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Search / Trial NCT07045519

Vibration Effects on Gait and Balance in CP

Launched by KIRIKKALE UNIVERSITY · Jun 22, 2025

Trial Information

Current as of July 27, 2025

Not yet recruiting

Keywords

Hemiparetic Cerebral Palsy Randomized Controlled Trial Modified Ashworth Scale Tardieu Scale Gross Motor Function Pediatric Physiotherapy Gait Analysis Balance Assessment Gastrocnemius Muscle Spasticity Local Vibration Therapy

ClinConnect Summary

This clinical trial is studying whether using gentle vibrations on a specific calf muscle can help improve balance and walking in children with hemiparetic cerebral palsy, a condition that affects movement on one side of the body. The study will include children between 4 and 18 years old who can walk on their own and have mild to moderate muscle stiffness in their calf. The goal is to see if a short session of vibration therapy can make an immediate difference in how well these children balance and walk.

If your child is eligible, they will be randomly placed into one of two groups—one that receives the vibration treatment and another that gets a placebo (a treatment without the vibration). Their balance and walking will be tested before the treatment, right after, and again 30 minutes later using simple and safe tests. The study does not involve surgery or injections during the trial, and your child will need to be able to follow basic instructions. Participation requires consent from a parent or guardian, and the study aims to find out if this vibration therapy could be a helpful new tool in supporting children with cerebral palsy.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Children with cerebral palsy classified as GMFCS Level I-II who are able to walk independently,
  • Presence of spasticity in the gastrocnemius muscle (scored as 1, 1+, or 2 according to the Modified Ashworth Scale),
  • Ability to follow verbal instructions,
  • Aged between 4 and 18 years,
  • No botulinum toxin injection within the past 3 months and no surgical intervention within the past 6 months,
  • Voluntary participation in the study with written and verbal informed consent obtained from their parents or legal guardians.
  • Exclusion Criteria:
  • Children who have undergone botulinum toxin injections or surgical procedures for spasticity in the past 6 months,
  • Children with neurological disorders other than CP or musculoskeletal issues (such as joint pain or lower extremity fractures in the past 6 months) that may affect independent standing and walking,
  • Presence of severe mental retardation that hinders communication and comprehension of basic commands,
  • Children exhibiting behavioral problems or poor cooperation that interfere with the administration of assessments,
  • Children whose parents do not provide written informed consent to participate in the study.

About Kırıkkale University

Kırıkkale University is a distinguished academic institution based in Turkey, recognized for its commitment to advancing medical research and education. The university actively engages in clinical trials aimed at enhancing healthcare outcomes and contributing to the scientific community. With a focus on innovation and collaboration, Kırıkkale University leverages its multidisciplinary expertise to conduct rigorous clinical studies that address pressing health challenges. Its research initiatives are guided by ethical standards and a dedication to improving patient care through evidence-based findings.

Locations

Kırıkkale, , Turkey

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported