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

Brain Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196739
• Other study ID #: VRfeasibility1.2
• Status: Completed
• Phase: N/A
• Start date: June 20, 2017
• Est. completion date: June 6, 2018

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 6, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Musculoskeletal Diseases
• Upper Extremity Dysfunction

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Korea Workers' Compensation & Welfare Service Incheon Hospital	Incheon
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change of Modified Barthel Index	Evaluation of activities of daily living	at study completion, an average of 1 month
Secondary	Time of participation	Total time of patient's participation in the study intervention	at study completion, an average of 1 month
Secondary	Patient's satisfaction	Evaluation of patient's satisfaction to the study intervention using a Likert scale	at study completion, an average of 1 month
Secondary	Patient's discomfort	Evaluation of patient's discomfort to the study intervention using a Likert	at study completion, an average of 1 month