Actively Recruiting

Age: 6Months - 9Years
All Genders
Healthy Volunteers
ID05197764

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

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

229

Participants Needed

1

Research Sites

N/A

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

Researchers are studying how muscle growth changes over time in children with spastic cerebral palsy (SCP). The study aims to describe how muscles develop as children age and to understand how muscle changes relate to brain injuries, neuromuscular problems, and treatments. This research uses 3D freehand ultrasound to look at muscle structure and compares children with SCP to typically developing children, focusing on two lower limb muscles. The study includes two parts: One follows children aged 2 to 9 years over two years with yearly check-ins, comparing muscle changes across different age groups and severity levels. The second part tracks younger children with brain injuries over two years with five check-ins every six months, relating muscle changes to brain lesion characteristics based on MRI scans. Participants include children with congenital SCP, acquired brain injury, and typically developing peers. Participants undergo muscle ultrasound measurements and provide medical records including brain MRI, treatment details, physical exams, and motor development tests. Researchers measure muscle volume, length, echo-intensity, joint motion, spasticity, strength, and motor skills over two years. Data collection occurs during hospital visits and rehabilitation center appointments, aiming to improve understanding of muscle development and support tailored treatment for children with SCP.

CONDITIONS

Brief 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 high risk for spastic cerebral palsy
  • Suspected Gross Motor Function Classification Scale levels I-III
  • Children aged between 6 months and 9 years
  • Ambulatory children (able to walk)
Not Eligible

You will not qualify if you...

  • Non-ambulatory children
  • Botulinum neurotoxin type-A injections within 6 months before enrollment
  • Lower limb surgery within 2 years before enrollment
  • Muscle surgery at lower limb muscles
  • History of selective dorsal rhizotomy
  • Presence of ataxia or dystonia
  • Severe co-morbidities such as severe epilepsy or severe behavior problems that prevent cooperation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Long-term Monitoring

Duration - 2 years

Participants are evaluated over a 2-year period with assessments every 6 months to observe muscle growth and related neuromuscular changes.

5 visits every 6 months

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

L

Lauraine Staut

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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Published Research Related To This Trial

Mechanical and material properties of the plantarflexor muscles and Achilles tendon in children with spastic cerebral palsy and typically developing children.

Nicola Theis, Amir A Mohagheghi, Thomas Korff

https://pubmed.ncbi.nlm.nih.gov/27515440

Could muscle deformity in children with spastic cerebral palsy be related to an impairment of muscle growth and altered adaptation?

Martin Gough, Adam P Shortland

https://pubmed.ncbi.nlm.nih.gov/22364585

Morphological Medial Gastrocnemius Muscle Growth in Ambulant Children with Spastic Cerebral Palsy: A Prospective Longitudinal Study.

Nathalie De Beukelaer, Ines Vandekerckhove, Ester Huyghe...

https://pubmed.ncbi.nlm.nih.gov/36836099