Virtual Activities of Living for Occupational Rehabilitation (VALOR)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Upper Extremity (FMUE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Rater-blinded: outcome assessors blinded to group assignment; participants, therapists, and telehealth providers not blinded due to intervention nature.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: VALOR Home Exercise Program (HEP) (Device)
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.
干预措施: Usual Care Treatment (UCT) Control (Other)
结局指标
主要结局
Fugl-Meyer Upper Extremity (FMUE)
时间窗: baseline, post-treatment (baseline + 8 weeks), follow-up (3 months post-treatment)
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.
次要结局
- 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))
- Adherence metrics(weekly (during the 8-week intervention period))
- 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))