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 participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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.