NCT06583343

Effect of Botulinum Toxin on Selective Motor Control and Pain in Diplegic Cerebral Palsy

Effects of Botulinum Toxin A on Selective Motor Control in Cerebral Palsy: A Simultaneous Assessment of Upper and Lower Extremities

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Gaziosmanpasa Research and Education Hospital · Other Government
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate the effects of Botulinum Neurotoxin-A (BoNT-A) injection applied to spastic muscles on pain sensation and Selective Motor Control (SMC) in cases diagnosed with diplegic spastic Cerebral Palsy.

Detailed description

Cerebral Palsy (CP) is a non-progressive, permanent neurological disorder that occurs in the fetal or infant brain. CP, defined as a group of non-progressive movement and posture disorders, is the most common cause of neurological disability in children. The primary cause is insufficient oxygen supply to the fetus and brain asphyxia. However, other underlying factors may also be involved. Preterm birth is the most important risk factor that should be considered first. Musculoskeletal problems mainly arise due to positive findings such as spasticity, clonus, hyperreflexia related to Upper Motor Neuron damage, and negative findings such as weakness and reduced Selective Motor Control (SMC). Selective Motor Control (SMC) is the ability to achieve muscle activation in an appropriate pattern, in an isolated manner, to produce a voluntary movement or posture. Studies have shown that the impact of SMC on motor performance is as significant as routinely measured issues such as spasticity and contracture. Pain is a common problem in CP, with more than half of children and adults with CP reporting pain as an issue. Assessing pain in children with CP is particularly challenging, especially in those who cannot express themselves verbally. The most common potential causes of pain include neuromuscular problems such as muscle spasms, musculoskeletal problems like hip dislocation and scoliosis, and gastrointestinal issues such as gastroesophageal reflux and constipation. Botulinum Neurotoxin-A (BoNT-A), when applied intramuscularly, inhibits presynaptic acetylcholine (Ach) release by preventing the fusion of Ach vesicles with the plasma membrane. BoNT-A acts on the motor endplate, providing reversible chemical denervation. It is used for localized spasticity and can be applied to multiple muscles in a single session. It is generally used for spasticity starting from the age of 2. Along with rehabilitation, it aids in motor learning, promotes functional progression, and delays or prevents the development of orthopedic deformities. The aim of our study is to investigate the effects of BoNT-A injections into spastic muscles on pain perception and SMC in patients with diplegic spastic CP.

Conditions

• Cerebral Palsy Spastic Diplegia

Interventions

Type	Name	Description
DRUG	OnabotulinumtoxinA	Botulinum toxin injections were administered in appropriate doses to the spastic muscles of children with cerebral palsy.
OTHER	Conventional Physical Therapy	Conventional rehabilitation program; consisting of walking-balance exercises, range of motion exercises, stretching, and strengthening exercises, was provided for 1 hour, 5 days a week, totaling 30 sessions

Timeline

• Start date: 2022-06-25
• Primary completion: 2023-05-25
• Completion: 2024-04-25
• First posted: 2024-09-04
• Last updated: 2026-03-06

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated drug study