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Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VR rehabilitation for motor function
Sponsored by
National Central University, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, rehabilitation

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    VR rehabilitation

    control- conventional rehabilitation

    Arm Description

    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).

    conventional rehabilitation therapy for motor function, 1 hour a time at an intensity of three times per week over 8 weeks (total, 24 sessions).

    Outcomes

    Primary Outcome Measures

    Change in FUGL- MEYER ASSESSMENT OF PHYSICAL PERFORMANCE (FMA)
    FUGL- MEYER ASSESSMENT OF PHYSICAL PERFORMANCE (FMA)

    Secondary Outcome Measures

    change in upper extremity performance evaluation test for the elderly (TEMPA)
    upper extremity performance evaluation test for the elderly (TEMPA)
    change in Brunnstrom stage
    Brunnstrom stage
    change in Wolf motor function
    Wolf motor function

    Full Information

    First Posted
    March 31, 2018
    Last Updated
    July 2, 2018
    Sponsor
    National Central University, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03502122
    Brief Title
    Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation
    Official Title
    Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 24, 2012 (Actual)
    Primary Completion Date
    May 28, 2014 (Actual)
    Study Completion Date
    May 28, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Central University, Taiwan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    stroke, rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    VR rehabilitation
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    control- conventional rehabilitation
    Arm Type
    Active Comparator
    Arm Description
    conventional rehabilitation therapy for motor function, 1 hour a time at an intensity of three times per week over 8 weeks (total, 24 sessions).
    Intervention Type
    Other
    Intervention Name(s)
    VR rehabilitation for motor function
    Other Intervention Name(s)
    VR rehabilitation therapy
    Intervention Description
    rehabilitation for motor function
    Primary Outcome Measure Information:
    Title
    Change in FUGL- MEYER ASSESSMENT OF PHYSICAL PERFORMANCE (FMA)
    Description
    FUGL- MEYER ASSESSMENT OF PHYSICAL PERFORMANCE (FMA)
    Time Frame
    pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )
    Secondary Outcome Measure Information:
    Title
    change in upper extremity performance evaluation test for the elderly (TEMPA)
    Description
    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 )
    Title
    change in Brunnstrom stage
    Description
    Brunnstrom stage
    Time Frame
    pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )
    Title
    change in Wolf motor function
    Description
    Wolf motor function
    Time Frame
    pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    undecided .

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    Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation

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