Early Intervention in Infants With Cerebral Palsy (CONTRACT)
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|ClinicalTrials.gov Identifier: NCT04250454|
Recruitment Status : Not yet recruiting
First Posted : January 31, 2020
Last Update Posted : April 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Behavioral: CONTRACT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
No Intervention: Control
Elsass Standard Care
Active Comparator: Intervention
Enriched eviroment, Feed back training, Electrical stimulation, nutrition
The intervention will consist of four elements:
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.
- 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.
- 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
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
|Contact: Jens Nielsen, Professorfirstname.lastname@example.org|
|Contact: Maria Willerslev-Olsen, Ph.Demail@example.com|