Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation

NCT ID: NCT03502122

Last Updated: 2018-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-24
• Study Completion Date: 2014-05-28

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

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

VR rehabilitation for motor function

Intervention Type: OTHER

rehabilitation for motor function

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).

Group Type: ACTIVE_COMPARATOR

VR rehabilitation for motor function

Intervention Type: OTHER

rehabilitation for motor function

Interventions

VR rehabilitation for motor function

rehabilitation for motor function

Intervention Type: OTHER

Other Intervention Names

VR rehabilitation therapy

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Central University, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Chun-Chuan Chen

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

201012009IA

Identifier Type: -

Identifier Source: org_study_id