RecruitingPhase 1NCT04630873

Low or High Botox Dilution for the Hemiplegic Gait?

Different Dilutions and Efficacy of Botulin Toxin in the Correction of the Hemiplegic Gait


Sponsor

University of Ioannina

Enrollment

20 participants

Start Date

Nov 20, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

There is debate regarding the efficiency of different dilutions of Botulin toxin type A (BTX-A) injections. Some authors believe that highly diluted BTX-A injections achieve greater neuromuscular blockade resulting in higher spasticity reduction. On the other hand, other researchers suggest that there is no difference in spasticity decrease if either high or low volume toxin is being injected. Studies on this subject lack either the design or the power of study was low. Therefore, there is no clear guideline for an optimal botulinum toxin dilution protocol. In an attempt to have a better understanding, a cross over study was designed. The material will be patients with spastic hemiparesis which will be treated with Botulin toxin at different dilutions. Gait analysis will be used for the evaluation of the Botulin toxin injection on gait improvement. To the best of our knowledge such a trial hasn't been performed yet.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different dilutions of Botox (botulinum toxin) injections to see which works better for treating a walking problem called hemiplegic gait with equinovarus deformity. Hemiplegia refers to weakness or paralysis on one side of the body, often caused by a stroke or brain injury. Equinovarus deformity means the foot turns inward and downward, making it difficult to walk normally. Botox injections relax overactive muscles and are commonly used to improve this condition. The researchers want to find out whether a high-dilution or low-dilution Botox injection leads to better walking outcomes. This is important because the way Botox spreads in muscle tissue depends on how it is diluted, and different dilutions may produce different effects on gait. You may be eligible if: - You have equinovarus foot deformity - You score an average of 3 on the Ashworth spasticity scale (indicating moderate muscle stiffness) - You are able to walk indoors, either freely or with a cane - You are 18 years of age or older You may NOT be eligible if: - You have a mental illness that affects your walking pattern - You have a musculoskeletal disease that significantly interferes with your gait Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBotulinum toxin

The triceps surae along with the posterior tibialis muscle will be injected. The units that will be injected are the average being injected in our University Clinic. I.e. 50 units for each head of the gastrocnemius muscle- single injection site, 100 units for the soleus muscle- two injection sites and 50 units for the posterior tibialis muscle- single injection site.

DIAGNOSTIC_TESTgait analysis

The gait analysis will be performed with two systems. A foot pressure sensitivity walkway (medicapteurs Win-Track), and an IMU network system (RehaGait Pro) using seven IMU's placed in specific anatomical positions. In combination those two systems can provide a wide range of spatiotemporal analytics of gait:


Locations(1)

Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina

Ioannina, Greece

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NCT04630873