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

NCT06096272 | Recruiting

• 1 other identifier: CHLA-23-00120
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Number of participants that complete mobile application delivered exercise program.

  Measured by proportion of time in the mobile application (180/360 total minutes).

  Baseline to 4 weeks.

• Number of participants that complete the standard exercise program.

  Measured by proportion of time (180/360 total minutes) to complete exercises in logbook.

  Baseline to 4 weeks.

Secondary Outcomes (2)

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

  At Week 4.

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

  Baseline to 4 weeks.

Study Arms (1)

Augment Therapy app

EXPERIMENTAL

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.

Device: Augment Reality Exergames

Interventions

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.

Augment Therapy app

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Jackie and Gene Autry Orthopedic Center, CHLA

Los Angeles, California, 90027, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Cell Phone Use; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Sedentary Behavior

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Communication; Behavior; Social Behavior; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Melissa Bent, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abigail Padilla, BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: October 23, 2023
• Study Start: June 7, 2024
• Primary Completion: May 31, 2025
• Study Completion: September 1, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)