RecruitingNot ApplicableNCT04250454

Early Intervention in Infants With Cerebral Palsy

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.

Sponsor

University of Copenhagen

Enrollment

36 participants

Start Date

May 20, 2021

Study Type

INTERVENTIONAL

Conditions

Cerebral Palsy

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.

Eligibility

Min Age: 8 WeeksMax Age: 20 Weeks

Inclusion Criteria1

Infants younger than 17 weeks CA with suspicion of brain lesion determined from a medical assessment, by MRI or ultrasound scan or abcent fidgety movements (FM) determined as part of General Movement Asessement (GMA) will be included. The brain lesion should be rated severe enough by the clinician to have informed the parents of the associated risk of CP.

Exclusion Criteria1

Infants otherwise eligible but with severe genetic abnormalties, severe heart problems, metabolic diseases, or still hospitalized will not be selected for the study.

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Interventions

BEHAVIORALCONTRACT

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.