RecruitingNot ApplicableNCT07045519

Vibration Effects on Gait and Balance in CP

The Acute Effects of Local Vibration Application to the Gastrocnemius Muscle on Gait and Balance in Individuals With Hemiparetic Cerebral Palsy


Sponsor

Kırıkkale University

Enrollment

40 participants

Start Date

Jun 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 4 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Local Vibration Therapy and a medical device called Sham Vibration for people with cerebral palsy hemiparetic cerebral palsy spasticity gait disorders, neurologic postural balance impairment. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 4 Years to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELocal Vibration Therapy

Local vibration (LV) will be applied using the Vibrasens© device (Techno Concept, Mane, France). Vibrasens© is a non-invasive therapeutic mechanical vibrator used for transcutaneous vibratory stimulation in sensorimotor rehabilitation. The system includes one pilot unit, one manual vibrator (VB200), four flat skin contactors for tendon applications, four round skin contactors for surface applications, a power supply, a user manual, and a protocol guide.

DEVICESham Vibration

Participants will receive sham stimulation by placing the Vibrasens© device on the same area as the treatment group for 10 minutes, without activating the vibration function. They will be informed that they will only feel the contact of the device.


Locations(2)

Ankara Yıldırım Beyazıt University

Ankara, Turkey (Türkiye)

Kırıkkale University

Kirikkale, Turkey (Türkiye)

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NCT07045519


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