Back to resultsFeasibility of Virtual Reality Games Using Head-mounted Display on Patients With Brain Disorders
Primary Purpose
Upper Extremity Dysfunction, Brain Diseases
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Virtual rehabilitation
Sponsored by
About this trial
This is an interventional device feasibility trial for Upper Extremity Dysfunction
Eligibility Criteria
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
Sites / Locations
- Korea Workers' Compensation & Welfare Service Incheon Hospital
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Virtual rehabilitation
Arm Description
Upper limb rehabilitation using virtual reality with a head-mounted display (HTC Vive; HTC Co., New Taipei City, Taiwan)
Outcomes
Primary Outcome Measures
Change of Action Research Arm Test
19 items including grasp, grip, pinch, and gross arm movement
Secondary Outcome Measures
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
Change of Modified Barthel Index
Evaluation of activities of daily living
Time of participation
Total time of patient's participation in the study intervention
Patient's satisfaction
Evaluation of patient's satisfaction to the study intervention using a Likert scale
Patient's discomfort
Evaluation of patient's discomfort to the study intervention using a Likert
Full Information
NCT ID
NCT03196739
First Posted
June 20, 2017
Last Updated
June 7, 2018
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03196739
Brief Title
Feasibility of Virtual Reality Games Using Head-mounted Display on Patients With Brain Disorders
Official Title
Feasibility of Virtual Reality Games Using Head-mounted Display on Patients With Brain Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
June 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Extremity Dysfunction, Brain Diseases
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual rehabilitation
Arm Type
Experimental
Arm Description
Upper limb rehabilitation using virtual reality with a head-mounted display (HTC Vive; HTC Co., New Taipei City, Taiwan)
Intervention Type
Device
Intervention Name(s)
Virtual rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Action Research Arm Test
Description
19 items including grasp, grip, pinch, and gross arm movement
Time Frame
at study completion, an average of 1 month
Secondary Outcome Measure Information:
Title
Change of Box and Block Test
Description
the number of blocks carried over the partition from one compartment to the other during the one-minute trial period
Time Frame
at study completion, an average of 1 month
Title
Change of Modified Barthel Index
Description
Evaluation of activities of daily living
Time Frame
at study completion, an average of 1 month
Title
Time of participation
Description
Total time of patient's participation in the study intervention
Time Frame
at study completion, an average of 1 month
Title
Patient's satisfaction
Description
Evaluation of patient's satisfaction to the study intervention using a Likert scale
Time Frame
at study completion, an average of 1 month
Title
Patient's discomfort
Description
Evaluation of patient's discomfort to the study intervention using a Likert
Time Frame
at study completion, an average of 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Korea Workers' Compensation & Welfare Service Incheon Hospital
City
Incheon
ZIP/Postal Code
21417
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Feasibility of Virtual Reality Games Using Head-mounted Display on Patients With Brain Disorders
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