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

Cerebral Palsy Clinical Trial

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

Status Recruiting

Clinical 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 12 weeks. Demographic data will be collected, and validated surveys assessing baseline activity level and quality of life will be administered. Participants will have an exercise program assigned and will be given a logbook to record their exercise adherence. They will be randomized to one of the two arms: Augment Reality (AR) app or control group. The AR app group will have exercises administered through the AR app.

The Control group will do an at-home program using handouts. At the end of the program, participants will complete final surveys and activity tests. The control group will have access to the AR component after the 12 week period.

Clinical Trial 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 randomized, pilot study.

Children with CP, GMFCS I-II between the ages of 5-10 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 8-12 years, English or Spanish speaking, and no plans for lower extremity surgery in the next 4 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: There will be two groups: 1) Group 1: AR app 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 12-week period. A coach 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. 2) Group 2: Control Participants will be given an at home program consisting of virtual coaching, and handouts showing the exercises. They will record their exercise activity in a self log book. They will be given the opportunity to use the AR app after their final outcome assessment so all participants have access to trying the app. 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 quality of life questionnaires, activity monitor daily step count, and strength and endurance measures will be administered to evaluate the effect of the intervention at baseline and final assessment. ;

Related Conditions & MeSH terms

• Cerebral Palsy
• Mobile Phone Use
• Pediatric ALL
• Physical Disability
• Physical Inactivity

• NCT number: NCT06096272
• Study type: Interventional
• Source: Children's Hospital Los Angeles
• Contact: Abigail Padilla, BS
• Phone: 323-361-2142
• Email: OrthoResearch@chla.usc.edu
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2024
• Completion date: September 1, 2024