Actively Recruiting
Evaluation of Microscopic Muscle Properties in Growing Children With Cerebral Palsy and Their Relation to Macroscopic Muscle Properties
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-05-05
130
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating how muscle development and growth are altered at the microscopic level over time in children with cerebral palsy (CP). This study focuses on understanding the microscopic muscle properties in young children with CP and how these relate to larger muscle features, neuromuscular symptoms, and treatments like botulinum toxin (BTX) injections. The goal is to identify different CP muscle types and improve personalized treatment strategies. The study collects muscle biopsies using a minimally invasive needle technique, sometimes under general anesthesia during routine treatments like BTX injections or orthopedic procedures. Biopsies will be taken from children with CP at varying ages and treatment stages and from typically developing children during surgeries. The research includes analyzing muscle fiber size, satellite cells, collagen content, and genetic factors. One part of the study follows changes before and after BTX treatment over up to 1.2 years. Participants will undergo ultrasound muscle imaging, clinical assessments of spasticity and strength, and gait analysis. Muscle biopsies are collected at multiple time points for detailed microscopic examination. Researchers will measure changes in muscle fiber characteristics, muscle volume and length, and muscle activation patterns. Data will be used to define integrated muscle and symptom profiles and how they respond to treatments over the study period, which may last up to 1.2 years for some participants.
CONDITIONS
Brief Title
3D-Microscopic Muscle Architecture in Cerebral Palsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children diagnosed with predominantly spastic cerebral palsy
- Unilateral or bilateral involvement
- Gross Motor Function Classification Scale Level I-III
- Aged between 2 and 9 years
- Scheduled for orthopedic intervention requiring general anesthesia (e.g., botulinum toxin injections, surgery, or diagnostic imaging)
- Typically developing children aged 2 to 9 years scheduled for surgery under general anesthesia (e.g., upper limb orthopedic or trauma surgery)
- Adolescents or adults diagnosed with Hereditary Spastic Paraplegia (HSP), SPG3a or SPG4
- Gross Motor Function Classification Scale Level I-III for HSP patients
- Adolescents aged 12 to 18 years or adults aged 18 to 40 years with HSP
- Typically developing adolescents and adults matched by age and gender with HSP patients
You will not qualify if you...
- Presence of dystonia or ataxia
- Surgery less than 6 months ago on the muscles being studied
- Severe co-morbidities that prevent proper assessment, such as severe cognitive problems
- History of neurological or orthopedic problems in typically developing children and adults
- Trauma to the lower limbs
- Participation in elite or high-performance sports exceeding specified hours per week
- Recent sport activity less than 72 hours before biopsy collection for typically developing adolescents and adults
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline assessments prior to biopsy and treatment
Participants undergo assessments including ultrasound measures, gait analysis, clinical scales, and instrumented evaluations of spasticity and strength to characterize muscle properties and neuromuscular symptoms.
1 to 2 visits depending on assessments
Duration - Up to 1.2 years with multiple biopsy sessions
Muscle microbiopsies are collected from participants under general or local anesthesia at multiple time points to study microscopic muscle properties and their changes over time, including before and after botulinum toxin (BTX) injections.
Up to 5 visits (baseline, 3 months pre-BTX, 3 months post-BTX, 6 months post-BTX, and 1.2 years post-BTX)
Duration - Up to 1.2 years
Participants are observed longitudinally to evaluate changes in muscle properties, neuromuscular symptoms, and treatment effects over time.
Regular follow-up visits for assessments during the study period
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
A
Anke Andries
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
4
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