Spinal mechanisms and feasibility of Dry Needling versus Botulinum Toxin Type A in post-stroke lower limb spasticity: A proof-of-concept randomized clinical trial protocol (STROKE-POC).

Overview

1. Faculty of Health and Sciences, Department of Physiotherapy, Universidad Europea de Valencia‌‌, Valencia, Spain
2. Instituto de Investigación Sanitaria de Aragón, Zaragoza, Spain
3. Faculty of Health Sciences and Medicine, Department of Rehabilitation Sciences and Physiotherapy‌‌, University of Antwerp, Antwerp, Belgium
4. Universidad de Alcalá, Facultad de Medicina y Ciencias de la Salud, Departamento de Enfermería y Fisioterapia, Grupo de Investigación Fisioterapia y Dolor, Alcalá de Henares, Spain
5. Faculty of Health Sciences, Universidad San Jorge, Villanueva de Gállego, Zaragoza, Spain
6. Faculty of Medicine, Department of Neurology and Neurosurgery, McGill University, Montreal, Quebec, Canada
7. Faculty of Health Sciences, Department of Physiotherapy, Universidad de Zaragoza, Zaragoza, Spain
8. McGill University, School of Physical and Occupational Therapy, Montreal, Quebec, Canada
9. Center for Interdisciplinary Research in Rehabilitation of Greater Montreal (CRIR), Montreal, Quebec, Canada

Abstract

Introduction: Stroke often causes spasticity, impacting mobility and quality of life. Botulinum Toxin type A (BTX-A) and Dry Needling (DN) are treatments that reduce spasticity, although Botulinum Toxin type A injections can cause adverse effects. No studies have directly compared their effects at spinal, muscular, functional, quality-of-life, and cost-effectiveness levels. This study aims to determine the spinal mechanisms of BTX-A and DN on post-stroke lower limb spasticity, while also assessing feasibility, safety, and exploratory effects at muscular, functional, quality-of-life, and cost-effectiveness levels.

Methods and analysis: This is a protocol of a proof-of-concept, feasibility randomized clinical trial including 90 participants from Canada, Belgium, and Spain who experienced a first stroke in the previous 12 months and present plantar flexor spasticity. Time since stroke (0–12 months) will be recorded and explored as a potential modifier of treatment response. Participants will be randomly assigned to receive either one session of BTX-A or 12 weekly sessions of DN. Blinded evaluators will assess outcomes before, during, and after treatment, with a 4-week follow-up. The primary outcome will be spinal mechanisms of spasticity, measured using the Tonic Stretch Reflex Threshold and its velocity sensitivity. Secondary outcomes will assess: a) muscular architecture and echotexture (measured with ultrasound); b) muscle tone/resistance using the Modified Ashworth Scale; c) gait and mobility (instrumented analysis, Timed Up and Go, 10-Meter Walk Test); d) muscle strength with dynamometry; e) quality of life with the EuroQoL questionnaire; and f) cost-effectiveness (analytic model). The findings will provide preliminary data to inform a future definitive trial.

Ethics and Dissemination: This research project has secured funding from the NEURON ERA-NET 2022 call, supported by the European Union’s Horizon 2020 program (GA 964215) and co-funded by the European Union-Next Generation, and has undergone peer review. Ethical approval has been obtained from Spain, Canada, and Belgium. The study is registered in ClinicalTrials.gov (NCT06296082) and the Clinical Trials Information System (CTIS) under the number 2024-510866-18-00. The study protocol is registered on Zenodo (https://doi.org/10.5281/zenodo.20034064)

Clinical Trials: Clinical Trials NCT06296082; https://clinicaltrials.gov/study/NCT06296082

Reproduced under the paper's license (CC BY), from the paper cited above.

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Data

Datasets cited

• zenodo:20034064, at Zenodo; found in “Data deposition and curation”

Data Availability

The study protocol and supporting documentation are publicly available on Zenodo at https://doi.org/10.5281/zenodo.20034064 (CC BY 4.0). Participant-level data are not yet available as data collection has not commenced. Anonymized data will be deposited in the same repository upon study completion.

Reproduced under the paper's license (CC BY), from the paper cited above.

Data deposition and curation

The STROKE-POC project data are publicly available on Zenodo at https://doi.org/10.5281/zenodo.20034064 (CC BY 4.0). Mean/median values for missing data will be imputed. Double data-entry and automated range checks will be implemented; details are described in the trial’s Data Management Plan available on request.

Reproduced under the paper's license (CC BY), from the paper cited above.

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Version 2, 28 September 2026

• Funding: added European Commission: 964215; Fonds Wetenschappelijk Onderzoek: 49317; Fonds de Recherche du Québec - Santé: 324226; Instituto de Salud Carlos III: AC22/00016; H2020 European Institute of Innovation and Technology: GA 964215

Version 1, 28 September 2026: the first record

Recorded: type, language, journal, volume, issue, pages, dates, 8 authors, 19 MeSH terms, 47 references.

Cite

This paper

Pujol-Fuentes, C., Eeckhaut, B., Fernández Carnero, S., Fernández Sanchís, D., Wein, T., Herrero, P., Saeys, W., & Levin, M. F. (2026). Spinal mechanisms and feasibility of Dry Needling versus Botulinum Toxin Type A in post-stroke lower limb spasticity: A proof-of-concept randomized clinical trial protocol (STROKE-POC). PloS one, 21(5), e0334571. https://doi.org/10.1371/journal.pone.0334571

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