How Are the Muscles Affected in Cerebral Palsy? A Study of Muscle Biopsies Taken During Orthopaedic Surgery.
Key facts
- Who runs it
- Eva Ponten
- Where
- Sweden1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 150 people, planned
- Started
- 15 Jan 2002
- Expected to end
- 15 Dec 2033
- Type of study
- Observational, 2 groups
- Record updated
- 18 August 2022
Who can take part
- Age
- 2 years to 18 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- Children and adolescents undergoing clinically needed orthopaedic surgery
- with Cerebral Palsy or Acquired Brain Injury
- Typically developed children and adolescents (control)
Who cannot take part
- for CP/ABI: Progressive neurological disease, other metabolic or muscle disease
- for TD (Control): Cerebral Palsy, Acquired Brain injury, other metabolic or muscle diseases
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 18 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
* 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.
The 2 groups in the trial
- Cerebral Palsy (CP) / Acquired Brain Injury (ABI)
Children and adolescents with cerebral palsy and acquired brain injury.
- TD (Typically Developed)
Typically developed children and adolescents.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- How Are the Muscles Affected in Cerebral Palsy? A Study of Muscle Biopsies Taken During Orthopaedic Surgery of Children With Cerebral Palsy and Typically Developed Children (Control).
- Fit questions
- Built from NCT05506228, who can take part
- Record updated
- 18 August 2022