Virtual Activities of Living for Occupational Rehabilitation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBarron Associates, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
VALOR Home Exercise Program (HEP)
DeviceThe 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 interventionParticipants 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.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: VALOR Home Exercise Program (HEP)Experimental treatment 1 intervention
Group B: Usual Care Treatment (UCT) ControlActive comparator 1 intervention
Trial outcomes
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.
Time frame
baseline, post-treatment (baseline + 8 weeks), follow-up (3 months post-treatment)Secondary outcomes
1
Wolf Motor Function Test (WMFT)
The test consists of 15 motor tasks scored both for time and quality of movement. WMFT-TIME is a quantitative measure calculated using the average time to complete the tasks. Lower WMFT-TIME represents better function. The WMFT Functional Assessment (WMFT-FA) is an observational assessment of movement quality and scored using a ordinal rating scale that ranges from 0 to 5. A total WMFT-FA score is calculated by taking the average over all tasks. A higher WMFT-FA score represents better function.
Time frame
baseline, post-treatment (baseline + 8 weeks), follow-up (3 months post-treatment)2
Motor Activity Log (MAL)
The MAL is a self-assessment of use of the stroke affected arm in 30 daily activities in the client's real-life experience. The amount and quality of use is graded on a 6 level Likert scale. A total score is calculated by taking the average over all activities. A higher score represents better use/quality.
Time frame
baseline, post-treatment (baseline + 8 weeks), follow-up (3 months post-treatment)3
System Usability Scale (SUS)
A widely-accepted Likert-scale instrument for assessing the usability of systems and software. SUS yields a score ranging from 0 to 100. Higher score indicates better usability.
Time frame
post-treatment (baseline + 8 weeks)4
Technology Acceptance Model (TAM)
Likert-scale instrument supporting assessment of the relationship between patient perception, behavioral preferences, socio-demographic factors, and system usage. There are 32 questions. Responses are coded as: 1 = Strongly Disagree, 2 = Disagree, 3 = Agree, 4 = Strongly Agree. The theoretical range is thus \[32, 128\]. Higher scores indicate greater acceptance.
Time frame
post-treatment (baseline + 8 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Barron Associates, Inc.
Lead sponsor
Duke University
Collaborator
Source ClinicalTrials.gov
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