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

NCT03196739 | Completed

• 1 other identifier: VRfeasibility1.2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Upper Extremity Dysfunction; Brain Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change of Box and Block Test

  at study completion, an average of 1 month

• Change of Modified Barthel Index

  at study completion, an average of 1 month

• Time of participation

  at study completion, an average of 1 month

• Patient's satisfaction

  at study completion, an average of 1 month

• Patient's discomfort

  at study completion, an average of 1 month

Study Arms (1)

Virtual rehabilitation

EXPERIMENTAL

Upper limb rehabilitation using virtual reality with a head-mounted display (HTC Vive; HTC Co., New Taipei City, Taiwan)

Device: Virtual rehabilitation

Interventions

Virtual rehabilitation DEVICE

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.

Virtual rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (2)

Korea Workers' Compensation & Welfare Service Incheon Hospital

Incheon, 21417, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Brain Diseases

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 23, 2017
• Study Start: June 20, 2017
• Primary Completion: May 30, 2018
• Study Completion: June 6, 2018
• Last Updated: June 8, 2018

Record last verified: 2018-03

Locations

KR (2)