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The purpose of the protocol is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one botulinum toxin type-A (BoNT-A) injection cycle in accordance with routine practices.
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| Measure | Description | Time Frame |
|---|---|---|
| Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS). | Assessed using the Goal Attainment Scale (GAS). | Between 1 and 3 months from inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Overall attainment of treatment goals | Assessed using the GAS T-Score. | Between 1 and 3 months from inclusion |
| The use of standardized outcome measures and their results (e.g. muscle tone reduction, pain scores, functional tests). |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Maritimo de Oza | A Coruña | Spain | ||||
| Hospital de Cruces |
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| ID | Term |
|---|---|
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
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| Up to 5 months |
| Description of injection practices (BoNT-A: doses, volume, injection points, electromyography, electrostimulation and ecography). | Up to 5 months |
| Global assessment of benefits by both the investigator and the subject (or guardian). | Assessed using a 5-point scale - much worse/worse/unchanged/better/much better | Up to 5 months |
| Barakaldo |
| Spain |
| Hospital Clinic i Provincial de Barcelona | Barcelona | Spain |
| Hospital de Bellvitge | Barcelona | Spain |
| Hospital Mutua de Terrassa | Barcelona | Spain |
| Hospital Sant Pau | Barcelona | Spain |
| Hospital Vall Hebron | Barcelona | Spain |
| Hospital Puerta del Mar | Cadiz | Spain |
| Hospital de Magdalena | Castellon | Spain |
| Hospital de Gorliz | Gorraiz | Spain |
| Hospital Dr. Negrín | Las Palmas de Gran Canaria | Spain |
| Hospital Insular | Las Palmas de Gran Canaria | Spain |
| Hospital De la Fundación Jimenez | Madrid | Spain |
| Hospital la Paz | Madrid | Spain |
| Hospital La Princesa | Madrid | Spain |
| Hospital Carlos Haya | Málaga | Spain |
| Hospital Virgen de la Victoria | Málaga | Spain |
| Hospital Morales Meseguer | Murcia | Spain |
| Hospital Ntra. Sra. De La Candelaria | Santa Cruz de Tenerife | Spain |
| Hospital de Valdecilla | Santander | Spain |
| Hospital La Fe | Valencia | Spain |
| Hospital Valencia al Mar | Valencia | Spain |
| Hospital Povisa | Vigo | Spain |
| Hospital Xeral de Vigo | Vigo | Spain |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |