RECRUITING

Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy

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Conditions

Cerebral Palsy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy

Quick Facts

Study Start:2022-02-23
Study Completion:2027-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04997109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Months to 13 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Aged 4 to 13 months, corrected age
  2. * Patient at a participating neonatal intensive care unit (NICU) Early Developmental Clinic, outpatient physical and occupational therapy clinic and stroke clinic
  3. * Diagnosis of CP or classification of high-risk for CP as determined by published guidelines (\>95% risk of later CP)
  4. * Hammersmith Infant Neurological Exam (HINE) arm asymmetry score of greater than or equal to 2 and/or neuroimaging consistent with perinatal involvement
  5. * Hand Assessment for Infants (HAI) difference between hands ≥2, with an observable and relative difference in quality or amount of movement between hands, as determined by HAI-certified study therapists and/or a unimanual Bayley score difference between hands \>1
  6. * Parent/legal guardian is able to provide informed consent
  1. * Congenital malformation of the brain or musculoskeletal system (MSK)
  2. * Receipt of botulinum toxin to the affected extremity within 3 months of study entry
  3. * Any prior long-term hard constraint programs

Contacts and Locations

Study Contact

Nathalie Maitre, MD, PhD
CONTACT
(678) 476-5332
nathalie.linda.maitre@emory.edu

Principal Investigator

Nathalie Maitre, MD, PhD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Emory University
Atlanta, Georgia, 30322
United States
Kennedy Krieger Institute
Baltimore, Maryland, 21205
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
The University of Utah
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Emory University

  • Nathalie Maitre, MD, PhD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-23
Study Completion Date2027-02-28

Study Record Updates

Study Start Date2022-02-23
Study Completion Date2027-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Cerebral Palsy