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Locomotor Learning in Infants at High Risk for Cerebral Palsy

Locomotor Learning in Infants at High Risk for Cerebral Palsy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04561232
Enrollment
60
Registered
2020-09-23
Start date
2020-12-15
Completion date
2025-08-04
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

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

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.

Interventions

BEHAVIORALProne 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.

Sponsors

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

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Weeks
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Gross Motor Function Measure-66Up to 18 monthsThe 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 SystemUp to 18 monthsThe Movement Observation Coding System will use video coding to assess postural control, arm and leg movements, and goal directed movement.

Secondary

MeasureTime frameDescription
Early spontaneous movementUp to 4 monthsWearable sensor data will be analyzed to describe leg movements produced across in the natural environment.
Error rate - proneUp to 18 monthsError during prone locomotor training will measured using the Self-Initiated Prone Progression Crawler (SIPPC).
Error rate - uprightUp to 18 monthsError during upright locomotor training will measured using the dynamic weight support (DWS) technology.
Movement indexUp to 18 monthsMovement index is the percent of time moving during each therapy session which will be recorded by sensors.
Postural controlUp to 18 monthsPostural control will be measured from video coding of therapy sessions.
Movement variability - proneUp to 18 monthsMovement variability during prone locomotor training will be measured using the Self-Initiated Prone Progression Crawler (SIPPC).
Movement variability - uprightUp to 18 monthsMovement variability during upright locomotor training will be measured by video coding.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLaura Prosser, PhD

Research Scientist

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026