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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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