Clinical trial NCT06583343: Effect of Botulinum Toxin on Selective Motor Control and Pain in Diplegic Cerebral Palsy
Official title: Evaluation of the Effect of Botulinum Toxin Application on Selective Motor Control and Pain in Children Diagnosed With Diplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cerebral Palsy Spastic Diplegia
Keywords: Cerebral Palsy
Selective Motor Control
Botulinum Neurotoxin Injection
Spasticity
Pain
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2024-09-04
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group receiving conventional physical therapy as the control group, along with another experimental group
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: SCALE (Selective Control Assessment of the Lower Extremity)
timeFrame: six weeks
measure: Boyd and Graham SMC Test
timeFrame: six weeks
measure: Visual Analog Scale (VAS)
timeFrame: six weeks
Secondary outcomes:
measure: SCUES (Selective Control of the Upper Extremity Scale)
timeFrame: six weeks
measure: Functional Independence Measure for Children (WeeFIM)
timeFrame: six weeks
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: six weeks
measure: Child and Adolescent Participation Questionnaire (CASP)
timeFrame: six weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Research and Education Hospital
state: Gaziosmanpaşa
Study officials:
affiliation: Gaziosmanpasa Research and Education Hospital
name: Ebru Yılmaz Yalçınkaya
role: PRINCIPAL_INVESTIGATOR
affiliation: Gaziosmanpasa Research and Education Hospital
name: Ozan Baş
role: PRINCIPAL_INVESTIGATOR
References: