Stroke
Conditions
Keywords
stroke, virtual reality, rehabilitation
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 environments.
Interventions
Virtual Reality Headset with Virtual Reality Applications
Sponsors
Study design
Intervention 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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm Test | 4 weeks | 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. |
| Fugl-Meyer Assessment Upper Extremity | 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Outcomes Questionnaire-VA | 4 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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). | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Single Arm Within-participants Pre-post |
|---|---|
| Action Research Arm Test | 29.60 Units on a Scale STANDARD_DEVIATION 22.68 |
| Age, Continuous | 67 Years STANDARD_DEVIATION 6.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fugl-Meyer Assessment of Motor Recovery after Stroke-Upper Extremity Joint Pain | 21.40 Units on a Scale STANDARD_DEVIATION 3.53 |
| Fugl-Meyer Assessment of Motor Recovery after Stroke-Upper Extremity Motor Function | 45.70 Units on a Scale STANDARD_DEVIATION 20.95 |
| Fugl-Meyer Assessment of Motor Recovery after Stroke-Upper Extremity Passive Joint ROM | 22.80 Units on a Scale STANDARD_DEVIATION 2.7 |
| Fugl-Meyer Assessment of Motor Recovery after Stroke-Upper Extremity Sensation | 11.20 Units on a Scale STANDARD_DEVIATION 1.69 |
| Pain Outcomes Questionnaire for Veterans - Pain Numeric Rating Scale | 1.40 units on a scale STANDARD_DEVIATION 2.67 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 2 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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.
Time frame: 4 weeks
Population: The target population was Veterans receiving care for a stroke in a Comprehensive Interdisciplinary Inpatient Rehabilitation Program.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm Within-participants Pre-post | Action Research Arm Test | 38.80 Units on a Scale | Standard Deviation 22.03 |
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.
Time frame: 4 weeks
Population: The target population was Veterans receiving care for a stroke in a Comprehensive Interdisciplinary Inpatient Rehabilitation Program.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm Within-participants Pre-post | Fugl-Meyer Assessment Upper Extremity | Joint Pain | 21.60 Units on a Scale | Standard Deviation 3.63 |
| Single Arm Within-participants Pre-post | Fugl-Meyer Assessment Upper Extremity | Motor Function | 51.90 Units on a Scale | Standard Deviation 18.64 |
| Single Arm Within-participants Pre-post | Fugl-Meyer Assessment Upper Extremity | Passive Joint ROM | 23.20 Units on a Scale | Standard Deviation 1.69 |
| Single Arm Within-participants Pre-post | Fugl-Meyer Assessment Upper Extremity | Sensation | 11.60 Units on a Scale | Standard Deviation 0.84 |
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.
Time frame: 4 weeks
Population: The target population was Veterans receiving care for a stroke in a Comprehensive Interdisciplinary Inpatient Rehabilitation Program.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm Within-participants Pre-post | Pain Outcomes Questionnaire-VA | 0.90 units on a scale | Standard Deviation 2.23 |