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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03196739
Other study ID # VRfeasibility1.2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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