Actively Recruiting

Phase Not Applicable
Age: 4Years - 18Years
All Genders
NCT07045519

Vibration Effects on Gait and Balance in CP

Led by Kırıkkale University · Updated on 2025-08-29

40

Participants Needed

2

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 effectiveness of localized vibration therapy in pediatric cerebral palsy rehabilitation.

CONDITIONS

Official Title

Vibration Effects on Gait and Balance in CP

Who Can Participate

Age: 4Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Ankara Yıldırım Beyazıt University

Ankara, Turkey (Türkiye)

Actively Recruiting

2

Kırıkkale University

Kirikkale, Turkey (Türkiye)

Actively Recruiting

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Research Team

B

Betül Ş Yılmaz, Pt.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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