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New treatment option for Cerebral Palsy Hemiparetic Cerebral Palsy Spasticity Gait Disorders,...
Official title Vibration Effects on Gait and Balance in CP
ClinicalTrials.gov ID: NCT07045519
What this study is testing
- What it's testing
- 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.
- Time commitment: about 6 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 18
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ankara, Turkey (Türkiye)
- Kirikkale, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ankara, Turkey (Türkiye); Kirikkale, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.