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| ID | Type | Description | Link |
|---|---|---|---|
| I21RX003449 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immersive Virtual Reality | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Device | Virtual Reality Headset with Virtual Reality Applications |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
-Veterans who have been diagnosed with
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johanna E. Tran, MD | James A. Haley Veterans' Hospital, Tampa, FL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James A. Haley Veterans' Hospital, Tampa, FL | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29313388 | Background | Tieri G, Morone G, Paolucci S, Iosa M. Virtual reality in cognitive and motor rehabilitation: facts, fiction and fallacies. Expert Rev Med Devices. 2018 Feb;15(2):107-117. doi: 10.1080/17434440.2018.1425613. Epub 2018 Jan 10. | |
| 24681826 | Background | Lohse KR, Hilderman CG, Cheung KL, Tatla S, Van der Loos HF. Virtual reality therapy for adults post-stroke: a systematic review and meta-analysis exploring virtual environments and commercial games in therapy. PLoS One. 2014 Mar 28;9(3):e93318. doi: 10.1371/journal.pone.0093318. eCollection 2014. |
| Label | URL |
|---|---|
| SAS Macro for Effects Size Computations | View source |
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No participants were excluded from study participation. This was due to inclusion/exclusion criteria alignment with admission criteria for the inpatient stroke rehabilitation program. The post-treatment measurement period was reduced from week 4 to week 3 secondary to COVID-19 hospital policies which prioritized shorter inpatient stays when feasible. Specifically, the hospital triage approach prioritized inpatient beds for COVID-19 patients
Veterans diagnosed with an acute ischemic or hemorrhagic stroke who were admitted to James A. Haley VA Hospital inpatient rehabilitation were recruited from 6/17/21 thru 9/7/22. Potential subjects were identified by the Physical Medicine & Rehabilitation Physician, PI Tran, or the study coordinator in Dr. Tran's absence. The PI and/or study coordinator used a HIPAA Waiver and a Waiver of Informed Consent to review inclusion/exclusion criteria with the medical records to determine eligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Within-participants Pre-post | The VR intervention uses off the shelf technology: Oculus Quest Head Mounted Display and commercially available APPs specifically developed or adapted for Oculus Quest. APP selection for individual patients will be guided by motor difficulty of the APPs. As tolerated, patients will advance to more difficult APPs which require hand and finger movement, with the high-level APPs requiring controlled movement. Participants will be measures at inpatient stroke rehabilitation program entry (baseline) and and again upon program discharge (post). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The target population was Veterans receiving care for a stroke in a Comprehensive Interdisciplinary Inpatient Rehabilitation Program.
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Within-participants Pre-post | The VR intervention uses off the shelf technology: Oculus Quest Head Mounted Display and commercially available APPs specifically developed or adapted for Oculus Quest. APP selection for individual patients will be guided by motor difficulty of the APPs. As tolerated, patients will advance to more difficult APPs which require hand and finger movement, with the high-level APPs requiring controlled movement. Participants will be measures at inpatient stroke rehabilitation program entry (baseline) and and again upon program discharge (post). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The target population was Veterans receiving care for a stroke in a Comprehensive Interdisciplinary Inpatient Rehabilitation Program. | Posted | Mean | Standard Deviation | Units on a Scale | 4 weeks |
|
Adverse events data was collected across the entire study, up to 15 months.
The therapeutic risks to subjects include the potential for "cybersickness" (e.g. vertigo, nausea), emotional adverse effects (e.g. fear, anxiety) and discomfort or inconvenience related to the VR equipment (e.g. ill-fitting headset, facial pain). VR, in general, is well tolerated and risks to subjects are expected to be small and, if present, mild in severity. The advantage of implementing this intervention in an inpatient environment is that adverse events can be immediately addressed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm Within-participants Pre-post | The VR intervention uses off the shelf technology: Oculus Quest Head Mounted Display and commercially available APPs specifically developed or adapted for Oculus Quest. APP selection for individual patients will be guided by motor difficulty of the APPs. As tolerated, patients will advance to more difficult APPs which require hand and finger movement, with the high-level APPs requiring controlled movement. Participants will be measured at inpatient stroke rehabilitation program entry (baseline) and and again upon program discharge (post). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cybersickness | Ear and labyrinth disorders | Non-systematic Assessment | Virtual reality induced dizziness, nausea, or motion sickness. |
COVID-19 hospital policy contributed to slow recruitment, reduced inpatient stays, and competition for beds. Low referral rates led to more higher functioning patients. Unreliable hospital Wifi presented challenges for using VR APPs and installing updates. Team competed for treatment times with clinical staff. Thus, twice daily sessions were often completed back-to-back. Storing devices in locked offices per IRB protocol limited clinical staff access to technology for further use with Veterans.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher Fowler | James A Haley Veterans Hospital | 619-647-4470 | christopher.fowler3@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 24, 2023 | Dec 14, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 15, 2021 | Oct 27, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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| Market projections for VR in Healthcare | View source |
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| Fugl-Meyer Assessment of Motor Recovery after Stroke-Upper Extremity | The 63-item Fugl-Meyer Assessment of Motor Recovery after Stroke-Upper Extremity is a measure of upper extremity stroke recovery, specifically functional impairment 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 function. Test scores were summed within each sub-domain: Joint Pain = 0-24, Motor Function = 0-66; Passive Joint Range of Motion = 0-24; Sensation = 0-12. Within each sub-domain, higher scores indicate greater improvement in upper extremity function. | Mean | Standard Deviation | Units on a Scale |
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| Action Research Arm Test | The Action Research Arm Test includes 19 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 for each domain: Grasp= 0-18, Grip= 0-12; Pinch= 0-18; Gross Movement= 0-9. A total score is then summed from sub-domains (range= 0-57) with higher scores indicating better hand dexterity. | Mean | Standard Deviation | Units on a Scale |
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| Pain Outcomes Questionnaire for Veterans - Pain Numeric Rating Scale | 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. | Mean | Standard Deviation | units on a scale |
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The VR intervention uses off the shelf technology: Oculus Quest Head Mounted Display and commercially available APPs specifically developed or adapted for Oculus Quest. APP selection for individual patients will be guided by motor difficulty of the APPs. As tolerated, patients will advance to more difficult APPs which require hand and finger movement, with the high-level APPs requiring controlled movement. Participants will be measures at inpatient stroke rehabilitation program entry (baseline) and and again upon program discharge (post). |
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| 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. | The target population was Veterans receiving care for a stroke in a Comprehensive Interdisciplinary Inpatient Rehabilitation Program. | Posted | Mean | Standard Deviation | Units on a Scale | 4 weeks |
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| 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. | The target population was Veterans receiving care for a stroke in a Comprehensive Interdisciplinary Inpatient Rehabilitation Program. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| 0 |
| 10 |
| 0 |
| 10 |
| 2 |
| 10 |
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| Headset discomfort. | Product Issues | Non-systematic Assessment | Discomfort or inconvenience related to the VR equipment (e.g. ill-fitting headset, facial pain). Subject felt itchiness on bridge of nose. Research staff placed band-aid on the bridge of participants nose to prevent itchiness. |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Title | Measurements |
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| Sensation |
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