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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07803276
Comparison Between Palpatory and Ultrasound-guided Methods for Botulinum Toxin Administration in Spastic Paraplegia
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Bruna de Oliveira, MD
- Número de teléfono: 5521999200801
- Correo electrónico: b_andrade@id.uff.br
Ubicaciones de estudio
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Rio de Janeiro
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Rio de Janeiro, Rio de Janeiro, Brasil, 22290-140
- Reclutamiento
- Instituto de Neurologia Deolindo Couto
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Contacto:
- Bruna de Oliveira
- Número de teléfono: 5521999200801
- Correo electrónico: b_andrade@id.uff.br
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria
- Age over 18 years
- Clinical diagnosis of spastic paraplegia
- Spasticity with Ashworth Scale score between 2 and 3 in at least one muscle group with indication for botulinum toxin treatment
- Muscle strength ≥ 3 on the Muscle Strength Assessment Scale
- Enrollment in a rehabilitation program
- For women of childbearing potential, a negative beta-hCG test at the time of injection
Exclusion Criteria
- Concomitant neuromuscular disorders
- History of hypersensitivity to botulinum toxin
- Active infection at the injection site
- Ashworth Scale score of 4
- Pregnancy or breastfeeding
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Spastic Paraplegia Cohort (Anatomical Toxin Injection followed by USG-Guided Injection)
Participants with spastic paraplegia receive two sequential treatments separated by a 16-week washout period: First intervention: AbobotulinumtoxinA injection using the conventional anatomical/palpation technique. Washout period: 16 weeks. Second intervention: AbobotulinumtoxinA injection using the ultrasound-guided technique |
Administration of AbobotulinumtoxinA (500U) into spastic lower limb target muscles under real-time ultrasound guidance to ensure precise muscle localization.
Performed 16 weeks after the first intervention.
Assessments are performed pre-injection and 4 weeks post-injection
Administration of AbobotulinumtoxinA (500U) into spastic lower limb target muscles using standard anatomical landmarks and manual palpation.
Assessments are performed at baseline and 4 weeks post-injection.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in spasticity after BoNT-A injection techniques
Periodo de tiempo: Baseline and 4 weeks after each injection session
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Change in spasticity measured by the Modified Ashworth Scale (MAS), comparing conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections in patients with spastic paraplegia.
The Modified Ashworth Scale ranges from 0 to 4, with higher scores indicating greater muscle tone/spasticity (worse outcome)
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Baseline and 4 weeks after each injection session
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Functional improvement assessed by Goal Attainment Scaling
Periodo de tiempo: Baseline and 4 weeks after each intervention
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Functional improvement assessed by Goal Attainment Scaling (GAS) after conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections. The Goal Attainment Scaling score ranges from -2 to +2, with higher scores indicating greater achievement of the predefined treatment goals (better outcome) |
Baseline and 4 weeks after each intervention
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Functional mobility assessed by the Timed Up and Go Test
Periodo de tiempo: Baseline and 4 weeks after each intervention
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Change in functional mobility measured by the Timed Up and Go (TUG) Test, comparing conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections. The Timed Up and Go Test is measured in seconds, with lower times indicating better functional mobility (better outcome) |
Baseline and 4 weeks after each intervention
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Change in functional independence assessed by the Modified Barthel Index
Periodo de tiempo: Baseline and 4 weeks after each intervention
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Change in functional independence measured by the Modified Barthel Index, comparing conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections. The Modified Barthel Index ranges from 0 to 100, with higher scores indicating greater functional independence (better outcome). |
Baseline and 4 weeks after each intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain intensity after BoNT-A injection techniques
Periodo de tiempo: Baseline and 4 weeks after each intervention
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Change in pain intensity measured by the Visual Analog Scale (VAS).
The Visual Analog Scale ranges from 0 to 10, with higher scores indicating greater pain intensity (worse outcome)
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Baseline and 4 weeks after each intervention
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Quality of life after BoNT-A injection techniques
Periodo de tiempo: Baseline and 4 weeks after each intervention
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Change in quality of life assessed by the 36-Item Short Form Health Survey (SF-36). The SF-36 assesses eight health domains, with scores ranging from 0 to 100 for each domain. Higher scores indicate better health status (better outcome) |
Baseline and 4 weeks after each intervention
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Adverse events related to BoNT-A injection techniques
Periodo de tiempo: Up to 16 weeks after each injection
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Incidence and severity of adverse events associated with conventional landmark-guided and ultrasound-guided botulinum toxin type A injections
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Up to 16 weeks after each injection
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 90758725.3.0000.5243
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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