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Early Intervention in Infants With Cerebral Palsy

NCT04250454 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-05-09

No results posted yet for this study

Summary

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.

Conditions

  • Cerebral Palsy

Interventions

BEHAVIORAL

CONTRACT

The intervention will consist of four elements: 1. Personal meeting - detailed information to the parents before the age of 15 weeks CA (1-3 days) 2. Home Activity Plan (HAP) 3. Home-based Feedback training 4. Electrical muscle stimulation Combination of these elements has been chosen in order to ensure that optimal muscle growth is achieved through multi-modal stimulation of the motor and cognitive development of the child.

Sponsors & Collaborators

  • Elsass Foundation

    collaborator OTHER

  • University of Copenhagen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Weeks
Max Age
20 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2025-12-31
Completion
2029-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04250454 on ClinicalTrials.gov