Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation

July 2, 2018 updated by: Chun-Chuan Chen, National Central University, Taiwan
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Other: VR rehabilitation for motor function
rehabilitation for motor function
Other Names:
  • VR rehabilitation therapy
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).
Other: VR rehabilitation for motor function
rehabilitation for motor function
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)
Time Frame: pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )
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)
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)
pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )
change in Brunnstrom stage
Time Frame: pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )
Brunnstrom stage
pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )
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
pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Central University, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2012

Primary Completion (Actual)

May 28, 2014

Study Completion (Actual)

May 28, 2014

Study Registration Dates

First Submitted

March 31, 2018

First Submitted That Met QC Criteria

April 17, 2018

First Posted (Actual)

April 18, 2018

Study Record Updates

Last Update Posted (Actual)

July 5, 2018

Last Update Submitted That Met QC Criteria

July 2, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201012009IA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

undecided .

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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