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Could shock waves boost botox for Stroke-Related foot stiffness?

NCT ID NCT07758322

Symptom relief Sponsor: María Belén Martínez Luna Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial investigates whether adding focused shock wave therapy to standard Botox injections can better ease foot stiffness and improve walking in people with post-stroke spastic equinovarus foot. Participants are randomly assigned to receive Botox alone, shock waves just before Botox, or shock waves two weeks after. The study measures changes in spasticity, ankle movement, muscle strength, and walking ability over a year to see if the timing of shock wave therapy makes a difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Botulinum toxin type A (Botox) combined with focused extracorporeal shock wave therapy
What this could lead to
If adding shock wave therapy improves outcomes, it could establish a better standard of care for post-stroke foot spasticity, enhancing mobility and quality of life.
What could go wrong
This is a small, early-stage trial, and the optimal timing of shock wave therapy remains uncertain. Results may not generalize, and individual responses to Botox and shock waves can vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

69 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults aged 18 to 87 years. * Clinical diagnosis of chronic stroke. * Presence of unilateral spastic equinovarus foot. * Lower-limb spasticity requiring treatment with botulinum toxin type A. * Ability to understand the study procedures and provide written informed consent. Exclusion Criteria: * Botulinum toxin type A injection in the affected lower limb within the previous 12 weeks. * Previous extracorporeal shock wave therapy in the affected lower limb within the previous 12 weeks. * Fixed ankle contracture preventing passive correction. * Other neurological or musculoskeletal disorders affecting gait assessment. * Pregnancy or breastfeeding. * Contraindications to botulinum toxin type A or extracorporeal shock wave therapy. * Severe cognitive impairment preventing participation or informed consent. * Participation in another interventional clinical trial.

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Conditions

The condition(s) this trial relates to.

Muscle Spasticity stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Post-stroke spasticity Spastic equinovarus foot

Contacts and locations

Locations

  • Hospital Clinico San Carlos

    Madrid, Madrid, 28040, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.