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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)

Must not have

Moderate to severe developmental or cognitive delay

Significant hearing loss or visual impairment

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a significant learning or developmental delay.

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I have significant hearing or vision loss.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants that complete mobile application delivered exercise program.

Number of participants that complete the standard exercise program.

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 5Eligibility criteria met