Observational Longitudinal Study on the Outbreak and Management of Stroke Related Spasticity

Study Overview
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Brief Summary
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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

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

Conditions
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Spasticity as Sequela of Stroke

Intervention / Treatment
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* Drug: Botulinum toxin type A


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early BoNT treatment<br>Patients with PSS treated with BoNT within the first Quartile of injection timing distribution | Drug: Botulinum toxin type A<br>* Botulinum neurotoxin (BoNT) Type A injection with either OnaBoNT-A, AboBoNT-A, IncoBoNT-A<br>|
| Late BoNT treatment<br>Patients with PSS treated with BoNT within the third Quartile of injection timing distribution | Drug: Botulinum toxin type A<br>* Botulinum neurotoxin (BoNT) Type A injection with either OnaBoNT-A, AboBoNT-A, IncoBoNT-A<br>|
| Not treated with BoNT<br>Natural controls with PSS not treated with BoNT | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper limb post stroke-spasticity development | Detection of a Modified Ashworth Scale (MAS) >/= 1 at the upper limb (MAS is a 0 to 5 score, with score 5 as the worst rigidity possible) | 0-24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Stroke Spasticity in early vs late treatment | Comparison of the Modified Ashworth Scale (MAS) at the elbow and wrist (MAS is a 0 to 5 score, with score 5 as the worst rigidity possible) in early versus late treatment | 3-24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botulinum neurotoxin type A (BoNT-A), Stroke, Rehabilitation, Post-Stroke Spasticity (PSS)