Locomotor learning in infants at high risk for cerebral palsy: A study protocol

Abstract

BackgroundPhysical disability in individuals with cerebral palsy (CP) creates lifelong mobility challenges and healthcare costs. Despite this, very little is known about how infants at high risk for CP learn to move and acquire early locomotor skills, which set the foundation for lifelong mobility. The objective of this project is to characterize the evolution of locomotor learning over the first 18 months of life in infants at high risk for CP. To characterize how locomotor skill is learned, we will use robotic and sensor technology to provide intervention and longitudinally study infant movement across three stages of the development of human motor control: early spontaneous movement, prone locomotion (crawling), and upright locomotion (walking).Study designThis longitudinal observational/intervention cohort study (ClinicalTrials.gov Identifier: NCT04561232) will enroll sixty participants who are at risk for CP due to a brain injury by one month post-term age. Study participation will be completed by 18 months of age. Early spontaneous leg movements will be measured monthly from 1 to 4 months of age using inertial sensors worn on the ankles for two full days each month. Infants who remain at high risk for CP at 4 months of age, as determined from clinical assessments of motor function and movement quality, will continue through two locomotor training phases. Prone locomotor training will be delivered from 5 to 9 months of age using a robotic crawl training device that responds to infant behavior in real-time. Upright locomotor training will be delivered from 9 to 18 months of age using a dynamic weight support system to allow participants to practice skills beyond their current level of function. Repeated assessments of locomotor skill, training characteristics (such as movement error, variability, movement time and postural control), and variables that may mediate locomotor learning will be collected every two months during prone training and every three months during upright training.DiscussionThis study will develop predictive models of locomotor skill acquisition over time. We hypothesize that experiencing and correcting movement errors is critical to skill acquisition in infants at risk for CP and that locomotor learning is mediated by neurobehavioral factors outside of training.Project Number 1R01HD098364-01A1.ClinicalTrials.gov Identifier: NCT04561232

Agreement Between the Gross Motor Ability Estimator-2 and the Gross Motor Ability Estimator-3 in Young Children With Cerebral Palsy

“…One GMFM-66 was randomly selected for each participant for this analysis from all study assessments of up to 8 assessments 5 or up to 6 assessments. 6 A GMFM-66 score was calculated for each participant from the GMFM-88 scoresheets using the GMAE-2 software 2 and GMFM App+ which uses the GMAE-3 algorithm. 4 Eleven participants who had at least 1 GMFM-66 score of less than 25 were identified for further analysis to separately analyze agreement between scores at the lower end of the GMFM-66.…”

“…The order of item administration was variable and based on the child's behavior and comfort with the physical therapist. One GMFM-66 was randomly selected for each participant for this analysis from all study assessments of up to 8 assessments5 or up to 6 assessments 6. A GMFM-66 score was calculated for each participant from the GMFM-88 scoresheets using the GMAE-2 software2 and GMFM App+ which uses the GMAE-3 algorithm 4.…”

“…The data used for this secondary retrospective analysis were collected from 2 clinical trials of motor interventions for infants and young children with CP (ClinicalTrials.gov Identifier: NCT02340026) 5 or at risk for CP (ClinicalTrials.gov Identifier: NCT04561232). 6 These studies were approved by an Institutional Review Board and 1 parent or legal guardian provided informed consent. Data from 53 children were included in this analysis: 25 girls and 28 boys.…”