Clinical trial NCT05379413: Observational Longitudinal Study on the Outbreak and Management of Stroke Related Spasticity
Official title: Comprehensive Observational & Longitudinal Study on the Outbreak of Stroke Related Spasticity Focusing on the Early Onset Management With BoNT: The COLOSSEO-BoNT Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spasticity as Sequela of Stroke
Keywords: Botulinum neurotoxin type A (BoNT-A)
Stroke
Rehabilitation
Post-Stroke Spasticity (PSS)
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 960
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering for ischemic stroke with upper limb involvement treated at the Lazio region (Italy) stroke units.

Brief summary: Stroke is one of the leading cause of death and disability worldwide. Post-stroke spasticity (PSS) is outbreak after a stroke and is featured by disabling muscle stiffness. PSS could manifest in up tp 50% cases within 6 months after a stroke, especially in the upper limb. Despite it is an acknowledged condition it is insufficiently recognized and treated in clinical practice.

Focal and regional spasticity could improve with rehabilitation and in selected cases with botulinum neurotoxin (BoNT) type A injections. The latter causes muscle relaxation and fosters neuroplasticity, which is able in turn of ameliorating several patient functional aspects. Recent literature demonstrated that PSS patients treated with early BoNT (within 3 month since PSS outbreak) could improve in their clinical status better than patients with a later treatment.

An earlier recognition of PSS predictors could improve patient management. Hence, the investigators are going to perform a multicentric prospective observational real life study with BoNT, based on the best clinical practice and aimed at the early recognition and management of PSS through the identification of 1) early clinical predictors of spasticity (collected within 10 days since stroke), 2) BoNT clinical outcome relative to the timing of the treatment


Eligibility criteria: Inclusion Criteria:

* Ischemic stroke with onset not far than 10 days before the enrollment
* BoNT naive
* Ability to sign the informed consent

Exclusion Criteria:

* Hypersensitivity to BoNT or BoNT related substances
* Participant of Post-stroke spasticity RCT
* Persistent and severe altered mental status or concurrent severe medical condition able to hasten the rehabilitation path.

Primary outcomes:
measure: Upper limb post stroke-spasticity development
timeFrame: 0-24 months
Secondary outcomes:
measure: Post-Stroke Spasticity in early vs late treatment
timeFrame: 3-24 months
Other outcomes:
measure: Upper limb functionality
timeFrame: 3-24 months
measure: Quality of Life measurement
timeFrame: 3-24 months
measure: Pain measurement
timeFrame: 3-24 months
measure: Spasticity in Botulinum Toxin (BoNT) treated versus untreated patients
timeFrame: 3-24 months
measure: Functionality in Botulinum Toxin treated versus untreated patients
timeFrame: 3-24 months
measure: Quality of life in Botulinum Toxin treated versus untreated patients
timeFrame: 3-24 months
measure: Pain in Botulinum Toxin treated versus untreated patients
timeFrame: 3-24 months
Locations:
city: Roma
country: Italy
facility: ASL RM 1 San Filippo Neri Hospital
state: Lazio
city: Roma
country: Italy
facility: Sapienza University of Rome - Stroke Unit
state: Lazio
city: Roma
country: Italy
facility: Sapienza University of Rome
state: Lazio
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico
state: Lazio
Study officials:
References:
citation: Zeng H, Chen J, Guo Y, Tan S. Prevalence and Risk Factors for Spasticity After Stroke: A Systematic Review and Meta-Analysis. Front Neurol. 2021 Jan 20;11:616097. doi: 10.3389/fneur.2020.616097. eCollection 2020.
citation: Wissel J, Fheodoroff K, Hoonhorst M, Mungersdorf M, Gallien P, Meier N, Hamacher J, Hefter H, Maisonobe P, Koch M. Effectiveness of AbobotulinumtoxinA in Post-stroke Upper Limb Spasticity in Relation to Timing of Treatment. Front Neurol. 2020 Feb 28;11:104. doi: 10.3389/fneur.2020.00104. eCollection 2020.
citation: Picelli A, Santamato A, Cosma M, Baricich A, Chisari C, Millevolte M, Prete CD, Mazzu I, Girardi P, Smania N. Early Botulinum Toxin Type A Injection for Post-Stroke Spasticity: A Longitudinal Cohort Study. Toxins (Basel). 2021 May 24;13(6):374. doi: 10.3390/toxins13060374.
citation: Opheim A, Danielsson A, Alt Murphy M, Persson HC, Sunnerhagen KS. Early prediction of long-term upper limb spasticity after stroke: part of the SALGOT study. Neurology. 2015 Sep 8;85(10):873-80. doi: 10.1212/WNL.0000000000001908. Epub 2015 Aug 14.