Physical HealthiMOVENCT05876156
iMOVE: Virtual Reality PT Versus Traditional PT
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 pragmatic, crossover, randomized controlled study evaluates the efficacy of virtual reality assisted physical therapy (VRPT) for improving the physical activity of hospitalized children as compared to traditional physical therapy. Read more about this study
- Who is it for?
- Ages 10 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between age 10-25 years
- Diagnosed with cancer
- Has an active physical therapy consultation
- Anticipated inpatient stay for at least 3-days with the second PT session following between 24-72 hours after the first PT session
- Ability to understand and the willingness to personally sign the written Institutional Review Board (IRB) approved informed consent document by Legally Authorized Representative (LAR) if participant <18 years old or by participant if 18+
- Ability to understand and the willingness to personally sign the written IRB approved informed assent document for patient <18 years old.
Who cannot join
- Legal guardian does 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 caused by flashing light.
- Major surgery within the last 48 hours.
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- Does not speak English (required for surveys)
- With visual impairments or any degree of developmental delays
- Child on mechanical ventilation or ventilatory support
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lucile Packard Childrens Hospital Stanford
Palo Alto, California, 94304
Thomas Caruso, MD, Phd
About this study
Official title: Immersive Virtual Reality for Enhancement of Physical Activity in Pediatric Oncology : a Randomised Control Study (iMOVE)
This pragmatic, crossover, randomized controlled study evaluates the efficacy of virtual reality assisted physical therapy (VRPT) for improving the physical activity of hospitalized children as compared to traditional physical therapy. This is a pilot study that will be used to identify patient populations that can benefit the most from VRPT and estimate this effect for future studies.
Patients with a significant neurological condition, major developmental disability, active infection of the face or hand, history of severe motion sickness, history of seizures caused by flashing light or had a major surgery within the last 48 hours will be excluded.
Read the detailed description
Childhood cancer is a significant health concern worldwide. Despite improved 5-year survival rates (80%-85%), children undergoing treatment face physiological and psychosocial challenges, including chronic pain, limited mobility, muscle loss, low bone density, and mental distress. To mitigate negative therapy-related adverse health outcomes and improve quality of life, supportive care measures are emphasized during cancer treatments. The US Department of Health \& Human Services advises Pediatric oncology patients to engage in 30 minutes of moderate-intensity physical activity, 3 times a week, for a healthy lifestyle. Regular exercise during and after treatment profoundly impacts a child's physical, psychological, and social well-being. Inpatient and outpatient physical therapy is commonly suggested for patients. Yet, traditional physical therapy is usually monotonous and repetitive, leading to boredom and decreased adherence. Limited exercise variation may fail to captivate attention and provide motivation for consistent participation.
Virtual reality physical therapy (VRPT) provides dynamic and interactive exercise, overcoming traditional therapy's boredom. Exergaming offers fun and excitement through engaging virtual environments and gameplay. It enhances motivation, sustains interest, and encourages longer exercise. Personalized and adaptive interventions in virtual reality target individual needs and allow progress tracking.
- 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 |
|---|---|---|
| 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 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 oncology patients when undergo virtual reality assisted physical therapy and traditional physical therapy measured by ActiGraph watch
Measured: During physical therapy session
Secondary outcomes (8)
Total exercise time spend in moderate-vigorous activity
Compare the difference in total exercise time in moderate-vigorous activity of pediatric oncology patients when undergo virtual reality assisted physical therapy and traditional physical therapy measured by ActiGraph watch
Measured: During physical therapy session
Total exercise time spend in sedentary activity
change in total exercise time in sedentary activity of pediatric oncology patients when undergoing virtual reality assisted physical therapy compared to traditional physical therapy measured by ActiGraph watch. For this measure, both absolute change and difference in the proportion of time spent will be evaluated.
Measured: During physical therapy session
Total exercise time spend in light activity
change in the total exercise time in light activity of pediatric oncology patients when undergoing virtual reality assisted physical therapy compared to traditional physical therapy measured by ActiGraph watch. For this measure, both absolute change and difference in the proportion of time spent will be evaluated.
Measured: During physical therapy session
Change in OMNI RPE survey scores
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).
Measured: immediately after the physical therapy session
Feasibility and Usability Survey (Parent)
Tabulate the self -formulated Feasibility and Usability Survey. This questionnaire consists of 12 items, including 5 Likert questions, 6 yes/no questions and 1 open-end question. Measures are to be graded using a 1-10 scale, from 1=not at all, to 10=very much.
