iMOVE: Virtual Reality PT Versus Traditional PT

Официальное название

Immersive Virtual Reality for Enhancement of Physical Activity in Pediatric Oncology : a Randomised Control Study (iMOVE)

Обзор

This pragmatic, crossover, randomized controlled study evaluates the efficacy of virtual reality assisted physical therapy (VRPT) for improving the physical activity of hospitalized children as compared to traditional physical therapy. This is a pilot study that will be used to identify patient populations that can benefit the most from VRPT and estimate this effect for future studies. Patients with a significant neurological condition, major developmental disability, active infection of the face or hand, history of severe motion sickness, history of seizures caused by flashing light or had a major surgery within the last 48 hours will be excluded.

Подробное описание

Childhood cancer is a significant health concern worldwide. Despite improved 5-year survival rates (80%-85%), children undergoing treatment face physiological and psychosocial challenges, including chronic pain, limited mobility, muscle loss, low bone density, and mental distress. To mitigate negative therapy-related adverse health outcomes and improve quality of life, supportive care measures are emphasized during cancer treatments. The US Department of Health \& Human Services advises Pediatric oncology patients to engage in 30 minutes of moderate-intensity physical activity, 3 times a week, for a healthy lifestyle. Regular exercise during and after treatment profoundly impacts a child's physical, psychological, and social well-being. Inpatient and outpatient physical therapy is commonly suggested for patients. Yet, traditional physical therapy is usually monotonous and repetitive, leading to boredom and decreased adherence. Limited exercise variation may fail to captivate attention and provide motivation for consistent participation.

Virtual reality physical therapy (VRPT) provides dynamic and interactive exercise, overcoming traditional therapy's boredom. Exergaming offers fun and excitement through engaging virtual environments and gameplay. It enhances motivation, sustains interest, and encourages longer exercise. Personalized and adaptive interventions in virtual reality target individual needs and allow progress tracking.

Вмешательства

• Поведенческое Virtual Reality Physical Therapy
  Participants are allowed to freely choose one game from the game list. Participant will be asked to wear a validated activity tracker - ActiGraph. Baseline heart rate will be collected for 1 minute. Participants will be wearing the ActiGraph during Physical Therapy session. Participants receiving VR intervention will be instructed to wear an Oculus Quest 2 headset (Meta, Inc., Menlo Park, CA) and participate in VR applications under the supervision of the physical therapist.
• Поведенческое Traditional Physical Therapy
  Participants will receive traditional Physical Therapy sessions (standard care) under the supervision of the accredited physical therapist. Participants will be wearing the Actigraph during Physical Therapy session. Participants will perform regular physical exercise, such as 20 minutes walking or biking on a stationary bike, under the supervision of a physical therapist.

Первичные конечные точки

• ActiGraph data points [Срок оценки: During physical therapy session]

Вторичные конечные точки (8)

• Total exercise time spend in moderate-vigorous activity [Срок оценки: During physical therapy session]
• Total exercise time spend in sedentary activity [Срок оценки: During physical therapy session]
• Total exercise time spend in light activity [Срок оценки: During physical therapy session]
• Change in OMNI RPE survey scores [Срок оценки: immediately after the physical therapy session]
• Feasibility and Usability Survey (Parent) [Срок оценки: immediately after the physical therapy session]
• Acceptability of Intervention Measure (AIM) survey [Срок оценки: immediately after the physical therapy session]
• Intervention Appropriateness Measure (IAM) survey [Срок оценки: immediately after the physical therapy session]
• Feasibility of Intervention Measure (FIM) survey [Срок оценки: immediately after the physical therapy session]

Критерии участия

Критерии включения

• Between age 10-25 years
• Diagnosed with cancer
• Has an active physical therapy consultation
• Anticipated inpatient stay for at least 3-days with the second PT session following between 24-72 hours after the first PT session
• Ability to understand and the willingness to personally sign the written Institutional Review Board (IRB) approved informed consent document by Legally Authorized Representative (LAR) if participant <18 years old or by participant if 18+
• Ability to understand and the willingness to personally sign the written IRB approved informed assent document for patient <18 years old.

Критерии исключения

• Legal guardian does not present to obtain consent.
• Child with a significant neurological condition, or major developmental disability.
• Child with active infection of the face or hand.
• A history of severe motion sickness.
• A history of seizures caused by flashing light.
• Major surgery within the last 48 hours.
• Does not speak English (required for surveys)
• With visual impairments or any degree of developmental delays
• Child on mechanical ventilation or ventilatory support

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Lucile Packard Childrens Hospital Stanford — Palo Alto

Идентификаторы

NCT: NCT05876156 · 70481

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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