Role of Functional Translation After Immersive Virtual Reality Exposure in Persons With Stroke

This is a single-blinded randomized control trial aiming to explore the use of immersive virtual reality (VR) training in conjunction with real-life tasks therapy in 75 first time stroke patients with upper limb weakness.

Study Overview

• Status: Completed
• Conditions: Hemiparesis as Late Effect of Cerebrovascular Disease
• Intervention / Treatment: Other: Immersive virtual reality + related functional translation into real-life; Other: Immersive virtual reality + non-related translation into real-life

Detailed Description

Patients will be randomized to a control or experimental group. The experimental group will receive immersive VR training followed by the translation of related tasks in a real life environment. The control group will perform the same tasks in a real life environment but will receive immersive VR exposure to a non-related task.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Tom and Vi Zapara Rehabilitation Pavilion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18-90 years old
2. Hospitalized at Loma Linda East Campus Rehabilitation Hospital
3. First time stroke patient
4. Upper limb hemiparesis
5. English-speaking
6. Manual muscle testing of at least 2/5 in 3 or more muscle groups in affected upper limb

Exclusion Criteria:

1. Active neck pain, headaches, or vertigo limiting ability to tolerate Virtual Reality Head Mounted Device
2. Patients with hemicraniectomy
3. Current uncontrolled seizures
4. Active infections requiring contact precautions
5. Cognitively unable to participate
6. Vision loss limiting ability to participate with VR therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Virtual reality followed by translation into related functional tasks in a real life setting for 2 weeks + conventional therapies	Other: Immersive virtual reality + related functional translation into real-life; The experimental group will perform tasks in an immersive virtual reality setting designed to encourage functional task performance for 30 minutes. The patient will then be brought to a real-life setting and evaluated on similar task performances for an additional 30 minutes for a total of 60 minutes per day, 3 times a week for 2 weeks.
Active Comparator: Control; Virtual reality followed by translation into non-related functional tasks in a real life setting for 2 weeks + conventional therapies	Other: Immersive virtual reality + non-related translation into real-life; The control group will also be asked to perform tasks in an immersive VR setting for 30 minutes, however tasks will be unrelated to the tasks performed in the real-life setting in the following 30 minutes. The control group will also receive 60 minutes of therapy a day, 3 times a week, for 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor Activity Log	ADL Self-Reported Questionnaire Amount Scale (0-5) 0 = Did not use my weaker arm (not used) 5 = Used my weaker arm as often as before the stroke (same as pre-stroke). How well scale (0-5) 0 - My weaker arm was not used at all for that activity (not used). 5 - The ability to use my weaker arm for that activity was as good as before the stroke (normal).	Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Barthel's Index	Quality of Life Self-Reported Questionnaire 80-100 Independent 60-79 Minimally dependent 40-59 Partially dependent 20-39 Very dependent <20 Totally dependent	Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
Fugl-Meyer Upper Extremity Assessment	Post-stroke upper extremity assessment Very severe = 0-35 Severe = 36-55 Moderate. = 56-79 Slight = >79	Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
Montreal Cognitive Assessment	Cognitive Assessment No cognitive impairment: MoCA ≥ 25 Mild cognitive impairment: MoCA 20-24 Severe cognitive impairment: MoCA < 20	Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
Functional Independence Measurement Score	Functional evaluation 7 - complete independence 6 - modified indepdendence 5 - supervision/Setup 4 - minimal contact assistance 3 - moderate assistance 2 - maximal assistance 1 - total assistance 0 - activity does not occur	Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Christopher Tarver, MD, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2020
• Primary Completion (Actual): August 18, 2022
• Study Completion (Actual): August 18, 2022

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Paresis; Cerebrovascular Disorders
• Other Study ID Numbers: 5200147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No