Local vibration for balance and walking in children with hemiparetic cerebral palsy
The Acute Effects of Local Vibration Application to the Gastrocnemius Muscle on Gait and Balance in Individuals With Hemiparetic Cerebral Palsy
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 4 Years to 18 Years |
| Sex | All |
| Sponsor | Kırıkkale University Academic / other |
| Locations | 2 sites (Ankara and 1 other locations) |
| Trial ID | NCT07045519 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Ankara and 1 other locations
- 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 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.