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The objective of this study is to demonstrate the effect of intramuscular BoNT-A injections in relieving pain, in a broad population of patients who suffer pain as the primary problem associated with spasticity. Thus, this study will help to expand the information that is available regarding the impact of BoNT-A treatment in routine clinical practice conditions.
Treatment goals can vary greatly from one patient to another and there is no unique, single outcome that reflects the treatment benefits in all the cases. Therefore, this study with special focus on the achievement of therapeutic goals, will allow the identification of each patient's specific goals regarding the improvement of the functional outcomes, the quality of life and patient well-being.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-stroke lower limb spasticity patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Biological | This is an observational study designed to reflect the clinical practice in real life as closely as possible. Botulinum Toxin Type A (BoNT-A) injection administered according to the local Summary of Product Characteristics (SmPC) and the locally agreed treatment guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain relief on Numeric Rating Scale | Pain relief evaluated by Numeric Rating Scale (NRS). The NRS score for patient self-reporting of pain ranging from 0 (no pain) to 10 (the most severe pain). | Baseline visit and every 4 months up to 16 months (Visit 5). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain relief on Visual Assessment Scale | Pain relief evaluated by measuring changes in Visual Assessment Scale (VAS). The VAS used a 100 mm line in which values were reported, 0 (no pain) to 10 (the most severe pain). | Baseline visit and every 4 months up to 16 months (Visit 5). |
| Responder rate using goal Attainment Scale |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with post-stroke lower limb spasticity in Rehabilitation and Neurology Units of hospitals.
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Marítimo Oza | A Coruña | Spain | ||||
| Hospital General de Albacete |
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Responder rate assessed on the Goal Attainment Scale (GAS). GAS is a 5-point scale, with the degree of attainment captured for each goal area. |
| Every 4 months up to 16 months (Visit 5). |
| Albacete |
| Spain |
| Hospital de Basurto | Bilbao | Spain |
| Hospital de Cruces | Bilbao | Spain |
| Hospital de Galdácano | Bilbao | Spain |
| Hospital Gorliz | Bilbao | Spain |
| Hospital Guadalajara | Guadalajara | Spain |
| Hospital Dr Negrín | Las Palmas de Gran Canaria | Spain |
| Hospital Insular | Las Palmas de Gran Canaria | Spain |
| Hospital San Pedro | Logroño | Spain |
| Fundación Jimenez Díaz | Madrid | Spain |
| Hospital 12 Octubre | Madrid | Spain |
| Hospital Alcorcón | Madrid | Spain |
| Hospital General de Móstoles | Madrid | Spain |
| Hospital Principe de Asturias de Alcalá de Henares | Madrid | Spain |
| Hospital Universitario de la Princesa | Madrid | Spain |
| Hospital Ourense | Ourense | Spain |
| Hospital Son Espases | Palma de Mallorca | Spain |
| Clinica Ubarmin | Pamplona | Spain |
| Hospital Virgen de la Vega | Salamanca | Spain |
| Hospital de Donosti | San Sebastián | Spain |
| Hospital de la Candelaria | Santa Cruz de Tenerife | Spain |
| Hospital Universitario Canarias | Santa Cruz de Tenerife | Spain |
| Hospital Virgen de la Salud | Toledo | Spain |
| Hospital Reina Sofía | Tudela | Spain |
| Hospital Clinico Valladolid | Valladolid | Spain |
| Hospital Xeral de Vigo | Vigo | Spain |
| Hospital Universitario de Alaba | Vitoria-Gasteiz | Spain |
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C542869 | abobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| 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 |
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