Clinical trial Recruiting at 1 site Observational Ages 6 Months to 9

Examining muscle growth in infants and young children with spastic cerebral palsy

Official title: The Integration of Macroscopic and Microscopic Muscle Properties With Cell Modelling to Feature Altered Neuromuscular Behavior in Cerebral Palsy: 3D-Macroscopic Muscle Architecture in Cerebral Palsy

Run by Universitaire Ziekenhuizen KU Leuven · NCT05197764 · Data updated 2026-11-12

This study looks at how muscle growth changes in infants and young children with spastic cerebral palsy to see if these changes can help improve their treatment and outcomes.

More Acquired Brain Injury trials

Quick facts

Study typeObservational
Ages6 Months to 9 Years
SexAll
Enrollment229 (estimated)
SponsorUniversitaire Ziekenhuizen KU Leuven
Academic / other
Locations1 site (Leuven, Vlaams-Brabant)
StatusRecruiting
StartedFebruary 11, 2019
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedFebruary 12, 2026
Trial IDNCT05197764 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include infants and young children with a confirmed diagnosis of spastic cerebral palsy or those at high risk for the condition, particularly those classified as GMFCS levels I-III.

Probably not a fit

Patients who are non-ambulatory or have undergone specific surgical interventions related to their condition may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the macroscopic muscle changes in infants and young children diagnosed with spastic cerebral palsy (SCP) using 3D freehand ultrasound. It will track the onset and progression of muscle alterations in relation to brain lesions, neuromuscular impairments, and treatment over time. By comparing these changes to typically developing children, the study seeks to identify patterns that could inform treatment protocols and improve functional outcomes for children with SCP.

Why it matters

Potential benefit: If successful, this study could lead to tailored treatment strategies that enhance muscle growth and functional abilities in children with spastic cerebral palsy.

How similar studies have gone: While there is a growing interest in understanding muscle growth in children with cerebral palsy, this specific approach using 3D freehand ultrasound to correlate muscle morphology with brain lesions is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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)

Where it's running

  • UZ Leuven
    Leuven, Vlaams-Brabant, Belgium
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.