Immersive Virtual Reality for Enhancement of Physical Activity in Pediatric Oncology : a Randomised Control Study (iMOVE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- ActiGraph data points
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
VRPT then Traditional PT
Participants will receive Virtual Reality assisted Physical Therapy sessions (VRPT) in the first Physical Therapy (PT) session and will receive traditional Physical Therapy sessions (standard care) in the second Physical Therapy session under the supervision of the accredited physical therapist.
干预措施: Virtual Reality Physical Therapy (Behavioral)
VRPT then Traditional PT
Participants will receive Virtual Reality assisted Physical Therapy sessions (VRPT) in the first Physical Therapy (PT) session and will receive traditional Physical Therapy sessions (standard care) in the second Physical Therapy session under the supervision of the accredited physical therapist.
干预措施: Traditional Physical Therapy (Behavioral)
Traditional PT then VRPT
Participants will receive traditional Physical Therapy (PT) sessions (standard care) in the first Physical Therapy session and Virtual Reality assisted Physical Therapy sessions (VRPT) in the second Physical Therapy session under the supervision of the accredited physical therapist.
干预措施: Virtual Reality Physical Therapy (Behavioral)
Traditional PT then VRPT
Participants will receive traditional Physical Therapy (PT) sessions (standard care) in the first Physical Therapy session and Virtual Reality assisted Physical Therapy sessions (VRPT) in the second Physical Therapy session under the supervision of the accredited physical therapist.
干预措施: Traditional Physical Therapy (Behavioral)
结局指标
主要结局
ActiGraph data points
时间窗: During physical therapy session
Compare the total Metabolic Equivalent of Task (METs) rate of pediatric oncology patients when undergo virtual reality assisted physical therapy and traditional physical therapy measured by ActiGraph watch
次要结局
- Feasibility and Usability Survey (Parent)(immediately after the physical therapy session)
- Acceptability of Intervention Measure (AIM) survey(immediately after the physical therapy session)
- Total exercise time spend in sedentary activity(During physical therapy session)
- Change in OMNI RPE survey scores(immediately after the physical therapy session)
- Intervention Appropriateness Measure (IAM) survey(immediately after the physical therapy session)
- Total exercise time spend in moderate-vigorous activity(During physical therapy session)
- Total exercise time spend in light activity(During physical therapy session)
- Feasibility of Intervention Measure (FIM) survey(immediately after the physical therapy session)
研究者
Thomas Caruso
Clinical Professor
Stanford University