Feasibility of Virtual Reality Games Using Head-mounted Display on Patients With Brain Disorders

Because virtual reality can provide more enriched environment, repetitive goal-oriented tasks, and increased patients' interest and motivation, it is expected to stimulate neuroplasticity of injured brain and promote recovery in patients with brain disorders. On the other hand, immersive virtual reality using a head-mounted display has not yet been attempted in the rehabilitation of patients with brain disorders. In addition to the benefits of existing virtual reality or game rehabilitation, immersive virtual reality can further enhance brain plasticity, such as the effect of mirror therapy or action observation, through self-awareness of the body in the virtual space. The purpose of this study is to investigate the feasibility of applying the immersive virtual reality using a head-mounted display in patients with upper extremity dysfunction due to brain disorders.

Study Overview

• Status: Completed
• Conditions: Brain Diseases; Upper Extremity Dysfunction
• Intervention / Treatment: Device: Virtual rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of, 21417
    • Korea Workers' Compensation & Welfare Service Incheon Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with upper extremity dysfunction due to brain disorders (eg, stroke, traumatic brain injury, brain tumor, etc.)
• Patient who can move the upper limb against the gravity (MRC grade 3 or above in both shoulder and elbow flexion)
• Patient who can maintain stable sitting position
• Adults over 18 years old
• Patients who voluntarily agreed to participate in the study

Exclusion Criteria:

• A moderate-to-severe cognitive impairment score of 18 or less in Mini-Mental Status Examination (MMSE)
• Peripheral nerve injury, joint disease, other diseases of the upper extremity dysfunctions other than brain disorders
• Patients with a history of severe dizziness or epilepsy
• Patients with other medical illness that are difficult to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual rehabilitation; Upper limb rehabilitation using virtual reality with a head-mounted display (HTC Vive; HTC Co., New Taipei City, Taiwan)	Device: Virtual rehabilitation; A total of 10 sessions were held for 30 minutes, 2 to 3 times a week for upper limb rehabilitation using immersive virtual reality under the assistance of an occupational therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Action Research Arm Test	19 items including grasp, grip, pinch, and gross arm movement	at study completion, an average of 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Box and Block Test	the number of blocks carried over the partition from one compartment to the other during the one-minute trial period	at study completion, an average of 1 month
Change of Modified Barthel Index	Evaluation of activities of daily living	at study completion, an average of 1 month
Time of participation	Total time of patient's participation in the study intervention	at study completion, an average of 1 month
Patient's satisfaction	Evaluation of patient's satisfaction to the study intervention using a Likert scale	at study completion, an average of 1 month
Patient's discomfort	Evaluation of patient's discomfort to the study intervention using a Likert	at study completion, an average of 1 month

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2017
• Primary Completion (Actual): May 30, 2018
• Study Completion (Actual): June 6, 2018

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): June 8, 2018
• Last Update Submitted That Met QC Criteria: June 7, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Brain Diseases
• Other Study ID Numbers: VRfeasibility1.2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No