Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• medical conditions interfering with data interpretation.
• contraindications for BTX-A or DN treatment.
• changes in anti-spasticity medication dosage (if appropriate), either during the trial or within the 3 months prior to participation.
• pregnant or breastfeeding.

Where this trial is running

• Universiteit Antwerpen, Antwerp, Flanders, Belgium
• Jewish Rehabilitation Hospital, Montreal, Quebec, Canada
• Hospital Clínico Universitario Lozano Blesa, Zaragoza, Zaragoza, Spain

Who to contact

Pablo Herrero Gallego, PhD · +34646168248 · pherrero@unizar.es

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06296082.