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Vibration Effects on Gait and Balance in CP

NCT07045519 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-08-29

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy Hemiparetic Cerebral Palsy Spasticity Gait Disorders, Neurologic Postural Balance Impairment

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.

Sponsors & Collaborators

  • Kırıkkale University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-29
Primary Completion
2026-01-29
Completion
2026-03-29

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07045519 on ClinicalTrials.gov