Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation

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: Stroke
• Intervention / Treatment: Other: VR rehabilitation for motor function

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	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)	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	Brunnstrom stage	pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )
change in Wolf motor function	Wolf motor function	pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )

Collaborators and Investigators

• Sponsor: National Central University, Taiwan

Study record dates

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: stroke; rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• 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