iMOVE: VRPT VS Traditional PT

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05876156

Collaborator

(none)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Physical Health	Behavioral: Virtual Reality Physical Therapy Behavioral: Traditional Physical Therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

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.

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

Other Names:

VRPT

Behavioral: Traditional Physical Therapy

Outcome Measures

Primary Outcome Measures

ActiGraph data points [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

Secondary Outcome Measures

Total movement with wearable movement sensors [During physical therapy session]
Self-formulated process questions on satisfaction with inpatient care. The scale is ranging from 1 (very poor) to 5 (very good)
Patient Fatigue [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).
Difference in FACT-F questionnaire result [immediately after the physical therapy session]
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).
Change in current mental well being as measured by the modified WHO (Five) Well-Being Index [immediately after the physical therapy session]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator: Thomas J Caruso, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas Caruso, Clinical Professor, Stanford University

ClinicalTrials.gov Identifier:

NCT05876156

Other Study ID Numbers:

70481

First Posted:

May 25, 2023

Last Update Posted:

May 25, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Thomas Caruso, Clinical Professor, Stanford University

Virtual Reality

Physical Activity

Study Results

No Results Posted as of May 25, 2023