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The purpose of this study is to document the effectiveness of treating chronic post-stroke spastic patients with Botulinum Toxin type A.
As this is a non-interventional study, the decision to prescribe the product must be taken prior to, and independently from the decision to enrol the patient. This decision should be made in accordance with routine clinical practice at the hospital concerned. The clinical justification for prescribing any treatment should be recorded at the outset by the prescribing clinician.
This study will not interfere with the routine practice of the investigator or with the patient's treatment plan. Assessments will be done only if performed regularly in routine practice.
This study will be conducted in Brazil, wherein Marketing Authorization has been granted for the use of BoNT-A in the treatment of spasticity of the upper and lower limb in adult post-stroke patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin type A (BoNT-A) injection Naïve | Subjects naïve to BoNT-A treatment. Investigators follow their individual injection protocol for treatment with BoNT-A (modalities of administration in accordance with local Summary of Product Characteristics and locally agreed therapeutic guidelines). |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Goal Achievement Score (GAS). | 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in pain according to Verbal Numerical Scale (VNS). | Baseline and 3 months | |
| Change from baseline in Modified Ashworth Scale (MAS) score | Baseline and 3 months | |
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Inclusion Criteria:
Exclusion Criteria:
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Untreated chronic post-stroke spastic patients
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Study Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Bettina Ferro de Souza Campus IV da Universidade Federal do Pará | Belém | 66045-110 | Brazil | |||
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| ID | Term |
|---|---|
| D009128 | Muscle Spasticity |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
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| Change from baseline in functional independence according to Barthel index score |
| Baseline and 3 months |
| Change from baseline in Quality of Life according to Euro-5D-5L health questionnaire | Baseline and 3 months |
| Centro Catarinense de Reabilitação |
| Florianópolis |
| 88025-301 |
| Brazil |
| Centro de Reabilitação e Readaptação Dr. Henrique Santillo | Goiânia | 74653-230 | Brazil |
| Clinica Neurológica e Neurocirúrgica de Joinville | Joinville | 89202-165 | Brazil |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto | Ribeirão Preto | 14048-900 | Brazil |
| Hospital Universitário Clementino Fraga Filho (HUCFF) | Rio de Janeiro | 21941-913 | Brazil |
| Instituto de Reabilitação Lucy Montoro - FAMERP | São José do Rio Preto | 1591-240 | Brazil |
| Irmandade da Santa Casa de Misericórida de São Paulo | São Paulo | 01221-010 | Brazil |
| Hospital Alemão Oswaldo Cruz | São Paulo | 01323-903 | Brazil |
| Hospital São Paulo - UNIFESP | São Paulo | 04024-002 | Brazil |
| HCSP - Complexo Hospital das Clinicas Instituto de Medicina Fisica e Reabilitação | São Paulo | 05403-900 | Brazil |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |