The Effect of Botulinum Toxin and ESWT Applications on Spasticity and Functionality in Cerebral Palsy Patients

Cerebral Palsy (CP) is a group of movement and posture disorders associated with a non-progressive affect during brain development that can cause limitation of activity and disability. The most common movement disorders in CP are spasticity and dystonia. Currently, the treatment of muscle stiffness called spasticity includes physiotherapy, casting and device, various drugs and surgical treatment. Botulinum toxin injection into the muscle also acts by reducing muscle contraction. ESWT is a method used in various musculoskeletal diseases. It has been previously applied to pediatric patients and has been shown to be effective and painless in ankle muscle stiffness. However, there are few studies investigating the effect of ESWT on functionality.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy, Spastic
• Intervention / Treatment: Drug: Botilinum Toxin injection; Device: Extracorporeal Shock Wave Therapy

Detailed Description

Cerebral palsy (CP) is a permanent, non-progressive disorder in movement, posture, and motor development that occurs in the immature fetal or neonatal brain. Motor disturbances may be accompanied by secondary musculoskeletal problems such as spasticity and contractures. In the treatment of spasticity, various treatments such as exercise, occupational therapies, ultrasound, electrical stimulation, physiotherapy applications such as ESWT, orthoses, oral antispasticity agents, botulinum toxin injection, intrathecal baclofen, and surgery are applied. Botulinum toxin type A is one of the most widely used pharmacological treatments in the treatment of focal spasticity. Repeated injections may lead to the formation of neutralizing antibodies, resulting in a decrease in BoNT-A activity. In addition, a decrease in Botulinum toxin response may be observed due to the increase in intramuscular fat and connective tissue. In addition, in some patients with diffuse spasticity, the total dose of BoNT-A required may exceed the maximum dose. Therefore, various non-pharmacological treatment methods are recommended in addition to BoNT-A in the management of spasticity. Extracorporeal shock wave therapy (ESWT) is a treatment method for applying high pressure waves to the body. The effectiveness of ESWT on spasticity in patients with upper motor neuron damage has been demonstrated in previous studies. However, there are few studies investigating the effect of ESWT after BoNT-A injection on muscle tone, functionality and quality of life. Previous studies have shared the results of short-term follow-up after ESWT and BoNT-A injection.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nurahsen Zaben, Dr; Phone Number: 05453492877; Email: nrhsn_dmr@hotmail.com
• Study Contact Backup: Name: Evrim Karadag Saygı, Prof; Email: evrimkaradag4@hotmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34899
    • Recruiting
    • Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
    • Contact: Nurahsen Zaben, Dr.; Phone Number: 05453492877; Email: nrhsn_dmr@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Having a diagnosis of Spastic Cerebral Palsy confirmed by a pediatric neurologist, Patients with a spasticity value of at least 2 in the evaluation with the Modified Ashworth Scale (MAS), Patients with Botulinum Toxin injection indication by their physician, Having a mental level to understand the commands of the person making the assessment, agree to participate in the study

Exclusion Criteria:

