Virtual Reality in Stroke Rehabilitation

Study Overview
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Brief Summary
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The purpose of this research study is to investigate the effects of Virtual Reality (VR) as a treatment intervention to increase physical and cognitive function in stroke survivors.

Detailed Description
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In this pilot study, the objective is to determine if there is an increase in MoCA (Montreal Cognitive Assessment), MFRT (Modified Functional Reach Test), and FMA-UA (Fugl-Meyer Assessment Upper Extremity) scores of participants who receive the VR intervention in addition to traditional inpatient rehabilitation standard of care (experimental group) versus participants who receive the traditional standard of care (control group).

Official Title
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Efficacy of Virtual Reality in Stroke Rehabilitation

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: Virtual Reality (VR) System
* Procedure: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients Age 18 and older admitted to inpatient rehabilitation with a projected LOS (length of stay) of 10 days or more within the open data collection period for treatment of ischemic stroke and agree to participate in the study in addition to traditional intensive rehabilitation therapy. Exclusion Criteria: Individual patients who exhibit the following symptoms or medical history or are not medically cleared for participation will be excluded: History of, or high risk for, seizures Feed tube, tracheotomy, or other medical devices that would preclude the use or wear of the VR headset as it covers the face and head Blindness History of mental health issues such as schizophrenia, manic episodes, active psychosis, or other mental health issues that may be exacerbated by exposure to VR Open wounds that would preclude use for the VR headset

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group- Virtual Reality (VR) Treatment<br>The participants in the experimental group will complete the educational/training session on how to use the VR equipment and programs (30 minutes). The following day, participants will begin the VR intervention attending a daily 30-minute sessions for 8 days or until a discharge date has been set, whichever comes first. | Device: Virtual Reality (VR) System<br>* The participants will undergo daily 30-minute sessions for 8 days of Virtual Reality (VR) with a VR system using commercially available default programs in addition to traditional intensive therapy regimen provided during inpatient rehab.<br>Procedure: Standard of care<br>* Control group participants will receive the traditional daily 30-minute intensive therapy regimen provided during acute inpatient rehabilitation stroke treatment protocol.<br>|
| Active Comparator: Standard of care group<br>The control group participants will receive the traditional daily 30-minute intensive therapy regimen provided during acute inpatient rehabilitation stroke treatment protocol. Prior to discharge, control group participants will meet with a licensed clinical therapist to complete the cognitive and physical assessments for the posttest evaluation. | Procedure: Standard of care<br>* Control group participants will receive the traditional daily 30-minute intensive therapy regimen provided during acute inpatient rehabilitation stroke treatment protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment (MoCA) | Scores range from 0 to 30 with higher scores denoting better outcomes. | baseline | 
| Montreal Cognitive Assessment (MoCA) | Scores range from 0 to 30 with higher scores denoting better outcomes. | Up to 8 days after baseline | 
| Modified Functional Reach Test (MFRT) | The Modified Functional Reach Test will be used to measure physical functioning. Measurements are the maximum distance the patient can reach forward while sitting in a fixed position. A score of 6 or less indicates a significant increased risk of falls. A score between 6-10 inches indicates a moderate risk for falls. | baseline | 
| Modified Functional Reach Test (MFRT) | The Modified Functional Reach Test will be used to measure physical functioning. Measurements are the maximum distance the patient can reach forward while sitting in a fixed position. A score of 6 or less indicates a significant increased risk of falls. A score between 6-10 inches indicates a moderate risk for falls. | Up to 8 days after baseline | 
| FMA-UE (Fugl-Meyer Assessment for Upper Extremity) | Fugl-Meyer Assessment for Upper Extremity will be used to measure upper extremity motor function. Scores range from 0 (unable to do the task) to 66 (task performed fully). Higher scores denote better outcome. | baseline | 
| FMA-UE (Fugl-Meyer Assessment for Upper Extremity) | Fugl-Meyer Assessment for Upper Extremity will be used to measure upper extremity motor function. Scores range from 0 (unable to do the task) to 66 (task performed fully). Higher scores denote better outcome. | Up to 8 days after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity self-report ratings | For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity. | prior to VR treatment, day 1, and days 2, 3, 4, 5, 6, 7, and 8 after baseline | 
| Pain intensity self-report ratings | For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity. | immediately after VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline | 
| Wong-Baker FACES scale | For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity. | prior to VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline | 
| Wong-Baker FACES scale | For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity. | immediately after VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Stroke, National Stroke Association, Stroke Rehabilitation