Ultrasonographic Assessment of Muscle Morphology, Function, and Clinical Findings in Spastic Cerebral Palsy

NCT07118228 | Recruiting

• 2 other identifiers: 2025/301GOKAEK-2025/15/08
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Spasticity; Gait Disorders, Neurologic; Cerebral Palsy, Spastic

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At baseline (single assessment session)

Secondary Outcomes (1)

• Development of a Composite Muscle Quality Index Based on Ultrasonographic Parameters

  At baseline (single assessment session)

Study Arms (1)

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.

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University Faculty of Medicine

Kocaeli, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• 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.

  PMID: 35582513 RESULT

• Peeters 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.

  PMID: 36706682 RESULT

• Uzun 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.

  PMID: 39579461 RESULT

• Kawano 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.

  PMID: 29146092 RESULT

• Gitto 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.

  PMID: 32020529 RESULT

• Rosenbaum 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.

  PMID: 17370477 RESULT

Related Links

• Ultrasonographic evaluation of changes in the muscle architecture of the gastrocnemius with botulinum toxin treatment for lower extremity spasticity in children with cerebral palsy

MeSH Terms

Conditions

Muscle Spasticity; Gait Disorders, Neurologic; Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mustafa Kadıoğlu, MD

CONTACT

+90 262 303 75 00; mustafa.kadioglu@kocaeli.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: December 15, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

TU (1)