Virtual Activities of Living for Occupational Rehabilitation (NCT07450586) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Virtual Activities of Living for Occupational Rehabilitation
United States48 participantsStarted 2026-06-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Participant has had a right or left hemispheric stroke affecting normal hand function.
✓. At least 3 months have passed since the last stroke.
✓. 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.
✓. Participant has visual acuity with corrective lenses of 20/50 or better.
✓. 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 shoulder internal and external rotation.
✓. In the opinion of a study therapist, participant can independently and safely use the system at home or has an at-home caregiver who is willing and able to assist.
✓. In the opinion of a study therapist, participant has a suitable and safe space in their home for using the VALOR system.
✓. Participant is willing and able to provide informed consent.
Exclusion criteria
✕. Withholding or withdrawal of consent by the participant.
✕. Inability to understand and follow verbal directions.
✕. Determination by the Principal Investigator that participation would result in overexertion or significant discomfort or pain.
. A psychological diagnosis that in the determination of the Principal Investigator could significantly impact subject's participation or that could be aggravated by study participation (Principal Investigator will consult with candidate's personal physician as appropriate).
✕. Determination by the Principal Investigator that participation would result in significant agitation or elevated stress.
✕. Visual field deficit in either eye that impairs the ability to view the VR display.
✕. Significant contractures of the muscles, joints, tendons, ligaments, or skin that restrict normal upper extremity movement.
✕. More than mild tone/spasticity (measured on modified Ashworth, 5-point scale);