Clinical trial NCT04561232: Locomotor Learning in Infants at High Risk for Cerebral Palsy
Official title: Locomotor Learning in Infants at High Risk for Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: cerebral palsy
infant
physical therapy
motor learning
robotics
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
name: University of Oklahoma
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-09-23
Enrollment: 60
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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 cerebral palsy (CP). To characterize how locomotor skill is learned (or not learned) during this critical period, the investigators will combine established protocols using robust, unbiased robotic and sensor technology to longitudinally study infant movement across three consecutive stages during the development of impaired human motor control - early spontaneous movement, prone locomotion (crawling), and upright locomotion (walking).

Detailed description: Early spontaneous leg movements will be measured monthly from 1-4 months of age. Infants who remain at high risk for CP by month 4 as measured by the General Movements Assessment and the Test of Infant Motor Performance (TIMP) at 4 months of age will continue to locomotor training phases. Prone locomotor training using the Self-Initiated Prone Progression Crawler (SIPPC) will be delivered from 5-9 months of age. Upright locomotor training with dynamic weight support (DWS) will be delivered from 9-18 months of age. Repeated assessments of locomotor skill, movement quality, training characteristics, and variables that may mediate locomotor learning will be collected at time points from 1 month to 18 months of post-term age.

Investigators will examine the relationships between motor error and locomotor skill acquisition over time, anticipating that experiencing and correcting movement errors is critical to skill acquisition in infants at risk for CP; the contribution of other training characteristics (movement time, movement variability, and postural control) to locomotor learning; and how learning is mediated by neurobehavioral factors outside of training. Investigators will develop comprehensive models of training predictors and mediators for prone and upright locomotor learning.

Eligibility criteria: Inclusion Criteria:

* less than 6 weeks of age (corrected for prematurity, if applicable)
* have a history of an early brain injury associated with high risk for cerebral palsy including periventricular leukomalacia, hypoxic-ischemic encephalopathy, intraventricular hemorrhage, hydrocephalus, stroke, neonatal seizures, or intracranial cystic lesion
* family is able to commit to study visits

Exclusion Criteria:

\* known genetic condition unrelated to cerebral palsy (CP) or congenital abnormalities

Infants with fidgety movements on the General Movements Assessments (GMA) at 3 months of age or a score greater than -0.5sd below the mean on the Test of Infant Motor Performance at 4 months of age will not progress in the study because these infants are unlikely to have CP.

Primary outcomes:
measure: Gross Motor Function Measure-66
timeFrame: Up to 18 months
measure: Movement Observation Coding System
timeFrame: Up to 18 months
Secondary outcomes:
measure: Early spontaneous movement
timeFrame: Up to 4 months
measure: Error rate - prone
timeFrame: Up to 18 months
measure: Error rate - upright
timeFrame: Up to 18 months
measure: Movement index
timeFrame: Up to 18 months
measure: Postural control
timeFrame: Up to 18 months
measure: Movement variability - prone
timeFrame: Up to 18 months
measure: Movement variability - upright
timeFrame: Up to 18 months
Other outcomes:
measure: Cognition
timeFrame: Up to 18 months
measure: Motivation to Move Scale
timeFrame: Up to 18 months
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Research Scientist
name: Laura Prosser, PhD
role: PRINCIPAL_INVESTIGATOR
References: