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Completed

NCT Number: NCT04561232

Locomotor Learning in Infants at High Risk for Cerebral Palsy

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).

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

Up to 6 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Crawling therapy, Walking therapy

Primary outcomes

  1. Gross Motor Function Measure-66

    Time frame: 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.

  2. Movement Observation Coding System

    Time frame: 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 outcomes

  1. Early spontaneous movement

    Time frame: Up to 4 months

    Wearable sensor data will be analyzed to describe leg movements produced across in the natural environment.

  2. Error rate - prone

    Time frame: Up to 18 months

    Error during prone locomotor training will measured using the Self-Initiated Prone Progression Crawler (SIPPC).

  3. Error rate - upright

    Time frame: Up to 18 months

    Error during upright locomotor training will measured using the dynamic weight support (DWS) technology.

  4. Movement index

    Time frame: Up to 18 months

    Movement index is the percent of time moving during each therapy session which will be recorded by sensors.

  5. Postural control

    Time frame: Up to 18 months

    Postural control will be measured from video coding of therapy sessions.

  6. Movement variability - prone

    Time frame: Up to 18 months

    Movement variability during prone locomotor training will be measured using the Self-Initiated Prone Progression Crawler (SIPPC).

  7. Movement variability - upright

    Time frame: Up to 18 months

    Movement variability during upright locomotor training will be measured by video coding.

Other outcomes

  1. Cognition

    Time frame: Up to 18 months

    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.

  2. Motivation to Move Scale

    Time frame: Up to 18 months

    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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

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

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2020
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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