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.
Parallel
Botulinum toxin type A
DrugBotulinum toxin type A injections are a treatment technique to treat the spastic muscles in patients with stroke that targets on the neuromuscular endplate zone provoking a chimical disruption of dysfunctional endplates.
Dry Needling
Other interventionDry Needling is a treatment technique to treat the spastic muscles in patients with stroke that targets on the neuromuscular endplate zone provoking a mechanical disruption of dysfunctional endplates.
Tonic Stretch Reflex Threshold (TSRT)
TSRT is a novel measures of stretch reflex excitability that provide an indirect indicator of the excitability of α-motoneurons at the level of the spinal cord.
Muscle thickness
It is the estimation of the thickness of the muscle fiber, which is obtained by tracing a line that covers the length of the muscle between the deep and superficial aponeuroses.
Pennation angle
It is the angle between the deep fascia and the line of the fascicle length.
Concurrence matrices
Measures that describe the spatial distribution of gray levels in the texture of an ultrasound image. These matrices, also known as co-occurrence matrices, are used to analyze textural features and patterns in ultrasound images.
Resistance to passive stretching
It will be measured using the Modified Ashworth Scale (MAS). The scale ranges from a minimum value of 0 to a maximum of 4, with 0 indicating no spasticity (no resistance to passive stretching) and 4 representing the most severe spasticity (resistance to passive stretching), characterized by complete rigidity.
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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
