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Early Intervention in Infants With Cerebral Palsy

Study acronym: CONTRACT
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated May 9, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Re-verified, no change to tracked fieldsv5
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2020 to May 20, 2021
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 1 word
    v4
  3. Notable Start date: Mar 2020 to Jun 2020
    • Eligibility criteria expanded, about 12 words
    • Study description shortened, about 13 words
    v3
  4. Minor Study description shortened, about 249 wordsv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Contractures are a frequent cause of reduced mobility in children with Cerebral palsy (CP) already at the age of 2-3 years. Reduced muscle use and muscle growth have been suggested as key factors in the development of contractures, suggesting that efficient early prevention will have to involve stimuli that can facilitate muscle growth already before the age of 1 year. The present study protocol was developed to assess the effectiveness of an early intervention program, CONTRACT, on muscle growth and mobility in children at very high risk of CP compared with best standard care.
Trial Details
NCT Number NCT04250454
Lead Sponsor University of Copenhagen
Collaborators: Elsass Foundation
Conditions
(from sponsor)
Cerebral Palsy
Related terms Cerebral Palsy, Contracture
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov