iMOVE: VRPT VS Traditional PT (iMOVE)

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

This is an experimental study to evaluate the efficacy of a Virtual Reality aid Physical Therapy (VRPT) in increasing the physical activity levels and quality of life of children.

Study Overview

• Status: Not yet recruiting
• Conditions: Physical Health
• Intervention / Treatment: Behavioral: Virtual Reality Physical Therapy; Behavioral: Traditional Physical Therapy

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas J Caruso; Phone Number: 650-723-5728; Email: tjcaruso@stanford.edu
• Study Contact Backup: Name: Man Yee MY Suen; Phone Number: 650-723-5728; Email: msuen@stanfordchildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Between age 7-25
• has an active physical therapy consultation
• Anticipated inpatient stay for more than 2 days

Exclusion Criteria:

• Legal guardian 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 cause by flashing light
• Major surgery within the last 48 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VRPT then Traditional PT; 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; 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; Behavioral: Traditional Physical Therapy; 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.
Experimental: Traditional PT then VRPT; Participants will receive traditional Physical Therapy (PT) sessions (standard care) in the first Physical Therapy session and receive 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; 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; Behavioral: Traditional Physical Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Fatigue	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).	immediately after the physical therapy session
Difference in FACT-F questionnaire result	Measured by comparison Pediatric Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F) of patient in first physical therapy session and second physical therapy session . Pediatric Functional Assessment of Chronic Illness Therapy - Fatigue (peds FACIT-F) is a 13 items -questionnaire which measures the fatigue scale of the patient with minimum score at 0 (low fatigue score) and maximum score at 52 (high fatigue score).	immediately after the physical therapy session
Change in current mental well being as measured by the modified WHO (Five) Well-Being Index	The modified WHO (Five) Well-Being Index is a participant-reported outcome measure that assesses current mental well being. Questionnaire contains 5 questions . Scores range from 0 to 5, with higher scores indicating the corresponding feeling exists all the time	immediately after the physical therapy session
Total movement with wearable movement sensors	Compare the total movement of pediatric oncology patients when undergo virtual reality assisted physical therapy and traditional physical therapy measured by ActiGraph watch	During physical therapy session
Difference in Fatigue - Short Form 10a questionnaire result	Measured by comparison PROMIS Pediatric Item Bank GenPop v3.0 - Fatigue - Short Form 10a of patient in first physical therapy session and second physical therapy session . PROMIS Pediatric Item Bank GenPop v3.0 - Fatigue - Short Form 10a is a 10 items -questionnaire which measures the fatigue scale of the patient with scores range from 1 to 5,(1 = never and 5 = Almost always).	immediately after the physical therapy session

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Thomas J Caruso, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Physical Activity; Virtual Reality
• Other Study ID Numbers: 70481

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No