Ultrasonographic Assessment of Muscle Morphology, Function, and Clinical Findings in Spastic Cere… (NCT07118228) | Clinical Trial Compass
RecruitingNot Applicable
Ultrasonographic Assessment of Muscle Morphology, Function, and Clinical Findings in Spastic Cerebral Palsy
Turkey (Türkiye)36 participantsStarted 2025-12-15
Plain-language 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.
Who can participate
Age range
4 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Relationship between muscle morphology parameters and motor function in children with spastic cerebral palsy
Timeframe: At baseline (single assessment session)
2
Comparison Between Modified Heckmatt Scale and Quantitative Echo Intensity in Spastic Muscles
Timeframe: At baseline (single assessment session)