iMOVE: Virtual Reality PT Versus Traditional PT
ConditionPhysical Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-25
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Virtual Reality Physical Therapy
BehavioralParticipants 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.
Traditional Physical Therapy
BehavioralParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: VRPT then Traditional PTExperimental treatment 2 interventions
Group B: Traditional PT then VRPTExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
ActiGraph data points
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 sessionSecondary outcomes
1
Total exercise time spend in moderate-vigorous activity
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 session2
Total exercise time spend in sedentary activity
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 session3
Total exercise time spend in light activity
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
During physical therapy session4
Change in OMNI RPE survey scores
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 sessionSponsors and contacts
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Source ClinicalTrials.gov