NCT07118228 Ultrasonographic Assessment of Muscle Morphology, Function, and Clinical Findings in Spastic Cerebral Palsy
| NCT ID | NCT07118228 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kocaeli University |
| Condition | Muscle Spasticity |
| Study Type | OBSERVATIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2026-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 36 participants in total. It began in 2025-12-15 with a primary completion date of 2026-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07118228 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 18 Years, studying Muscle Spasticity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07118228 currently recruiting?
Yes, NCT07118228 is actively recruiting participants. Contact the research team at mustafa.kadioglu@kocaeli.edu.tr for enrollment information.
Where is the NCT07118228 trial being conducted?
This trial is being conducted at Kocaeli, Turkey (Türkiye).
Who is sponsoring the NCT07118228 clinical trial?
NCT07118228 is sponsored by Kocaeli University. The trial plans to enroll 36 participants.