Virtual Activities of Living for Occupational Rehabilitation

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Barron Associates, Inc.
Study ID
NCT07450586
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VALOR Home Exercise Program (HEP) — DEVICE
    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 — OTHER
    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 Details

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.

Key Dates

Start date
Jun 15, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Jul 29, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Fugl-Meyer Upper Extremity (FMUE) [ Time Frame: baseline, post-treatment (baseline + 8 weeks), follow-up (3 months post-treatment) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27705
Jody Feld, DPT, PhD
[email protected]
919-681-1979
Mary-Margaret Remchak, Ph.D.
[email protected]
919-681-0635

Find similar trials in Durham, NC

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Duke University· Durham, NC

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