NCT05197764 Evaluation of Macroscopic Muscle Growth in Infants and Young Children With Spastic Cerebral Palsy
| NCT ID | NCT05197764 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Spastic Cerebral Palsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 229 participants |
| Start Date | 2019-02-11 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 229 participants in total. It began in 2019-02-11 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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)
Contact & Investigator
Kaat Desloovere, Prof. dr.
PRINCIPAL INVESTIGATOR
Department of Rehabilitation Sciences, KU Leuven, Belgium
Frequently Asked Questions
Who can join the NCT05197764 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 9 Years, studying Spastic Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05197764 currently recruiting?
Yes, NCT05197764 is actively recruiting participants. Contact the research team at Nathalie.debeukelaer@kuleuven.be for enrollment information.
Where is the NCT05197764 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT05197764 clinical trial?
NCT05197764 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Kaat Desloovere, Prof. dr. at Department of Rehabilitation Sciences, KU Leuven, Belgium. The trial plans to enroll 229 participants.
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