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The objective of this study is to evaluate the effectiveness of BoNT-A on functional improvement in patients with post-stroke upper and/or lower limb spasticity in the early stage of spasticity development, according to routine clinical practice.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Goal Attainment Scale (GAS) score. | Baseline, 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Spasticity patterns will be defined in patients with upper and/or lower limb spasticity in the early stage after stroke | Descriptive statistics will be presented in addition to 95% confidence intervals for the mean and percentages | Baseline, 16 months |
| Change in Modified Ashworth Scale (MAS) score. |
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Inclusion Criteria:
Exclusion Criteria:
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Post-stroke spasticity
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barcelona | Spain | |||||
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| Baseline, 16 months |
| Baseline characteristics of patients | Demographic characteristics | Baseline |
| Percentage of patients reporting functional improvement evaluated by Goal Attainment Scale (GAS) score. | From baseline up to 16 months |
| Change in pain according to Visual Analog Scale (VAS). | Baseline, 16 months |
| Passive function of upper and/or lower limbs according to primary treatment target (PTT) from the disability assessment scale (DAS). | Baseline, 16 months |
| Comfortable barefoot walking speed, measured with the 10-meter walking speed test. | Baseline, 16 months |
| Change on EQ-5D quality of life questionnaire | Baseline, 16 months |
| Estimation of use of healthcare resources and costs associated with management of spasticity. | From baseline up to 16 months |
| Time interval between injections | From baseline up to 16 months |
| Cost per patient | From baseline up to 16 months |
| Bilbao |
| Spain |
| Cadiz | Spain |
| Córdoba | Spain |
| Granada | Spain |
| Huelva | Spain |
| Las Palmas de Gran Canaria | Spain |
| Lleida | Spain |
| Madrid | Spain |
| Murcia | Spain |
| Palma de Mallorca | Spain |
| Pontevedra | Spain |
| Salamanca | Spain |
| San Sebastián | Spain |
| Santiago | Spain |
| Seville | Spain |
| Valladolid | Spain |
| ID | Term |
|---|---|
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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