Clinical trial NCT05627921: The Effect of Botulinum Toxin and ESWT Applications on Spasticity and Functionality in Cerebral Palsy Patients
Official title: The Effect of Botulinum Toxin and ESWT Applications on Spasticity and Functionality in Cerebral Palsy Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy, Spastic
Keywords: botilinum toxin
spasticity
eswt
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-11-28
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Tardieu Scale
timeFrame: T0:Patients will be evaluated before botulinum toxin injection.
measure: Modified Tardieu Scale
timeFrame: T1:Patients will be evaluated 1 week after botulinum toxin injection.
measure: Modified Tardieu Scale
timeFrame: T2:Patients will be evaluated 1 month after botulinum toxin injection.
measure: Modified Tardieu Scale
timeFrame: T3:Patients will be evaluated 3 months after botulinum toxin injection.
measure: Modified Tardieu Scale
timeFrame: T4:Patients will be evaluated 6 months after botulinum toxin injection.
Secondary outcomes:
measure: Modified Ashworth Scale
timeFrame: T0:Patients will be evaluated before botulinum toxin injection.
measure: Modified Ashworth Scale
timeFrame: T1:Patients will be evaluated 1 week after botulinum toxin injection.
measure: Modified Ashworth Scale
timeFrame: T2:Patients will be evaluated 1 month after botulinum toxin injection.
measure: Modified Ashworth Scale
timeFrame: T3:Patients will be evaluated 3 months after botulinum toxin injection.
measure: Modified Ashworth Scale
timeFrame: T4:Patients will be evaluated 6 months after botulinum toxin injection.
measure: Range of Motion
timeFrame: T0:Patients will be evaluated before botulinum toxin injection.
measure: Range of Motion
timeFrame: T1:Patients will be evaluated 1 week after botulinum toxin injection.
measure: Range of Motion
timeFrame: T2:Patients will be evaluated 1 month after botulinum toxin injection.
measure: Range of Motion
timeFrame: T3:Patients will be evaluated 3 months after botulinum toxin injection.
measure: Range of Motion
timeFrame: T4:Patients will be evaluated 6 months after botulinum toxin injection.
measure: BIDA( Bodily Functioning Assessment Tool)
timeFrame: T0:Patients will be evaluated before botulinum toxin injection.
measure: BIDA( Bodily Functioning Assessment Tool)
timeFrame: T1:Patients will be evaluated 1 month after botulinum toxin injection.
measure: BIDA( Bodily Functioning Assessment Tool)
timeFrame: T2:Patients will be evaluated 3 months after botulinum toxin injection.
measure: BIDA( Bodily Functioning Assessment Tool)
timeFrame: T3:Patients will be evaluated 6 months after botulinum toxin injection.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Study officials:
References: