Low or High Botox Dilution for the Hemiplegic Gait?

Recruiting now · Phase 1

Conditions studied: Post Stroke Spastic Hemiplegia

In brief

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.

Key facts

Study ID

NCT04630873

Run by

University of Ioannina

People needed

20

Starts

2020-11-20

Expected to finish

2025-08-01

Last updated by the study team

2024-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• equinovarus deformity
• with an average 3 on Ashworth spasticity scale
• able to walk indoors either freely or with a cane.

You may not qualify if…

• patients suffering from any mental illness that would disturb the gait pattern
• patients suffering from musculoskeletal diseases that overtly interfere with the gait

Where it is running

• Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina — Ioannina, Greece (enrolling)

Full record on ClinicalTrials.gov

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