Botulinum Neurotoxin for Children With CP: a Delicate Balance Between Clinical Benefits and Muscular Harm

NCT06991725 | Recruiting

• 1 other identifier: S62187_Bo-Balance
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

A cross-sectional design study will be carried out to explore the morphological muscle properties and alterations in muscle composition on a macroscopic level in children with spastic cerebral palsy (CP). Muscle composition will be assessed using quantitative Magnetic Resonance Imaging (qMRI) and shear wave elastography (SWE), while macroscopic muscle size properties will be evaluated through 'Three-dimensional freehand ultrasound (3DfUS).

Conditions

Spastic Cerebral Palsy (sCP)

Keywords

Spastic Cerebral Palsy; Muscle composition; 3D freehand ultrasound; Shear wave elastography; Muscle morphology; Range of motion; Stiffness; Spasticity

Outcome Measures

Primary Outcomes (9)

• Evaluation of the muscle volume of the medial gastrocnemius muscle

  Estimation of the muscle belly volume by 3DfUS. Muscle volume will be normalized to anthropometric growth.

  Cross-sectional data collection at day 1.

• Evaluation of the muscle length of the medial gastrocnemius muscle

  Estimation of the muscle belly length, tendon length and muscle tendon unit complex length by 3DfUS. Muscle lengths will be normalized to anthropometric growth

  Cross-sectional data collection at day 1.

• Evaluation of the muscle echo-intensity of the medial gastrocnemius muscle

  Estimation of the echo-intensity by 3DfUS.

  Cross-sectional data collection at day 1.

• Evaluation of the fat fraction of the medial gastrocnemius muscle.

  Estimation of the fat fraction by Dixon sequence (MRI): a comparison of muscle fat fraction between children with CP and healthy age-matched TD controls in different age groups.

  Cross-sectional data collection at day 1.

• Indirect evaluation of collagen content of the medial gastrocnemius muscle

  Indirect estimation of collagen content by T1ƿ relaxation time (MRI): a comparison between children with CP and healthy age-matched TD controls in different age groups.

  Cross-sectional data collection at day 1.

• Evaluation of passive muscle stiffness across the medial gastrocnemius muscle.

  Estimation of the passive muscle stiffness by shear modulus (SWE): a comparison of passive muscle stiffness between children with CP and healthy age-matched TD controls in different age groups.

  Cross-sectional data collection at day 1.

• Evaluation of differences in fat fraction in different regions across the medial gastrocnemius muscle.

  Comparison of differences in fat fraction across three regions (proximal, midbelly, distal) of the muscle belly in children with CP compared to TD children.

  Cross-sectional data collection at day 1.

• Evaluation of differences in passive muscle stiffness in different regions across the medial gastrocnemius muscle.

  Comparison of differences in passive muscle stiffness across three regions (midbelly, distal, upper fascia of midbelly) of the muscle belly in children with CP compared to TD children.

  Cross-sectional data collection at day 1.

• Evaluation of the muscle strength (ankle torque).

  Evaluating the muscle strength (ankle torque) using the handheld dynamometer.

  Cross-sectional data collection at day 1.

Study Arms (2)

Children with spastic cerebral palsy

Children between 2 years and 16 years old

Typically developing children

Children between 2 years and 16 years old

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with spastic cerebral palsy, who have routine follow-up care at the CP reference center of the University Hospitals Leuven. Typically developing children are recruited through the social (family and friends) and professional (colleagues) network of involved researchers and thesis students, who approach participants through flyers, social media.

You may qualify if:

• Children (boys/girls) with congenital brain lesion, confirmed with neuro-imaging such as MRI
• At high-risk for CP or diagnosed spastic type of CP
• (Suspected) Gross Motor Function Classification Scale (GMFCS) Level I-III
• Uni or bilateral involvement
• Aged between 2-16 years

You may not qualify if:

• Presence of dyskinesia or ataxia
• Severe co-morbidities (cognitive problems)
• BTX treatment in the gastrocnemius in the past 10 months
• Previous surgery at the investigated muscles.
• Previous orthopedic or neurosurgery
• Severe ankle deformities
• Weight for height values \>2SD or \<-2SD from mean
• Typically developing children
• Aged between 2-16 years
• History of neurological, orthopedic or muscular problems
• Involvement in an elite or high-performance sporting program (Children performing the same sports for \> 5 hours/week will be excluded)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kaat Desloovere, Prof.dr.

  Department of Rehabilitation Sciences, KU Leuven, Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Lambrechts

CONTACT

+32489421264; charlotte.lambrechts@kuleuven.be

Julie Stegen

CONTACT

+32477273954; julie.stegen@kuleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 28, 2025
• Study Start: February 3, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2025-05

Locations

BE (1)