Ultrasound assessment of muscle structure and function in children with spastic cerebral palsy
Official title: Evaluation of the Relationship Between Ultrasonographic Muscle Morphology, Functional Properties, and Clinical Parameters in Children With Spastic Cerebral Palsy
Run by Kocaeli University · NCT07118228 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 4 Years to 18 Years |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Kocaeli University Academic / other |
| Locations | 1 site (Kocaeli) |
| Status | Recruiting |
| Started | December 15, 2025 |
| Main results expected | March 30, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | February 3, 2026 |
| Trial ID | NCT07118228 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
ZEPU AI9 lower-limb exoskeleton gait training for walking difficulties
This study tests whether the ZEPU AI9 exoskeleton can be safely and effectively added to standard rehabilitation to improve walking for adults with stroke, incomplete spinal cord injury, or gait problems after orthopedic surgery.
-
Balance and gait in multiple sclerosis: linking motion data to function
Researchers will see if precise motion measurements of balance and walking relate to everyday functional tests in adults with MS.
-
TWIICE Rise exoskeleton for assisted walking after spinal cord injury
This will test two versions of the TWIICE Rise wearable exoskeleton in adults with spinal cord injury to see if they can safely practice walking in clinic, at home, and in the community.
-
Non-invasive spinal stimulation combined with gait training to improve walking after incomplete spinal cord injury
This tests whether adding non-invasive spinal cord stimulation to gait training helps adults with chronic incomplete spinal cord injury walk better and have less spasticity.
-
Hand-and-arm intensive therapy with lower-limb training for children with spastic diplegic cerebral palsy
This trial tests whether an intensive bimanual hand-and-arm therapy that also includes lower-limb training (HABIT-ILE) helps children with spastic diplegic cerebral palsy improve motor and thinking skills.
-
Ultrasound-guided needle nerve stimulation to improve walking after stroke
This trial will test whether adding ultrasound-guided percutaneous nerve stimulation to regular physiotherapy helps adults who have had a stroke walk faster and move better.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.