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

Upper Extremity Dysfunction After the Stroke Clinical Trial

Official title:

Mobile Game-based Virtual Reality Rehabilitation Program for Upper Limb Dysfunction After Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02013999
• Other study ID #: B-1306/208-005
• Status: Completed
• Phase: N/A
• First received: December 3, 2013
• Last updated: January 28, 2018
• Start date: October 2013
• Est. completion date: November 24, 2014

Study information

• Verified date: January 2018
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 24, 2014
• Est. primary completion date: November 24, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Stroke
• Upper Extremity Dysfunction After the Stroke

Intervention

Other:
• Virtual reality program for upper extremity rehabilitation

• standard occupational therapy

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer upper extremity scale	for motor evaluation	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
Secondary	brunnström stage	for motor evaluation	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
Secondary	Modified Barthel Index	for ADL independence	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
Secondary	Medical Research Council (MRC) Scale for Muscle Strength	for motor evaluation	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
Secondary	Euroqol(EQ)-5D	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
Secondary	Virtual reality kinematic data	Automatically recorded	everytime when the patient uses program (automatically all recorded)
Secondary	questionnaire	for user satisfaction	at the end of the treatment for 2 weeks