Virtual Reality Exercises for Stroke Rehabilitation
(VALOR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Duke University will serve as the clinical research site for the Phase II RCT of the VALOR system, which enables telehealth delivery of evidence-based upper extremity (UE) stroke therapy in a patient's home using immersive VR headset technology for guided practice of activities of daily living (ADLs) and instrumental ADLs (IADLs). The study compares VALOR Home Exercise Program (HEP) to Usual Care Treatment (UCT) in adults with stroke-related UE impairment.
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-assessment
Participants undergo a pre-assessment visit involving administration of a battery of gold-standard UE function tests and headset fitting
Treatment
Participants in the VALOR HEP group use the VR system for UE practice at home, while UCT group continues usual care
Post-assessment
Participants return for a post-assessment visit to undergo the same battery of tests used in pre-assessment
Follow-up
Participants are monitored for safety and effectiveness after treatment with a follow-up assessment approximately 3 months after post-assessment
What Are the Treatments Tested in This Trial?
Interventions
- VALOR Home Exercise Program (HEP)
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The VALOR HEP will employ the Phase II-developed VR software for practice of ADL and IADLs with a commercial VR headset (Meta Quest). Independent at-home sessions will include completion of multiple activities targeting specific gross and fine motor skills. Patients will receive instruction on the VALOR system and HEP protocol during an initial outpatient visit, during which a study therapist will verify the patient's ability to safely and successfully use the system. An additional outpatient visit may be conducted if necessary to achieve proficiency. Participants will then be asked to employ the system for UE practice at home 45 minutes/day, 4 days/week over an 8-week period. Once per week, a study therapist will use a secure web application to remotely review adherence, dosage, and performance; and adjust the treatment plan as needed. Every other week, a study therapist will conduct a synchronous telehealth visit with the patient to verify health status, review progress, and update.
Participants assigned to the UCT group will be followed as they continue to receive their previously prescribed therapy services. These subjects will not receive any treatment services through the study as UCT group participants. Every other week, a study therapist will contact UCT group subjects to verify health status and collect information on other therapy services the patient is receiving. To promote equipoise, patients in the UCT group will be provided free access to the VALOR HEP following completion of the control protocol.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Barron Associates, Inc.
Lead Sponsor
Duke University
Collaborator
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