Clinical trial NCT06096272: Using Augmented Reality to Promote Physical Activity in Children With Cerebral Palsy
Official title: A Pilot Study Using Exergaming With Augmented Reality to Promote Physical Activity in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Mobile Phone Use
Pediatric ALL
Physical Disability
Physical Inactivity
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants that complete mobile application delivered exercise program.
timeFrame: Baseline to 4 weeks.
measure: Number of participants that complete the standard exercise program.
timeFrame: Baseline to 4 weeks.
Secondary outcomes:
measure: Engagement in the mobile application, Gold-Rizzo Immersion and Presence (GRIP) Inventory scale.
timeFrame: At Week 4.
measure: Change in Quality-of-Life measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Activity and Mobility.
timeFrame: Baseline to 4 weeks.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jackie and Gene Autry Orthopedic Center, CHLA
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Melissa Bent, MD
role: PRINCIPAL_INVESTIGATOR
References: