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Vibration Effects on Gait and Balance in CP

Key facts

Who runs it
Kırıkkale University
Where
Türkiye2 sites in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
40 people, planned
Started
29 Jun 2025
Planned end
29 Mar 2026
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Local Vibration Therapy
  • Sham Vibration
Record updated
29 August 2025

Who can take part

Age
4 years to 18 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Botulinum toxin injection or surgical intervention for spasticity within the past 6 months
  • Neurological disorders other than cerebral palsy
  • Severe cognitive impairment preventing understanding of basic commands
  • Musculoskeletal problems that may affect standing or walking (e.g., joint pain, lower extremity fractures within the past 6 months)
  • Behavioral problems or poor cooperation that interfere with assessments
  • Lack of written informed consent from parents or legal guardians

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 4 and 18 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Experimental: Local Vibration TherapyTreatment being tested

    Participants in the treatment group will receive local vibration applied for 10 minutes to the most prominent area of the spastic medial gastrocnemius muscle.

    Treatment: Local Vibration Therapy

  • Placebo Comparator: Sham VibrationPlacebo, for comparison

    Participants in the placebo group will be placed in the prone position and the vibration device will be placed on the same area as in the treatment group for 10 minutes without delivering any vibration.

    Treatment: Sham Vibration

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Acute Effects of Local Vibration Application to the Gastrocnemius Muscle on Gait and Balance in Individuals With Hemiparetic Cerebral Palsy
Fit questions
Built from NCT07045519, who can take part
Record updated
29 August 2025