iMOVE: Virtual Reality PT Versus Traditional PT

NCT05876156 | Recruiting

• 1 other identifier: IRB-70481
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Health

Keywords

Virtual Reality; Physical Activity

Outcome Measures

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

  During physical therapy session

Secondary Outcomes (8)

• Total exercise time spend in moderate-vigorous activity

  During physical therapy session

• Total exercise time spend in sedentary activity

  During physical therapy session

• Total exercise time spend in light activity

  During physical therapy session

• Change in OMNI RPE survey scores

  immediately after the physical therapy session

• Feasibility and Usability Survey (Parent)

  immediately after the physical therapy session

Study Arms (2)

VRPT then Traditional PT

EXPERIMENTAL

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.

Behavioral: Virtual Reality Physical Therapy; Behavioral: Traditional Physical Therapy

Traditional PT then VRPT

EXPERIMENTAL

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.

Behavioral: Virtual Reality Physical Therapy; Behavioral: Traditional Physical Therapy

Interventions

Virtual Reality Physical Therapy BEHAVIORAL

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.

Also known as: VRPT

Traditional PT then VRPT; VRPT then Traditional PT

Traditional Physical Therapy BEHAVIORAL

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.

Traditional PT then VRPT; VRPT then Traditional PT

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Childrens Hospital Stanford

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Thomas Caruso

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Caruso

CONTACT

650-723-5728; tjcaruso@stanford.edu

Man Yee Suen

CONTACT

650-723-5728; smy822@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)