Role of Functional Translation After Immersive Virtual Reality Exposure in Persons With Stroke

Study Overview
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Brief Summary
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This is a single-blinded randomized control trial aiming to explore the use of immersive virtual reality (VR) training in conjunction with real-life tasks therapy in 75 first time stroke patients with upper limb weakness.

Detailed Description
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Patients will be randomized to a control or experimental group. The experimental group will receive immersive VR training followed by the translation of related tasks in a real life environment. The control group will perform the same tasks in a real life environment but will receive immersive VR exposure to a non-related task.

Official Title
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Role of Functional Translation After Immersive Virtual Reality Exposure in Persons With Stroke

Conditions
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Hemiparesis as Late Effect of Cerebrovascular Disease

Intervention / Treatment
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* Other: Immersive virtual reality + related functional translation into real-life
* Other: Immersive virtual reality + non-related translation into real-life


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-90 years old Hospitalized at Loma Linda East Campus Rehabilitation Hospital First time stroke patient Upper limb hemiparesis English-speaking Manual muscle testing of at least 2/5 in 3 or more muscle groups in affected upper limb Exclusion Criteria: Active neck pain, headaches, or vertigo limiting ability to tolerate Virtual Reality Head Mounted Device Patients with hemicraniectomy Current uncontrolled seizures Active infections requiring contact precautions Cognitively unable to participate Vision loss limiting ability to participate with VR therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Virtual reality followed by translation into related functional tasks in a real life setting for 2 weeks + conventional therapies | Other: Immersive virtual reality + related functional translation into real-life<br>* The experimental group will perform tasks in an immersive virtual reality setting designed to encourage functional task performance for 30 minutes. The patient will then be brought to a real-life setting and evaluated on similar task performances for an additional 30 minutes for a total of 60 minutes per day, 3 times a week for 2 weeks.<br>|
| Active Comparator: Control<br>Virtual reality followed by translation into non-related functional tasks in a real life setting for 2 weeks + conventional therapies | Other: Immersive virtual reality + non-related translation into real-life<br>* The control group will also be asked to perform tasks in an immersive VR setting for 30 minutes, however tasks will be unrelated to the tasks performed in the real-life setting in the following 30 minutes. The control group will also receive 60 minutes of therapy a day, 3 times a week, for 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Activity Log | ADL Self-Reported Questionnaire Amount Scale (0-5) 0 = Did not use my weaker arm (not used) 5 = Used my weaker arm as often as before the stroke (same as pre-stroke). How well scale (0-5) 0 - My weaker arm was not used at all for that activity (not used). 5 - The ability to use my weaker arm for that activity was as good as before the stroke (normal). | Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Barthel's Index | Quality of Life Self-Reported Questionnaire 80-100 Independent 60-79 Minimally dependent 40-59 Partially dependent 20-39 Very dependent <20 Totally dependent | Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks) | 
| Fugl-Meyer Upper Extremity Assessment | Post-stroke upper extremity assessment Very severe = 0-35 Severe = 36-55 Moderate. = 56-79 Slight = >79 | Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks) | 
| Montreal Cognitive Assessment | Cognitive Assessment No cognitive impairment: MoCA ≥ 25 Mild cognitive impairment: MoCA 20-24 Severe cognitive impairment: MoCA < 20 | Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks) | 
| Functional Independence Measurement Score | Functional evaluation 7 - complete independence 6 - modified indepdendence 5 - supervision/Setup 4 - minimal contact assistance 3 - moderate assistance 2 - maximal assistance 1 - total assistance 0 - activity does not occur | Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks) |