How Are the Muscles Affected in Cerebral Palsy? A Study of Muscle Biopsies Taken During Orthopaedic Surgery.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-18
SponsorEva Ponten

About this trial

* Cerebral palsy (CP) is a motor disorder caused by an injury to the immature brain. Even though the brain damage does not change, children with CP will have progressively weaker, shorter and stiffer muscles that will lead to contractures, bony deformations, difficulty to walk and impaired manual ability. An acquired brain injury (ABI) later during childhood, such as after a stroke or an injury, will result in similar muscle changes, and will therefore also be included in this study. For simplicity, these participants will in this text be referred to as having CP. * The mechanism for the muscle changes is still unknown. Contractures and the risk for the hips to even dislocate is now treated by tendon lengthening, muscle release and bony surgery. During these surgeries muscle biopsies, tendon biopsies and blood samples will be taken and compared with samples from typically developed (TD) children being operated for fractures, knee injuries, and deformities. The specimens will be explored regarding inflammatory markers, signaling for muscle growth, signaling for connective tissue growth and muscle and tendon pathology. In blood samples, plasma and serum, e.g. pro-inflammatory cytokines and the cytoprotective polypeptide humanin will measured, and will be correlated to the amount humanin found in muscle. With this compound information the mechanism of contracture formation may be found, and hopefully give ideas for treatment that will protect muscle and joint health, including prevention of hip dislocation and general health. * The results will be correlated to the degree of contracture of the joint and the severity of the CP (GMFCS I-V, MACS I-V). * By comparing muscle biopsies from the upper limb with muscle biopsies from the lower limb, muscles that are used in more or less automated gait will be compared to muscles in the upper limb that are used more voluntarily and irregularly. * Muscles that flex a joint, often contracted, will be compared with extensor muscles from the same patient. Fascia, aponeurosis and tendon will also be sampled when easily attainable.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children and adolescents undergoing clinically needed orthopaedic surgery

with Cerebral Palsy or Acquired Brain Injury

Typically developed children and adolescents (control)

Disqualifiers

for CP/ABI: Progressive neurological disease, other metabolic or muscle disease

for TD (Control): Cerebral Palsy, Acquired Brain injury, other metabolic or muscle diseases

Trial population

Patients who are scheduled for clinically needed orthopaedic surgery.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • No intervention

    Other intervention

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Cerebral Palsy (CP) / Acquired Brain Injury (ABI)1 intervention
Group B: TD (Typically Developed)1 intervention

Trial outcomes

Primary outcomes

1

Muscle/tendon morphology

morphology classification

Time frame
2002- 2027
2

Muscle metabolism

NADH staining classification

Time frame
2002- 2027
3

Fiber area

um 2, square micrometer

Time frame
2002- 2027

Secondary outcomes

1

Clinical data, Contracture

degrees

Time frame
Pre-OP

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eva Ponten

Lead sponsor

Region Stockholm

Sponsor institution