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

Who is this study for? Patients with hemiplegic gait
What treatments are being studied? Botulinum toxin
Status: Recruiting
Location: See location...
Intervention Type: Drug, Diagnostic test
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• equinovarus deformity

• with an average 3 on Ashworth spasticity scale

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

Locations
Other Locations
Greece
Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina
RECRUITING
Ioannina
Time Frame
Start Date: 2020-11-20
Estimated Completion Date: 2025-08-01
Participants
Target number of participants: 20
Treatments
Active_comparator: LOW-HIGH VOLUME
Initially a low volume of the drug (100IU botulinum toxin diluted in 2 ml) after a safe washout period of 6 months the same patients will be injected with a high volume (100IU botulinum toxin in 4 ml) of the drug.
Experimental: HIGH-LOW VOLUME
initially a high volume of the drug (100IU botulinum toxin diluted in 4 ml) after a safe washout period of 6 months the same patients will be injected with a low volume (100IU botulinum toxin in 2 ml) of the drug.
Sponsors
Leads: University of Ioannina

This content was sourced from clinicaltrials.gov