Comparative study of the mechanism of action of Dry Needling and Botulinum Toxin type A as a treatment for lower limb post-stroke spasticity: a proof of concept controlled trial
Project aim: The primary objective is to determine the mechanisms of action of Botulinum Toxine Type A (BTX A) infiltration and Dry Needling (DN) on lower limb post-stroke spasticity at the muscle, central (spinal) and functional levels. The secondary objective is to compare the safety and feasibility of each treatment for spasticity. Work plan: A prospective multicenter feasibility proof-of-concept randomised clinical trial will be carried out to compare BTX A and DN treatments for post-stroke spasticity in the ankle plantar flexor muscles. 30 patients per country (Spain, Belgium, Canada) will be recruited. Effects of treatment will be evaluated at 3 levels of the International Classification of Functioning: Body Structure and Function level (muscle and central level), Activity Level (gait), and Participation Level (quality of life). Impact and potencial of the results:We hypothesize that DN treatment, a non-pharmacological minimally invasive technique, may be comparable to BTX A for the treatment of post-stroke spasticity without having secondary effects at the muscle level. Improving the knowledge of the mechanisms of action of both interventions will lead to better treatment prescription and better clinical outcomes for the individual patients. The inclusion of a Patient Advisory Group is expected to add the patient´s perspective and improve the research quality as well as contributing to the dissemination of results.
Electrophisiological approaches Clinical trial
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Pablo Herrero Gallego (Coordinator)