Muscle SpasticityUS-sCPNCT07118228
Ultrasonographic Assessment of Muscle Morphology, Function, and Clinical Findings in Spastic Cerebral Palsy
An observational study of Muscle Spasticity and Gait Disorders, Neurologic, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
This study focuses on children with spastic cerebral palsy and aims to examine how muscle morphology and tissue characteristics, as assessed by ultrasound, may relate to functional motor abilities. It is designed as a prospective, cross-sectional, observational study. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Muscle Spasticity, Gait Disorders, Neurologic, Cerebral Palsy, Spastic
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2025to 30 Jun 2026
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Ambulatory children aged 4 to 18 years diagnosed with spastic cerebral palsy, classified within GMFCS levels I-III and MACS levels I-IV, who are referred to a pediatric rehabilitation clinic for routine evaluation and are eligible for non-invasive ultrasound-based muscle morphology and clinical assessments.
Who may be able to join
- Diagnosis of spastic cerebral palsy (SCP) according to the criteria defined by Rosenbaum et al. (2007)
- Age between 4 and 18 years
- Gross Motor Function Classification System (GMFCS) Level I, II, or III
- Manual Ability Classification System (MACS) Level I, II, III, or IV
Who cannot join
- Non-spastic types of cerebral palsy (e.g., dyskinetic, ataxic)
- Diagnosis of neuromuscular disorders other than cerebral palsy (e.g., hereditary neuropathy, myopathy)
- Presence of muscle contractures or fixed deformities in the limbs selected for ultrasound and clinical assessment
- Cognitive or behavioral impairments that prevent cooperation during ultrasound or clinical evaluation
- Botulinum toxin-A (BoNT-A) injection applied to the target muscles within the last 6 months
- Current treatment with oral or intrathecal antispastic medications
- History of orthopedic surgery or selective dorsal rhizotomy involving the target muscles
- Acute infection, febrile illness, or severe systemic disease (e.g., advanced heart failure, respiratory insufficiency) that may compromise the safety of assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli University Faculty of Medicine
Kocaeli
Mustafa Kadıoğlu, MD, (0262) 303 75 75, mustafa.kadioglu@kocaeli.edu.tr
About this study
Official title: Evaluation of the Relationship Between Ultrasonographic Muscle Morphology, Functional Properties, and Clinical Parameters in Children With Spastic Cerebral Palsy
This study focuses on children with spastic cerebral palsy and aims to examine how muscle morphology and tissue characteristics, as assessed by ultrasound, may relate to functional motor abilities. It is designed as a prospective, cross-sectional, observational study. Planned ultrasound-based assessments include parameters such as muscle thickness, pennation angle, fascicle length, echo intensity, tissue stiffness (via shear wave elastography), and microvascular flow (via superb microvascular imaging). These measurements are intended to be compared with standard clinical evaluations, including the GMFCS, GMFM-66, MAS, MACS, and Tardieu Scale. The study seeks to contribute to a better understanding of the relationship between muscle architecture and functional outcomes, with the goal of generating insights that may inform individualized rehabilitation planning.
Read the detailed description
This prospective, cross-sectional observational study aims to explore the relationship between ultrasonographically assessed muscle morphology, functional muscle characteristics, and standardized clinical parameters in ambulatory children diagnosed with spastic cerebral palsy (CP). The research seeks to enhance the understanding of muscle structure-function relationships in this population, with the broader goal of contributing to personalized rehabilitation strategies and clinical decision-making.
Cerebral palsy is a non-progressive neurodevelopmental disorder resulting from brain injury or maldevelopment during the prenatal, perinatal, or early postnatal period. Spastic cerebral palsy is the most common subtype, characterized by upper motor neuron lesions that lead to increased muscle tone, spasticity, and movement dysfunction. These neuromuscular alterations often result in secondary changes in muscle morphology, such as increased stiffness, reduced muscle volume, shortened fascicle length, altered fiber orientation, and impaired microcirculation. Understanding how these changes relate to functional limitations remains an important goal in pediatric rehabilitation research.
In this study, both structural and functional properties of skeletal muscles are planned to be assessed using a combination of high-resolution ultrasound techniques. The targeted muscles for assessment include one lower limb and one upper limb muscle: the medial gastrocnemius and the brachialis. These muscles were selected due to their relevance in gross motor and upper limb function in children with spastic CP.
The ultrasonographic parameters planned for evaluation include muscle thickness (MT), fascicle length (FL), pennation angle (PA), cross-sectional area (CSA), and echo intensity (EI). Additionally, muscle stiffness will be estimated through shear wave elastography (SWE), and vascularity will be evaluated using superb microvascular imaging (SMI) or a similar non-contrast-enhanced microvascular ultrasound technique. These advanced imaging modalities allow for the assessment of tissue elasticity and intramuscular blood flow, serving as potential surrogate markers of muscle quality and pathology.
