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.
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.
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.
Universiteit Antwerpen
Lead sponsor
Instituto de Investigación Sanitaria Aragón
Collaborator
McGill University
Collaborator
Instituto de Salud Carlos III
Collaborator
Fonds de la Recherche en Santé du Québec
Collaborator
Research Foundation Flanders
Collaborator