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

Primary Purpose

Cerebral Palsy, Mobile Phone Use, Pediatric ALL

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Augment Reality Exergames
Sponsored by
Children's Hospital Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

5 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jackie and Gene Autry Orthopedic Center, CHLARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Augment Therapy app

Standard Exercise Handouts

Arm Description

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 12-week period. A coach will check in virtually with the participant during the program. They will complete baseline and final surveys and functional tests. Exercise data will be collected and stored through the Augment Therapy™ app and self log book.

Participants will be given an home based exercise program consisting of virtual coaching and handouts showing the exercises. They will complete baseline and final surveys and functional tests. They will record their exercise activity in a self log book. They will be given the opportunity to use the AR mobile app after their final outcome assessment so all participants have access to trying the mobile app.

Outcomes

Primary Outcome Measures

Number of participants that complete mobile application delivered exercise program.
Measured by proportion of time in the mobile application (180/360 total minutes).
Number of participants that complete the standard exercise program.
Measured by proportion of time (180/360 total minutes) to complete exercises in logbook.

Secondary Outcome Measures

Habitual Physical Activity
StepWatch™ Activity Monitor
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.
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.
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.
Change in performance in Single Leg Balance Test.
Change in seconds of Single Leg Balance Test from baseline to end of intervention.
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.

Full Information

First Posted
August 28, 2023
Last Updated
October 19, 2023
Sponsor
Children's Hospital Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT06096272
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2023 (Anticipated)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Mobile Phone Use, Pediatric ALL, Physical Disability, Physical Inactivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Augment Therapy app
Arm Type
Experimental
Arm Description
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 12-week period. A coach will check in virtually with the participant during the program. They will complete baseline and final surveys and functional tests. Exercise data will be collected and stored through the Augment Therapy™ app and self log book.
Arm Title
Standard Exercise Handouts
Arm Type
No Intervention
Arm Description
Participants will be given an home based exercise program consisting of virtual coaching and handouts showing the exercises. They will complete baseline and final surveys and functional tests. They will record their exercise activity in a self log book. They will be given the opportunity to use the AR mobile app after their final outcome assessment so all participants have access to trying the mobile app.
Intervention Type
Device
Intervention Name(s)
Augment Reality Exergames
Intervention Description
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 Information:
Title
Number of participants that complete mobile application delivered exercise program.
Description
Measured by proportion of time in the mobile application (180/360 total minutes).
Time Frame
Baseline to 12 weeks.
Title
Number of participants that complete the standard exercise program.
Description
Measured by proportion of time (180/360 total minutes) to complete exercises in logbook.
Time Frame
Baseline to 12 weeks.
Secondary Outcome Measure Information:
Title
Habitual Physical Activity
Description
StepWatch™ Activity Monitor
Time Frame
Week 1 (Pre-intervention) , Week 12 (Post-Intervention)
Title
Engagement in the mobile application, Gold-Rizzo Immersion and Presence (GRIP) Inventory scale.
Description
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.
Time Frame
At Week 12.
Title
Change in Quality-of-Life measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Activity and Mobility.
Description
Measure at baseline and end of intervention, change of PROMIS Physical Activity and Mobility scores, higher scores represent higher quality of life.
Time Frame
Baseline to 12 weeks.
Title
Change of Quality-of-Life measure Caregiver Priorities and Child Health Index of Life with Disabilities (CP CHILD).
Description
Measure at baseline and end of intervention, change of Caregiver Priorities and Child Health Index of Life with Disabilities (CP CHILD) score.
Time Frame
Baseline to 12 weeks.
Title
Change in performance in Single Leg Balance Test.
Description
Change in seconds of Single Leg Balance Test from baseline to end of intervention.
Time Frame
Baseline to 12 weeks.
Title
Change in performance in Timed Up and Go Test (TUG).
Description
Change in seconds of Timed Up and Go Test (TUG) from baseline to end of intervention.
Time Frame
Baseline to 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abigail Padilla, BS
Phone
323-361-2142
Email
OrthoResearch@chla.usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Bent, MD
Organizational Affiliation
Children's Hospital Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jackie and Gene Autry Orthopedic Center, CHLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abigail Padilla, BS
Phone
323-361-2142
Email
OrthoResearch@chla.usc.edu
First Name & Middle Initial & Last Name & Degree
Melissa Bent, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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