Comparing barefoot and shod whole body vibration training for children with cerebral palsy
Effects of Barefoot vs. Shod Whole Body Vibration Training on Pedobarographic Evaluation, Balance, Endurance and Lower Extremity Functions in Children With Cerebral Palsy: 3-Arm Randomized Controlled Single-Blind Study
This study tests whether whole body vibration training done barefoot or with shoes can help improve movement and balance in children with cerebral palsy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | Trakya University Academic / other |
| Locations | 1 site (Edirne, Merkez) |
| Trial ID | NCT06596525 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of barefoot versus shod whole body vibration training on children diagnosed with cerebral palsy. It aims to improve muscle tone, joint range of motion, strength, and balance, which are often compromised in these children due to neurological impairments. Participants will undergo different types of whole body vibration training, including conventional physical therapy, to assess their impact on mobility and gait. The study will include children aged 3 to 18 who can walk at least 10 meters, with specific inclusion and exclusion criteria to ensure safety and relevance of results.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 18 with a diagnosis of cerebral palsy who can walk at least 10 meters.
Not a fit: Patients with severe spasticity, recent fractures, or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance mobility and quality of life for children with cerebral palsy.
How similar studies have performed: Previous studies have shown promise in using whole body vibration training for improving motor function in children with cerebral palsy, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Between ages of 3 and 18 2. Diagnosed with CP 3. Able to walk at least 10 meters with or without assistive devices 4. GMFCS level 1-3 5. Able to stand independently or with self-support on a vibration platform for 3 minutes 6. Able to understand verbal commands and cooperate during clinical examination Exclusion Criteria: 1. History of lower extremity botulinum toxin injection or surgery in the past 6 months 2. Any bone fracture in the past 8 weeks 3. Acute thrombosis, muscle-tendon inflammation, nephrolithiasis 4. Presence of implants in the spine or lower extremities 5. Pregnancy 6. Presence of mental impairment, visual or hearing loss affecting balance 7. History of seizures in the past 6 months 8. ASH 4 spasticity/contracture in any lower extremity muscle group 9. Presence of cardiovascular or pulmonary disease 10. Diagnosis of dyskinetic cerebral palsy
Where this trial is running
Edirne, Merkez
- Trakya University Faculty of Medicine — Edirne, Merkez, Turkey (Recruiting)
Study contacts
- Principal investigator: Filiz Tuna, Assoc. Prof — Trakya University
- Study coordinator: Nur Kakilli, M.D.
- Email: nurkakilli@gmail.com
- Phone: +90 506 762 58 28
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.