Locomotor Learning in Infants at High Risk for Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Locomotor Learning in Infants at High Risk for Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04561232
• Other study ID #: 19-016773
• Secondary ID: 1R01HD098364-01A
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: March 1, 2026

Study information

• Verified date: January 2024
• Source: Children's Hospital of Philadelphia
• Contact: Laura Prosser, PhD
• Phone: 215-590-2495
• Email: prosserl[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Behavioral:
• Prone and Upright Locomotor Training
During the movement observation phase, infants will wear a wireless movement sensor at each ankle for two days. Research staff will show the caregivers how to place the sensors in the morning and charge them overnight. The training protocol for the prone training will consist of: 1) Warm-up. 2) Assisted movement of the arms and legs. 3) Calibration of the infant's arm and leg positions. 4) Self-initiated mobility for up to five minutes. For upright training, the environment will be arranged to encourage active motor exploration and variability in walking activities.The therapist will assist the child as needed to encourage upright locomotor activities, but only the minimum amount needed to perform the task. Weight assistance will be gradually reduced as postural control and coordination improve.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Children's Hospital Los Angeles, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognition	The cognition age equivalent obtained from the Bayley Scales of Infant and Toddler Development- Fourth Edition (BSID-IV). This value describes what age the child is currently similar to in their cognitive performance, and all values are reported in months of age. The range of values on the scale 0-42 months of age. A higher number value means a greater cognitive ability.	Up to 18 months
Other	Motivation to Move Scale	The Motivation to Move Scale is scored from video data of infant behavior during treatment sessions. Children are classified on a scale of 1 to 5 with higher scoring indicating increased motivation to move.	Up to 18 months
Primary	Gross Motor Function Measure-66	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.	Up to 18 months
Primary	Movement Observation Coding System	The Movement Observation Coding System will use video coding to assess postural control, arm and leg movements, and goal directed movement.	Up to 18 months
Secondary	Early spontaneous movement	Wearable sensor data will be analyzed to describe leg movements produced across in the natural environment.	Up to 4 months
Secondary	Error rate - prone	Error during prone locomotor training will measured using the Self-Initiated Prone Progression Crawler (SIPPC).	Up to 18 months
Secondary	Error rate - upright	Error during upright locomotor training will measured using the dynamic weight support (DWS) technology.	Up to 18 months
Secondary	Movement index	Movement index is the percent of time moving during each therapy session which will be recorded by sensors.	Up to 18 months
Secondary	Postural control	Postural control will be measured from video coding of therapy sessions.	Up to 18 months
Secondary	Movement variability - prone	Movement variability during prone locomotor training will be measured using the Self-Initiated Prone Progression Crawler (SIPPC).	Up to 18 months
Secondary	Movement variability - upright	Movement variability during upright locomotor training will be measured by video coding.	Up to 18 months