Cerebral PalsyNCT06096272
Using Augmented Reality to Promote Physical Activity in Children With Cerebral Palsy
A study testing Augment Reality Exergames in people with Cerebral Palsy and Mobile Phone Use, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
Children with cerebral palsy (CP), Gross Motor Functional Classification Scale (GMFCS) I-II will be recruited to participate in a home based physical activity intervention for 4 weeks. Demographic data will be collected, and validated surveys assessing baseline physical activity level and mobility will be completed. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cerebral Palsy, Mobile Phone Use, Pediatric ALL
- What is being tested?
- Augment Reality Exergames
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2024to 1 Sep 2025
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of cerebral palsy,
- Ambulatory (GMFCS I and II)
- English or Spanish speaking
- No plans for lower extremity surgery in the next 4 months
Who cannot join
- Moderate to severe developmental or cognitive delay
- Significant hearing loss or visual impairment
- Recent surgical procedure or fracture over the past 4 months that impacts physical activity
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
Jackie and Gene Autry Orthopedic Center, CHLA
Los Angeles, California, 90027
Abigail Padilla, BS, 323-361-2142, OrthoResearch@chla.usc.edu
Melissa Bent, MD
About this study
Official title: A Pilot Study Using Exergaming With Augmented Reality to Promote Physical Activity in Children With Cerebral Palsy
Children with cerebral palsy (CP), Gross Motor Functional Classification Scale (GMFCS) I-II will be recruited to participate in a home based physical activity intervention for 4 weeks. Demographic data will be collected, and validated surveys assessing baseline physical activity level and mobility will be completed. Participants will have an exercise program assigned and will be given a logbook to record their exercise adherence. They will be assigned to the Augment Reality (AR) app group. The AR app group will have exercises administered through the AR app. At the end of the program, participants will complete final surveys and an exit interview.
Read the detailed description
Muscle weakness in cerebral palsy (CP) results in a reduced level of physical activity. Reduced physical activity can lead to adverse health consequences. Augmented reality (AR) is increasingly being used to promote physical activity. The purpose of this study is to determine if adaptive exercise gaming program utilizing AR mobile app for children with cerebral palsy can promote physical activity through a prospective pilot study.
Children with CP, GMFCS I-II between the ages of 5-18 years old will be recruited to participate in a home-based physical activity AR games.
Study Population: Inclusion criteria are: diagnosis of cerebral palsy, ambulatory (GMFCS I and II), ages 5-18 years, English or Spanish speaking, and no plans for lower extremity surgery in the next 2 months. Exclusion criteria are: moderate to severe developmental or cognitive delay, severe visual or hearing condition, recent casting or surgical procedure over the past 4 months that impacts physical activity, or G-tube dependent. Interested participants will be scheduled for a virtual or in person visit in which informed consent will be obtained.
Study Design: All participants will use the app for 4-weeks. The app will be implemented with an iPad® provided by the research team if the participant does not have a compatible device, that will be securely integrated with a network-server for real-time data access and storage. Participants will be provided an on-site or virtual CHLA tutorial about using the app and set up of the gaming system. Augment Therapy support personnel will assist with home set up if needed. Participants will access their home program on the app at least for 20 minutes, 3 times a week over a 4-week period. A coordinator will check in virtually with the participant during the course of the program. Exercise data will be collected and stored through the Augment Therapy™ app and self log book. Feasibility will be defined as 1) Program Engagement measured by the app and program evaluation surveys 2) Program Adherence measured by exercise compliance defined as the number of self-reported exercises logged, app usage logs, and sessions completed for the intervention and control groups. Validated questionnaires will be administered to evaluate the effect of the intervention at baseline and final assessment.
- Being tested
- Augment Reality Exergames
- Medical subject headings
- Cerebral Palsy, Cell Phone Use, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augment Reality ExergamesDevice
Adaptive physical activity AR gaming modules were created in collaboration with physical therapists with expertise in CP and the Augment Therapy app development team. The program will consists of 5 games adapted for children with cerebral palsy.
| Study group | Role | What they receive |
|---|---|---|
| Augment Therapy app | Experimental | The app will be implemented with the participant's compatible iPad that will be securely integrated with a network-server for real-time data access and storage. If the participant does not have a compatible device, this will be provided by the research team. Participants will be provided an on-site or virtual CHLA tutorial about using the app and set up of the gaming system. Participants will access their home program on the app at least for 20 minutes, 3 times a week over a 4-week period. A coordinator will check in virtually with the participant during the program. They will complete baseline and final surveys. Exercise data will be collected and stored through the Augment Therapy™ app and self log book. Receives: Device: Augment Reality Exergames |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that complete mobile application delivered exercise program.
Measured by proportion of time in the mobile application (180/360 total minutes).
Measured: Baseline to 4 weeks.
Number of participants that complete the standard exercise program.
Measured by proportion of time (180/360 total minutes) to complete exercises in logbook.
Measured: Baseline to 4 weeks.
Secondary outcomes (2)
Engagement in the mobile application, Gold-Rizzo Immersion and Presence (GRIP) Inventory scale.
Measured by the Gold-Rizzo Immersion and Presence (GRIP) Inventory scores in the domains of immersion, feasibility, realism, transportation and satisfaction, higher scores reflect better experience.
Measured: At Week 4.
