The Development of Upper Extremity Rehabilitation Program Using Virtual Reality for the Stroke Patients

Not Applicable

Completed

• Conditions: Upper Extremity Dysfunction After the Stroke

• Registration Number: NCT02013999
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

Using the upper extremity rehabilitation program developed by virtual reality would help the recovery upper extremity function in patients with stroke.

Detailed Description

This randomized, double-blind, controlled trial included 24 patients with ischemic stroke. The intervention group received 30 min of conventional occupational therapy (OT) and 30 min of the mobile upper extremity rehabilitation program using a smartphone and a tablet PC (MoU-Rehab). The controls (n = 12) received conventional OT alone for 1 h per day. Rehabilitation consisted of 10 sessions of therapy, 5 days per week, for 2 weeks. The outcome measures (Fugl-Meyer Assessment of the upper extremity \[FMA-UE\], Brunnstr¨om stage \[B-stage\] for the arm and the hand, manual muscle testing \[MMT\], modified Barthel index \[MBI\], EuroQol-5 Dimension \[EQ-5D\], and Beck Depression Inventory \[BDI\]) were assessed at the beginning and end of treatment, and at 1 month. User satisfaction was evaluated by a qestionnaire.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-11
• Study First Posted: 2013-12-17
• Primary Completion: 2014-11-24
• Study Completion: 2014-11-24
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-28
• Last Update Posted: 2018-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• ischemic or hemorrhagic stroke confirmed by brain imaging study
• upper extremity dysfunction
• possible to use a simple device

Exclusion Criteria

• delirium, confusion or other evidence related to the consciousness
• uncontrolled medical or surgical disease
• unable to command to the order due to severe cognitive impairment
• visual impairment
• unable to sit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer upper extremity scale	baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks	for motor evaluation

Secondary Outcome Measures

Name	Time	Method
brunnström stage	baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks	for motor evaluation
questionnaire	at the end of the treatment for 2 weeks	for user satisfaction
Euroqol(EQ)-5D	baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks	EQ-5D
Virtual reality kinematic data	everytime when the patient uses program (automatically all recorded)	Automatically recorded
Medical Research Council (MRC) Scale for Muscle Strength	baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks	for motor evaluation
Modified Barthel Index	baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks	for ADL independence

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of