Virtual Activities of Living for Occupational Rehabilitation
Condition(s) studied
Investigational drug(s) / intervention(s)
VALOR Home Exercise Program (HEP): 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.
Usual Care Treatment (UCT) Control: 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.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Fugl-Meyer Upper Extremity (FMUE) — baseline, post-treatment (baseline + 8 weeks), follow-up (3 months post-treatment)
The FMUE subscale incorporates 33 items relevant to shoulder, elbow, forearm, wrist, hand, and grasp function. Individual movements associated with specific motor functions are scored using a 3-point ordinal scale (0, 1, or 2), creating a possible range of 0 to 66 points. A higher score represents better motor function.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Duke University | Durham | North Carolina |
More Barron Associates, Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07450586 on ClinicalTrials.gov ↗ ← All trials in the USA