Immersive Virtual Reality Based Training for Rehabilitation of Subacute Stroke

Study Overview
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Brief Summary
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The investigators will conduct a single-blind, randomized controlled trial of 60 patients with subacute stroke. Patients will be randomly assigned into a control group and an intervention group. The intervention group will participate in immersion VR training for 3 weeks. The control group will receive for traditional rehabilitation training for 3 weeks. Then, the patients will be reevaluated to determine changes in upper extremity function, cognitive function, cortical and subcortical activation patterns, and performance of activities of daily living after the baseline assessment.

Official Title
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Immersive Virtual Reality Based Training for Motor Function Rehabilitation of Upper Limbs After Subacute Stroke：Study Protocol of a Randomized Clinical Trial

Conditions
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Immersion Virtual Reality Training ,Stroke, Upper Extremity, Randomized Controlled Trial

Intervention / Treatment
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* Other: immersion virtual reality (VR)-based rehabilitation
* Other: traditional rehabilitation training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: having had an ischemic stroke in the first time age 30 to 80 years old first stroke within 2 month GCS score >8 the upper-limb function BrunnstromⅡ、Ⅲ Exclusion Criteria: hemorrhage or transient ischemic attack(TIA) important organs such as heart, lung, liver, kidney function decline or failure previous history of brain neurosurgery or epilepsy had severe cognitive impairments or aphasia, which made the participants unable to understand the instructions given by the investigators with claustrophobia and body with metal (such as metal teeth, etc.) are not suitable for to MRI scanning

Ages Eligible for Study
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Minimum Age: 30 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The intervention group<br>The intervention group will participate in immersion virtual reality based rehabilitation training for 3 weeks. | Other: immersion virtual reality (VR)-based rehabilitation<br>* Intervention group received VR-based rehabilitation,including Virtual kitchen and so on.The patients took part in the exercise program for 30 minutes each day, five times per week, for 3 weeks. All subjects received physiotherapy, which accounts for an average of 30 minutes of physiotherapy per day on tolerance.<br>|
| Other: The control group<br>The control group will receive for traditional rehabilitation training for 3 weeks. | Other: traditional rehabilitation training<br>* The traditional rehabilitation training included occupational therapy and physical therapy, patients took part in the traditional rehabilitation training for 60 minutes each day, five times per week, for 3 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Arm Movement Ability at 3 months | The Fugl-Meyer Assessment | Baseline and at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Activities of Daily Living (ADL) at 3 months | The Barthel index | Baseline and at 3 months | 
| Change from Baseline Cognitive Function at 3 months | the Korea-MiniMental Status Evaluation (K-MMSE) | Baseline and at 3 months | 
| Change from Baseline Cortical and Subcortical Activation Patterns at 3 months | Functional MRI (fMRI) | Baseline and at 3 months |