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OpenTrials
Completed

NCT Number: NCT03502122

Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation

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

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VR rehabilitation for motor function

Other

rehabilitation for motor function

Other names: VR rehabilitation therapy

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. change in Brunnstrom stage

    Time frame: pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )

    Brunnstrom stage

  3. 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

Sponsors and collaborators

Lead sponsor

National Central University, Taiwan

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 18, 2018
Registry last updated
Jul 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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