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Physical HealthiMOVE-GNCT06140121

Immersive Technology to Improve Physical Therapy Engagement

A study testing Virtual Reality Physical Therapy and Traditional Physical Therapy in people with Physical Health, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 7 to 25 years
Conditions the study is for
Physical Health
What is being tested?
Virtual Reality Physical Therapy and Traditional Physical Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
13 Mar 2024to 7 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Between age 7-25
  • has an active physical therapy consultation
  • Anticipated inpatient stay for more than 2 days

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Lucile Packard Childrens Hospital Stanford

    Palo Alto, California, 94304

Other trials in United States

About this study

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.

Conditions
Physical Health
Being tested
Virtual Reality Physical Therapy, Traditional Physical Therapy
Keywords
Virtual Reality, Physical Activity
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality Physical TherapyBehavioural

    Also called VRPT

    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 TherapyBehavioural

    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.

Study groups in NCT06140121
Study groupRoleWhat they receive
Experimental: VRPT then Traditional PTExperimentalParticipants 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.
Receives: Behavioral: Virtual Reality Physical Therapy; Behavioral: Traditional Physical Therapy
Traditional PT then VRPTExperimentalParticipants 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.
Receives: Behavioral: Virtual Reality Physical Therapy; Behavioral: Traditional Physical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: During physical therapy session

Secondary outcomes (10)
  1. 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

    Measured: During physical therapy session

  2. 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).

    Measured: baseline, during physical therapy session, immediately after the physical therapy session

  3. 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).

    Measured: immediately after the physical therapy session

  4. 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

    Measured: immediately after the physical therapy session

  5. 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.

    Measured: immediately after the physical therapy session

  6. 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.

    Measured: immediately after the physical therapy session

  7. 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.

    Measured: immediately after the physical therapy session

  8. 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.

    Measured: immediately after the physical therapy session

  9. 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.

    Measured: immediately after the physical therapy session

  10. 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).

    Measured: immediately after the physical therapy session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start13 Mar 2024
  3. Primary completion7 Feb 2025
  4. Study completion7 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06140121
Sponsor's protocol ID
72980
Acronym
iMOVE-G
Status last verified
Jan 2026
First submitted
9 Nov 2023
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality Physical Therapy and Traditional Physical Therapy in people with Physical Health, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ActiGraph data points (time frame: During physical therapy session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.

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