Efficacy of Virtual Reality in Upper Extremity Rehabilitation for Stroke Patients

Study Overview
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Brief Summary
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To investigate the therapeutic effect of including virtual reality-based digital content in the upper limb motor function rehabilitation of stroke patients and to develop a treatment method to improve the upper limb motor function of stroke patients in the future.

Official Title
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Efficacy of Virtual Reality in Upper Extremity Rehabilitation for Stroke Patients

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: VR-based occupational therapy


Participation Criteria
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Eligibility Criteria
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1. Inclusion Criteria for experimental group: Patients aged 19 to 80 years with unilateral stroke within 6 months of stroke onset Motor function evaluation: Patients showing moderate or lower upper limb dysfunction with an upper limb FMA (Fugl-Meyer Assessment) score of less than 58 points on the affected side. Patients receiving or planning to receive exercise rehabilitation treatment 5 days a week 2. Inclusion Criteria for control group: 1) Patients who have been admitted to our hospital's rehabilitation medicine department and received rehabilitation treatment within the past 5 years 2) Patients with unilateral stroke within 6 months of stroke onset who are between 19 and 80 years old at the time of hospitalization 3) Patients who were admitted to the rehabilitation medicine department of our hospital and received exercise rehabilitation treatment for 4 weeks, 5 days a week 4) Patients with similar characteristics below compared to the test group Age: Difference within 5 years Gait function: Functional Ambulatory Category (FAC) Upper extremity function: Fugl-Meyer Assessment (FMA) difference within 6 points Cognitive function: Korean Version of Mini Mental State Examination (K-MMSE) difference within 5 points Daily living skills: Korean Version of Modified Barthel Index (K-MBI) difference within 10 points 3. Exclusion Criteria: Accompanying existing serious neurogenic disease Cases accompanied by existing serious psychiatric diseases such as major schizophrenia, bipolar disorder, dementia, etc. Cases where it is difficult to understand task performance due to severe cognitive decline (Korean Mini-Mental State Examination, K-MMSE 10 points or less) If there are difficulties in conducting research Other patients who are judged by the principal investigator to have difficulty participating in this study.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Control group will be recruited by propensity matching with the experimental group according to the dataset from retrospective data
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stroke patients<br> | Behavioral: VR-based occupational therapy<br>* All patients will undergo 20 sessions of virtual reality based occupational therapy for 30 minutes a day, 5 days a week for 4weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment of upper extremity | Fugl-Meyer assessment for motor function of upper extremity in score | baseline, 4 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Korean version of modified Barthel index | Korean version of modified Barthel index for functional status in score | baseline, 4 weeks after intervention | 
| Korean version of mini mental state examination | Korean version of mini mental state examination for cognitive function in score | baseline, 4 weeks after intervention | 
| Grip and pinch strength test | Grip and pinch strength test for hand and finger strength in score | baseline, 4 weeks after intervention | 
| Nine-hole pegboard test | Nine-hole pegboard test for dexterity in seconds | baseline, 4 weeks after intervention | 
| Motion analysis | Motion analysis is a process of measuring and evaluating kinematic and kinetic parameters including moment (Nm/kg) and power(Nm/s*Kg) of each joint through Qualisys motion analysis system | baseline, 4 weeks after intervention |