Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation

N

National Central University, Taiwan

Status

Completed

Conditions

Stroke

Treatments

Other: VR rehabilitation for motor function

Study type

Interventional

Funder types

Other

Identifiers

NCT03502122
201012009IA

Details and patient eligibility

About

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

Enrollment

48 patients

Sex

All

Ages

20 to 85 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

48 participants in 2 patient groups

VR rehabilitation
Experimental group
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).
Treatment:
Other: VR rehabilitation for motor function
control- conventional rehabilitation
Active Comparator group
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).
Treatment:
Other: VR rehabilitation for motor function

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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