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Comparison of Botulinum Toxin Injection Techniques in Spasticity

Phase 4
Not yet recruiting
Conditions
Spastic Hemiplegia
Interventions
Registration Number
NCT05615987
Lead Sponsor
Konya Beyhekim Training and Research Hospital
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
60
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Classic injectionOnabotulinumtoxina for Injection200iu/2ml OnabotulinumtoxinA in total to 2-4 points proximal to the gastrocnemius muscle
İnjection along the length of the muscleOnabotulinumtoxina for InjectionA total of 200iu/2ml of onabotulinumtoxinA by spreading along the length of the gastrocnemius muscle
Primary Outcome Measures
NameTimeMethod
ambulation level (change between pre-injection and 1-month control)before injection and 1 month after injection

functional ambulation scale

Spasticity assessment (change between pre-injection and 1-month control)before injection and 1 month after injection

Joint range of motion measurement

ambulation velocity (change between pre-injection and 1-month control)before injection and 1 month after injection

preferred walking speed

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Konya Beyhekim Research and Training Hospital

🇹🇷

Konya, Selçuklu, Turkey

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