Comparing Dry Needling and Botulinum Toxin for Stiffness After Stroke
Compares two treatments for leg stiffness in adults after a recent first stroke.
Plain-language title generated from the registry record
Registry title: Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity
Key facts
- Where
- Malle, BelgiumSee the site
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06296082, who can take part
Where in Belgium
- EmmauesMalle, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universiteit Antwerpen
- Trial code
- NCT06296082EU 2024-510866-18-00
- Record updated
- 4 May 2026
- Original description
This is a randomized parallel group clinical trial which will be conducted in three countries (Spain, Canada and Belgium) comparing Botulinum Toxin type A (BTX-A) and Dry Needling (DN) effectiveness for post-stroke spasticity in participants who had a first stroke in the previous 12 months and have plantar flexor spasticity. Participants will be randomly allocated to receive either one session of BTX-A or 12 weekly sessions of DN. Blinded evaluators will assess the effects before, during, and after treatment, and at a 4-week follow-up.Read full original descriptionShow less
Comparative Study of the Mechanism of Action of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity: a Proof of Concept Controlled Trial
This is a randomized parallel group clinical trial which will be conducted in three countries (Spain, Canada and Belgium) comparing Botulinum Toxin type A (BTX-A) and Dry Needling (DN) effectiveness for post-stroke spasticity in participants who had a first stroke in the previous 12 months and have plantar flexor spasticity. Participants will be randomly allocated to receive either one session of BTX-A or 12 weekly sessions of DN. Blinded evaluators will assess the effects before, during, and after treatment, and at a 4-week follow-up.
Inclusion: aged 18-75 years; post-stroke spasticity in ankle plantar flexors (Modified Ashworth Scale (MAS) scores of 1-2); first stroke; 0-12 months evolution; no previous BTX-A or DN treatment for spasticity; ankle passive range of motion ≥ 20° (approximately) with knee flexion ~30°; independent ambulation with or without aids.
Exclusion: changes in anti-spasticity medication dosage (if appropriate), either during the trial or within the 3 months prior to participation; medical conditions interfering with data interpretation; contraindications for BTX-A or DN treatment; pregnant or breastfeeding.