Vibration Effects on Gait and Balance in CP (NCT07045519) | Clinical Trial Compass
RecruitingNot Applicable
Vibration Effects on Gait and Balance in CP
Turkey (Türkiye)40 participantsStarted 2025-06-29
Plain-language 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.
Who can participate
Age range
4 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Botulinum toxin injection or surgical intervention for spasticity within the past 6 months
* Neurological disorders other than cerebral palsy
* Musculoskeletal problems that may affect standing or walking (e.g., joint pain, lower extremity fractures within the past 6 months)
* Severe cognitive impairment preventing understanding of basic commands
* Behavioral problems or poor cooperation that interfere with assessments
* Lack of written informed consent from parents or legal guardians
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Modified Tardieu Scale (MTS)
Timeframe: Baseline and immediately after intervention
2
Gross Motor Function Classification System (GMFCS):
Timeframe: Baseline
3
Pediatric Berg Balance Scale (PBBS):
Timeframe: Baseline
4
Timed Up and Go Test (TUG):
Timeframe: Baseline and immediately after intervention
5
10-Meter Walk Test (10MWT):
Timeframe: Baseline and immediately after intervention
6
Pediatric Reach Test
Timeframe: Baseline and immediately after intervention
7
Tandem Stance Test
Timeframe: Baseline and immediately after intervention