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RECRUITING
NCT07045519
NA

Vibration Effects on Gait and Balance in CP

Sponsor: Kırıkkale University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

4 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-06-29

Completion Date

2026-03-29

Last Updated

2025-08-29

Healthy Volunteers

No

Interventions

DEVICE

Local 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.

DEVICE

Sham 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

Kırıkkale, Turkey (Türkiye)