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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 months

Awards & highlights

Study 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.Check my eligibility

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).See study design

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

Select...

I had a brain injury as a baby that could lead 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Gross Motor Function Measure-66

Movement Observation Coding System

Secondary outcome measures

Early spontaneous movement

Error rate - prone

Error rate - upright

+4 more

Other outcome measures

Cognition

Motivation to Move Scale

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor

708 Previous Clinical Trials

8,582,760 Total Patients Enrolled

2 Trials studying Cerebral Palsy

322 Patients Enrolled for Cerebral Palsy

Children's Hospital Los AngelesOTHER

232 Previous Clinical Trials

5,076,464 Total Patients Enrolled

2 Trials studying Cerebral Palsy

54 Patients Enrolled for Cerebral Palsy

University of OklahomaOTHER

455 Previous Clinical Trials

95,863 Total Patients Enrolled

2 Trials studying Cerebral Palsy

75 Patients Enrolled for Cerebral Palsy

Media Library

Prone and Upright Locomotor Training Clinical Trial Eligibility Overview. Trial Name: NCT04561232 — N/A

Cerebral Palsy Research Study Groups: Locomotor Learning

Cerebral Palsy Clinical Trial 2023: Prone and Upright Locomotor Training Highlights & Side Effects. Trial Name: NCT04561232 — N/A

Prone and Upright Locomotor Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT04561232 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial still open to volunteers?

"According to the clinicaltrials.gov data, this trial is open for recruitment and was initially posted on December 15th 2020 before being revised on January 4th 2022."

Answered by AI

Does my profile fit the criteria to partake in this research?

"This research is seeking 60 infants aged 0-6 Weeks and diagnosed with cerebral palsy. Furthermore, in order to participate the family must be able to attend all study visits. Additionally, the baby's condition has to have been caused by an early brain injury such as periventricular leukomalacia, hypoxic-ischemic encephalopathy, intraventricular hemorrhage, hydrocephalus, stroke, neonatal seizures or intracranial cystic lesions."

Answered by AI

Is age a factor in determining eligibility for participation in this research?

"To be eligible for this trial, applicants must fall between 0 and 6 weeks in age. There are 148 trials open to individuals younger than 18 years old and 71 available for those 65 or older."

Answered by AI

What is the primary objective of this investigation?

"This 18-month long study seeks to assess Gross Motor Function Measure-66. Additionally, the Movement Index (percent of time moving during each therapy session), Early Spontaneous Movement (leg movements captured by wearable sensors in natural environment) and Movement Variability - Prone (measured using Self-Initiated Prone Progression Crawler) will be monitored as secondary objectives."

Answered by AI

What is the highest cap on enrollment for this clinical trial?

"Absolutely. According to the clinicaltrials.gov portal, this medical investigation has been open for enrollment since December 15th 2020 and is actively recruiting participants. 60 people need to be enrolled from a solitary site in order to complete the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Locomotor Learning in Infants at High Risk for Cerebral Palsy

2020. "Locomotor Learning in Infants at High Risk for Cerebral Palsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04561232.

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