- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00983450
The Influences of Watching a Movie Clip of Normal Walking on Measurable Walking Parameters Among Post-Brain-Stroke Patients as Opposed to the Influences of a Control Movie Clip Showing Backwards Walking
The Influences of Watching a Movie Clip of Normal Walking on Measurable Walking Parameters Among Post-brain-stroke Patients as Opposed to the Influences of a Control Movie Clip Showing Backwards Walking
The study will include 20 subjects who will be randomly divided to two groups: a ten person group being the study group and a ten person group acting as a control group (each group will include a similar number of females and males as the other group). In addition, the physiotherapy treatments at the rehabilitation center, the study group will gain an intervention consisting of 12 therapy sessions, administered for 12 consecutive days (apart of weekends). The intervention will include 6 minutes of watching a movie clip alternately showing a healthy man and a healthy woman at their sixties, walking while being filmed from various angles. Immediately after watching, the subject will perform 6 minutes of walking, under the experimenters supervision, but without his or hers intervention. Immediately following the walking, the whole procedure will be repeated (watching a clip and walking).
The control group will undergo 12 treatments of the same nature, but will watch the movie clip shown backwards, so that the people filmed will seem to walk backwards (it was established that watching a reversed action does not activate the MNS system activated by a regular execution of the activity [Celnik et al., 2008]), followed by 6 minutes of walking under the experimenters supervision, then watching the movie again and walking again.
The person performing the examinations will be blinded as to the division of the subjects to the study group and the control group. After performing the previously noted examinations needed to participate in the research, the subjects found fit will be examined before the beginning of the intervention, at its end and then three months after its conclusion. The examinations will include smart step and walking parameters.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Jerusalem, Israel
- Hadassah University Hospital
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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:
- People after a first ischemic or hemorrhagic stroke, up to 60 days following the event.
- A FAC (Functional Ambulation Category) score test result of 2 or 3, in order to ensure basic mobility, even if still requiring supervision.
- A NIHSS (National Institutes of Health Stroke Scale) score of 3 to 18.
Patients suffering from the following will not be part of the study:
- Significant neglect (a BIT score under 129 in the conventional tests).
- Hemianopsy as determined upon a clinical examination by a rehabilitation physician.
- Clarity of vision problem, determined upon an SC based examination.
- Significant cognitive decline (a Mini mental test score of under 24).
- Aphasia which prevents understanding the signing a Helsinki form.
Exclusion Criteria:
- Patients participating in concurrent researches will not participate
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: study group
People after a first ischemic or hemorrhagic stroke, up to 60 days following the event.
|
the study group will gain an intervention consisting of 12 therapy sessions, administered for 12 consecutive days (apart of weekends).
The intervention will include 6 minutes of watching a movie clip alternately showing a healthy man and a healthy woman at their sixties, walking while being filmed from various angles.
Immediately after watching, the subject will perform 6 minutes of walking, under the experimenters supervision, but without his or hers intervention.
Immediately following the walking, the whole procedure will be repeated (watching a clip and walking).
|
Experimental: CONTROL
People after a first ischemic or hemorrhagic stroke, up to 60 days following the event.
|
The control group will undergo 12 treatments of the same nature, but will watch the movie clip shown backwards, so that the people filmed will seem to walk backwards (it was established that watching a reversed action does not activate the MNS system activated by a regular execution of the activity [Celnik et al., 2008]), followed by 6 minutes of walking under the experimenters supervision, then watching the movie again and walking again.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Smart step examination- Average weight on the hind foot and fore foot. Cycle - time (in seconds) from one initial contact to the other (on the same foot). Stance and swing average percentage of one walking cycle, Cadence
Periodo de tiempo: before the beginning of the intervention, at its end and then three months after its conclusion.
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before the beginning of the intervention, at its end and then three months after its conclusion.
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
2. Two min. walking test. 3. Ten meter walking test. 4. An ABC questioner to determine the personal confidence in regards to walking.
Periodo de tiempo: before the beginning of the intervention, at its end and then three months after its conclusion.
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before the beginning of the intervention, at its end and then three months after its conclusion.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Zeev meiner, M.D, Hadassah Medical Organization
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Carrera
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Hormonas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Hormona adrenocorticotrópica
- Hormonas estimulantes de melanocitos
- beta-endorfina
Otros números de identificación del estudio
- 0303-09-HMO
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