Measurements will be acquired under standardized conditions, with the muscles in a relaxed state and proper anatomical alignment. Multiple images and repeated measurements will be obtained to ensure consistency. Longitudinal and transverse imaging planes will be used depending on the parameter being evaluated. The ultrasonographic protocol is designed to minimize operator-dependent variability and to ensure reproducibility across participants.
Clinical assessments will be conducted using standardized functional and spasticity-related scales. Gross motor function will be evaluated using the Gross Motor Function Classification System (GMFCS) and the Gross Motor Function Measure-66 (GMFM-66). Hand function will be categorized using the Manual Ability Classification System (MACS). Spasticity will be evaluated through the Modified Ashworth Scale (MAS) and the Tardieu Scale, which include assessments of the angle of muscle reaction (R1), passive range of motion (R2), and their difference (R2-R1). Where applicable, additional tools such as the Assisting Hand Assessment (AHA) and the Observational Gait Scale (OGS) may be employed to further characterize upper limb use and gait function.
Eligible participants include children aged 4 to 18 years with a diagnosis of spastic cerebral palsy, classified within GMFCS levels I to III. Children with recent exposure to interventions that could alter muscle morphology, such as botulinum toxin injection (within 6 months) or orthopedic surgery, will be excluded. Other exclusion criteria include the presence of non-spastic CP subtypes, neuromuscular disorders unrelated to CP, or inability to cooperate with assessments. All assessments will be performed in a single visit, without any therapeutic intervention being administered as part of the study.
The study involves no invasive procedures and is considered minimal risk. Its aim is descriptive and correlational, without testing any treatment or hypothesis regarding clinical efficacy. A power analysis was conducted to determine the required sample size for detecting statistically significant correlations. Ethical approval has been obtained from the relevant institutional ethics board. Data collected from participants will be anonymized and managed according to institutional and national data protection guidelines.
Planned statistical analyses include correlation coefficients between imaging parameters and clinical scores, along with regression analyses to identify potential predictors of motor function. Subgroup analyses may explore differences based on GMFCS level, age, or previous therapy exposure. The findings may provide insights into the associations between muscle architecture and clinical function in children with spastic CP, contributing to the development of individualized rehabilitation protocols and improved clinical monitoring.
- Keywords
- Spastic Cerebral Palsy, Muscle Morphology, Shear Wave Elastography, Muscle Architecture, Superb Microvascular Imaging, Muscle Stiffness, Pennation Angle, Fascicle Length, Intramuscular Vascularity, Echo Intensity, GMFM-66, Gross Motor Function, Muscle Morphology and Function, Ultrasound Imaging, Ultrasound Imaging of Spastic Muscle, Functional Assessment
- Medical subject headings
- Muscle Spasticity, Gait Disorders, Neurologic, Cerebral Palsy
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 |
|---|---|---|
| Spastic CP Cohort | Ambulatory children with spastic cerebral palsy classified within GMFCS levels I to III. Participants undergo clinical and ultrasound-based assessments to evaluate muscle morphology, functional properties, and their relationship with motor function. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between muscle morphology parameters and motor function in children with spastic cerebral palsy
This outcome assesses the correlation between ultrasound-derived muscle morphology parameters-including muscle thickness, fascicle length, pennation angle, echo intensity, cross-sectional area, stiffness (via shear wave elastography), and vascularity (via microvascular imaging)-and standardized motor function scores (e.g., GMFM-66, GMFCS, MACS, MAS, and Tardieu Scale) in ambulatory children with spastic cerebral palsy.
Measured: At baseline (single assessment session)
Comparison Between Modified Heckmatt Scale and Quantitative Echo Intensity in Spastic Muscles
This outcome evaluates the agreement between visual muscle echogenicity scores based on the Modified Heckmatt Scale and quantitative grayscale echo intensity values obtained via B-mode ultrasonography in spastic upper and lower limb muscles of children with spastic cerebral palsy. The analysis aims to determine the clinical utility of the Modified Heckmatt Scale in representing objective muscle echotexture.
Measured: At baseline (single assessment session)
Secondary outcomes (1)
Development of a Composite Muscle Quality Index Based on Ultrasonographic Parameters
This outcome explores the development of a composite muscle quality scoring system that integrates multiple ultrasonographic parameters-including muscle echo intensity, stiffness (via shear wave elastography), vascularity (via superb microvascular imaging), and architectural features (e.g., muscle thickness, pennation angle, and fascicle length). The aim is to identify a reliable, non-invasive ultrasonographic muscle quality index for characterizing spastic muscles in children with cerebral palsy, potentially guiding future clinical assessment and rehabilitation planning.
