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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03196739

Collaborator

(none)

Enrollment

Locations

Arm

11.5

Actual Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Upper Extremity Dysfunction Brain Diseases	Device: Virtual rehabilitation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

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

Actual Study Start Date :

Jun 20, 2017

Actual Primary Completion Date :

May 30, 2018

Actual Study Completion Date :

Jun 6, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change of Action Research Arm Test [at study completion, an average of 1 month]
19 items including grasp, grip, pinch, and gross arm movement

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea Workers' Compensation & Welfare Service Incheon Hospital	Incheon		Korea, Republic of	21417
2	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Han Gil Seo, Clinical Assistant Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT03196739

Other Study ID Numbers:

VRfeasibility1.2

First Posted:

Jun 23, 2017

Last Update Posted:

Jun 8, 2018

Last Verified:

Mar 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Brain Diseases

Study Results

No Results Posted as of Jun 8, 2018