RecruitingPhase 1

Low or High Botox Dilution for the Hemiplegic Gait?

Greece20 participantsStarted 2020-11-20

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of Ankle motion from baseline to 1 month postinjection

Timeframe: Day 1 (baseline) and at 1 month postinjection

Change of modifies Ashworth scale (from 0 to 4, higher grade means worse spasticity) of the ankle from baseline to 1 month postinjection

Timeframe: Day 1 (baseline) and at 1 month postinjection

Change of standing balance from baseline to 1 month postinjection

Timeframe: Day 1 (baseline) and at 1 month postinjection

Change of walking balance from baseline to 1 month postinjection

Timeframe: Day 1 (baseline) and at 1 month postinjection

Trial details

NCT IDNCT04630873

SponsorUniversity of Ioannina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-01

View on ClinicalTrials.gov More Post Stroke Spastic Hemiplegia trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change of Ankle motion from baseline to 1 month postinjection

Timeframe: Day 1 (baseline) and at 1 month postinjection

Change of modifies Ashworth scale (from 0 to 4, higher grade means worse spasticity) of the ankle from baseline to 1 month postinjection

Timeframe: Day 1 (baseline) and at 1 month postinjection

Change of standing balance from baseline to 1 month postinjection

Timeframe: Day 1 (baseline) and at 1 month postinjection

Change of walking balance from baseline to 1 month postinjection

Timeframe: Day 1 (baseline) and at 1 month postinjection