Change in Quality-of-Life measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Activity and Mobility.
Measure at baseline and end of intervention, change of PROMIS Physical Activity and Mobility scores, higher scores represent higher quality of life.
Measured: Baseline to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start7 Jun 2024
- Primary completion31 May 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Bent, Children's Hospital Los Angeles
- Investigators
- Melissa Bent, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096272
- Sponsor's protocol ID
- CHLA-23-00120
- Status last verified
- Jan 2025
- First submitted
- 28 Aug 2023
- Last updated
- 20 Jan 2025
- 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 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Using Exergaming With Augmented Reality to Promote Physical Activity in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06096272
- Acronym / sponsor ID
- CHLA-23-00120
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 23 Oct 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.
Children with cerebral palsy (CP), Gross Motor Functional Classification Scale (GMFCS) I-II will be recruited to participate in a home based physical activity intervention for 4 weeks. Demographic data will be collected, and validated surveys assessing baseline physical activity level and mobility will be completed. Participants will have an exercise program assigned and will be given a logbook to record their exercise adherence. They will be assigned to the Augment Reality (AR) app group. The AR app group will have exercises administered through the AR app. At the end of the program, participants will complete final surveys and an exit interview.
Detailed description
Muscle weakness in cerebral palsy (CP) results in a reduced level of physical activity. Reduced physical activity can lead to adverse health consequences. Augmented reality (AR) is increasingly being used to promote physical activity. The purpose of this study is to determine if adaptive exercise gaming program utilizing AR mobile app for children with cerebral palsy can promote physical activity through a prospective pilot study.
Children with CP, GMFCS I-II between the ages of 5-18 years old will be recruited to participate in a home-based physical activity AR games.
Study Population: Inclusion criteria are: diagnosis of cerebral palsy, ambulatory (GMFCS I and II), ages 5-18 years, English or Spanish speaking, and no plans for lower extremity surgery in the next 2 months. Exclusion criteria are: moderate to severe developmental or cognitive delay, severe visual or hearing condition, recent casting or surgical procedure over the past 4 months that impacts physical activity, or G-tube dependent. Interested participants will be scheduled for a virtual or in person visit in which informed consent will be obtained.
Study Design: All participants will use the app for 4-weeks. The app will be implemented with an iPad® provided by the research team if the participant does not have a compatible device, that will be securely integrated with a network-server for real-time data access and storage. Participants will be provided an on-site or virtual CHLA tutorial about using the app and set up of the gaming system. Augment Therapy support personnel will assist with home set up if needed. Participants will access their home program on the app at least for 20 minutes, 3 times a week over a 4-week period. A coordinator will check in virtually with the participant during the course of the program. Exercise data will be collected and stored through the Augment Therapy™ app and self log book. Feasibility will be defined as 1) Program Engagement measured by the app and program evaluation surveys 2) Program Adherence measured by exercise compliance defined as the number of self-reported exercises logged, app usage logs, and sessions completed for the intervention and control groups. Validated questionnaires will be administered to evaluate the effect of the intervention at baseline and final assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Augment Therapy app | Experimental | Device: Augment Reality ExergamesThe app will be implemented with the participant's compatible iPad that will be securely integrated with a network-server for real-time data access and storage. If the participant does not have a compatible device, this will be provided by the research team. Participants will be provided an on-site or virtual CHLA tutorial about using the app and set up of the gaming system. Participants will access their home program on the app at least for 20 minutes, 3 times a week over a 4-week period. A coordinator will check in virtually with the participant during the program. They will complete baseline and final surveys. Exercise data will be collected and stored through the Augment Therapy™ app and self log book. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosis of cerebral palsy,
- Ambulatory (GMFCS I and II)
- English or Spanish speaking
- No plans for lower extremity surgery in the next 4 months
Key exclusion criteria (3 listed)
- Moderate to severe developmental or cognitive delay
- Significant hearing loss or visual impairment
- Recent surgical procedure or fracture over the past 4 months that impacts physical activity
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 |
|---|---|---|
| Augment Reality ExergamesAdaptive physical activity AR gaming modules were created in collaboration with physical therapists with expertise in CP and the Augment Therapy app development team. The program will consists of 5 games adapted for children with cerebral palsy. | Device | Augment Therapy app |
Primary outcome
Number of participants that complete mobile application delivered exercise program.
Time frame: Baseline to 4 weeks.
Measured by proportion of time in the mobile application (180/360 total minutes).
Number of participants that complete the standard exercise program.
Time frame: Baseline to 4 weeks.
Measured by proportion of time (180/360 total minutes) to complete exercises in logbook.
2 secondary outcomes
Engagement in the mobile application, Gold-Rizzo Immersion and Presence (GRIP) Inventory scale.
Time frame: At Week 4.
Change in Quality-of-Life measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Activity and Mobility.
Time frame: Baseline to 4 weeks.
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 20 Jan 2025.
- 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.
Melissa Bent, MD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augment Reality Exergames in people with Cerebral Palsy and Mobile Phone Use, run by Children's Hospital Los Angeles 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 4 inclusion and 3 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 20 Jan 2025. 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 Abigail Padilla, BS (323-361-2142, OrthoResearch@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that complete mobile application delivered exercise program. (time frame: Baseline to 4 weeks.). The study lists 2 primary outcomes in all. 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 20 Jan 2025.