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Early Intervention in Infants With Cerebral Palsy (CONTRACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250454
Recruitment Status : Not yet recruiting
First Posted : January 31, 2020
Last Update Posted : April 22, 2020
Sponsor:
Collaborator:
Elsass Foundation
Information provided by (Responsible Party):
Maria Willerslev-Olsen, University of Copenhagen

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Behavioral: CONTRACT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2029

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Elsass Standard Care
Active Comparator: Intervention
Enriched eviroment, Feed back training, Electrical stimulation, nutrition
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.





Primary Outcome Measures :
  1. Muscle growth rate [ Time Frame: 48 months ]

    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.



Secondary Outcome Measures :
  1. Evaluation of passive stiffness and reflex stiffness [ Time Frame: 48 months ]

    Passive and reflex-mediated stiffness of the ankle plantar-flexors will be objectively assessed according to the methods described in Lorentzen et al. (Lorentzen et al 2010) and Willerslev-Olsen et al (Willerslev-Olsen et al 2018). Data will be sampled at a rate of 512Hz and transferred to a computer via Bluetooth for further analysis in Matlab (Mathworks, Natick, MA, USA).

    With the use of the device the researcher will move the ankle joint from maximal plantar flexed position to maximal dorsiflexion in order for the devise to estimate the ROM. Manual movements will then be performed by the researcher at either a slow velocity (~<20deg/sec) or as fast as possible through the entire ROM. EMG activity is sampled from bipolar surface EMG electrodes (0.5mm diameter, 2cm between electrodes; Ambu Blue Sensor NF-00-S/12; Ambu, Ballerup, Denmark) placed over the soleus muscle at the distal part of the gastrocnemius muscles and the Tibialis Anterior muscle. The device is equipped with strain




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Ages Eligible for Study:   8 Weeks to 20 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants younger than 17 weeks CA with suspicion of brain lesion determined from a medical assessment, by MRI or ultrasound scan or abnormal general movements 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 Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250454


Contacts
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Contact: Jens Nielsen, Professor +4528757450 jbnielsen@sund.ku.dk
Contact: Maria Willerslev-Olsen, Ph.D +4522834005 mwo@elsassfonden.dk

Sponsors and Collaborators
University of Copenhagen
Elsass Foundation
Publications:

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Responsible Party: Maria Willerslev-Olsen, Ph.d, University of Copenhagen
ClinicalTrials.gov Identifier: NCT04250454    
Other Study ID Numbers: CONTRACT333
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The university of Copenhagen has a data server available for open acces to research data. We aim to make all annonymised data available through the server as soon as the study has been published in a peer reviewed scientific journal.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: When the study has been published in a peer reviewed scientific journal.
Access Criteria: University affiliation

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Willerslev-Olsen, University of Copenhagen:
Early intervention
Contractures
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases