Immersive Virtual Reality in Stroke Pilot Study

Stroke Clinical Trial

— VR  

Official title:

Immersive Virtual Reality to Improve Outcomes in Patients With Stroke: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04429945
• Other study ID #: N3449-P
• Secondary ID: I21RX003449
• Status: Completed
• Phase: N/A
• Start date: June 17, 2021
• Est. completion date: December 14, 2022

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Over 15,000 Veterans are treated by the VA for stroke each year. A stroke means that part of the brain dies. Many people who have a stroke have difficulty with moving their arm, using their hand, and they have pain. Virtual reality is a video-game based treatment that may help people with stroke improve in these areas. Virtual reality involves using a computer and goggles to make a person feel like they are in a different world with new sights and sounds, relaxing on a beach where there is no pain, or playing the piano. In virtual reality, stroke patients can practice movement in a safe and motivating environment. For example, a person with stroke who has weakness in his/her arm can safely reach for plates in a virtual cupboard. In a virtual environment, the plates can't break. This study will help investigators to determine if people with strokes who are treated with virtual reality like it, and if they have less pain and better movement.

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 environments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 14, 2022
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Virtual Reality
Virtual Reality Headset with Virtual Reality Applications

Locations

Country	Name	City	State
United States	James A. Haley Veterans' Hospital, Tampa, FL	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (48)

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* Note: There are 48 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Action Research Arm Test	The Action Research Arm Test includes 19 clinician-administered tests across 4 sub-domains: Grasp, Grip, Pinch, Gross Movement. Each test is scored on a 0 (no movement possible) to 3 (movement performed normally) scale. Within each domain a score of 3 on the first and hardest test, the remaining tests are also scored as 3. A score of 0 on the second, easiest test, remaining tests are scored as 0. Tests are summed within each domain: Grasp (range = 0-18), Grip (range = 0-12); Pinch (range = 0-18); Gross Movement (range = 0-9). A total score was then calculated by summing the scores from each sub-domains (range= 0-57) with higher scores indicating better hand dexterity.	4 weeks
Primary	Fugl-Meyer Assessment Upper Extremity	The Fugl-Meyer Assessment of Motor Recovery after Stroke-Upper Extremity is a measure of upper extremity stroke recovery, specifically functional impairment. It consists of 63 functional rests across 4 sub-domains: Joint Pain, Motor Function, Passive Joint Range of Motion, and Sensation. Each functional test is rated on a 0 to 2 scale with higher scores indicating greater functioning. Test scores were then summed within each sub-domain: Joint Pain (range = 0-24), Motor Function (range = 0-66); Passive Joint Range of Motion (range = 0-24); Sensation (range = 0-12). Within each sub-domain, higher scores indicate greater improvement in upper extremity function.	4 weeks
Secondary	Pain Outcomes Questionnaire-VA	The 0 (no pain at all) to 10 (worst pain possible) pain numeric rating scale from the Pain Outcomes Questionnaire-VA was used to measure post-stroke pain intensity.	4 weeks

External Links

•   Market projections for VR in Healthcare
•   SAS Macro for Effects Size Computations