Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: VR rehabilitation for motor function


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the first time hemiparetic stroke; diagnosis confirmed by a physician on the basis of the findings of neurological examinations and brain imaging (magnetic resonance imaging or computed tomography scan); aged between 20 and 85 years; Brunnstrom's stage II to V over the proximal and distal part of the upper extremity on the affected side; no cognitive dysfunction, measured by the Mini-Mental State Exam (≧24; suggested by 36 with respect to age and educational level) willing/able to participate and having signed an informed consent form. Exclusion Criteria: unstable vital sign irreversible contracture over any of the joints of the affected upper extremity history of surgery, fracture, arthritis, pain, or any other complications that might influence the recovery of upper extremity function like aphasia, apraxia and neglect; having spasticity, as measured using the Modified Ashworth scale (score > 2); poststroke seizure; heart attack within 3 months poststroke; cortical lesions in any of the five core motor areas of interest, including the bilateral M1, the bilateral PM, and the SMA.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR rehabilitation<br>Virtual Reality based rehabilitation therapy for motor function, 1 hour a time at an intensity of three times per week over 8 weeks (total, 24 sessions). | Other: VR rehabilitation for motor function<br>* rehabilitation for motor function<br>* Other names: VR rehabilitation therapy;|
| Active Comparator: control- conventional rehabilitation<br>conventional rehabilitation therapy for motor function, 1 hour a time at an intensity of three times per week over 8 weeks (total, 24 sessions). | Other: VR rehabilitation for motor function<br>* rehabilitation for motor function<br>* Other names: VR rehabilitation therapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FUGL- MEYER ASSESSMENT OF PHYSICAL PERFORMANCE (FMA) | FUGL- MEYER ASSESSMENT OF PHYSICAL PERFORMANCE (FMA) | pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in upper extremity performance evaluation test for the elderly (TEMPA) | upper extremity performance evaluation test for the elderly (TEMPA) | pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention ) | 
| change in Brunnstrom stage | Brunnstrom stage | pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention ) | 
| change in Wolf motor function | Wolf motor function | pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention ) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rehabilitation, stroke