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

RecruitingPhase 2, Phase 3Ages 18 Years - 75 YearsAllUniversiteit Antwerpen
NCT06296082 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Botulinum toxin type A
  • Dry Needling
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Where

3 sites
Universiteit Antwerpen
Antwerp, Belgium
Jewish Rehabilitation Hospital
Montreal, Canada
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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