Ultrasound assessment of muscle structure and function in children with spastic cerebral palsy
Evaluation of the Relationship Between Ultrasonographic Muscle Morphology, Functional Properties, and Clinical Parameters in Children With Spastic Cerebral Palsy
This project uses detailed ultrasound scans to test whether differences in muscle size, stiffness, and microvascular flow relate to motor abilities in ambulatory children (ages 4–18) with spastic cerebral palsy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 36 (estimated) |
| Ages | 4 Years to 18 Years |
| Sex | All |
| Sponsor | Kocaeli University Academic / other |
| Locations | 1 site (Kocaeli) |
| Trial ID | NCT07118228 on ClinicalTrials.gov |
What this trial studies
This is a prospective, cross-sectional observational project that performs high-resolution ultrasound on the medial gastrocnemius (lower limb) and brachialis (upper limb) to capture muscle thickness, pennation angle, fascicle length, echo intensity, shear wave elastography stiffness, and superb microvascular imaging. These imaging measures will be compared with standard clinical scales such as GMFCS, GMFM-66, MAS, MACS, and the Tardieu Scale. Participants are ambulatory children with spastic cerebral palsy who can cooperate with ultrasound and clinical testing. The goal is to better define structure–function links that could inform individualized rehabilitation planning and clinical decision-making.
Who should consider this trial
Good fit: Ambulatory children aged 4–18 years with a diagnosis of spastic cerebral palsy (GMFCS I–III, MACS I–IV) who can cooperate with ultrasound and clinical testing are ideal candidates.
Not a fit: Children with non-spastic CP, fixed contractures in the target limbs, recent botulinum toxin-A to the target muscles, current oral or intrathecal antispastic medications, prior relevant orthopedic surgery or selective dorsal rhizotomy, or severe cognitive/behavioral impairments preventing cooperation are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the results could help clinicians personalize rehabilitation and treatment plans by linking specific ultrasound muscle features to functional abilities.
How similar studies have performed: Previous work using ultrasound and shear wave elastography in spastic cerebral palsy has shown promising correlations between muscle stiffness or architecture and motor function, though methods and clinical application remain an active area of research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kocaeli
- Kocaeli University Faculty of Medicine — Kocaeli, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Mustafa Kadıoğlu, MD
- Email: mustafa.kadioglu@kocaeli.edu.tr
- Phone: +90 262 303 75 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.