ArticleJMIR research protocols2025
Effect of Early Treatment of Spasticity After Stroke on Motor Recovery: Protocol for the Baclotox Multicenter, Double-Blind, Double-Dummy Randomized Controlled Trial.
Article in JMIR research protocols, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02462317 (Study of the Effects on Motor Recovery of Early Post-stroke Spasticity Treatment), which is not on this map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Study of the Effects on Motor Recovery of Early Post-stroke Spasticity Treatment: Double Blinded Comparison Between Botulinum Toxin and Baclofen.
Who cites it
3 citing papers in PubMed.
- NMDA Receptor Mediated Mechanisms in the Post-Stroke Brain: From Physiology to Pathology.Biomolecules · 2026Review
- Stretching-Positioned Extracorporeal Shock Wave Therapy Yields Superior Short-Term Efficacy for Post-Stroke Upper-Limb Spasticity: A Retrospective Comparative Study.Medical science monitor : international medical journal of experimental and clinical research · 2026Article
- Evoked potentials in stroke rehabilitation: current applications, emerging technologies, and future directions.Frontiers in neuroscience · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIndividuals with poststroke hemiplegia often develop spasticity, which increases disability. Antispastic treatments such as baclofen and botulinum toxin are commonly prescribed in poststroke recovery. However, their impact on motor recovery, especially when administered within the first 2 months after stroke, remains unclear.
objectiveThis study aims to compare the motor recovery effects of botulinum toxin versus oral baclofen. The hypothesis is that botulinum toxin is more supportive of motor recovery than baclofen and enhances functional recovery.
methodsThe study is a multicenter, controlled phase IV, comparative, prospective, randomized, double-blind, double-dummy, superiority trial to compare the toxin and baclofen, and a noninferiority trial to compare the toxin and the placebo. It focuses on the time course of the Fugl-Meyer Motor Assessment (FMA) as the primary outcome. The main inclusion criterion is patients with a single stroke in the past 2 months. Treatment comprises 1 intramuscular injection at treatment initiation and oral tablets for 4 months. Randomized patients are allocated to 3 arms: botulinum toxin with placebo baclofen, baclofen with placebo botulinum toxin, and placebo baclofen with placebo botulinum toxin. FMA scores are assessed at pretreatment, 1 month, and 3 months later. Spasticity, functional abilities, activities of daily living, pain, and quality of life are also evaluated. Adverse effects are monitored. A positive difference of 13 points in the FMA time course between the botulinum toxin and baclofen groups is considered a relevant effect. The data analysis plan involves linear regression models to compare primary and secondary outcomes, with adjustments for covariates such as age, center, and associated treatments. Subgroup analyses will examine proportional recovery profiles, and missing data in Fugl-Meyer scores will be addressed using imputation methods.
resultsA total of 179 participants were randomized across 18 centers, with inclusions delayed due to the COVID-19 pandemic. As of December 2024, the data manager currently has all the data, and a review of data quality is in progress. No statistical analysis has been conducted so far, and the blind will be lifted after the analysis.
conclusionsThis study identifies the most suitable spasticity treatment, considering the specificities of the stroke and constraints during the recovery phase. It will provide recommendations for the primary treatment of early spasticity post stroke.
trial registrationClinicalTrials.gov NCT02462317; https://clinicaltrials.gov/study/NCT02462317; European clinical trials (EudraCT) 2010-022881-28; https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-022881-28/FR. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/62951.
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