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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early BoNT treatment | Patients with PSS treated with BoNT within the first Quartile of injection timing distribution |
| |
| Late BoNT treatment | Patients with PSS treated with BoNT within the third Quartile of injection timing distribution |
| |
| Not treated with BoNT | Natural controls with PSS not treated with BoNT |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Drug | Botulinum neurotoxin (BoNT) Type A injection with either OnaBoNT-A, AboBoNT-A, IncoBoNT-A |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Upper limb functionality | Comparison of functional items of upper limb functionality (arm activity measure scale, i.e. ARM-A a 0-84 scale - a higher score means a worse upper limb function) of early versus late treatments | 3-24 months |
| Quality of Life measurement |
Inclusion Criteria:
Exclusion Criteria:
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Patients suffering for ischemic stroke with upper limb involvement treated at the Lazio region (Italy) stroke units.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Massimo Marano, MD | Contact | +3906225411220 | m.marano@policlinicocampus.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASL RM 1 San Filippo Neri Hospital | Rome | Lazio | 00100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33551975 | Background | 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. | |
| 32184753 | Background | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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Comparison of Quality of Life (EuroQoL-5D or EQ-5D scale , 5 to 25 scale where 25 is the worst quality of life possible) of patients with early versus late treatments |
| 3-24 months |
| Pain measurement | Comparison of pain (Visual Analogue scale or VAS in units on a 0-10 grading system, where 10 is the worst pain possible) of patients with early versus late treatments | 3-24 months |
| Spasticity in Botulinum Toxin (BoNT) treated versus untreated patients | Comparison of modified ashworth scale (MAS) in BoNT treated versus untreated subjects (MAS is a 0 to 5 score, where 5 is the worst rigidity possible). Herein an aggregated wrist and elbow score (on a 0 - 10 scale with 10 being the worst spasticity) will be used. | 3-24 months |
| Functionality in Botulinum Toxin treated versus untreated patients | Comparison of functionality (arm activity measure, i.e. ARM-A total score, a 0 to 84 scoring system - higher score means a worse upper limb function) in BoNT treated versus untreated subjects | 3-24 months |
| Quality of life in Botulinum Toxin treated versus untreated patients | Comparison of Quality of life (EuroQoL-5D or EQ-5D scale is a 5 to 25 scale where 25 is the lower quality of life possible) in BoNT treated versus untreated patients | 3-24 months |
| Pain in Botulinum Toxin treated versus untreated patients | Comparison of pain (visual analogue scale, VAS, 0-10 scale where 10 is the worst pain possible) in BoNT treated versus untreated patients | 3-24 months |
| Sapienza University of Rome - Stroke Unit | Rome | Lazio | 00100 | Italy |
|
| Sapienza University of Rome | Rome | Lazio | 00100 | Italy |
|
| Fondazione Policlinico Universitario Campus Bio-Medico | Rome | Lazio | 00128 | Italy |
|
| 34073918 | Background | 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. |
| 26276377 | Background | 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. |
| 38950995 | Derived | Marano M, Suppa A, Palmieri MG, Cecconi E, Frisullo G, Bovenzi R, Riso V, Anzini A, Brienza M, Anticoli S, Crupi D, Giovannelli M, Massimiani A, Rinalduzzi S, Morena E, Massara MC, Cupini L, Bressi F, Pilato F, Maggi L, Sauchelli D, Iezzi E, Centonze D, Aprile I, Di Lazzaro V, Toni D, Altavista MC; COLOSSEO study group. 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. BMJ Open. 2024 Jul 1;14(6):e085484. doi: 10.1136/bmjopen-2024-085484. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |