Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583343
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-01
Brief Title:
Effect of Botulinum Toxin on Selective Motor Control and Pain in Diplegic Cerebral Palsy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Effect of Botulinum Toxin Application on Selective Motor Control and Pain in Children Diagnosed With Diplegic Cerebral Palsy
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None