- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04542772
Educación sobre la terapia del espejo para pacientes con accidente cerebrovascular agudo
Eficacia de la educación del paciente sobre la terapia con espejos para mejorar la función de las extremidades superiores en pacientes con accidente cerebrovascular agudo
In Canada, the number of stroke survivors is equivalent to the size of one of the four Atlantic Provinces. The incident rate of stroke has been increasing steadily since 1995. The majority of the stroke survivors lose upper extremity function, resulting in diminished activities of daily living (ADL). Many therapeutic interventions are recommended to improve upper extremity function or ADLs of stroke survivors, however, Mirror Therapy (MT), inexpensive intervention, can be self-administered by stroke survivors with intact cognition. Thus, the research question is whether a self-administered MT technique improves acute stroke patients' upper extremity motor function and recovery?
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Greater Sudbury, Ontario, Canadá, P3E 5J1
- Health Sciences North
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Admitted with diagnosis of stroke with onset within two weeks
- Medically stable
- Able to follow directions
- No severe cognitive impairments that could interfere with patient participation
- Consent to treatment by patient
- Alpha-Functional Independence Measure (Alpha-FIM) score of > 40
Exclusion Criteria:
- Medical instability
- Lack of motivation
- Recurrent/ chronic stroke
- Recent upper extremity musculoskeletal injuries with movement restrictions
- Receptive or global aphasia
- Delirium
- Unilateral neglect
- Visual field deficiency.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Mirror Therapy + Standard of Care
Participants in this group will receive standard of care based on their needs along with mirror therapy education. |
Participants will receive the standard-of-care; multidisciplinary rehabilitation intervention based on their needs and tolerance, and will receive an additional 30 min of Mirror Therapy education. During Mirror Therapy education, the patients will be educated or shown how to perform MT and the patients will complete the recommended exercises on their own for 30 minutes/day for 5 days a week/ for 4 weeks. Standard Mirror Therapy Protocol will be followed. Participants will receive the standard-of-care, multidisciplinary rehabilitation intervention based on their needs and tolerance. |
|
Comparador activo: Standard of Care
Participants in this group will receive only standard of care based on their needs. |
Participants will receive the standard-of-care, multidisciplinary rehabilitation intervention based on their needs and tolerance. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fugl-Meyer Assessment scale
Periodo de tiempo: Assessment will be completed at 2 points: Pre-test assessment will be done within 48 hours of stroke admission and post-test assessment will be done at 4 weeks.
|
Scores of < 31 corresponded with 'no to poor' upper extremity capacity, 32 to 47 represented 'limited capacity', 48 to 52 represented 'notable capacity' and 53 to 66 represented 'full' upper extremity capacity. |
Assessment will be completed at 2 points: Pre-test assessment will be done within 48 hours of stroke admission and post-test assessment will be done at 4 weeks.
|
|
Wolf Motor Function Test
Periodo de tiempo: : Assessment will be completed at 2 points: Pre-test assessment will be done within 48 hours of stroke admission and post-test assessment will be done at 4 weeks
|
Assess upper extremity function; maximum Score is 75; lower scores are indicative of lower functional levels. |
: Assessment will be completed at 2 points: Pre-test assessment will be done within 48 hours of stroke admission and post-test assessment will be done at 4 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Modified Barthel Index
Periodo de tiempo: : Assessment will be completed at 2 points: Pre-test assessment will be done within 48 hours of stroke admission and post-test assessment will be done at 4 weeks
|
Assess Activity of Daily Living, Scores of <15 usually represents moderate disability and <10 usually represents severe disability. |
: Assessment will be completed at 2 points: Pre-test assessment will be done within 48 hours of stroke admission and post-test assessment will be done at 4 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- C-20-15
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .