iMOVE: VRPT VS Traditional PT

Physical Health Clinical Trial

— iMOVE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05876156
• Other study ID #: 70481
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Stanford University
• Contact: Thomas J Caruso
• Phone: 650-723-5728
• Email: tjcaruso[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Health

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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