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Immersive VR in Stroke Pilot Study

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, virtual reality, rehabilitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • James A. Haley Veterans' Hospital, Tampa, FL

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Immersive Virtual Reality

Arm Description

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.

Outcomes

Primary Outcome Measures

Action Research Arm Test
measures recovery of arm and hand function
Fugl-Meyer Assessment Upper Extremity
measures problems with sensation and movement

Secondary Outcome Measures

Pain Outcomes Questionnaire-VA:Intake
level of pain
Pain Outcomes Questionnnaire-VA: Discharge
level of pain

Full Information

First Posted
June 10, 2020
Last Updated
January 4, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04429945
Brief Title
Immersive VR in Stroke Pilot Study
Official Title
Immersive Virtual Reality to Improve Outcomes in Patients With Stroke: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
December 14, 2022 (Actual)
Study Completion Date
December 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, virtual reality, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Once patients are enrolled, baseline data and pre-intervention outcome measures will be collected. APPs will be selected from the VR Toolkit that best address the individual patient's treatment goals. Patients will be instructed in the use of the head mounted display with VR APPs. VR dosage will be two one-half hour sessions per therapy day. Patients can initiate use of a more challenging APPs that gradually includes hand/arm movement.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immersive Virtual Reality
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Other Intervention Name(s)
Oculus Quest
Intervention Description
Virtual Reality Headset with Virtual Reality Applications
Primary Outcome Measure Information:
Title
Action Research Arm Test
Description
measures recovery of arm and hand function
Time Frame
4 weeks
Title
Fugl-Meyer Assessment Upper Extremity
Description
measures problems with sensation and movement
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Pain Outcomes Questionnaire-VA:Intake
Description
level of pain
Time Frame
baseline, pre-intervention
Title
Pain Outcomes Questionnnaire-VA: Discharge
Description
level of pain
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johanna E. Tran, MD
Organizational Affiliation
James A. Haley Veterans' Hospital, Tampa, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
James A. Haley Veterans' Hospital, Tampa, FL
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Immersive VR in Stroke Pilot Study

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