Immersive VR in Stroke Pilot Study
Keywords
Abstract
Description
Background. Over the last decade, Virtual Reality (VR) has emerged as a cutting-edge technology in stroke rehabilitation. VR is defined as a type of user-computer interface that implements real-time simulation of an activity or environment allowing user interaction via multiple sensory modalities. VR interventions in a stroke population have been shown to be equivalent to usual care therapies and to enhance motor recovery when utilized as an adjunct. Significance/Impact/Innovation. This research will advance knowledge in rehabilitation research by testing state-of-the-art immersive 3-dimensional VR technology with the post-acute stroke Veteran population. The proposed project addresses: (1) the RR&D goal of maximizing functional recovery, (2) interest in non-pharmacological activity-based interventions for pain, and (3) supports modernization of the Veterans' Health Administration by incorporating technology-assisted rehabilitation.
Specific Aims. (1) Determine the feasibility and tolerability of using a therapeutic VR platform in an inpatient comprehensive stroke rehabilitation program and (2) Estimate the initial clinical efficacy, or effect size, associated with the VR platform using APPS for distraction and upper extremity exercise for Veterans post-stroke.
Methodology. Prospective within-subject pre-post pilot and survey study designs will be used. The target populations are (1) clinical staff who work on the Comprehensive Interdisciplinary Inpatient Rehabilitation Program (CIIRP) at the James A. Haley Veterans' Hospital (JAHVH) in Tampa (sample size N=10) and Veterans who are inpatients in the CIIRP (sample size N=10). The VR intervention consists of wearing a head mounted display that plays APPs ranging from music and nature views for pain distraction to more challenging strengthening and coordination activities such as playing the piano virtually. The intervention will last four weeks. The analytic approach will use descriptive statistics and qualitative methods. Aim 1 will administer a survey with open and closed ended questions to clinicians to examine the feasibility of successfully integrating a VR intervention into the flow of usual care. Feasibility constructs include adaptability (can VR intervention be adapted to an inpatient unit), patient need (do Veterans like and benefit from the intervention), and staff comments/impressions. Responses for each construct will be entered into an excel spreadsheet, one tab for each construct. Responses will then be grouped by similar content. Results will be reported as themes and subthemes. Aim 1 will also track patient VR tolerability by documenting and discussing patient complaints and adverse events. Tolerability data will be extracted from meeting minutes and grouped by similar occurrences. Results will be reported as themes and subthemes. Aim 2 will estimate effect sizes and degree of precision for upper extremity neurologic recovery, hand dexterity, and pain outcomes measured pre and post VR intervention. Neurologic recovery is measured with the Fugl-Meyer Assessment of Motor Recovery after Stroke-Upper Extremity, dexterity is measured with the Action Research Arm Test, and pain is measured with the Pain Outcomes Questionnaire-VA. Because standard scores do not necessarily translate to meaningful clinical differences (improvements), the investigators will identify the proportion of subjects who experience the minimal clinically important difference (MCID). Metrics will also be compared across outcomes.
Next Steps/Implementation. Our next step is to work with our Program Partner in the Physical Medicine and Rehabilitation Office to conduct a large multi-site clinical trial that will incorporate the lessons learned from this feasibility pilot study to test the efficacy of a VR intervention in inpatient rehabilitation and transition to home evironments.
Dates
Last Verified: | 05/31/2020 |
First Submitted: | 06/09/2020 |
Estimated Enrollment Submitted: | 06/09/2020 |
First Posted: | 06/11/2020 |
Last Update Submitted: | 06/14/2020 |
Last Update Posted: | 06/16/2020 |
Actual Study Start Date: | 12/31/2020 |
Estimated Primary Completion Date: | 10/30/2022 |
Estimated Study Completion Date: | 10/30/2022 |
Condition or disease
Intervention/treatment
Device: Immersive Virtual Reality
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Experimental: Immersive Virtual Reality A Virtual Reality headset will be used for 30 minutes twice per day outside of usual therapy times while in bed with bedrails raised. Virtual Reality games will be selected that will help with relaxation, pain, and arm and hand recovery after a stroke. | Device: Immersive Virtual Reality Virtual Reality Headset with Virtual Reality Applications |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
Criteria | Inclusion Criteria: -Veterans who have been diagnosed with - an acute ischemic or hemorrhagic stroke and - post-stroke are admitted to James A. Haley Veterans' Hospital inpatient rehabilitation - age 18-80 with stroke diagnosis verified by brain imaging. Exclusion Criteria: - Unable to follow instructions or participate in immersive VR therapy due to significant cognitive impairment, - History of seizures. |
Outcome
Primary Outcome Measures
1. Action Research Arm Test [4 weeks]
2. Fugl-Meyer Assessment Upper Extremity [4 weeks]
Secondary Outcome Measures
1. Pain Outcomes Questionnaire-VA:Intake [baseline, pre-intervention]
2. Pain Outcomes Questionnnaire-VA: Discharge [4 weeks]