Lucile Packard Childrens Hospital Stanford
Palo Alto, California, 94304, United States
Location status: Recruiting
Location contact
Thomas Caruso, MD, Phd
CONTACT
NCT Number: NCT05876156
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.
Interested in participating?
Request Info10 year–25 year
All sexes
Interventional
Not applicable
Palo Alto, California, 94304, United States
Location status: Recruiting
Thomas Caruso, MD, Phd
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: VRPT
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.
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
Time frame: During physical therapy session
Compare the difference in total exercise time in moderate-vigorous activity of pediatric oncology patients when undergo virtual reality assisted physical therapy and traditional physical therapy measured by ActiGraph watch
Time frame: During physical therapy session
change in total exercise time in sedentary activity of pediatric oncology patients when undergoing virtual reality assisted physical therapy compared to traditional physical therapy measured by ActiGraph watch. For this measure, both absolute change and difference in the proportion of time spent will be evaluated.
Time frame: During physical therapy session
change in the total exercise time in light activity of pediatric oncology patients when undergoing virtual reality assisted physical therapy compared to traditional physical therapy measured by ActiGraph watch. For this measure, both absolute change and difference in the proportion of time spent will be evaluated.
Time frame: immediately after the physical therapy session
Patients will self-report fatigue according to the Adult OMNI-Walk/Run RPE Scale (OMNI RPE) scale after both the VR and standard of care portion. The OMNI RPE is an 11-categories perceived exertion rating scale with a numerical rating from 0 to 10 (0= Not Tired at All, 10= Very, Very Tired).
Time frame: immediately after the physical therapy session
Tabulate the self -formulated Feasibility and Usability Survey. This questionnaire consists of 12 items, including 5 Likert questions, 6 yes/no questions and 1 open-end question. Measures are to be graded using a 1-10 scale, from 1=not at all, to 10=very much.
Time frame: immediately after the physical therapy session
This questionnaire consists of 4 items. Measures are to be graded using a 1-5 scale, from 1=completely disagree, to 5= completely agree
Time frame: immediately after the physical therapy session
This questionnaire consists of 4 items. Measures are to be graded using a 1-5 scale, from 1=completely disagree, to 5= completely agree
Time frame: immediately after the physical therapy session
This questionnaire consists of 4 items. Measures are to be graded using a 1-5 scale, from 1=completely disagree, to 5= completely agree
Contact information is provided by the study sponsor or research team.
Man Yee Suen
CONTACT
Thomas Caruso
CONTACT
Stanford University
Other
Immersive Virtual Reality for Enhancement of Physical Activity in Pediatric Oncology : a Randomised Control Study (iMOVE)
Acronym: iMOVE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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