Measured: At baseline (single assessment session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start15 Dec 2025
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Muscle SpasticityStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nigar Dursun, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118228
- Sponsor's protocol ID
- 2025/301
- Other IDs
- GOKAEK-2025/15/08
- Acronym
- US-sCP
- Status last verified
- Jan 2026
- First submitted
- 5 Aug 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to share individual participant data (IPD) is currently undecided. The study involves pediatric participants with spastic cerebral palsy, and IPD sharing will depend on institutional policies, ethical committee approval, and the extent to which anonymization and parental consent can ensure participant privacy.
Publications
Atalay KG, Saygi EK, Akbas F, Coskun OK, Akgulle AH, Yagci I. Does ultrasound imaging of the spastic muscle have an additive effect on clinical examination tools in patients with cerebral palsy?: A pilot study. North Clin Istanb. 2022 Mar 11;9(2):102-108. doi: 10.14744/10.14744/nci.2020.78045. eCollection 2022.
PubMed 35582513Peeters N, Hanssen B, Bar-On L, De Groote F, De Beukelaer N, Coremans M, Van den Broeck C, Dan B, Van Campenhout A, Desloovere K. Associations between muscle morphology and spasticity in children with spastic cerebral palsy. Eur J Paediatr Neurol. 2023 May;44:1-8. doi: 10.1016/j.ejpn.2023.01.007. Epub 2023 Jan 10.
PubMed 36706682Uzun Akkaya K, Akkaya HE, Bezgin S, Atalan Efkere P, Firat T, Yildiz C, Elbasan B. Long-Term Effects of Different Number of Botulinum Toxin Injections Into the Gastrocnemius Muscle on Function and Muscle Morphology in Children With Cerebral Palsy. Pediatr Neurol. 2025 Jan;162:97-104. doi: 10.1016/j.pediatrneurol.2024.10.013. Epub 2024 Oct 22.
PubMed 39579461Kawano A, Yanagizono T, Kadouchi I, Umezaki T, Chosa E. Ultrasonographic evaluation of changes in the muscle architecture of the gastrocnemius with botulinum toxin treatment for lower extremity spasticity in children with cerebral palsy. J Orthop Sci. 2018 Mar;23(2):389-393. doi: 10.1016/j.jos.2017.10.012. Epub 2017 Nov 14.
PubMed 29146092Gitto S, Messina C, Chianca V, Tuscano B, Lazzara A, Corazza A, Pedone L, Albano D, Sconfienza LM. Superb microvascular imaging (SMI) in the evaluation of musculoskeletal disorders: a systematic review. Radiol Med. 2020 May;125(5):481-490. doi: 10.1007/s11547-020-01141-x. Epub 2020 Feb 4.
PubMed 32020529Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
PubMed 17370477
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Ultrasonographic Muscle Morphology, Functional Properties, and Clinical Parameters in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07118228
- Acronym / sponsor ID
- US-sCP / 2025/301
- Keywords
- Spastic Cerebral Palsy, Muscle Morphology, Shear Wave Elastography, Muscle Architecture, Superb Microvascular Imaging, Muscle Stiffness, Pennation Angle, Fascicle Length
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 12 Aug 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.
This study focuses on children with spastic cerebral palsy and aims to examine how muscle morphology and tissue characteristics, as assessed by ultrasound, may relate to functional motor abilities. It is designed as a prospective, cross-sectional, observational study. Planned ultrasound-based assessments include parameters such as muscle thickness, pennation angle, fascicle length, echo intensity, tissue stiffness (via shear wave elastography), and microvascular flow (via superb microvascular imaging). These measurements are intended to be compared with standard clinical evaluations, including the GMFCS, GMFM-66, MAS, MACS, and Tardieu Scale. The study seeks to contribute to a better understanding of the relationship between muscle architecture and functional outcomes, with the goal of generating insights that may inform individualized rehabilitation planning.
Detailed description
This prospective, cross-sectional observational study aims to explore the relationship between ultrasonographically assessed muscle morphology, functional muscle characteristics, and standardized clinical parameters in ambulatory children diagnosed with spastic cerebral palsy (CP). The research seeks to enhance the understanding of muscle structure-function relationships in this population, with the broader goal of contributing to personalized rehabilitation strategies and clinical decision-making.
