Evidence map›Paper›PMID 38950995›Full record

ArticleBMJ open2024

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.

Massimo Marano, Antonio Suppa, Maria Giuseppina Palmieri, Emanuela Cecconi, Giovanni Frisullo, Roberta Bovenzi, Vittorio Riso, Alexia Anzini, Marianna Brienza, Sabrina Anticoli and 18 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05379413 (Comprehensive Observational & Longitudinal Study on the Outbreak of Stroke Related Spasticity Focusing on the Early Onset Management With BoNT), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT05379413 unknown statusnot on this map

Comprehensive Observational & Longitudinal Study on the Outbreak of Stroke Related Spasticity Focusing on the Early Onset Management With BoNT: The COLOSSEO-BoNT Study

TypeobservationalSponsorCampus Bio-Medico UniversityRan2022 to 2025Enrolled960ConditionsSpasticity as Sequela of StrokeArmsBotulinum toxin type A
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors.

Massimo MaranoFondazione Policlinico Universitario Campus Bio-Medico, Viale Alvaro del Portillo 200, 00128, Rome, Italy m.marano@policlinicocampus.it.ORCID 0000-0001-9885-3666
Antonio SuppaDepartment of Human Neurosciences, Sapienza University of Rome, Rome, Italy.
Maria Giuseppina PalmieriDepartment of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy.
Emanuela CecconiNeurovascular Treatment Unit, Belcolle Hospital, Viterbo, Italy.
Giovanni FrisulloDipartimento di neuroscienze, Organi di Senso e Torace, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Roberta BovenziDepartment of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy.
Vittorio RisoNeurovascular Treatment Unit, Belcolle Hospital, Viterbo, Italy.
Alexia AnziniDepartment of Human Neurosciences, Sapienza University of Rome, Rome, Italy.
Marianna BrienzaUnit of Neurology, San Filippo Neri Hospital ASL RM1, Rome, Italy.
Sabrina AnticoliNeck and Neuroscience Department, San Camillo Forlanini Hospital, Roma, Italy.
Domenica CrupiHead, Neck and Neuroscience Department, Stroke Unit, San Camillo-Forlanini Hospital, Rome, Italy.
Morena GiovannelliNeurology Unit, Sant'Andrea University Hospital, Rome, Italy.
Andrea MassimianiDepartment of Neuroscience, Mental Health and Sensory Organs, Sapienza University of Rome, Rome, Italy.
Steno RinalduzziUnit of Neurology, San Camillo de Lellis Hospital, Rieti, Italy.
Emanuele MorenaUnit of Neurology, San Camillo de Lellis Hospital, Rieti, Italy.
Maria Carlotta MassaraUnit of Neurology, Sant'Eugenio Hospital ASL RM2, Rome, Italy.
Letizia CupiniUnit of Neurology, Sant'Eugenio Hospital ASL RM2, Rome, Italy.
Federica BressiFondazione Policlinico Universitario Campus Bio-Medico, Viale Alvaro del Portillo 200, 00128, Rome, Italy.
Fabio PilatoFondazione Policlinico Universitario Campus Bio-Medico, Viale Alvaro del Portillo 200, 00128, Rome, Italy.
Loredana MaggiDipartimento di neuroscienze, Organi di Senso e Torace, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Donato SauchelliUnit of Physical Medicine and Rehabilitation, Villa Immacolata Hospital, Viterbo, Italy.
Ennio IezziIRCCS Neuromed Institute, Pozzilli, Italy.
Diego CentonzeIRCCS Neuromed Institute, Pozzilli, Italy.
Irene AprileIRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.
Vincenzo Di LazzaroFondazione Policlinico Universitario Campus Bio-Medico, Viale Alvaro del Portillo 200, 00128, Rome, Italy.
Danilo ToniDepartment of Human Neurosciences, Sapienza University of Rome, Rome, Italy.
Maria Concetta AltavistaUnit of Neurology, San Filippo Neri Hospital ASL RM1, Rome, Italy.
COLOSSEO study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPoststroke 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.

Indexed as

Botulinum Toxins, Type AMuscle SpasticityNeuromuscular AgentsStrokeUpper ExtremityFemaleHumansLongitudinal StudiesMaleObservational Studies as TopicProspective StudiesStroke RehabilitationBotulinum Toxins, Type ANeuromuscular AgentsClinical trialsNEUROLOGYPAIN MANAGEMENTQuality of LifeREHABILITATION MEDICINESTROKE MEDICINE

Identifiers

PMID38950995
PMCPMC11340275

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.