Virtual Activities of Living for Occupational Rehabilitation

Official title

Virtual Activities of Living for Occupational Rehabilitation (VALOR)

Overview

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.

Interventions

• 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 vi
• 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 followin

Primary outcome measures

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

Secondary outcome measures (6)

• Wolf Motor Function Test (WMFT) [Time frame: baseline, post-treatment (baseline + 8 weeks), follow-up (3 months post-treatment)]
• Motor Activity Log (MAL) [Time frame: baseline, post-treatment (baseline + 8 weeks), follow-up (3 months post-treatment)]
• System Usability Scale (SUS) [Time frame: post-treatment (baseline + 8 weeks)]
• Technology Acceptance Model (TAM) [Time frame: post-treatment (baseline + 8 weeks)]
• Simulator Sickness Questionnaire (SSQ) [Time frame: weekly (during the 8-week intervention period)]
• Adherence metrics [Time frame: weekly (during the 8-week intervention period)]

Eligibility criteria

Criteria for inclusion:

• 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.

Criteria for exclusion:

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Duke University — Durham

Identifiers

NCT: NCT07450586 · VALOR · R44HD107718

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