Recruiting

Augmented Reality

Sponsor:

Children's Hospital Los Angeles

Code:

NCT06096272

Conditions

Cerebral Palsy

Mobile Phone Use

Pediatric ALL

Physical Disability

Physical Inactivity

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

Interventions

Augment Reality Exergames

Study Details

Brief 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. 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.

Conditions

Cerebral Palsy

Mobile Phone Use

Pediatric ALL

Physical Disability

Physical Inactivity

Study ID

NCT06096272

Start date

Jun 7, 2024

Status verified date

Jan, 2025

Completion date

Sep 1, 2025

Anticipated

Primary completion date

May 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Augment Therapy app

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.

Interventions

Augment Reality Exergames

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 outcome measure

  • Number of participants that complete mobile application delivered exercise program. [ Time Frame: Baseline to 4 weeks. ]
  • Number of participants that complete the standard exercise program. [ Time Frame: Baseline to 4 weeks. ]

Central Contacts and Locations

Central contacts

Abigail Padilla, BS

323-361-2142OrthoResearch@chla.usc.edu

Locations

Jackie and Gene Autry Orthopedic Center, CHLA

Recruiting

Los Angeles, California, United States, 90027

Contacts

Abigail Padilla, BS

323-361-2142OrthoResearch@chla.usc.edu

Principal Investigator:

Melissa Bent, MD

More Information

Sponsor

Children's Hospital Los Angeles

Last update posted

Jan 20, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital Los Angeles on 2025-01-20.