Trial Outcomes & Findings for Immersive Virtual Reality in Stroke Pilot Study (NCT NCT04429945)

Last Updated: 2024-02-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

4 weeks

Results posted on

2024-02-28

Participant Flow

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.

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

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immersive Virtual Reality in Stroke Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm Within-participants Pre-post n=10 Participants 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).
Age, Continuous	67 Years STANDARD_DEVIATION 6.83 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants
Fugl-Meyer Assessment of Motor Recovery after Stroke-Upper Extremity Joint Pain	21.40 Units on a Scale STANDARD_DEVIATION 3.53 • n=5 Participants
Fugl-Meyer Assessment of Motor Recovery after Stroke-Upper Extremity Motor Function	45.70 Units on a Scale STANDARD_DEVIATION 20.95 • n=5 Participants
Fugl-Meyer Assessment of Motor Recovery after Stroke-Upper Extremity Passive Joint ROM	22.80 Units on a Scale STANDARD_DEVIATION 2.70 • n=5 Participants
Fugl-Meyer Assessment of Motor Recovery after Stroke-Upper Extremity Sensation	11.20 Units on a Scale STANDARD_DEVIATION 1.69 • n=5 Participants
Action Research Arm Test	29.60 Units on a Scale STANDARD_DEVIATION 22.68 • n=5 Participants
Pain Outcomes Questionnaire for Veterans - Pain Numeric Rating Scale	1.40 units on a scale STANDARD_DEVIATION 2.67 • n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome measures
Measure	Single Arm Within-participants Pre-post n=10 Participants 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).
Action Research Arm Test	38.80 Units on a Scale Standard Deviation 22.03

PRIMARY outcome

Timeframe: 4 weeks

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

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.

Outcome measures

Outcome measures
Measure	Single Arm Within-participants Pre-post n=10 Participants 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).
Fugl-Meyer Assessment Upper Extremity Joint Pain	21.60 Units on a Scale Standard Deviation 3.63
Fugl-Meyer Assessment Upper Extremity Motor Function	51.90 Units on a Scale Standard Deviation 18.64
Fugl-Meyer Assessment Upper Extremity Passive Joint ROM	23.20 Units on a Scale Standard Deviation 1.69
Fugl-Meyer Assessment Upper Extremity Sensation	11.60 Units on a Scale Standard Deviation 0.84

SECONDARY outcome

Timeframe: 4 weeks

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

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.

Outcome measures

Outcome measures
Measure	Single Arm Within-participants Pre-post n=10 Participants 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).
Pain Outcomes Questionnaire-VA	0.90 units on a scale Standard Deviation 2.23

Adverse Events

Single Arm Within-participants Pre-post

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Single Arm Within-participants Pre-post n=10 participants at risk 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).
Ear and labyrinth disorders Cybersickness	10.0% 1/10 • Number of events 2 • 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.
Product Issues Headset discomfort.	10.0% 1/10 • Number of events 4 • 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.

Additional Information

Dr. Christopher Fowler

James A Haley Veterans Hospital

Phone: 619-647-4470

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place