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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Experimental: VRPT then Traditional PT | Experimental | 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. Receives: Behavioral: Virtual Reality Physical Therapy; Behavioral: Traditional Physical Therapy |
| Traditional PT then VRPT | Experimental | 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. 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.
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)
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
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
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
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
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
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
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
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
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
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.
- First posted18 Nov 2023
- Study start13 Mar 2024
- Primary completion7 Feb 2025
- Study completion7 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical HealthStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Caruso, Stanford University
- Investigators
- Thomas Caruso, Study director, Stanford University
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Technology to Improve Physical Therapy Engagement
- ClinicalTrials.gov ID
- NCT06140121
- Acronym / sponsor ID
- iMOVE-G / 72980
- Conditions
- Physical Health
- Keywords
- Virtual Reality, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: VRPT then Traditional PT | Experimental | Behavioral: Virtual Reality Physical Therapy, Behavioral: Traditional Physical TherapyParticipants 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. |
| Traditional PT then VRPT | Experimental | Behavioral: Virtual Reality Physical Therapy, Behavioral: Traditional Physical TherapyParticipants 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. |
Who may qualify
- Ages
- 7 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Between age 7-25
- has an active physical therapy consultation
- Anticipated inpatient stay for more than 2 days
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Physical TherapyAlso: VRPTParticipants 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. | Behavioural | Experimental: VRPT then Traditional PT, Traditional PT then VRPT |
| Traditional Physical TherapyParticipants 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. | Behavioural | Experimental: VRPT then Traditional PT, Traditional PT then VRPT |
Primary outcome
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
10 secondary outcomes
Total movement with wearable movement sensor
Time frame: During physical therapy session
Perceived exertion
Time frame: baseline, during physical therapy session, immediately after the physical therapy session
Difference in Fatigue - Short Form 10a questionnaire result
Time frame: immediately after the physical therapy session
Change in current mental well being as measured by the modified WHO (Five) Well-Being Index
Time frame: immediately after the physical therapy session
Acceptability of Intervention Measure (AIM)
Time frame: immediately after the physical therapy session
Intervention Appropriateness Measure (IAM)
Time frame: immediately after the physical therapy session
Feasibility of Intervention Measure (FIM)
Time frame: immediately after the physical therapy session
Feasibility and acceptability survey(patient)
Time frame: immediately after the physical therapy session
Feasibility and acceptability survey(parent)
Time frame: immediately after the physical therapy session
Difference in FACIT-F questionnaire result
Time frame: immediately after the physical therapy session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Caruso study director
Stanford University
1 site in 1 country: see every site and its status.
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.