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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
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.
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.
Lucile Packard Childrens Hospital Stanford
Palo Alto, California, United States
ActiGraph data points
Compare the total Metabolic Equivalent of Task (METs) rate of pediatric patients when undergo virtual reality assisted physical therapy and traditional physical therapy measured by ActiGraph watch
Time frame: During physical therapy session
Total movement with wearable movement sensor
Compare the total movement of pediatric patients when undergo virtual reality assisted physical therapy and traditional physical therapy measured by ActiGraph watch
Time frame: During physical therapy session
Perceived exertion
Patients will self-report perceived exertion 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).
Time frame: baseline, during physical therapy session, immediately after the physical therapy session
Difference in Fatigue - Short Form 10a questionnaire result
Measured by comparison PROMIS Pediatric Item Bank GenPop v2.0 - 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).
Time frame: 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
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Time frame: immediately after the physical therapy session
Acceptability of Intervention Measure (AIM)
Acceptability, of the traditional physical therapy or virtual reality physical therapy interventions will be assessed using the Acceptability of Intervention Measure (AIM) which is a subscale of the Triple P Tool. Scale items are scored on a Likert scale from 1 to 5 where higher scores indicate higher acceptability of the intervention.
Time frame: immediately after the physical therapy session
Intervention Appropriateness Measure (IAM)
Appropriateness, of the traditional physical therapy or virtual reality physical therapy interventions will be assessed using the Intervention Appropriateness Measure (IAM) which is a subscale of the Triple P Tool. Scale items are scored on a Likert scale from 1 to 5 where higher scores indicate higher appropriateness of the intervention.
Time frame: immediately after the physical therapy session
Feasibility of Intervention Measure (FIM)
Feasibility, of the traditional physical therapy or virtual reality physical therapy interventions will be assessed using the Feasibility of Intervention Measure (FIM) which is a subscale of The Triple P Tool. Scale items are scored on a Likert scale from 1 to 5 where higher scores indicate higher feasibility.
Time frame: immediately after the physical therapy session
Feasibility and acceptability survey(patient)
This is an self developed feasibility survey. Feasibility, of the virtual reality physical therapy interventions will be assessed using the Feasibility and acceptability survey(patient). Survey contains 10 items. First 5 items are yes no questions. Last 5 items are scored on a Likert scale from 1 to 10 where higher scores indicate higher feasibility.
Time frame: immediately after the physical therapy session
Feasibility and acceptability survey(parent)
This is an self developed feasibility survey. Feasibility, of the virtual reality physical therapy interventions will be assessed using the Feasibility and acceptability survey(parent). Survey contains 3 items. Scale items are scored on a Likert scale from 1 to 5 where higher scores indicate higher satisfaction.
Time frame: immediately after the physical therapy session
Difference in FACIT-F questionnaire result
Measured by comparison Pediatric Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) of patient in first physical therapy session and second physical therapy session . Pediatric Functional Assessment of Chronic Illness Therapy - Fatigue (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).
Time frame: immediately after the physical therapy session