Comprehensive Observational and Longitudinal study on the Outbreak of Stroke-related Spasticity focusing on the Early Onset management with Botulinum NeuroToxin (COLOSSEO-BoNT): protocol for a real-world prospective observational study on upper limb spasticity
Vincenzo Di Lazzaro,
Claudio Gasperini,
Diego Centonze,
Danilo Toni,
Deepak Gupta,
Irene Aprile,
Fabio Pilato,
Marina Diomedi,
Massimo Marano,
Giovanni Frisullo,
Marco Andrighetti,
Maria Concetta Altavista,
Luigi Polidori,
Antonio Suppa,
Maria Giuseppina Palmieri,
Emanuela Cecconi,
Roberta Bovenzi,
Vittorio Riso,
Alexia Anzini,
Marianna Brienza,
Sabrina Anticoli,
Domenica Crupi,
Morena Giovannelli,
Andrea Massimiani,
Steno Rinalduzzi,
Emanuele Morena,
Maria Carlotta Massara,
Letizia Cupini,
Federica Bressi,
Loredana Maggi,
Donato Sauchelli,
Ennio Iezzi,
Alessandro Magliozzi,
Stefano Toro,
Gaia Anzini,
Claudia Celletti,
Paolo Amisano,
Marco Falletti,
Pierandrea Rizzo,
Grazia Libutti,
Marilena Mangiardi,
Francesca Romana Pezzella,
Silvia La Cesa,
Marina Cao,
Francesco Asci,
Serena Capobianco,
Luisella D’Angeli,
Caterina Galluccio
Affiliations
Vincenzo Di Lazzaro
Unit of Neurology, Neurophysiology, Neurobiology and Psychiatry, Department of Medicine, University Campus Bio-Medico of Rome, Rome, Italy
Claudio Gasperini
MS Centre, Department of Neurosciences, San Camillo Forlanini Hospital, Roma, Italy
Diego Centonze
IRCCS Neuromed Institute, Pozzilli, Italy
Danilo Toni
Department of Human Neurosciences, Sapienza University of Rome, Rome, Italy
Deepak Gupta
Irene Aprile
IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy
Introduction Poststroke spasticity (PSS) affects up to 40% of patients who had a stroke. Botulinum neurotoxin type A (BoNT-A) has been shown to improve spasticity, but the optimal timing of its application remains unclear. While several predictors of upper limb PSS are known, their utility in clinical practice in relation to BoNT-A treatment has yet to be fully elucidated. The COLOSSEO-BoNT study aims to investigate predictors of PSS and the effects of BoNT-A timing on spasticity-related metrics in a real-world setting.Methods and analysis The recruitment will involve approximately 960 patients who have recently experienced an ischaemic stroke (within 10 days, V0) and will follow them up for 24 months. Parameters will be gathered at specific intervals: (V1) 4, (V2) 8, (V3) 12, (V4) 18 months and (V5) 24 months following enrolment. Patients will be monitored throughout their rehabilitation and outpatient clinic journeys and will be compared based on their BoNT-A treatment status—distinguishing between patients receiving treatment at different timings and those who undergo rehabilitation without treatment. Potential predictors will encompass the Fugl-Meyer assessment, the National Institute of Health Stroke Scale (NIHSS), stroke radiological characteristics, performance status, therapies and access to patient care pathways. Outcomes will evaluate muscle stiffness using the modified Ashworth scale and passive range of motion, along with measures of quality of life, pain, and functionality.Ethics and dissemination This study underwent review and approval by the Ethics Committee of the Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy. Regardless of the outcome, the findings will be disseminated through publication in peer-reviewed journals and presentations at national and international conferences.Trial registration number NCT05379413.
