Virtual Activities of Living for Occupational Rehabilitation (VALOR)
Barron Associates, Inc.
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.
Description
Duke University will serve as the clinical research site for the Phase II RCT, under the direction of Jody Feld, PT, DPT, PhD, and Assistant Professor in Department of Orthopaedic Surgery and Department of Neurology. The team will be supported by an experienced Clinical Research Coordinator (CRC), an experienced OT research advisor and the OT staff of Duke Health. The study design is a single site rater-blinded randomized trial comparing the effects of a VALOR HEP to a UCT control condition. Up to 48 adults with a history of a right or left hemispheric stroke that affects normal hand function…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Criteria for inclusion: 1. Participant has had a right or left hemispheric stroke affecting normal hand function. 2. At least 3 months have passed since the last stroke. 3. Participant has sufficient active finger flexion at the MCP joint in at least one finger to be detected by visual observation by a study therapist. 4. Participant has visual acuity with corrective lenses of 20/50 or better. 5. Participant must have active movement against gravity of at least 30 degrees shoulder flexion, 45 degrees elbow flexion, elbow extension to within 30 degrees of full extension, and 15 degrees shoulde…
Interventions
- DeviceVALOR 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.
- OtherUsual 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.
Location
- Duke UniversityDurham, North Carolina