Small single-site registrations of robotic, mirror and virtual reality arm rehabilitation after stroke in Latin America

Alfredo Javier Pérez Gamboa and Alfredo.perez@cienciasas.org

SAP Gamification and Augmented Reality, 2024

Abstract: Introduction: Robotic, mirror and virtual reality training are widely proposed for arm recovery after stroke, but the trial portfolio registered in Latin America and the completeness of its registry entries have not been described. Methods: Cross-sectional registry study of interventional trials in ClinicalTrials.gov with stroke or hemiparesis conditions, at least one site in a Latin American country and a start year between 2012 and 2024. Records were screened by keywords and manual review, and eligible trials were coded by intervention class, design and completeness of upper-limb outcome registration. Proportions are reported with Wilson 95% confidence intervals. Results: Of 208 records with a Latin American site, 15 trials were eligible: 8 robotic, 5 virtual reality or game-based and 2 mirror therapy. All were single-site, from Brazil (8), Chile (4) and Mexico (3). Median registered enrollment was 32 participants (IQR 17-48). A primary outcome named the upper limb or an upper-limb instrument in 12 trials (80.0%; 95% CI 54.8-93.0), an adverse-event outcome was registered in 2 (13.3%) and results were posted for 1 (6.7%). Registration preceded the start month in 6 trials (40.0%). Conclusions: The registered portfolio is small, concentrated in three countries and led by robotic devices, and its entries rarely document safety, results or prospective registration. Registrants should state the limb, instrument and time point of each primary outcome and post results.

Date: 2024
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Persistent link: https://EconPapers.repec.org/RePEc:cwf:grarti:gr202423

DOI: 10.62486/gr202423

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