Locomotor Learning in Infants at High Risk for Cerebral Palsy

NCT04561232 | Completed

• 2 other identifiers: 19-0167731R01HD098364-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Cerebral Palsy

Keywords

cerebral palsy; infant; physical therapy; motor learning; robotics

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Early spontaneous movement

  Up to 4 months

• Error rate - prone

  Up to 18 months

• Error rate - upright

  Up to 18 months

• Movement index

  Up to 18 months

• Postural control

  Up to 18 months

Other Outcomes (2)

• Cognition

  Up to 18 months

• Motivation to Move Scale

  Up to 18 months

Study Arms (1)

Locomotor Learning

OTHER

This study has three phases. The first phase of the study will be the observation of early spontaneous leg movements which will be measured monthly from 1-4 months of age. The prone locomotor intervention phase using the Self-Initiated Prone Progression Crawler (SIPPC) will occur from 5-9 months of post-term age, or end earlier if the child achieves the ability to crawl six feet. Treatment will occur at an intensity of 3 times per week for 15-30 minutes. Infants will use the SIPPC for the duration of each therapy session The upright locomotor intervention phase using DWS will occur from 9-18 months of age, or begin earlier if the child achieves the ability to crawl six feet before 9 months of age, and end earlier if the child achieves independent walking before 18 months of age. Treatment will occur at an intensity of 3 times per week for 30 minutes. Infants will receive dynamic weight support (DWS) for the duration of the 30-minute therapy session.

Behavioral: Prone and Upright Locomotor Training

Interventions

Prone and Upright Locomotor Training BEHAVIORAL

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.

Also known as: Crawling therapy, Walking therapy

Locomotor Learning

Eligibility Criteria

• Age: Up to 6 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \* 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Children's Hospital Los Angeles: collaborator
• University of Oklahoma: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• Pierce SR, Skorup J, Kolobe THA, Smith BA, Prosser LA. Agreement Between the Gross Motor Ability Estimator-2 and the Gross Motor Ability Estimator-3 in Young Children With Cerebral Palsy. Pediatr Phys Ther. 2024 Jan 1;36(1):37-40. doi: 10.1097/PEP.0000000000001065. Epub 2023 Nov 30.

  PMID: 38033276 DERIVED

• Prosser LA, Skorup J, Pierce SR, Jawad AF, Fagg AH, Kolobe THA, Smith BA. Locomotor learning in infants at high risk for cerebral palsy: A study protocol. Front Pediatr. 2023 Feb 23;11:891633. doi: 10.3389/fped.2023.891633. eCollection 2023.

  PMID: 36911033 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Laura Prosser, PhD

  Research Scientist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 23, 2020
• Study Start: December 15, 2020
• Primary Completion: August 6, 2025
• Study Completion: August 6, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

US (1)