Spastic Cerebral Palsy (sCP)Bo-BalanceNCT06991725
Botulinum Neurotoxin for Children With CP: a Delicate Balance Between Clinical Benefits and Muscular Harm
An observational study of Spastic Cerebral Palsy (sCP), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Spastic Cerebral Palsy (sCP)
- How many people
- 51 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Feb 2025to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
- Aged between 2-16 years
Who cannot join
- 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
Show all 10Show fewer
- Weight for height values >2SD or <-2SD from mean
- Typically developing children
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Kaat Desloovere, prof. dr., +3216338009, kaat.desloovere@kuleuven.be
About this study
Official title: Botulinum Neurotoxin for Children With Cerebral Palsy: a Delicate Balance Between Clinical Benefits and Muscular Harm
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).
Read the detailed description
Background: Altered muscle composition, including increased fat infiltration and collagen content, is a key factor in impaired muscle function in cerebral palsy (CP). However, quantitative data on muscle composition in CP is limited. Traditional methods like ultrasound can only indirectly assess these changes through echo-intensity, while invasive muscle biopsies are impractical for children. Recent advancements in quantitative Magnetic Resonance Imaging (qMRI) and shear wave elastography (SWE) provide non-invasive alternatives. The qMRI Dixon sequence can assess fat infiltration, while the T1ρ sequence can estimate collagen content. SWE can measure passive muscle stiffness as a surrogate marker for collagen. Combining these techniques allows for a comprehensive evaluation of muscle composition and its impact on muscle function in CP. Next to muscle composition, children with CP also exhibit muscle size deficits compared to typically developing (TD) children. More specifically, when accounting for the effect of natural muscle growth, normalized muscle volume was found to be reduced, which could be attributed to a reduction in normalized cross-sectional area and normalized muscle belly length. Because muscle morphology (or muscle size) can be estimated using accessible ultrasonography techniques, alterations in muscle size have been well-described in growing children with CP. However, since muscle composition can only be estimated through more advanced, recent muscle imaging techniques, its alteration in CP remains underexplored.
Aim: To comprehensively describe the alterations in intrinsic muscle properties, the evaluation of altered muscle morphology (or muscle size) will be complemented with the description of alterations in muscle composition. Unlike muscle size, which increases with age, muscle composition remains relatively stable in typically developing children. Since comprehensive assessment of muscle composition requires MRI, a less practical tool compared to ultrasonography, the study will adopt a cross-sectional descriptive design. We aim to create an integrated dataset of muscle composition combined with muscle size, passive muscle stiffness and clinical assessments for CP and TD children that are equally distributed over pre-school, grade-school and teen-aged.
Methods/design: Children with CP who participated in previous studies within this project will be invited to join the current study. 34 children with CP participants will be recruited to reach the target sample size . The CP group will be evenly divided between those who are botulinum neurotoxin (BTX) naïve and those who have received BTX treatment. Only children with a Gross Motor Function Classification System (GMFCS) level of I, II, or III will be included. In total, 34 children with CP and 17 age-matched typically developing (TD) children will be enrolled in the study.
Participants will be evaluated at the University Hospitals Leuven (UZ Leuven) at campus Gasthuisberg or campus Pellenberg. Data will be collected during a hospital visit and every participant will undergo at least a 3DfUS and SWE measurement of the medial gastrocnemius. Other information that will be collected out of the available medical records includes the results of the structural brain MRI, the use of medication, treatment details (physiotherapy, orthotics and/or orthopedic interventions), anthropometric measures (body weight and length and leg lengths), data of a standard clinical examination (joint range of motion, spasticity, and muscle selectivity and strength).
- Conditions
- Spastic Cerebral Palsy (sCP)
- Keywords
- Spastic Cerebral Palsy, Muscle composition, 3D freehand ultrasound, Shear wave elastography, Muscle morphology, Range of motion, Stiffness, Spasticity
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with spastic cerebral palsy | Children between 2 years and 16 years old | |
| Typically developing children | Children between 2 years and 16 years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Cross-sectional data collection at day 1.
Evaluation of the muscle strength (ankle torque).
Evaluating the muscle strength (ankle torque) using the handheld dynamometer.
Measured: Cross-sectional data collection at day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start3 Feb 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spastic Cerebral Palsy (sCP)Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaat Desloovere, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Kaat Desloovere, Prof.dr., Principal investigator, Department of Rehabilitation Sciences, KU Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991725
- Sponsor's protocol ID
- S62187_Bo-Balance
- Acronym
- Bo-Balance
- Status last verified
- May 2025
- First submitted
- 16 May 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lambrechts C, Dewit T, Peeters R, Wang Z, Van Campenhout A, Cenni F, Desloovere K. Multimodal characterisation of skeletal muscle properties in children with and without cerebral palsy using a non-invasive approach: an observational study protocol. BMJ Open. 2026 Jul 29;16(7):e120234. doi: 10.1136/bmjopen-2026-120234.
