Tiny study aims to Fine-Tune botox for stroke foot spasms
NCT ID NCT06767631
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study looks at how botulinum toxin (Botox) injections affect the muscles, tendons, and nerves in the feet of people who have had a stroke and developed a tight, twisted foot (equinovarus). Researchers will use special ultrasound and movement tests to track these changes in 12 first-time stroke patients. The main goal is to gather data to design larger studies, not to test a new treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures * 2\. At least 18 years of age at the time of signing the Informed Consent Form (ICF) * 3\. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner. * 4\. Pes equinovarus due to spasticity * 5\. Clinical need for BoNT injection at the lower leg * 6\. Any previous injection of BoNT into the muscles to be investigated was at least 3 months ago * 7\. First-ever, unilateral stroke Exclusion Criteria: * Musculoskeletal or other neurological problems affecting the lower limb * Presence of spinal cord pathology that could lead to spasticity, ataxia, dystonia * Cognitive problems that impede measurements * Severe co-morbidities * Irritated skin or open wounds where ultrasound will be placed * Pregnancy * Profound atrophy of the muscles in the target area(s) of injection * Participation in an interventional Trial with an investigational medicinal product (IMP) or device * The effect of botulinum toxin A can theoretically be potentiated by agents affecting neuromuscular transmission, such as aminoglycoside antibiotics (e.g., gentamicin, tobramycin), lithium salts, cholinesterase inhibitors and tubocurarine-like muscle relaxants ((cis)atracurium, rocuronium, suxamethonium, vecuronium). Therefore, patients on whom these medications are started during the course of the trail will be excluded.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Uz Leuven
RECRUITINGLeuven, 3000, Belgium
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