Virtual Activities of Living for Occupational Rehabilitation

NCT07450586 | Not Yet Recruiting FDA Device

• 2 other identifiers: VALORR44HD107718
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Stroke Rehabilitation; Virtual Reality; Upper Extremity; Telehealth; Home Exercise Program; Activities of Daily Living; Fugl-Meyer Assessment; Wolf Motor Function Test; Motor Activity Log; Hand Function; Hemiplegia; Occupational Therapy

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Upper Extremity (FMUE)

  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.

  baseline, post-treatment (baseline + 8 weeks), follow-up (3 months post-treatment)

Secondary Outcomes (6)

• Wolf Motor Function Test (WMFT)

  baseline, post-treatment (baseline + 8 weeks), follow-up (3 months post-treatment)

• Motor Activity Log (MAL)

  baseline, post-treatment (baseline + 8 weeks), follow-up (3 months post-treatment)

• System Usability Scale (SUS)

  post-treatment (baseline + 8 weeks)

• Technology Acceptance Model (TAM)

  post-treatment (baseline + 8 weeks)

• Simulator Sickness Questionnaire (SSQ)

  weekly (during the 8-week intervention period)

Study Arms (2)

VALOR Home Exercise Program (HEP)

EXPERIMENTAL

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.

Device: VALOR Home Exercise Program (HEP)

Usual Care Treatment (UCT) Control

ACTIVE COMPARATOR

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.

Other: Usual Care Treatment (UCT) Control

Interventions

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.

Usual Care Treatment (UCT) Control

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.

VALOR Home Exercise Program (HEP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• Severe pre-stroke co-morbidities, such as cardiovascular, neurological, orthopedic, or rheumatoid impairments before stroke that may interfere with task performance.
• Severe sensory deficits from the involved UE; or
• Hemispatial neglect that impairs the ability to process and perceive visual stimuli provided through the VR display.
• As the system will be adaptable to a wide range of hand dexterity, no restriction will be made for fine control of digits. Patients will not be excluded due to inability to use the VR headset. If at any time the study therapist, in consultation with the Duke PI, determines the patient is not tolerating VR headset use, the patient will be given the option to use a non-immersive version of the VALOR system which employs a TV monitor and depth sensor in lieu of the headset. Please see Potential Risks section for additional details on controls and mitigations for potential cyber sickness.

Sponsors & Collaborators

• Duke University: collaborator
• Barron Associates, Inc.: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

Related Links

• ClinicalTrials.gov

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Richard Adams

CONTACT

434-825-3435; adams@bainet.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Rater-blinded: outcome assessors blinded to group assignment; participants, therapists, and telehealth providers not blinded due to intervention nature.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: VALOR HEP (immersive VR home exercise) vs. Usual Care Treatment (UCT) control with telehealth monitoring.

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 4, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): July 29, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)