Low or High Botox Dilution for the Hemiplegic Gait?

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Ioannina
• Treatments: Botulinum Toxins

Criteria

Inclusion Criteria:

• equinovarus deformity

• with an average 3 on Ashworth spasticity scale

• able to walk indoors either freely or with a cane.

Exclusion Criteria:

• patients suffering from any mental illness that would disturb the gait pattern

• patients suffering from musculoskeletal diseases that overtly interfere with the gait