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Needles vs. botox: which eases Post-Stroke stiffness best?

NCT ID NCT06296082

Symptom relief Sponsor: Universiteit Antwerpen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests two treatments for muscle stiffness in the lower leg after a stroke: Botox injections (a single session) and dry needling (12 weekly sessions). Researchers will measure changes in muscle reflexes and thickness in 90 participants across Belgium, Spain, and Canada. The goal is to see which approach works better and how they affect the nervous system.

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) and dry needling
What this could lead to
If successful, this could show that dry needling is a safe, non-drug alternative to Botox for reducing muscle stiffness after a stroke.
What could go wrong
This is a small, early-stage proof-of-concept trial. Results may not apply to all stroke survivors, and dry needling may be less effective or require more sessions than Botox.

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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Mar 2027

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 to 75 years

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: 1. aged 18-75 years. 2. post-stroke spasticity in ankle plantar flexors (Modified Ashworth Scale (MAS) scores of 1-2). 3. first stroke. 4. 0-12 months evolution. 5. no previous BTX-A or DN treatment for spasticity. 6. ankle passive range of motion ≥ 20° (approximately) with knee flexion \~30°. 7. independent ambulation with or without aids. Exclusion Criteria: 1. medical conditions interfering with data interpretation. 2. contraindications for BTX-A or DN treatment. 3. changes in anti-spasticity medication dosage (if appropriate), either during the trial or within the 3 months prior to participation. 4. pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

stroke disorder

As listed by the trial registrant

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

Stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Hospital Clínico Universitario Lozano Blesa

    RECRUITING

    Zaragoza, Zaragoza, 50009, Spain

  • Jewish Rehabilitation Hospital

    RECRUITING

    Montreal, Quebec, H7V 1R2, Canada

  • Universiteit Antwerpen

    RECRUITING

    Antwerp, Flanders, 2000, Belgium

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