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Locomotor Training for Infants at High Risk of Cerebral Palsy

N/A

Recruiting

Led By Laura Prosser, PhD

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be younger than 18 years old

Must not have

Known genetic condition unrelated to cerebral palsy (CP) or congenital abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how infants at high risk for cerebral palsy learn to move during the first 18 months of life.

Who is the study for?

This trial is for infants under 6 weeks old at high risk for cerebral palsy due to early brain injury. Families must commit to study visits. Infants with certain genetic conditions, normal movement assessments, or better-than-expected motor performance scores are excluded.

What is being tested?

The study tests how babies at risk of cerebral palsy learn to move from birth up to walking age. It uses special robotic and sensor technology over three stages: early movements, crawling (prone locomotion), and walking (upright locomotion).

What are the potential side effects?

Since the interventions involve physical training exercises designed for infants, side effects may include typical reactions such as tiredness or frustration during sessions but no significant medical side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a brain injury as a baby that could lead to cerebral palsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a genetic condition not related to cerebral palsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Gross Motor Function Measure-66

Movement Observation Coding System

Secondary study objectives

Early spontaneous movement

Error rate - prone

Error rate - upright

+4 more

Other study objectives

Cognition

Motivation to Move Scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Locomotor LearningExperimental Treatment1 Intervention

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.

0 / 2Eligibility criteria met