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Behavioural Intervention

Augmented Reality Exercise for Cerebral Palsy

N/A

Recruiting

Led By Melissa Bent, MD

Research Sponsored by Children's Hospital Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of cerebral palsy

Ambulatory (GMFCS I and II)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 1 (pre-intervention) , week 12 (post-intervention)

Awards & highlights

Study Summary

This trial is recruiting children with CP to do physical activity for 12 weeks, either with AR app or handouts. They will record results and take surveys.

Who is the study for?

This trial is for English or Spanish-speaking children with cerebral palsy who can walk (GMFCS I-II) and have no major surgeries planned for their legs in the next 4 months. It's not for kids with moderate to severe cognitive delays, significant hearing or vision problems, or recent surgeries/fractures affecting activity.Check my eligibility

What is being tested?

The study tests if augmented reality exergames can increase physical activity over a 12-week period at home. Kids will be split into two groups randomly: one uses an AR app for exercises, while the other follows a traditional exercise program with handouts.See study design

What are the potential side effects?

Since this trial involves physical activity through games, potential side effects may include typical exercise-related issues like muscle soreness or fatigue. However, specific risks related to using AR technology are not detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with cerebral palsy.

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I can walk without assistance.

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I do not plan to have leg surgery in the next 4 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1 (pre-intervention) , week 12 (post-intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 1 (pre-intervention) , week 12 (post-intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 (pre-intervention) , week 12 (post-intervention) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants that complete mobile application delivered exercise program.

Number of participants that complete the standard exercise program.

Secondary outcome measures

Change in Quality-of-Life measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Activity and Mobility.

Change in performance in Single Leg Balance Test.

Change in performance in Timed Up and Go Test (TUG).

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Augment Therapy appExperimental Treatment1 Intervention

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 12-week period. A coach will check in virtually with the participant during the program. They will complete baseline and final surveys and functional tests. Exercise data will be collected and stored through the Augment Therapy™ app and self log book.

Group II: Standard Exercise HandoutsActive Control1 Intervention

Participants will be given an home based exercise program consisting of virtual coaching and handouts showing the exercises. They will complete baseline and final surveys and functional tests. They will record their exercise activity in a self log book. They will be given the opportunity to use the AR mobile app after their final outcome assessment so all participants have access to trying the mobile app.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesLead Sponsor

232 Previous Clinical Trials

5,076,504 Total Patients Enrolled

2 Trials studying Cerebral Palsy

94 Patients Enrolled for Cerebral Palsy

Melissa Bent, MDPrincipal InvestigatorChildren's Hospital Los Angeles

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to enroll in this research study?

"A maximum of 20 young patients, aged 5 to 10 years old and with a diagnosis of cerebral palsy, will be chosen for this clinical trial."

Answered by AI

Is this research project accepting senior citizens as participants?

"This trial is only available to children between the ages of 5 and 10. Additionally, there are 218 trials for minors under 18 years old and 143 clinical studies specifically geared towards seniors over 65."

Answered by AI

Is the application process for this trial currently accepting new participants?

"According to the clinicaltrials.gov website, recruitment for this trial is currently in progress. This protocol was initially posted on October 30th 2023 and last modified on October 19th 2023."

Answered by AI

To what extent is the population engaging in this trial?

"Affirmative. The information available on clinicaltrials.gov reveals this trial is presently accepting patients; it was first posted on October 30th 2023 and recently updated on October 19th 2023. This medical study requires a total of twenty participants from one site to take part in the experiment."

Answered by AI

What objectives has this clinical research endeavor set out to accomplish?

"This study will use a Baseline to 12 weeks timeframe to assess the primary outcome of participants that complete the standard exercise program. Secondary outcomes include engagement with the mobile application, scores from Gold-Rizzo Immersion and Presence (GRIP) Inventory in terms of immersion, feasibility, realism, transportation and satisfaction; change of Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Activity and Mobility scores for quality-of life measure; and finally Change of Caregiver Priorities and Child Health Index of Life with Disabilities (CP CHILD)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Using Augmented Reality to Promote Physical Activity in Children With Cerebral Palsy

Melissa Bent 2024. "Using Augmented Reality to Promote Physical Activity in Children With Cerebral Palsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06096272.

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