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

NCT06583343 | Completed Phase 4 FDA Drug

• 1 other identifier: GaziosmanpasaTREH-FTR-OB-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy Spastic Diplegia

Keywords

Cerebral Palsy; Selective Motor Control; Botulinum Neurotoxin Injection; Spasticity; Pain

Outcome Measures

Primary Outcomes (3)

• SCALE (Selective Control Assessment of the Lower Extremity)

  SCALE; it is a scale that can be easily applied in outpatient clinic conditions, does not require any equipment. A total of 5 regions are assessed: the hip, knee, ankle, subtalar joint, and toes. Scoring is as follows: 0 (cannot be performed), 1 (impaired SMC), and 2 (normal). If the patient performs the movement correctly within 3 seconds, without moving any other joint besides the one being evaluated and without any mirror movement, it is considered normal SMC (2 points). If there is movement in another joint, mirror movement occurs, the range of motion is less than 50% of the passive ROM (Range Of Motion), or the movement takes longer than 3 seconds, it is considered impaired SMC (1 point). If the patient cannot initiate the movement or develops flexor/extensor synergy, it is scored as unachievable (0 points).

  six weeks

• Boyd and Graham SMC Test

  This test, developed by Boyd and Graham, aims to evaluate the Selective Motor Control (SMC) of ankle dorsiflexion. The test assesses the patient's ability to activate the muscles responsible for ankle dorsiflexion (DF). It consists of 5 items and is scored on a scale from 0 to 4. 0: No movement at all when asked to dorsiflexion the foot. 1. Limited dorsiflexion achieved primarily through the use of extensor hallucis longus (EHL) and/or extensor digitorum brevis (EDB). 2. Limited dorsiflexion achieved using EHL, EDB, and some tibialis anterior (TA) muscle. 3. Dorsiflexion primarily using TA, but with accompanying hip and knee flexion. 4. Isolated selective ankle dorsiflexion (DF) achieved through isolated TA muscle activity without hip or knee flexion.

  six weeks

• Visual Analog Scale (VAS)

  The Visual Analog Scale (VAS) is a very simple and easy-to-use pain scale where patients assess the intensity of their pain between "no pain" (0 points) and "unbearable pain" (10 points). The patient rates their pain on a scale from 0 to 10: 0: No pain 1-3: Mild pain 4-6: Moderate pain 7-10: Severe pain

  six weeks

Secondary Outcomes (4)

• SCUES (Selective Control of the Upper Extremity Scale)

  six weeks

• Functional Independence Measure for Children (WeeFIM)

  six weeks

• Pediatric Quality of Life Inventory (PedsQL)

  six weeks

• Child and Adolescent Participation Questionnaire (CASP)

  six weeks

Study Arms (2)

Conventional Physical Therapy Group

ACTIVE COMPARATOR

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

Other: Conventional Physical Therapy

Botulinum toxin injection group

ACTIVE COMPARATOR

Administration of botulinum toxin injection prior to the conventional rehabilitation program

Drug: OnabotulinumtoxinA; Other: Conventional Physical Therapy

Interventions

OnabotulinumtoxinA DRUG

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

Also known as: botox

Botulinum toxin injection group

Conventional Physical Therapy 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; Conventional Physical Therapy Group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpasa Research and Education Hospital

Istanbul, Gaziosmanpaşa, 34255, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity; Pain

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Ebru Yılmaz Yalçınkaya

  Gaziosmanpasa Research and Education Hospital

  PRINCIPAL INVESTIGATOR

• Ozan Baş

  Gaziosmanpasa Research and Education Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: One group receiving conventional physical therapy as the control group, along with another experimental group

Study Record Dates

• First Submitted: September 1, 2024
• First Posted: September 4, 2024
• Study Start: June 25, 2022
• Primary Completion: May 25, 2023
• Study Completion: April 25, 2024
• Last Updated: March 6, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)