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Vibration Effects on Gait and Balance in CP

RecruitingNAAges 4 Years - 18 YearsAllKırıkkale University
NCT07045519 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This randomized controlled study aims to investigate the acute effects of local vibration applied to the spastic medial gastrocnemius muscle on balance and spatiotemporal gait parameters in children with hemiparetic cerebral palsy. Children aged 4 to 18 years with spasticity levels of 1 to 2 on the Modified Ashworth Scale and Gross Motor Function Classification System (GMFCS) levels I-II will be included. Participants will be randomly assigned to either a treatment group receiving local vibration or a placebo group. Assessments will be conducted before, immediately after, and 30 minutes after the intervention. Balance will be assessed using the Timed Up and Go Test (TUG), Pediatric Reach Test, Tandem Stance Test, and Pediatric Berg Balance Scale. Spatiotemporal gait parameters will be measured using a digital gait analysis system. The results will provide insights into the immediate effe

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📋 Eligibility rules (as published)
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
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What it tests

  • Local Vibration Therapy
  • Sham Vibration
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Where

2 sites
Ankara Yıldırım Beyazıt University
Ankara, Turkey (Türkiye)
Kırıkkale University
Kirikkale, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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