Immersive Virtual Reality in Stroke Pilot Study

NCT04429945 | Completed Results FDA Device

• 2 other identifiers: N3449-PI21RX003449
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; virtual reality; rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Pain Outcomes Questionnaire-VA

  4 weeks

Study Arms (1)

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.

Device: Virtual Reality

Interventions

Virtual Reality DEVICE

Virtual Reality Headset with Virtual Reality Applications

Also known as: Oculus Quest

Immersive Virtual Reality

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unable to follow instructions or participate in immersive VR therapy due to significant cognitive impairment,
• History of seizures.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

Related Publications (48)

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Related Links

• SAS Macro for Effects Size Computations
• Market projections for VR in Healthcare

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Christopher Fowler
• Organization: James A Haley Veterans Hospital

christopher.fowler3@va.gov

619-647-4470

Study Officials

• Johanna E. Tran, MD

  James A. Haley Veterans' Hospital, Tampa, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: June 17, 2021
• Primary Completion: December 14, 2022
• Study Completion: December 14, 2022
• Last Updated: February 28, 2024
• Results First Posted: February 28, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)