Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT04630873

Low or High Botox Dilution for the Hemiplegic Gait?

Led by University of Ioannina · Updated on 2024-12-06

20

Participants Needed

1

Research Sites

245 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Low or High Botox Dilution for the Hemiplegic Gait?

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Equinovarus deformity
  • Average level 3 on Ashworth spasticity scale
  • Able to walk indoors either freely or with a cane
Not Eligible

You will not qualify if you...

  • Mental illness that disturbs the gait pattern
  • Musculoskeletal diseases that overtly interfere with gait

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina

Ioannina, Greece, 45100

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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