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NCT05876156 | NOT YET RECRUITING | Physical Health

iMOVE: Virtual Reality PT Versus Traditional PT
Sponsor:

Stanford University

Information provided by (Responsible Party):

Thomas Caruso

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.

Condition or disease

Physical Health

Intervention/treatment

Virtual Reality Physical Therapy

Traditional Physical Therapy

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Immersive Virtual Reality for Enhancement of Physical Activity in Pediatric Oncology : a Randomised Control Study (iMOVE)
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2026-05-31
Estimated Study Completion Date : 2026-05-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 10 Years to 25 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
iMOVE: Virtual Reality PT Versus Traditional PT

Location Details

NCT05876156

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How to Participate

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Locations

Not yet recruiting

United States, California

Lucile Packard Childrens Hospital Stanford

Palo Alto, California, United States, 94304