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Spastic paraparesis is one of the most disabling functional deficits in the population with multiple sclerosis between 18 and 80 years of age and at any functional level. Infiltration with Botulinum Toxin is a clinical practice that has been carried out for years with clinical evidence of improvement in the patient's walking patterns and quality of life. We assume that the infiltration of this product can generate a direct benefit in the walking ability of these patients and secondarily improve their quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with spastic lower limb paresis | Experimental | patients with spastic lower limb paresis secondary to Multiple Sclerosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A infiltrations | Drug | Echo-guided infiltration of botulinum toxin type A (Dysport®) in the lower limbs according to normal service practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of repeated Botulinum Toxin infiltrations using objective results obtained by the clinician (Six Minutes Walking Test - 6MWT). | To assess the effectiveness of repeated Botulinum Toxin infiltrations on gait in patients with Multiple Sclerosis who presented limb spasticity less than 4 weeks after infiltration and its maintenance over time at 12 months, using objective results obtained by the clinician (Six Minutes Walking Test - 6MWT). Higher scores mean a better outcome. | 12 months |
| Effectiveness of repeated Botulinum Toxin infiltrations using results reported by the patient (Twelve item Multiple Sclerosis Walking Scale - MSWS-12). | To assess the effectiveness of repeated Botulinum Toxin infiltrations on gait in patients with Multiple Sclerosis who presented limb spasticity less than 4 weeks after infiltration and its maintenance over time at 12 months, using results reported by the patient (Twelve item Multiple Sclerosis Walking Scale - MSWS-12). Higher scores mean a worse outcome. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of spasticity using Modified Ashworth Spasticity scale (MAS scale). | Evaluation of spasticity using Modified Ashworth Spasticity scale (MAS scale). Higher scores mean a worse outcome. | 12 months |
| Evaluation of disability using Expanded Disability Status Scale de Kurtzke (EDSS scale). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Puerta de Hierro | Majadahonda | Madrid | 28220 | Spain | ||
| Hospital Universitario de la Princesa |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Evaluation of disability using Expanded Disability Status Scale de Kurtzke (EDSS scale). Higher scores mean a worse outcome. |
| 12 months |
| Evaluation of the quality of life after the use of botulinum toxin type A using Multiple Sclerosis Quality of Life 54 (MSQoL-54). | Evaluation of the quality of life after the use of botulinum toxin type A using Multiple Sclerosis Quality of Life 54 (MSQoL-54). Higher scores mean a better outcome. | 12 months |
| Assessment of medium and long-term objectives using Goal Attainment Scaling (GAS scale). | Assessment of medium and long-term objectives using Goal Attainment Scaling (GAS scale). Higher scores mean a better outcome. | 12 months |
| Number of adverse events. | Number of adverse events. | 12 months |
| Madrid |
| 28006 |
| Spain |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |