Using Augmented Reality to Promote Physical Activity in Children With Cerebral Palsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-18
SponsorChildren's Hospital Los Angeles
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of cerebral palsy,
Ambulatory (GMFCS I and II)
English or Spanish speaking
No plans for lower extremity surgery in the next 4 months
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Augment Reality Exergames
DeviceAdaptive 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Augment Therapy appExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants that complete mobile application delivered exercise program.
Measured by proportion of time in the mobile application (180/360 total minutes).
Time frame
Baseline to 4 weeks.2
Number of participants that complete the standard exercise program.
Measured by proportion of time (180/360 total minutes) to complete exercises in logbook.
Time frame
Baseline to 4 weeks.Secondary outcomes
1
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.
Time frame
At Week 4.2
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.
Time frame
Baseline to 4 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov