Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT04250454
NA

Early Intervention in Infants With Cerebral Palsy

Sponsor: University of Copenhagen

View on ClinicalTrials.gov

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.

Official title: Protocol of a Two-group Open-label Randomized Clinical Trial With Blinded Assessment for Prevention of Contractures in Infants With High Risk of Cerebral Palsy.

Key Details

Gender

All

Age Range

8 Weeks - 20 Weeks

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2021-05-20

Completion Date

2029-12

Last Updated

2024-05-09

Healthy Volunteers

No

Conditions

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.

Locations (1)

Elsass Foundation

Charlottenlund, København City, Denmark