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OpenTrials
Completed

NCT Number: NCT06140121

Immersive Technology to Improve Physical Therapy Engagement

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.

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Key information

Age range

7 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Childrens Hospital Stanford

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Physical Therapy

Behavioral

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

Traditional physical therapy

Behavioral

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.

Primary outcomes

  1. ActiGraph data points

    Time frame: During physical therapy session

    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

Secondary outcomes

  1. Total movement with wearable movement sensor

    Time frame: During physical therapy session

    Compare the total movement of pediatric patients when undergo virtual reality assisted physical therapy and traditional physical therapy measured by ActiGraph watch

  2. Perceived exertion

    Time frame: baseline, during physical therapy session, immediately after the physical therapy session

    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).

  3. Difference in Fatigue - Short Form 10a questionnaire result

    Time frame: immediately after the physical therapy session

    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).

  4. Change in current mental well being as measured by the modified WHO (Five) Well-Being Index

    Time frame: 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

  5. Acceptability of Intervention Measure (AIM)

    Time frame: immediately after the physical therapy session

    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.

  6. Intervention Appropriateness Measure (IAM)

    Time frame: immediately after the physical therapy session

    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.

  7. Feasibility of Intervention Measure (FIM)

    Time frame: immediately after the physical therapy session

    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.

  8. Feasibility and acceptability survey(patient)

    Time frame: immediately after the physical therapy session

    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.

  9. Feasibility and acceptability survey(parent)

    Time frame: immediately after the physical therapy session

    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.

  10. Difference in FACIT-F questionnaire result

    Time frame: immediately after the physical therapy session

    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).

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: iMOVE-G

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2023
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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