Actively Recruiting

Phase Not Applicable
Age: 4Months - 13Months
All Genders
NCT04997109

Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy

Led by Emory University · Updated on 2025-10-14

267

Participants Needed

4

Research Sites

261 weeks

Total Duration

On this page

Sponsors

E

Emory University

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study assesses two active treatments in different sequences and a standard of care group among infants with cerebral palsy.

CONDITIONS

Official Title

Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy

Who Can Participate

Age: 4Months - 13Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 4 to 13 months, corrected age
  • Diagnosis of cerebral palsy or classified as high risk for cerebral palsy (>95% risk)
  • Hammersmith Infant Neurological Exam arm asymmetry score of 2 or higher and/or neuroimaging showing perinatal brain involvement
  • Hand Assessment for Infants difference between hands of 2 or more with observed movement difference, or unimanual Bayley score difference between hands greater than 1
  • Parent or legal guardian able to provide informed consent
Not Eligible

You will not qualify if you...

  • Congenital malformation of the brain or musculoskeletal system
  • Received botulinum toxin treatment in the affected extremity within 3 months before entering the study
  • Prior participation in long-term hard constraint therapy programs

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Emory University

Atlanta, Georgia, United States, 30322

Actively Recruiting

2

Kennedy Krieger Institute

Baltimore, Maryland, United States, 21205

Actively Recruiting

3

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

4

The University of Utah

Salt Lake City, Utah, United States, 84112

Actively Recruiting

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Research Team

N

Nathalie Maitre, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

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