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Clinical Trials/NCT05876156
NCT05876156
Recruiting
Not Applicable

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

Stanford University1 site in 1 country40 target enrollmentJune 1, 2025
ConditionsPhysical Health

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physical Health
Sponsor
Stanford University
Enrollment
40
Locations
1
Primary Endpoint
ActiGraph data points
Status
Recruiting
Last Updated
5 months ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2025
End Date
May 31, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

ActiGraph data points

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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