NCT04630873RecruitingPhase 1
Low or High Botox Dilution for the Hemiplegic Gait?
Different Dilutions and Efficacy of Botulin Toxin in the Correction of the Hemiplegic Gait
Source: ClinicalTrials.gov · Last updated 6 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 31 Oct 2020
- Start date
- 20 Nov 2020
- Primary completion date
- 1 Aug 2025
- Lead sponsor
- University of Ioannina
- Diseases
- Stroke
- NCT number
- NCT04630873
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 20 Nov 2020 to the primary completion date, 1 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- patients suffering from any mental illness that would disturb the gait pattern
- patients suffering from musculoskeletal diseases that overtly interfere with the gait
Who the study is looking for
- equinovarus deformity
- with an average 3 on Ashworth spasticity scale
- able to walk indoors either freely or with a cane.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina Coordinator of this site? Confirm its status | Ioannina | Greece | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.