Actively Recruiting

Age: 6Months - 9Years
All Genders
Healthy Volunteers
NCT05197764

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

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-02-12

229

Participants Needed

1

Research Sites

407 weeks

Total Duration

On this page

Sponsors

U

Universitaire Ziekenhuizen KU Leuven

Lead Sponsor

P

Pulderbos revalidatiecentrum

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 6Months - 9Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of spastic cerebral palsy or patients at high-risk for spastic cerebral palsy
  • Suspected GMFCS levels I-III (Gross Motor Function Classification Scale expressing overall functional impairment level)
Not Eligible

You will not qualify if you...

  • Non-ambulatory status
  • Botulinum neurotoxin type-A injections within 6 months prior to enrollment
  • Lower limb surgery within 2 years prior to enrollment
  • Muscle surgery at the muscles in the lower limb
  • History of selective dorsal rhizotomy treatment
  • Presence of ataxia or dystonia
  • Severe co-morbidities such as severe epilepsy or severe behavior problems that interfere with cooperation

AI-Screening

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Trial Site Locations

Total: 1 location

1

UZ Leuven

Leuven, Vlaams-Brabant, Belgium, 3000

Actively Recruiting

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Research Team

N

Nathalie De Beukelaer

CONTACT

L

Lauraine Staut

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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