Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: May 28, 2014

Interventions

  • Other: VR rehabilitation for motor function
    • rehabilitation for motor function

Arms, Groups and Cohorts

  • Experimental: VR rehabilitation
    • 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).
  • Active Comparator: control- conventional rehabilitation
    • conventional rehabilitation therapy for motor function, 1 hour a time at an intensity of three times per week over 8 weeks (total, 24 sessions).

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Central University, Taiwan
  • Provider of Information About this Clinical Study
    • Principal Investigator: Chun-Chuan Chen, Associate professor – National Central University, Taiwan

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