Effect of Upper Extremity Rehabilitation Using Immersive Virtual Reality in Chronic Stroke Patients.

Study Overview
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Brief Summary
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The study aimed to investigate the effect of exergames using virtual reality with head mounted device on motor recovery of upper extremities in chronic stroke patients.

Detailed Description
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This is a crossover study for comparing conventional occupational therapy and exercise with game format using virtual reality (virtual reality exergame). The virtual reality exergame is designed to maximize the movement of upper extremities, primary to the shoulder and elbow. Thirty-six chronic stroke patient will receive conventional occupational treatment and virtual reality exergame in random order with a two-week-washout period. Outcome measures will be evaluated within two days before and after each treatment, conventional treatment and virtual reality exergame.

Official Title
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Effect of Upper Extremity Rehabilitation Using Fully-immersive Virtual Reality for Motor Recovery in Chronic Stroke Patients: A Prospective, Multicenter, Single-blind, Explorative, Randomized Crossover Trial

Conditions
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Stroke

Intervention / Treatment
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* Device: Virtual reality exergames
* Behavioral: Conventional occupational therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic stroke patients who have passed 6 months or more without additional stroke after the first stroke Patients with upper extremity dysfunction due to stroke (ischemic, hemorrhagic) Patients who can move the upper extremity against gravity with a manual muscle test of grade 3 or higher in the affected shoulder and elbow, respectively Patients who can stably maintain a sitting position Patients who voluntarily agreed to participate in the study Exclusion Criteria: Patients with moderate or severe cognitive impairment with a score of 18 or less on the Mini-Mental Status Examination (K-MMSE) Patients with other causes of upper extremity dysfunction, such as peripheral nerve damage, joint disease, etc. Patients with a history of severe vertigo or epilepsy Patients with medical reasons such as medical conditions that make it difficult to participate in research Patients who may be pregnant or who are pregnant or lactating

Ages Eligible for Study
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Minimum Age: 19 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional therapy first<br>Group receiving conventional occupational therapy first and then virtual reality exergames. | Device: Virtual reality exergames<br>* Twelve sessions of virtual reality exergames involving upper extremities will be conducted. Each session is 30 minutes and will be held 3 times a week. The washout period between the two types of interventions is 2 weeks.<br>Behavioral: Conventional occupational therapy<br>* Conventional occupational therapy involving upper extremities will be conducted. Each session is 30 minutes and will be held 3 times a week. The washout period between the two types of interventions is 2 weeks.<br>|
| Experimental: Virtual reality first<br>Group receiving virtual reality exergames with virtual reality first and then conventional occupational therapy. | Device: Virtual reality exergames<br>* Twelve sessions of virtual reality exergames involving upper extremities will be conducted. Each session is 30 minutes and will be held 3 times a week. The washout period between the two types of interventions is 2 weeks.<br>Behavioral: Conventional occupational therapy<br>* Conventional occupational therapy involving upper extremities will be conducted. Each session is 30 minutes and will be held 3 times a week. The washout period between the two types of interventions is 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Action Research Arm Test | As an upper extremity function evaluation tool, it tests grasp, grip, pinch, and gross arm movement function as sub-tests. | Within 2 days after the end of each intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Box and Block test | an upper extremity function evaluation tool | Within 2 days after the end of each intervention | 
| Fugl-Meyer (FM) Assessment | an upper extremity function evaluation tool | Within 2 days after the end of each intervention | 
| Modified Barthel Index | an evaluation tool for assessing activities of daily living | Within 2 days after the end of each intervention | 
| Grip strength | Strength of hand grip, palmar pinch and lateral pinch power measured by grip force meter | Within 2 days after the end of each intervention | 
| Beck Depression Inventory (BDI) | an evaluation tool for severity of depression in normal and psychiatric populations | Within 2 days after the end of each intervention | 
| Simulator Sickness Questionnaire | an evaluation tool for assessing the subjective severity of simulator sickness symptoms | Day 1 and Day 12 of virtual reality exergames intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Virtual reality, Upper Extremity Paresis