Botulinum toxin effects on motor control and pain in children with diplegic cerebral palsy
Evaluation of the Effect of Botulinum Toxin Application on Selective Motor Control and Pain in Children Diagnosed With Diplegic Cerebral Palsy
This study is testing if Botulinum toxin injections can help reduce pain and improve movement control in children with diplegic cerebral palsy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 4 Years to 12 Years |
| Sex | All |
| Sponsor | Gaziosmanpasa Research and Education Hospital Government |
| Locations | 1 site (Istanbul, Gaziosmanpaşa) |
| Trial ID | NCT06583343 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of Botulinum Neurotoxin-A (BoNT-A) injections on pain sensation and Selective Motor Control (SMC) in children diagnosed with diplegic spastic Cerebral Palsy. The research focuses on children aged 4-12 who exhibit spasticity and related musculoskeletal issues. By assessing the effectiveness of BoNT-A in improving SMC and reducing pain, the study aims to enhance the quality of life for these patients. Participants will also receive conventional physical therapy as part of their treatment regimen.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 4-12 with a diagnosis of diplegic spastic Cerebral Palsy and appropriate indications for BoNT-A injections.
Not a fit: Patients with severe motor impairment (GMFCS 5), mental retardation, or those who have undergone specific surgical interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved motor control and reduced pain for children with diplegic cerebral palsy.
How similar studies have performed: Previous studies have shown promising results with the use of Botulinum toxin for managing spasticity and improving motor function in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with Cerebral Palsy * Between the ages of 4-12 * GMFCS (Gross Motor Function Classification System)1-4 * Patients who have received an appropriate indication for BoNT-A injection from an experienced physiatrist * Patients who have not had botulinum toxin administered in the last 6 months Exclusion Criteria: * Mental retardation * GMFCS 5 * Have an intrathecal baclofen pump for spasticity treatment or history of soft tissue and/or bone surgery * Underwent dorsal rhizotomy * Have an active infection or a localized skin infection at the injection site * Using aminoglycoside antibiotics * Contracture
Where this trial is running
Istanbul, Gaziosmanpaşa
- Gaziosmanpasa Research and Education Hospital — Istanbul, Gaziosmanpaşa, Turkey (Recruiting)
Study contacts
- Principal investigator: Ebru Yılmaz Yalçınkaya — Gaziosmanpasa Research and Education Hospital
- Study coordinator: Ozan Baş
- Email: drozanbas@gmail.com
- Phone: +905438893324
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.