Cerebral palsy is a non-progressive neurodevelopmental disorder resulting from brain injury or maldevelopment during the prenatal, perinatal, or early postnatal period. Spastic cerebral palsy is the most common subtype, characterized by upper motor neuron lesions that lead to increased muscle tone, spasticity, and movement dysfunction. These neuromuscular alterations often result in secondary changes in muscle morphology, such as increased stiffness, reduced muscle volume, shortened fascicle length, altered fiber orientation, and impaired microcirculation. Understanding how these changes relate to functional limitations remains an important goal in pediatric rehabilitation research.
In this study, both structural and functional properties of skeletal muscles are planned to be assessed using a combination of high-resolution ultrasound techniques. The targeted muscles for assessment include one lower limb and one upper limb muscle: the medial gastrocnemius and the brachialis. These muscles were selected due to their relevance in gross motor and upper limb function in children with spastic CP.
The ultrasonographic parameters planned for evaluation include muscle thickness (MT), fascicle length (FL), pennation angle (PA), cross-sectional area (CSA), and echo intensity (EI). Additionally, muscle stiffness will be estimated through shear wave elastography (SWE), and vascularity will be evaluated using superb microvascular imaging (SMI) or a similar non-contrast-enhanced microvascular ultrasound technique. These advanced imaging modalities allow for the assessment of tissue elasticity and intramuscular blood flow, serving as potential surrogate markers of muscle quality and pathology.
Measurements will be acquired under standardized conditions, with the muscles in a relaxed state and proper anatomical alignment. Multiple images and repeated measurements will be obtained to ensure consistency. Longitudinal and transverse imaging planes will be used depending on the parameter being evaluated. The ultrasonographic protocol is designed to minimize operator-dependent variability and to ensure reproducibility across participants.
Clinical assessments will be conducted using standardized functional and spasticity-related scales. Gross motor function will be evaluated using the Gross Motor Function Classification System (GMFCS) and the Gross Motor Function Measure-66 (GMFM-66). Hand function will be categorized using the Manual Ability Classification System (MACS). Spasticity will be evaluated through the Modified Ashworth Scale (MAS) and the Tardieu Scale, which include assessments of the angle of muscle reaction (R1), passive range of motion (R2), and their difference (R2-R1). Where applicable, additional tools such as the Assisting Hand Assessment (AHA) and the Observational Gait Scale (OGS) may be employed to further characterize upper limb use and gait function.
Eligible participants include children aged 4 to 18 years with a diagnosis of spastic cerebral palsy, classified within GMFCS levels I to III. Children with recent exposure to interventions that could alter muscle morphology, such as botulinum toxin injection (within 6 months) or orthopedic surgery, will be excluded. Other exclusion criteria include the presence of non-spastic CP subtypes, neuromuscular disorders unrelated to CP, or inability to cooperate with assessments. All assessments will be performed in a single visit, without any therapeutic intervention being administered as part of the study.
The study involves no invasive procedures and is considered minimal risk. Its aim is descriptive and correlational, without testing any treatment or hypothesis regarding clinical efficacy. A power analysis was conducted to determine the required sample size for detecting statistically significant correlations. Ethical approval has been obtained from the relevant institutional ethics board. Data collected from participants will be anonymized and managed according to institutional and national data protection guidelines.
Planned statistical analyses include correlation coefficients between imaging parameters and clinical scores, along with regression analyses to identify potential predictors of motor function. Subgroup analyses may explore differences based on GMFCS level, age, or previous therapy exposure. The findings may provide insights into the associations between muscle architecture and clinical function in children with spastic CP, contributing to the development of individualized rehabilitation protocols and improved clinical monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spastic CP Cohort | – | –Ambulatory children with spastic cerebral palsy classified within GMFCS levels I to III. Participants undergo clinical and ultrasound-based assessments to evaluate muscle morphology, functional properties, and their relationship with motor function. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Ambulatory children aged 4 to 18 years diagnosed with spastic cerebral palsy, classified within GMFCS levels I-III and MACS levels I-IV, who are referred to a pediatric rehabilitation clinic for routine evaluation and are eligible for non-invasive ultrasound-based muscle morphology and clinical assessments.
