Comparing Botox dilutions to improve walking after stroke
Tests two strengths of botulinum toxin injection in adults with stroke-related leg stiffness.
Plain-language title generated from the registry record
Registry title: Low or High Botox Dilution for the Hemiplegic Gait?
Key facts
- Where
- Ioannina, GreeceSee the site
- Phase
- Phase 1
Where in Greece
- Department of Physical Medicine and Rehabilitation, University Hospital of IoanninaIoannina, GreeceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Ioannina
- Trial code
- NCT04630873
- Record updated
- 6 December 2024
- Original description
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.Read full original descriptionShow less
Different Dilutions and Efficacy of Botulin Toxin in the Correction of the Hemiplegic Gait
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.
Inclusion: equinovarus deformity; with an average 3 on Ashworth spasticity scale; able to walk indoors either freely or with a cane.
Exclusion: patients suffering from any mental illness that would disturb the gait pattern; patients suffering from musculoskeletal diseases that overtly interfere with the gait.