Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation

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

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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