Key inclusion criteria (4 listed)
- Diagnosis of spastic cerebral palsy (SCP) according to the criteria defined by Rosenbaum et al. (2007)
- Age between 4 and 18 years
- Gross Motor Function Classification System (GMFCS) Level I, II, or III
- Manual Ability Classification System (MACS) Level I, II, III, or IV
Key exclusion criteria (8 listed)
- Non-spastic types of cerebral palsy (e.g., dyskinetic, ataxic)
- Diagnosis of neuromuscular disorders other than cerebral palsy (e.g., hereditary neuropathy, myopathy)
- Presence of muscle contractures or fixed deformities in the limbs selected for ultrasound and clinical assessment
- Cognitive or behavioral impairments that prevent cooperation during ultrasound or clinical evaluation
- Botulinum toxin-A (BoNT-A) injection applied to the target muscles within the last 6 months
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
Relationship between muscle morphology parameters and motor function in children with spastic cerebral palsy
Time frame: At baseline (single assessment session)
This outcome assesses the correlation between ultrasound-derived muscle morphology parameters-including muscle thickness, fascicle length, pennation angle, echo intensity, cross-sectional area, stiffness (via shear wave elastography), and vascularity (via microvascular imaging)-and standardized motor function scores (e.g., GMFM-66, GMFCS, MACS, MAS, and Tardieu Scale) in ambulatory children with spastic cerebral palsy.
Comparison Between Modified Heckmatt Scale and Quantitative Echo Intensity in Spastic Muscles
Time frame: At baseline (single assessment session)
This outcome evaluates the agreement between visual muscle echogenicity scores based on the Modified Heckmatt Scale and quantitative grayscale echo intensity values obtained via B-mode ultrasonography in spastic upper and lower limb muscles of children with spastic cerebral palsy. The analysis aims to determine the clinical utility of the Modified Heckmatt Scale in representing objective muscle echotexture.
1 secondary outcome
Development of a Composite Muscle Quality Index Based on Ultrasonographic Parameters
Time frame: At baseline (single assessment session)
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 3 Feb 2026.
- Results publication: PubMed 35582513Atalay KG, Saygi EK, Akbas F, Coskun OK, Akgulle AH, Yagci I. Does ultrasound imaging of the spastic muscle have an additive effect on clinical examination tools in patients with cerebral palsy?: A pilot study. North Clin Istanb. 2022 Mar 11;9(2):102-108. doi: 10.14744/10.14744/nci.2020.78045. eCollection 2022.
- Results publication: PubMed 36706682Peeters N, Hanssen B, Bar-On L, De Groote F, De Beukelaer N, Coremans M, Van den Broeck C, Dan B, Van Campenhout A, Desloovere K. Associations between muscle morphology and spasticity in children with spastic cerebral palsy. Eur J Paediatr Neurol. 2023 May;44:1-8. doi: 10.1016/j.ejpn.2023.01.007. Epub 2023 Jan 10.
- Results publication: PubMed 39579461Uzun Akkaya K, Akkaya HE, Bezgin S, Atalan Efkere P, Firat T, Yildiz C, Elbasan B. Long-Term Effects of Different Number of Botulinum Toxin Injections Into the Gastrocnemius Muscle on Function and Muscle Morphology in Children With Cerebral Palsy. Pediatr Neurol. 2025 Jan;162:97-104. doi: 10.1016/j.pediatrneurol.2024.10.013. Epub 2024 Oct 22.
- Results publication: PubMed 29146092Kawano A, Yanagizono T, Kadouchi I, Umezaki T, Chosa E. Ultrasonographic evaluation of changes in the muscle architecture of the gastrocnemius with botulinum toxin treatment for lower extremity spasticity in children with cerebral palsy. J Orthop Sci. 2018 Mar;23(2):389-393. doi: 10.1016/j.jos.2017.10.012. Epub 2017 Nov 14.
- Results publication: PubMed 32020529Gitto S, Messina C, Chianca V, Tuscano B, Lazzara A, Corazza A, Pedone L, Albano D, Sconfienza LM. Superb microvascular imaging (SMI) in the evaluation of musculoskeletal disorders: a systematic review. Radiol Med. 2020 May;125(5):481-490. doi: 10.1007/s11547-020-01141-x. Epub 2020 Feb 4.
- Results publication: PubMed 17370477Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
- Ultrasonographic evaluation of changes in the muscle architecture of the gastrocnemius with botulinum toxin treatment for lower extremity spasticity in children with cerebral palsyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The plan to share individual participant data (IPD) is currently undecided. The study involves pediatric participants with spastic cerebral palsy, and IPD sharing will depend on institutional policies, ethical committee approval, and the extent to which anonymization and parental consent can ensure participant privacy.
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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.
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 Muscle Spasticity and Gait Disorders, Neurologic, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 4 inclusion and 8 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 3 Feb 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 Turkey (Türkiye). 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 Mustafa Kadıoğlu, MD (+90 262 303 75 00, mustafa.kadioglu@kocaeli.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between muscle morphology parameters and motor function in children with spastic cerebral palsy (time frame: At baseline (single assessment session)). The study lists 2 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 NCT07118228, which also lists 6 linked publications.
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 3 Feb 2026.