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Low or High Botox Dilution for the Hemiplegic Gait?

StatusRecruiting
PhasePhase 1
Started
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Record status
This record was last updated December 6, 2024 (before its estimated August 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Aug 1, 2024 to Aug 1, 2025
    • Study completion date: Dec 1, 2024 to Aug 1, 2025
    v6
  2. Primary completion date: Aug 1, 2022 to Aug 1, 2024
    • Study completion date: Dec 1, 2022 to Dec 1, 2024
    v5
  3. Primary completion date: Aug 1, 2021 to Aug 1, 2022
    • Study completion date: Dec 1, 2021 to Dec 1, 2022
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 10, 2020 to Nov 20, 2020
    • Site details revised
    v3
  5. Primary endpoints revised (4)v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Ioannina
16 trials monitored
See 1 trial at risk
Stroke
3,531 trials monitored
See 153 trials at risk
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.
Trial Details
NCT Number NCT04630873
Lead Sponsor University of Ioannina
Conditions
(from sponsor)		 Post Stroke Spastic Hemiplegia
Related terms Hemiplegia, Stroke
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov