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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06096272
• Other study ID #: CHLA-23-00120
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2024
• Source: Children's Hospital Los Angeles
• Contact: Abigail Padilla, BS
• Phone: 323-361-2142
• Email: OrthoResearch[@]chla.usc.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 1, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Jackie and Gene Autry Orthopedic Center, CHLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 12 weeks.
Primary	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 12 weeks.
Secondary	Habitual Physical Activity: StepWatch™ Activity Monitor	Measure number of daily steps using the StepWatch™ Activity Monitor which will be worn on participant's ankle.	Week 1 (Pre-intervention) , Week 12 (Post-Intervention)
Secondary	Engagement in the mobile application, Gold-Rizzo Immersion and Presence (GRIP) Inventory scale.	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.	At Week 12.
Secondary	Change in Quality-of-Life measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Activity and Mobility.	Measure at baseline and end of intervention, change of PROMIS Physical Activity and Mobility scores, higher scores represent higher quality of life.	Baseline to 12 weeks.
Secondary	Change of Quality-of-Life measure Caregiver Priorities and Child Health Index of Life with Disabilities (CP CHILD).	Measure at baseline and end of intervention, change of Caregiver Priorities and Child Health Index of Life with Disabilities (CP CHILD) score. Scores for each domain and for the total survey are standardized and range from 0 (worse) to 100 (best), higher scores mean better health related quality of life.	Baseline to 12 weeks.
Secondary	Change in performance in Single Leg Balance Test.	Change in seconds of Single Leg Balance Test from baseline to end of intervention.	Baseline to 12 weeks.
Secondary	Change in performance in Timed Up and Go Test (TUG).	Change in seconds of Timed Up and Go Test (TUG) from baseline to end of intervention.	Baseline to 12 weeks.