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Clinical Trials in Belgium / NCT05197764
Recruiting Observational

Evaluation of Macroscopic Muscle Growth in Infants and Young Children With Spastic Cerebral Palsy

NCT05197764 · tracked via the Priya Life Science Belgium tracker
Sponsor
Universitaire Ziekenhuizen KU Leuven
Phase
Observational
Started
2019-02-11
Last updated
2026-02-12

Condition(s) studied

Spastic Cerebral PalsyAcquired Brain Injury

Study 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

Sex
ALL
Min age
6 Months
Max age
9 Years
Healthy volunteers
Accepted
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)

Primary outcome measure(s)

  • Overall change in muscle volume of the medial gastrocnemius muscle and the semitendinosus muscle — Through a study participation of 2 years, with an evaluation moment every 6 months.
    Estimation of the muscle belly volume by 3DfUS. Muscle volume will be normalized to anthropometric growth.
  • Overall change in muscle length of the medial gastrocnemius muscle and the semitendinosus muscle. — Through a study participation of 2 years, with an evaluation moment every 6 months.
    Estimation of the muscle belly length, tendon length and muscle tendon unit complex length by 3DfUS. Muscle lengths will be normalized to anthropometric growth.
  • Overall change in muscle echo-intensity of the medial gastrocnemius muscle and the semitendinosus muscle. — Through a study participation of 2 years, with an evaluation moment every 6 months.
    Estimation of the echo-intensity by 3DfUS.
  • Evaluation of the brain lesion based on MRI imaging — Once during the study participation of 2 years.
    Estimation of the type, extend and location of the brain lesion by MRI imaging assessment tool (Fiori scale)

Trial sites (1)

FacilityCityRegionStatus
UZ Leuven Leuven Vlaams-Brabant Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05197764 on ClinicalTrials.gov ↗ ← All trials in Belgium