Local vibration for balance and walking in children with hemiparetic cerebral palsy
Official title: The Acute Effects of Local Vibration Application to the Gastrocnemius Muscle on Gait and Balance in Individuals With Hemiparetic Cerebral Palsy
Run by Kırıkkale University · NCT07045519 · Data updated 2026-11-12
This trial will see if applying gentle local vibration to the calf muscle improves balance and walking in children aged 4–18 with hemiparetic cerebral palsy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 4 Years to 18 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Kırıkkale University Academic / other |
| Locations | 2 sites (Ankara and 1 other locations) |
| Status | Recruiting |
| Started | June 29, 2025 |
| Main results expected | January 29, 2026 |
| Study ends | March 29, 2026 |
| Registry record updated | August 29, 2025 |
| Trial ID | NCT07045519 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 4–18 with hemiparetic cerebral palsy who walk independently, are GMFCS level I–II, and have mild to moderate gastrocnemius spasticity (Modified Ashworth Scale 1–2) are ideal candidates.
✕Probably not a fit
Children with more severe mobility limitations (GMFCS III–V), very high spasticity, recent lower-limb surgery or botulinum toxin injections, other neurological or musculoskeletal conditions, or who cannot follow simple instructions are unlikely to receive benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, placebo-controlled study will enroll children with hemiparetic cerebral palsy aged 4–18 who are GMFCS level I–II and have mild to moderate calf spasticity. Participants will be randomly assigned to receive a short session of local vibration applied to the medial gastrocnemius or a sham (placebo) vibration. Balance will be measured with standardized clinical tests (TUG, Pediatric Reach Test, Tandem Stance, Pediatric Berg Balance Scale) and spatiotemporal gait parameters will be captured with a digital gait analysis system before, immediately after, and 30 minutes after the intervention. The trial focuses on acute, short-term effects to determine whether a single application produces measurable changes in tone, balance, or walking patterns.
Why it matters
Potential benefit: If successful, the approach could briefly reduce calf spasticity and improve balance and walking, helping everyday mobility and therapy sessions.
How similar studies have gone: Previous studies, mostly using whole-body vibration, have reported improvements in walking and spasticity, but local calf vibration is less studied and current evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of cerebral palsy, classified as GMFCS Level I or II * Aged between 4 and 18 years * Presence of spasticity in the gastrocnemius muscle (Modified Ashworth Scale score of 1, 1+, or 2) * Able to walk independently * Ability to follow verbal instructions * No botulinum toxin injection in the past 3 months * No lower limb surgery in the past 6 months * Voluntary participation with written and verbal informed consent obtained from parents or legal guardians Exclusion Criteria: * Botulinum toxin injection or surgical intervention for spasticity within the past 6 months * Neurological disorders other than cerebral palsy * Musculoskeletal problems that may affect standing or walking (e.g., joint pain, lower extremity fractures within the past 6 months) * Severe cognitive impairment preventing understanding of basic commands * Behavioral problems or poor cooperation that interfere with assessments * Lack of written informed consent from parents or legal guardians
Where it's running
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Ankara Yıldırım Beyazıt University
Ankara, Turkey (Türkiye) Recruiting -
Kırıkkale University
Kirikkale, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Betül Ş Yılmaz, Pt.
- Email: betulsevvalunal1@gmail.com
- Phone: +905069627501
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.