iMOVE: VRPT VS Traditional PT

Study Overview
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Brief Summary
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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.

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

Conditions
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Physical Health

Intervention / Treatment
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* Behavioral: Virtual Reality Physical Therapy
* Behavioral: Traditional Physical Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VRPT then Traditional PT<br>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<br>* 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.<br>* Other names: VRPT;Behavioral: Traditional Physical Therapy<br>* 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.<br>|
| Experimental: Traditional PT then VRPT<br>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<br>* 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.<br>* Other names: VRPT;Behavioral: Traditional Physical Therapy<br>* 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.<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Physical Activity