Skip to main content
Clinical Trials/NCT07118228
NCT07118228RecruitingNot Applicable

Evaluation of the Relationship Between Ultrasonographic Muscle Morphology, Functional Properties, and Clinical Parameters in Children With Spastic Cerebral Palsy

Kocaeli University1 site in 1 country36 target enrollmentStarted: December 15, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
36
Locations
1
Primary Endpoint
Relationship between muscle morphology parameters and motor function in children with spastic cerebral palsy

Study Overview

Brief 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. 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
4 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Development of a Composite Muscle Quality Index Based on Ultrasonographic Parameters(At baseline (single assessment session))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nigar Dursun

Principal Investigator, Department of Physical Medicine and Rehabilitation

Kocaeli University

Study Sites (1)

Loading locations...

Similar Trials