Measured: immediately after the physical therapy session
Acceptability of Intervention Measure (AIM) survey
This questionnaire consists of 4 items. Measures are to be graded using a 1-5 scale, from 1=completely disagree, to 5= completely agree
Measured: immediately after the physical therapy session
Intervention Appropriateness Measure (IAM) survey
This questionnaire consists of 4 items. Measures are to be graded using a 1-5 scale, from 1=completely disagree, to 5= completely agree
Measured: immediately after the physical therapy session
Feasibility of Intervention Measure (FIM) survey
This questionnaire consists of 4 items. Measures are to be graded using a 1-5 scale, from 1=completely disagree, to 5= completely agree
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 posted25 May 2023
- Study start1 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Caruso, Stanford University
- Investigators
- Thomas Caruso, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876156
- Sponsor's protocol ID
- 70481
- Acronym
- iMOVE
- Status last verified
- Jun 2026
- First submitted
- 16 May 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Virtual Reality for Enhancement of Physical Activity in Pediatric Oncology : a Randomised Control Study (iMOVE)
- ClinicalTrials.gov ID
- NCT05876156
- Acronym / sponsor ID
- iMOVE / 70481
- Conditions
- Physical Health
- Keywords
- Virtual Reality, Physical Activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 May 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 pragmatic, crossover, randomized controlled study evaluates the efficacy of virtual reality assisted physical therapy (VRPT) for improving the physical activity of hospitalized children as compared to traditional physical therapy. This is a pilot study that will be used to identify patient populations that can benefit the most from VRPT and estimate this effect for future studies.
Patients with a significant neurological condition, major developmental disability, active infection of the face or hand, history of severe motion sickness, history of seizures caused by flashing light or had a major surgery within the last 48 hours will be excluded.
Detailed description
Childhood cancer is a significant health concern worldwide. Despite improved 5-year survival rates (80%-85%), children undergoing treatment face physiological and psychosocial challenges, including chronic pain, limited mobility, muscle loss, low bone density, and mental distress. To mitigate negative therapy-related adverse health outcomes and improve quality of life, supportive care measures are emphasized during cancer treatments. The US Department of Health \& Human Services advises Pediatric oncology patients to engage in 30 minutes of moderate-intensity physical activity, 3 times a week, for a healthy lifestyle. Regular exercise during and after treatment profoundly impacts a child's physical, psychological, and social well-being. Inpatient and outpatient physical therapy is commonly suggested for patients. Yet, traditional physical therapy is usually monotonous and repetitive, leading to boredom and decreased adherence. Limited exercise variation may fail to captivate attention and provide motivation for consistent participation.
Virtual reality physical therapy (VRPT) provides dynamic and interactive exercise, overcoming traditional therapy's boredom. Exergaming offers fun and excitement through engaging virtual environments and gameplay. It enhances motivation, sustains interest, and encourages longer exercise. Personalized and adaptive interventions in virtual reality target individual needs and allow progress tracking.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 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
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Between age 10-25 years
- Diagnosed with cancer
- Has an active physical therapy consultation
- Anticipated inpatient stay for at least 3-days with the second PT session following between 24-72 hours after the first PT session
- Ability to understand and the willingness to personally sign the written Institutional Review Board (IRB) approved informed consent document by Legally Authorized Representative (LAR) if participant <18 years old or by participant if 18+
Key exclusion criteria (9 listed)
- Legal guardian does 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 caused 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 | Traditional PT then VRPT, VRPT then Traditional PT |
| 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 | Traditional PT then VRPT, VRPT then Traditional PT |
Primary outcome
ActiGraph data points
Time frame: During physical therapy session
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
8 secondary outcomes
Total exercise time spend in moderate-vigorous activity
Time frame: During physical therapy session
Total exercise time spend in sedentary activity
Time frame: During physical therapy session
Total exercise time spend in light activity
Time frame: During physical therapy session
Change in OMNI RPE survey scores
Time frame: immediately after the physical therapy session
Feasibility and Usability Survey (Parent)
Time frame: immediately after the physical therapy session
Acceptability of Intervention Measure (AIM) survey
Time frame: immediately after the physical therapy session
Intervention Appropriateness Measure (IAM) survey
Time frame: immediately after the physical therapy session
Feasibility of Intervention Measure (FIM) survey
Time frame: immediately after the physical therapy session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Thomas Caruso principal investigator
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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 4 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Caruso (650-723-5728, tjcaruso@stanford.edu), or a site near the patient. 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 4 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.