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

NCT ID: NCT06583343

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-03
• Study Completion Date: 2025-05-05

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.

Conditions

Cerebral Palsy Spastic Diplegia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional Physical Therapy Group

Conventional rehabilitation, personalized and administered under the guidance of a physiotherapist

Group Type: ACTIVE_COMPARATOR

Conventional Physical Therapy

Intervention Type: OTHER

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

Botulinum toxin injection group

Administration of botulinum toxin injection prior to the conventional rehabilitation program

Group Type: ACTIVE_COMPARATOR

OnabotulinumtoxinA

Intervention Type: DRUG

Botulinum toxin injections were administered in appropriate doses to the spastic muscles of children with cerebral palsy.

Conventional Physical Therapy

Intervention Type: OTHER

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

Interventions

OnabotulinumtoxinA

Botulinum toxin injections were administered in appropriate doses to the spastic muscles of children with cerebral palsy.

Intervention Type: DRUG

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

Intervention Type: OTHER

Other Intervention Names

botox

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ebru Yılmaz Yalçınkaya

Role: PRINCIPAL_INVESTIGATOR

Gaziosmanpasa Research and Education Hospital

Ozan Baş

Role: PRINCIPAL_INVESTIGATOR

Gaziosmanpasa Research and Education Hospital

Locations

Gaziosmanpasa Research and Education Hospital

Istanbul, Gaziosmanpaşa, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ozan Baş

Role: CONTACT

drozanbas@gmail.com

+905438893324

Facility Contacts

Ozan Baş

Role: primary

drozanbas@gmail.com

+905438893324

Other Identifiers

GaziosmanpasaTREH-FTR-OB-01

Identifier Type: -

Identifier Source: org_study_id