Low or High Botox Dilution for the Hemiplegic Gait?
Different Dilutions and Efficacy of Botulin Toxin in the Correction of the Hemiplegic Gait
University of Ioannina
20 participants
Nov 20, 2020
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
Inclusion Criteria3
- equinovarus deformity
- with an average 3 on Ashworth spasticity scale
- able to walk indoors either freely or with a cane.
Exclusion Criteria2
- patients suffering from any mental illness that would disturb the gait pattern
- patients suffering from musculoskeletal diseases that overtly interfere with the gait
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Interventions
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.
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)
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NCT04630873