Comparing low and high Botox dilution for improving walking after stroke
Official title: Different Dilutions and Efficacy of Botulin Toxin in the Correction of the Hemiplegic Gait
Run by University of Ioannina · NCT04630873 · Data updated 2026-11-12
This study is testing whether using highly diluted Botox injections can help improve walking in people who have had a stroke better than using lower dilutions.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | University of Ioannina Academic / other |
| Locations | 1 site (Ioannina) |
| Status | Recruiting |
| Started | November 20, 2020 |
| Main results expected | August 1, 2025 |
| Study ends | August 1, 2025 |
| Registry record updated | December 6, 2024 |
| Trial ID | NCT04630873 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals with equinovarus deformity and an average spasticity score of 3 on the Ashworth scale who can walk indoors with or without assistance.
✕Probably not a fit
Patients with mental illnesses that affect gait patterns or musculoskeletal diseases that interfere with walking may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of different dilutions of Botulin toxin type A (BTX-A) injections on gait improvement in patients with post-stroke spastic hemiplegia. It aims to determine whether highly diluted BTX-A injections provide a greater reduction in spasticity compared to lower dilutions. The study employs a crossover design, allowing participants to receive both treatment types, with gait analysis used to evaluate outcomes. This research addresses a significant gap in existing literature regarding optimal botulinum toxin dilution protocols.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment protocols for improving gait in stroke survivors with spastic hemiplegia.
How similar studies have gone: While there is ongoing debate regarding the efficacy of different BTX-A dilutions, this specific crossover study design has not been previously performed, making it a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * equinovarus deformity * with an average 3 on Ashworth spasticity scale * able to walk indoors either freely or with a cane. Exclusion Criteria: * 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's running
-
Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina
Ioannina, Greece Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.