• Patients diagnosed with dyskinetic, ataxic, mixed type cerebral palsy, Hypersensitivity to Onabotulinumtoxin A or any of the excipients, Infection at the planned injection site or sites, Having an uncontrolled epileptic seizure, Upper/lower extremity contracture, coagulopathy, Refusing to participate in the study, The patient is not oriented and cooperative, Contraindication of anesthesia for the group requiring anesthesia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: botulinum toxin group	Drug: Botilinum Toxin injection; Spastic muscles will be determined by examination. Botulinum toxin-A will be injected into the spastic muscles with Stumplex.
Experimental: botilinum toxin and ESWT group	Drug: Botilinum Toxin injection; Spastic muscles will be determined by examination. Botulinum toxin-A will be injected into the spastic muscles with Stumplex.; Device: Extracorporeal Shock Wave Therapy; Spastic muscles will be determined by examination. Botulinum toxin-A will be injected into the spastic muscles with Stumplex. 1 week after the injection, patients will receive 3 sessions of radial ESWT treatment, 1 session/week. rESWT application will be applied with the 'MODUS ESWT' device and a 35 mm radial soft applicator will be used. rESWT will be applied with a soft applicator. The soft applicator is designed for application to sensitive and painful areas and applications will be painless.Shock waves will be applied at 1500/beat, 8 Hz, 0.030 Mj/mm2, 2 bar per muscle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Tardieu Scale	The intensity of muscle tone is evaluated at different determined rates. At the joint, the first angle at which the increase in resistance is detected is recorded. The range of motion is compared to the angle at completion.	T0:Patients will be evaluated before botulinum toxin injection.
Modified Tardieu Scale	The intensity of muscle tone is evaluated at different determined rates. At the joint, the first angle at which the increase in resistance is detected is recorded. The range of motion is compared to the angle at completion.	T1:Patients will be evaluated 1 week after botulinum toxin injection.
Modified Tardieu Scale	The intensity of muscle tone is evaluated at different determined rates. At the joint, the first angle at which the increase in resistance is detected is recorded. The range of motion is compared to the angle at completion.	T2:Patients will be evaluated 1 month after botulinum toxin injection.
Modified Tardieu Scale	The intensity of muscle tone is evaluated at different determined rates. At the joint, the first angle at which the increase in resistance is detected is recorded. The range of motion is compared to the angle at completion.	T3:Patients will be evaluated 3 months after botulinum toxin injection.
Modified Tardieu Scale	The intensity of muscle tone is evaluated at different determined rates. At the joint, the first angle at which the increase in resistance is detected is recorded. The range of motion is compared to the angle at completion.	T4:Patients will be evaluated 6 months after botulinum toxin injection.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Ashworth Scale	muscle tone 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension	T0:Patients will be evaluated before botulinum toxin injection.
Modified Ashworth Scale	muscle tone 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension	T1:Patients will be evaluated 1 week after botulinum toxin injection.
Modified Ashworth Scale	muscle tone 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension	T2:Patients will be evaluated 1 month after botulinum toxin injection.
Modified Ashworth Scale	muscle tone 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension	T3:Patients will be evaluated 3 months after botulinum toxin injection.
Modified Ashworth Scale	muscle tone 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension	T4:Patients will be evaluated 6 months after botulinum toxin injection.
Range of Motion	The joint is positioned according to the anatomical position and this position is considered as 0 starting position. Active and passive joint movement is measured with the help of a goniometer.	T0:Patients will be evaluated before botulinum toxin injection.
Range of Motion	The joint is positioned according to the anatomical position and this position is considered as 0 starting position. Active and passive joint movement is measured with the help of a goniometer.	T1:Patients will be evaluated 1 week after botulinum toxin injection.
Range of Motion	The joint is positioned according to the anatomical position and this position is considered as 0 starting position. Active and passive joint movement is measured with the help of a goniometer.	T2:Patients will be evaluated 1 month after botulinum toxin injection.
Range of Motion	The joint is positioned according to the anatomical position and this position is considered as 0 starting position. Active and passive joint movement is measured with the help of a goniometer.	T3:Patients will be evaluated 3 months after botulinum toxin injection.
Range of Motion	The joint is positioned according to the anatomical position and this position is considered as 0 starting position. Active and passive joint movement is measured with the help of a goniometer.	T4:Patients will be evaluated 6 months after botulinum toxin injection.
BIDA( Bodily Functioning Assessment Tool)	The BIDA has been created to evaluate functional status, to assess therapeutic needs and changes after treatment in 2 to 18 years old children and adolescents who have orthopedic problems. The BIDAhas three forms; parent form for children, parent and self report forms for adolescents. Instrument has 86 items assessing 'upper extremity and physical function', 'transfer and basic mobility', 'sports and physical function', 'pain/comfort', 'happiness', 'global functioning' and 'expectations from treatment domains'.	T0:Patients will be evaluated before botulinum toxin injection.
BIDA( Bodily Functioning Assessment Tool)	The BIDA has been created to evaluate functional status, to assess therapeutic needs and changes after treatment in 2 to 18 years old children and adolescents who have orthopedic problems. The BIDAhas three forms; parent form for children, parent and self report forms for adolescents. Instrument has 86 items assessing 'upper extremity and physical function', 'transfer and basic mobility', 'sports and physical function', 'pain/comfort', 'happiness', 'global functioning' and 'expectations from treatment domains'.	T1:Patients will be evaluated 1 month after botulinum toxin injection.
BIDA( Bodily Functioning Assessment Tool)	The BIDA has been created to evaluate functional status, to assess therapeutic needs and changes after treatment in 2 to 18 years old children and adolescents who have orthopedic problems. The BIDAhas three forms; parent form for children, parent and self report forms for adolescents. Instrument has 86 items assessing 'upper extremity and physical function', 'transfer and basic mobility', 'sports and physical function', 'pain/comfort', 'happiness', 'global functioning' and 'expectations from treatment domains'.	T2:Patients will be evaluated 3 months after botulinum toxin injection.
BIDA( Bodily Functioning Assessment Tool)	The BIDA has been created to evaluate functional status, to assess therapeutic needs and changes after treatment in 2 to 18 years old children and adolescents who have orthopedic problems. The BIDAhas three forms; parent form for children, parent and self report forms for adolescents. Instrument has 86 items assessing 'upper extremity and physical function', 'transfer and basic mobility', 'sports and physical function', 'pain/comfort', 'happiness', 'global functioning' and 'expectations from treatment domains'.	T3:Patients will be evaluated 6 months after botulinum toxin injection.

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Anticipated): July 15, 2023
• Study Completion (Anticipated): July 15, 2023

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 28, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: spasticity; botilinum toxin; eswt
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Muscle Spasticity
• Other Study ID Numbers: 09.2022.1312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No