NCT07450586

Virtual Activities of Living for Occupational Rehabilitation

Virtual Activities of Living for Occupational Rehabilitation (VALOR)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Barron Associates, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 will be enrolled in the study. Half will be randomized to each condition. Following administration of informed consent, participants will be scheduled for a pre-assessment outpatient visit involving administration of a battery of gold-standard UE function tests by a blinded study therapist. These include: the FMUE, the WMFT, and the MAL. In this initial visit, the therapist will also perform a headset fitting and screening for sensory or behavioral concerns. Subjects will then be randomized to either the VALOR HEP or UCT control group. Subjects assigned to VALOR HEP will participate in an additional outpatient visit with a non-blinded study therapist in which the subjects are introduced to and trained on independent use of the VALOR system. Upon completion of this visit, subjects will be provided with a VALOR system to take home. VALOR HEP assigned subjects will subsequently be asked to employ the VALOR system for UE practice at home with 4 sessions per week, 45 minutes/session, over an 8-week period. See Potential Risks for details regarding patient monitoring, mitigations, and contingencies for potential VR sickness. Patients who do not tolerate the VR headset will be offered a PC version of the system. Patients in the UCT group will not receive any treatment through the study and will continue to receive any previously prescribed therapy services. Every week during the 8-week VALOR HEP participation period, a non-blinded study therapist will review patient progress using the VALOR provider dashboard web application. Every other week during the 8-week VALOR HEP participation period (4 times total), a non-blinded study therapist will conduct a telehealth visit (e.g., Zoom Health) with the patient to review progress, set goals, and address other concerns. This includes completion of the SSQ to assess potential cybersickness. In the final telehealth visit, participants will be asked to respond to questionnaire-based instruments including the System Usability Scale (SUS) instrument, the Technology Acceptance Model (TAM), and a narrative format patient interview. At the end of the 8-week participation, all subjects (both VALOR HEP and UCT) will return for a post-assessment visit during which a blinded therapist will administer the same battery of tests used in pre-assessment. All subjects will additionally be asked to return for a follow-up assessment approximately 3 months after post-assessment, during which a blinded therapist will administer the same battery of tests used in pre- and post-assessment. To promote equipoise, participants in the UCT group will be offered training and free access to the VALOR software system following completion of the study.

Conditions

• Stroke
• Occupational Therapy
• Activities of Daily Living
• Rehabilitation
• Virtual Reality

Interventions

Type	Name	Description
DEVICE	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.
OTHER	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.

Timeline

• Start date: 2026-06-15
• Primary completion: 2027-03-31
• Completion: 2027-07-29
• First posted: 2026-03-04
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study