About this trial
Cerebral palsy (CP) is a motor impairment due to a brain malformation or a brain lesion before the age of two. Spasticity, hypertonus in flexor muscles, dyscoordination and an impaired sensorimotor control are cardinal symptoms. The brain lesion is non-progressive, but the flexor muscles of the limbs will during adolescence become relatively shorter and shorter (contracted), forcing the joints into a progressively flexed position. This will worsen the positions of already paretic and malfunctioning arms and legs. Due to bending forces across the joints, bony malformations will occur, worsening the function even further. Since about 25 years a combination treatment with intramuscular botulinum toxin injections, braces and training has had a tremendous and increasing popularity, although lasting long-term clinical advantage is not yet proven.
Muscle morphology of the biceps brachii and the gastrocnemius muscles:
* The hypothesis is that care as usual, i.e. training and splinting sessions with botulinum toxin as adjuvant treatment, will reduce (normalize) the expression of the fast fatigable myosin heavy chain MyHC IIx and increase the expression of developmental myosin, as a possible sign of growth. As the biceps in the arm is used irregularly and voluntarily, and the gastrocnemius is activated during automated gait, the adaptations of those muscles will be different. Methods: Baseline muscle biopsies: Percutaneous biopsies are taken just before the first intramuscular botulinum toxin injection is given. The doses and the intervals for the botulinum toxin treatment will follow clinical routines. Biopsies 4-6 months, 12 months and 24 months after the first botulinum toxin injection: The exact same procedure as above will be performed, but the biopsies will be taken 2 cm distant, medial or lateral, from previous biopsy sites * Significance:. More knowledge is warranted regarding the actual molecular process in the muscle leading to a contracture, and its relation to the constant communication with the injured central nervous system. This study will give answers that could result in new, early prophylactic treatment of joint movement restrictions and motor impairment in children with CP.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Cerebral Palsy, Aquired Brain Injury
Disqualifiers
Progressive neural disease
Trial population
Children with cerebral palsy and aquired brain injury who, as a part of care as usual, gets botulinum toxin injections in muscles. Children are recruited consecutively.
Trial design
Cohort
Prospective
Treatments tested in this trial
no intervention. Care as ususal
Other interventionNo intervention
Treatment groups
Trial outcomes
Primary outcomes
Muscle fiber area
um2, square micrometers, measured on specimens
Muscle fiber types based on myosin heavy chain isoforms
Percentage of all fibers
Extracellular matrix, area
um2, square micrometers, measured on specimens
Capillaries per fiber area
number of capillaries/um2
Secondary outcomes
Clinical assessment, contracture
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Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Eva Ponten
Lead sponsor
Region Stockholm
Sponsor institution