Locomotor Learning in Infants at High Risk for Cerebral Palsy

Not Applicable

Active, not recruiting

• Conditions: Cerebral Palsy

• Registration Number: NCT04561232
• Lead Sponsor: Children's Hospital of Philadelphia

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.

Study Timeline

• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-23
• Study Start: 2020-12-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-28
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Gross Motor Function Measure-66	Up to 18 months	The Gross Motor Function Measure-66 (GMFM-66) is a Rasch-analyzed measure of gross motor function designed for children with cerebral palsy (CP). Computation of the GMFM-66 score involves statistical weighting of the raw item scores for difficulty. Scores range from 0 to 100 with higher scores indicating more functional ability.
Movement Observation Coding System	Up to 18 months	The Movement Observation Coding System will use video coding to assess postural control, arm and leg movements, and goal directed movement.

Secondary Outcome Measures

Name	Time	Method
Error rate - prone	Up to 18 months	Error during prone locomotor training will measured using the Self-Initiated Prone Progression Crawler (SIPPC).
Error rate - upright	Up to 18 months	Error during upright locomotor training will measured using the dynamic weight support (DWS) technology.
Movement index	Up to 18 months	Movement index is the percent of time moving during each therapy session which will be recorded by sensors.
Movement variability - prone	Up to 18 months	Movement variability during prone locomotor training will be measured using the Self-Initiated Prone Progression Crawler (SIPPC).
Postural control	Up to 18 months	Postural control will be measured from video coding of therapy sessions.
Early spontaneous movement	Up to 4 months	Wearable sensor data will be analyzed to describe leg movements produced across in the natural environment.
Movement variability - upright	Up to 18 months	Movement variability during upright locomotor training will be measured by video coding.

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States