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

被引：1

作者：

Marano, Massimo ^{[1
,2
]}

Suppa, Antonio ^{[3
,4
]}

Palmieri, Maria Giuseppina ^{[5
]}

Cecconi, Emanuela ^{[6
]}

Frisullo, Giovanni ^{[7
]}

Bovenzi, Roberta ^{[5
]}

Riso, Vittorio ^{[6
]}

Anzini, Alexia ^{[3
,8
]}

Brienza, Marianna ^{[9
]}

Anticoli, Sabrina ^{[10
,11
]}

Crupi, Domenica ^{[11
]}

Giovannelli, Morena ^{[12
]}

Massimiani, Andrea ^{[13
]}

Rinalduzzi, Steno ^{[14
]}

Morena, Emanuele ^{[14
,15
]}

Massara, Maria Carlotta ^{[16
]}

Cupini, Letizia ^{[16
]}

Bressi, Federica ^{[1
,17
]}

Pilato, Fabio ^{[1
,2
]}

Maggi, Loredana ^{[7
]}

Sauchelli, Donato ^{[18
]}

Iezzi, Ennio ^{[4
]}

Centonze, Diego ^{[4
]}

Aprile, Irene ^{[19
]}

Di Lazzaro, Vincenzo ^{[1
,2
]}

Toni, Danilo ^{[3
,8
]}

Altavista, Maria Concetta ^{[9
]}

机构：

[1] Fdn Policlin Univ Campus Biomed, Viale Alvaro Portillo 200, I-00128 Rome, Italy

[2] Univ Campus Biomed Rome, Dept Med, Unit Neurol Neurophysiol Neurobiol & Psychiat, Rome, Italy

[3] Sapienza Univ Rome, Dept Human Neurosci, Rome, Italy

[4] IRCCS Neuromed Inst, Pozzilli, Italy

[5] Univ Roma Tor Vergata, Dept Syst Med, Rome, Italy

[6] Belcolle Hosp, Neurovasc Treatment Unit, Viterbo, Italy

[7] Fdn Policlin Univ A Gemelli IRCCS, Dipartimento Neurosci Organi Senso & Torace, Rome, Italy

[8] Sapienza Univ Rome, Emergency Dept, Stroke Unit, Rome, Italy

[9] San Filippo Neri Hosp ASL RM1, Unit Neurol, Rome, Italy

[10] San Camillo Forlanini Hosp, Neck & Neurosci Dept, Rome, Italy

[11] San Camillo Forlanini Hosp, Head Neck & Neurosci Dept, Stroke Unit, Rome, Italy

[12] St Andrea Univ Hosp, Neurol Unit, Rome, Italy

[13] Sapienza Univ Rome, Dept Neurosci Mental Hlth & Sensory Organs, Rome, Italy

[14] San Camillo Lellis Hosp, Unit Neurol, Rieti, Italy

[15] San Camillo Lellis Hosp, Rieti, Italy

[16] St Eugenio Hosp ASL RM2, Unit Neurol, Rome, Italy

[17] Univ Campus Biomed Rome, Dept Med, Unit Phys Med & Rehabil, Rome, Italy

[18] Villa Immacolata Hosp, Unit Phys Med & Rehabil, Viterbo, Italy

[19] IRCCS Fdn Don Carlo Gnocchi, Florence, Italy

来源：

BMJ OPEN | 2024年 / 14卷 / 06期

关键词：

REHABILITATION MEDICINE; STROKE MEDICINE; NEUROLOGY; PAIN MANAGEMENT; Quality of Life; Clinical trials; TOXIN; ONABOTULINUMTOXINA; EPIDEMIOLOGY; ASSOCIATION; PREDICTORS; GUIDANCE;

D O I：

10.1136/bmjopen-2024-085484

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：1 / 9

页数：9

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