Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation

NCT03502122 | Completed DMC

• 1 other identifier: 201012009IA
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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

Keywords

stroke; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in FUGL- MEYER ASSESSMENT OF PHYSICAL PERFORMANCE (FMA)

  FUGL- MEYER ASSESSMENT OF PHYSICAL PERFORMANCE (FMA)

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

Secondary Outcomes (3)

• change in 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

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

• change in Wolf motor function

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

Study Arms (2)

VR rehabilitation

EXPERIMENTAL

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

control- conventional rehabilitation

ACTIVE COMPARATOR

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

Interventions

VR rehabilitation for motor function OTHER

rehabilitation for motor function

Also known as: VR rehabilitation therapy

VR rehabilitation; control- conventional rehabilitation

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Central University, Taiwan: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 31, 2018
• First Posted: April 18, 2018
• Study Start: April 24, 2012
• Primary Completion: May 28, 2014
• Study Completion: May 28, 2014
• Last Updated: July 5, 2018

Record last verified: 2018-07