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

NCT05627921 | Unknown

• 1 other identifier: 09.2022.1312
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy, Spastic

Keywords

botilinum toxin; spasticity; eswt

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (14)

• Modified Ashworth Scale

  T0:Patients will be evaluated before botulinum toxin injection.

• Modified Ashworth Scale

  T1:Patients will be evaluated 1 week after botulinum toxin injection.

• Modified Ashworth Scale

  T2:Patients will be evaluated 1 month after botulinum toxin injection.

• Modified Ashworth Scale

  T3:Patients will be evaluated 3 months after botulinum toxin injection.

• Modified Ashworth Scale

  T4:Patients will be evaluated 6 months after botulinum toxin injection.

Study Arms (2)

botulinum toxin group

EXPERIMENTAL

Drug: Botilinum Toxin injection

botilinum toxin and ESWT group

EXPERIMENTAL

Device: Extracorporeal Shock Wave Therapy; Drug: Botilinum Toxin injection

Interventions

Extracorporeal Shock Wave Therapy DEVICE

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.

botilinum toxin and ESWT group

Botilinum Toxin injection DRUG

Spastic muscles will be determined by examination. Botulinum toxin-A will be injected into the spastic muscles with Stumplex.

botilinum toxin and ESWT group; botulinum toxin group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, 34899, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Interventions

Extracorporeal Shockwave Therapy

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)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Nurahsen Zaben, Dr

CONTACT

05453492877; nrhsn_dmr@hotmail.com

Evrim Karadag Saygı, Prof

CONTACT

evrimkaradag4@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The person performing the examinations and evaluating the data was blind to the treatment administered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized into two equal groups using the closed envelope system. The patients in the first group will be injected with Botulinum Toxin-A with the Stumplex device into the spastic muscle. The patients in the second group will be injected with Botulinum toxin with the same procedure. 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.

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 28, 2022
• Study Start: November 15, 2022
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: November 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)