PubMed 42526915
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Neurotoxin for Children With Cerebral Palsy: a Delicate Balance Between Clinical Benefits and Muscular Harm
- ClinicalTrials.gov ID
- NCT06991725
- Acronym / sponsor ID
- Bo-Balance / S62187_Bo-Balance
- Conditions
- Spastic Cerebral Palsy (sCP)
- Keywords
- Spastic Cerebral Palsy, Muscle composition, 3D freehand ultrasound, Shear wave elastography, Muscle morphology, Range of motion, Stiffness, Spasticity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Background: Altered muscle composition, including increased fat infiltration and collagen content, is a key factor in impaired muscle function in cerebral palsy (CP). However, quantitative data on muscle composition in CP is limited. Traditional methods like ultrasound can only indirectly assess these changes through echo-intensity, while invasive muscle biopsies are impractical for children. Recent advancements in quantitative Magnetic Resonance Imaging (qMRI) and shear wave elastography (SWE) provide non-invasive alternatives. The qMRI Dixon sequence can assess fat infiltration, while the T1ρ sequence can estimate collagen content. SWE can measure passive muscle stiffness as a surrogate marker for collagen. Combining these techniques allows for a comprehensive evaluation of muscle composition and its impact on muscle function in CP. Next to muscle composition, children with CP also exhibit muscle size deficits compared to typically developing (TD) children. More specifically, when accounting for the effect of natural muscle growth, normalized muscle volume was found to be reduced, which could be attributed to a reduction in normalized cross-sectional area and normalized muscle belly length. Because muscle morphology (or muscle size) can be estimated using accessible ultrasonography techniques, alterations in muscle size have been well-described in growing children with CP. However, since muscle composition can only be estimated through more advanced, recent muscle imaging techniques, its alteration in CP remains underexplored.
Aim: To comprehensively describe the alterations in intrinsic muscle properties, the evaluation of altered muscle morphology (or muscle size) will be complemented with the description of alterations in muscle composition. Unlike muscle size, which increases with age, muscle composition remains relatively stable in typically developing children. Since comprehensive assessment of muscle composition requires MRI, a less practical tool compared to ultrasonography, the study will adopt a cross-sectional descriptive design. We aim to create an integrated dataset of muscle composition combined with muscle size, passive muscle stiffness and clinical assessments for CP and TD children that are equally distributed over pre-school, grade-school and teen-aged.
Methods/design: Children with CP who participated in previous studies within this project will be invited to join the current study. 34 children with CP participants will be recruited to reach the target sample size . The CP group will be evenly divided between those who are botulinum neurotoxin (BTX) naïve and those who have received BTX treatment. Only children with a Gross Motor Function Classification System (GMFCS) level of I, II, or III will be included. In total, 34 children with CP and 17 age-matched typically developing (TD) children will be enrolled in the study.
Participants will be evaluated at the University Hospitals Leuven (UZ Leuven) at campus Gasthuisberg or campus Pellenberg. Data will be collected during a hospital visit and every participant will undergo at least a 3DfUS and SWE measurement of the medial gastrocnemius. Other information that will be collected out of the available medical records includes the results of the structural brain MRI, the use of medication, treatment details (physiotherapy, orthotics and/or orthopedic interventions), anthropometric measures (body weight and length and leg lengths), data of a standard clinical examination (joint range of motion, spasticity, and muscle selectivity and strength).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with spastic cerebral palsy | – | –Children between 2 years and 16 years old |
| Typically developing children | – | –Children between 2 years and 16 years old |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the muscle volume of the medial gastrocnemius muscle
Time frame: Cross-sectional data collection at day 1.
Estimation of the muscle belly volume by 3DfUS. Muscle volume will be normalized to anthropometric growth.
Evaluation of the muscle length of the medial gastrocnemius muscle
Time frame: Cross-sectional data collection at day 1.
Estimation of the muscle belly length, tendon length and muscle tendon unit complex length by 3DfUS. Muscle lengths will be normalized to anthropometric growth
Evaluation of the muscle echo-intensity of the medial gastrocnemius muscle
Time frame: Cross-sectional data collection at day 1.
Estimation of the echo-intensity by 3DfUS.
Evaluation of the fat fraction of the medial gastrocnemius muscle.
Time frame: Cross-sectional data collection at day 1.
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.
Indirect evaluation of collagen content of the medial gastrocnemius muscle
Time frame: Cross-sectional data collection at day 1.
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.
Evaluation of passive muscle stiffness across the medial gastrocnemius muscle.
Time frame: Cross-sectional data collection at day 1.
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.
Evaluation of differences in fat fraction in different regions across the medial gastrocnemius muscle.
Time frame: Cross-sectional data collection at day 1.
Comparison of differences in fat fraction across three regions (proximal, midbelly, distal) of the muscle belly in children with CP compared to TD children.
Evaluation of differences in passive muscle stiffness in different regions across the medial gastrocnemius muscle.
Time frame: Cross-sectional data collection at day 1.
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.
Evaluation of the muscle strength (ankle torque).
Time frame: Cross-sectional data collection at day 1.
Evaluating the muscle strength (ankle torque) using the handheld dynamometer.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 42526915Lambrechts C, Dewit T, Peeters R, Wang Z, Van Campenhout A, Cenni F, Desloovere K. Multimodal characterisation of skeletal muscle properties in children with and without cerebral palsy using a non-invasive approach: an observational study protocol. BMJ Open. 2026 Jul 29;16(7):e120234. doi: 10.1136/bmjopen-2026-120234.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaat Desloovere, Prof.dr. principal investigator
Department of Rehabilitation Sciences, KU Leuven, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spastic Cerebral Palsy (sCP), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Lambrechts (+32489421264, charlotte.lambrechts@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the muscle volume of the medial gastrocnemius muscle (time frame: Cross-sectional data collection at day 1.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06991725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.