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NCT Number: NCT06096272

Using 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.

Recruiting

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Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jackie and Gene Autry Orthopedic Center, CHLA

Los Angeles, California, 90027, United States

Location status: Recruiting

Location contact

Abigail Padilla, BS

CONTACT

[email protected]

323-361-2142

Melissa Bent, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of cerebral palsy,
  • Ambulatory (GMFCS I and II)
  • English or Spanish speaking
  • No plans for lower extremity surgery in the next 4 months

Exclusion criteria

  • 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

Treatment and study plan

Augment Reality Exergames

Device

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.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. Engagement in the mobile application, Gold-Rizzo Immersion and Presence (GRIP) Inventory scale.

    Time frame: At Week 4.

    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.

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

    Time frame: Baseline to 4 weeks.

    Measure at baseline and end of intervention, change of PROMIS Physical Activity and Mobility scores, higher scores represent higher quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Abigail Padilla, BS

CONTACT

[email protected]

323-361-2142

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Registry information

Official study title

A Pilot Study Using Exergaming With Augmented Reality to Promote Physical Activity in Children With Cerebral Palsy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 23, 2023
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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