Early Intervention in Infants With Cerebral Palsy

NCT04250454 | Recruiting

• 1 other identifier: CONTRACT333
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Early intervention; Contractures

Outcome Measures

Primary Outcomes (1)

• Muscle growth rate

  The primary outcome measure is the rate of muscle growth in the children evaluated from the start of the study until the final end point measurement at 48 month. Researchers with high experience in the use of ultrasound (US) examines the entire length of the MG muscle to assess muscle volume. Height, weight, circumference of the widest part of the crus and fibula length is measured. US is performed on the most affected leg or if possible, on both legs, with the infant's ankle fixed in a neutral angle. To estimate muscle thickness and fascicle length one recording is performed with the probe positioned longitudinally at the mid-belly of the MG, with the infant's ankle fixed in a 90-degree angle. The probe was hand-held and fixed vertically with the lower leg for all images.

  48 months

Secondary Outcomes (1)

• Evaluation of passive stiffness and reflex stiffness

  48 months

Study Arms (2)

Control

NO INTERVENTION

Elsass Standard Care

Intervention

ACTIVE COMPARATOR

Enriched eviroment, Feed back training, Electrical stimulation, nutrition

Behavioral: CONTRACT

Interventions

CONTRACT BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 8 Weeks - 20 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Copenhagen: lead
• Elsass Foundation: collaborator

Study Sites (1)

Elsass Foundation

Charlottenlund, København City, 2920, Denmark

RECRUITING

Related Publications (12)

• Rosenbaum P. The natural history of gross motor development in children with cerebral palsy aged 1 to 15 years. Dev Med Child Neurol. 2007 Oct;49(10):724. doi: 10.1111/j.1469-8749.2007.00724.x. No abstract available.

  PMID: 17880638 BACKGROUND

• Hagglund G, Wagner P. Spasticity of the gastrosoleus muscle is related to the development of reduced passive dorsiflexion of the ankle in children with cerebral palsy: a registry analysis of 2,796 examinations in 355 children. Acta Orthop. 2011 Dec;82(6):744-8. doi: 10.3109/17453674.2011.618917. Epub 2011 Sep 6.

  PMID: 21895507 BACKGROUND

• Shikako-Thomas K, Majnemer A, Law M, Lach L. Determinants of participation in leisure activities in children and youth with cerebral palsy: systematic review. Phys Occup Ther Pediatr. 2008 May;28(2):155-69. doi: 10.1080/01942630802031834.

  PMID: 18846895 BACKGROUND

• Spittle A, Orton J, Anderson PJ, Boyd R, Doyle LW. Early developmental intervention programmes provided post hospital discharge to prevent motor and cognitive impairment in preterm infants. Cochrane Database Syst Rev. 2015 Nov 24;2015(11):CD005495. doi: 10.1002/14651858.CD005495.pub4.

  PMID: 26597166 BACKGROUND

• Tedroff K, Lowing K, Jacobson DN, Astrom E. Does loss of spasticity matter? A 10-year follow-up after selective dorsal rhizotomy in cerebral palsy. Dev Med Child Neurol. 2011 Aug;53(8):724-9. doi: 10.1111/j.1469-8749.2011.03969.x. Epub 2011 May 18.

  PMID: 21585367 BACKGROUND

• Guzzetta A, Mercuri E, Rapisardi G, Ferrari F, Roversi MF, Cowan F, Rutherford M, Paolicelli PB, Einspieler C, Boldrini A, Dubowitz L, Prechtl HF, Cioni G. General movements detect early signs of hemiplegia in term infants with neonatal cerebral infarction. Neuropediatrics. 2003 Apr;34(2):61-6. doi: 10.1055/s-2003-39597.

  PMID: 12776225 BACKGROUND

• Willerslev-Olsen M, Choe Lund M, Lorentzen J, Barber L, Kofoed-Hansen M, Nielsen JB. Impaired muscle growth precedes development of increased stiffness of the triceps surae musculotendinous unit in children with cerebral palsy. Dev Med Child Neurol. 2018 Jul;60(7):672-679. doi: 10.1111/dmcn.13729. Epub 2018 Mar 24.

  PMID: 29573407 BACKGROUND

• Williams PTJA, Jiang YQ, Martin JH. Motor system plasticity after unilateral injury in the developing brain. Dev Med Child Neurol. 2017 Dec;59(12):1224-1229. doi: 10.1111/dmcn.13581. Epub 2017 Oct 3.

  PMID: 28972274 BACKGROUND

• Herskind A, Ritterband-Rosenbaum A, Willerslev-Olsen M, Lorentzen J, Hanson L, Lichtwark G, Nielsen JB. Muscle growth is reduced in 15-month-old children with cerebral palsy. Dev Med Child Neurol. 2016 May;58(5):485-91. doi: 10.1111/dmcn.12950. Epub 2015 Oct 28.

  PMID: 26510820 BACKGROUND

• Willerslev-Olsen M, Lorentzen J, Sinkjaer T, Nielsen JB. Passive muscle properties are altered in children with cerebral palsy before the age of 3 years and are difficult to distinguish clinically from spasticity. Dev Med Child Neurol. 2013 Jul;55(7):617-23. doi: 10.1111/dmcn.12124. Epub 2013 Mar 20.

  PMID: 23517272 BACKGROUND

• Ritterband-Rosenbaum A, Justiniano MD, Nielsen JB, Christensen MS. Are sensorimotor experiences the key for successful early intervention in infants with congenital brain lesion? Infant Behav Dev. 2019 Feb;54:133-139. doi: 10.1016/j.infbeh.2019.02.001. Epub 2019 Feb 12.

  PMID: 30769300 BACKGROUND

• Willerslev-Olsen M, Lorentzen J, Rohder K, Ritterband-Rosenbaum A, Justiniano M, Guzzetta A, Lando AV, Jensen AB, Greisen G, Ejlersen S, Pedersen LZ, Andersen B, Lipthay Behrend P, Nielsen JB. COpenhagen Neuroplastic TRaining Against Contractures in Toddlers (CONTRACT): protocol of an open-label randomised clinical trial with blinded assessment for prevention of contractures in infants with high risk of cerebral palsy. BMJ Open. 2021 Jul 6;11(7):e044674. doi: 10.1136/bmjopen-2020-044674.

  PMID: 34230015 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Contracture

Interventions

Contracts

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases

Intervention Hierarchy (Ancestors)

Jurisprudence; Social Control, Formal; Health Care Economics and Organizations

Central Study Contacts

Jens Nielsen, Professor

CONTACT

+4528757450; jbnielsen@sund.ku.dk

Maria Willerslev-Olsen, Ph.D

CONTACT

+4522834005; mwo@elsassfonden.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.d

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 31, 2020
• Study Start: May 20, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: When the study has been published in a peer reviewed scientific journal.
• Access Criteria: University affiliation

Locations

DK (1)