Botulinum Neurotoxin for Children With CP: a Delicate Balance Between Clinical Benefits and Muscu… (NCT06991725) | Clinical Trial Compass
RecruitingNot Applicable
Botulinum Neurotoxin for Children With CP: a Delicate Balance Between Clinical Benefits and Muscular Harm
Belgium51 participantsStarted 2025-02-03
Plain-language summary
A cross-sectional design study will be carried out to explore the morphological muscle properties and alterations in muscle composition on a macroscopic level in children with spastic cerebral palsy (CP). Muscle composition will be assessed using quantitative Magnetic Resonance Imaging (qMRI) and shear wave elastography (SWE), while macroscopic muscle size properties will be evaluated through 'Three-dimensional freehand ultrasound (3DfUS).
Who can participate
Age range
2 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
\- Children with spastic cerebral palsy
Inclusion criteria:
* Children (boys/girls) with congenital brain lesion, confirmed with neuro-imaging such as MRI
* At high-risk for CP or diagnosed spastic type of CP
* (Suspected) Gross Motor Function Classification Scale (GMFCS) Level I-III
* Uni or bilateral involvement
* Aged between 2-16 years
Exclusion criteria:
* Presence of dyskinesia or ataxia
* Severe co-morbidities (cognitive problems)
* BTX treatment in the gastrocnemius in the past 10 months
* Previous surgery at the investigated muscles.
* Previous orthopedic or neurosurgery
* Severe ankle deformities
* Weight for height values \>2SD or \<-2SD from mean
* Typically developing children
Inclusion criteria:
• Aged between 2-16 years
Exclusion criteria:
* History of neurological, orthopedic or muscular problems
* Involvement in an elite or high-performance sporting program (Children performing the same sports for \> 5 hours/week will be excluded)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of the muscle volume of the medial gastrocnemius muscle
Timeframe: Cross-sectional data collection at day 1.
2
Evaluation of the muscle length of the medial gastrocnemius muscle
Timeframe: Cross-sectional data collection at day 1.
3
Evaluation of the muscle echo-intensity of the medial gastrocnemius muscle
Timeframe: Cross-sectional data collection at day 1.
4
Evaluation of the fat fraction of the medial gastrocnemius muscle.
Timeframe: Cross-sectional data collection at day 1.
5
Indirect evaluation of collagen content of the medial gastrocnemius muscle
Timeframe: Cross-sectional data collection at day 1.
6
Evaluation of passive muscle stiffness across the medial gastrocnemius muscle.
Timeframe: Cross-sectional data collection at day 1.
7
Evaluation of differences in fat fraction in different regions across the medial gastrocnemius muscle.