Comparison of Botulinum Toxin Injection Techniques in Spasticity

Study Overview
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Brief Summary
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The aim of the study is to compare the effectiveness of the classical (2-4 points to the muscle proximal) application of botulinum toxin in the treatment of spasticity with the application along the length of the gastrecnemius muscle. The main question it aims to answer Is botulinum toxin more effective in the treatment of spasticity than the classical application applied along the length of the gastrocnemius muscle? Participants will be evaluated for spasticity before and 1 month after injection. Researchers will compare classical versus application along the length of the muscle to see if there is a reduction in spasticity.

Official Title
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Comparison of the Efficacy of 2 Different Botulinum Toxin Injection Techniques in Gastrocnemius Muscle Spasticity in Hemiplegic Patients: A Randomized Double-blind Controlled Study.

Conditions
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Spastic Hemiplegia

Intervention / Treatment
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* Drug: Onabotulinumtoxina for Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with spastic hemiplegia Spasticity in the gastrocnemius muscle Exclusion Criteria: Those who have spasticity in other muscles that will affect ankle movements Those who use myorelaxant or myospasm-effective drugs Those who have been applied botulinum toxin in the last 3 months Those who have contractures in the ankle and knee due to orthopedic reasons.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Classic injection<br>200iu/2ml OnabotulinumtoxinA in total to 2-4 points proximal to the gastrocnemius muscle | Drug: Onabotulinumtoxina for Injection<br>* 200iu/2ml in both groups<br>|
| Experimental: İnjection along the length of the muscle<br>A total of 200iu/2ml of onabotulinumtoxinA by spreading along the length of the gastrocnemius muscle | Drug: Onabotulinumtoxina for Injection<br>* 200iu/2ml in both groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spasticity assessment (change between pre-injection and 1-month control) | Modified ashworth scale | before injection and 1 month after injection | 
| Spasticity assessment (change between pre-injection and 1-month control) | Tardieu scale | before injection and 1 month after injection | 
| Spasticity assessment (change between pre-injection and 1-month control) | Joint range of motion measurement | before injection and 1 month after injection | 
| ambulation level (change between pre-injection and 1-month control) | functional ambulation scale | before injection and 1 month after injection | 
| ambulation velocity (change between pre-injection and 1-month control) | preferred walking speed | before injection and 1 month after injection |