Ultrasonographic Assessment of Muscle Morphology, Function, and Clinical Findings in Spastic Cerebral Palsy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-18
SponsorKocaeli University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
36 Participants
are grouped into 1 trial groupGroup A: Spastic CP Cohort
Trial outcomes
Primary outcomes
1
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.
Time frame
At baseline (single assessment session)2
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.
Time frame
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.
Time frame
At baseline (single assessment session)Sponsors and contacts
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Source ClinicalTrials.gov