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Immersive Virtual Reality in Stroke Pilot Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04429945
Acronym
VR
Enrollment
10
Registered
2020-06-12
Start date
2021-06-17
Completion date
2022-12-14
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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

DEVICEVirtual Reality

Virtual Reality Headset with Virtual Reality Applications

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Action Research Arm Test4 weeksThe 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 Extremity4 weeksThe 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

MeasureTime frameDescription
Pain Outcomes Questionnaire-VA4 weeksThe 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

ArmCount
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
Total10

Baseline characteristics

CharacteristicSingle Arm Within-participants Pre-post
Action Research Arm Test29.60 Units on a Scale
STANDARD_DEVIATION 22.68
Age, Continuous67 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 Scale1.40 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 typeEG000
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

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.

Time frame: 4 weeks

Population: The target population was Veterans receiving care for a stroke in a Comprehensive Interdisciplinary Inpatient Rehabilitation Program.

ArmMeasureValue (MEAN)Dispersion
Single Arm Within-participants Pre-postAction Research Arm Test38.80 Units on a ScaleStandard Deviation 22.03
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.

Time frame: 4 weeks

Population: The target population was Veterans receiving care for a stroke in a Comprehensive Interdisciplinary Inpatient Rehabilitation Program.

ArmMeasureGroupValue (MEAN)Dispersion
Single Arm Within-participants Pre-postFugl-Meyer Assessment Upper ExtremityJoint Pain21.60 Units on a ScaleStandard Deviation 3.63
Single Arm Within-participants Pre-postFugl-Meyer Assessment Upper ExtremityMotor Function51.90 Units on a ScaleStandard Deviation 18.64
Single Arm Within-participants Pre-postFugl-Meyer Assessment Upper ExtremityPassive Joint ROM23.20 Units on a ScaleStandard Deviation 1.69
Single Arm Within-participants Pre-postFugl-Meyer Assessment Upper ExtremitySensation11.60 Units on a ScaleStandard Deviation 0.84
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.

Time frame: 4 weeks

Population: The target population was Veterans receiving care for a stroke in a Comprehensive Interdisciplinary Inpatient Rehabilitation Program.

ArmMeasureValue (MEAN)Dispersion
Single Arm Within-participants Pre-postPain Outcomes Questionnaire-VA0.90 units on a scaleStandard Deviation 2.23

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026