Evaluation of Macroscopic Muscle Growth in Infants and Young Children With Spastic Cerebral Palsy (NCT05197764) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Macroscopic Muscle Growth in Infants and Young Children With Spastic Cerebral Palsy
Belgium229 participantsStarted 2019-02-11
Plain-language summary
A mixed longitudinal design study will be carried out to explore the onset and time course of morphological muscle changes on a macroscopic level in children with spastic cerebral palsy (SCP). Therefore, this project aims to (1) describe the macroscopic morphological muscle changes with increasing age and (2) evaluate the onset and development of muscle alterations in relation to the brain lesion (e.g., timing, extent and location), to the neuromuscular impairments and to treatment. Overall, this project will evaluate the macroscopic muscle properties by means of 3D freehand ultrasound (3DfUS).
Who can participate
Age range
6 Months – 9 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.
Inclusion Criteria:
* Confirmed diagnosis of spastic cerebral palsy or patients at high-risk for spastic cerebral palsy
* Suspected GMFCS levels I-III (GMFCS = Gross Motor Function Classification Scale, expressing the overall functional level of impairment)
Exclusion Criteria:
* Non-ambulatory
* Botulinum neurotoxin type-A injections six months prior to enrollment
* Lower limb surgery two years prior to enrollment
* Muscle surgery at the muscles in the lower limb
* Selective dorsal rhizotomy as treatment history
* Presence of ataxia or dystonia
* Severe co-morbidities (severe epilepsy, severe behavior problems that impede the cooperation)
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
Overall change in muscle volume of the medial gastrocnemius muscle and the semitendinosus muscle
Timeframe: Through a study participation of 2 years, with an evaluation moment every 6 months.
2
Overall change in muscle length of the medial gastrocnemius muscle and the semitendinosus muscle.
Timeframe: Through a study participation of 2 years, with an evaluation moment every 6 months.
3
Overall change in muscle echo-intensity of the medial gastrocnemius muscle and the semitendinosus muscle.
Timeframe: Through a study participation of 2 years, with an evaluation moment every 6 months.
4
Evaluation of the brain lesion based on MRI imaging
Timeframe: Once during the study participation of 2 years.