- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01723046
Therapeutic Effects of a New Upper Limb Robot Assisted Therapy Device for Persons After Stroke (ARTHE)
Active Smart Wearable Orthosis Using Painted EMG Electrodes for Home Based Therapy With Augmentative Feedback
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The number of physically weak individuals is increasing, resulting in a higher burden on health care and health care workers. The use of robot assisted therapy (RAT) might partly solve this problem. Rehabilitation progress highly depends on training intensity and training duration, favouring the use of RAT.
In this pilot study, the clinical effects of using a new upper arm RAT device for upper arm rehabilitation in patients with stroke is investigated. Myo-electrical signals will serve as input for the device, assisting the user in flexion and extension of the elbow. The device is coupled to a virtual environments, creating a stimulating therapy environment.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Lore Van de Perre, MSc
- Número de teléfono: +32 14 56 23 10
- Correo electrónico: lore.van.de.perre@khk.be
Ubicaciones de estudio
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Antwepen
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Geel, Antwepen, Bélgica, 2440
- Thomas More Kempen
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Contacto:
- Lore Van de Perre, MSc
- Número de teléfono: +32 14 56 23 10
- Correo electrónico: lore.van.de.perre@khk.be
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Contacto:
- Peter Karsmakers, PhD
- Número de teléfono: +32 14 56 23 10
- Correo electrónico: peter.karsmakers@khk.be
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Investigador principal:
- Lore Van de Perre, MSc
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Sub-Investigador:
- Roy Sevit, MSc
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Sub-Investigador:
- Koen Janssens, MSc
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Sub-Investigador:
- Peter Karsmakers, PhD
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Sub-Investigador:
- Louis Peeraer, Prof.PhD
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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:
- Patients with stroke, more than three months post onset
- No or moderate spasticity in the upper limb (maximum score of 3 on Modified Ashworth Scale)
- Observable voluntary muscle activity in biceps and triceps muscle of the affected upper limb (minimal score of 1 on the Medical research council score)
- Able to sit on a chair with adequate trunk stability
- Able to follow verbal instructions
- Able to communicate verbal information to the researchers
Exclusion Criteria:
- Patients who are medically unstable
- Cognitive disorders impeding the intervention
- Visual disorders impeding the intervention
- Subluxation of the shoulder joint
- Pusher syndrome
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Training with the device
Training with new upper limb robot assisted therapy device
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During 8 weeks, 3 times a week, 1 hour therapy sessions with the device
Otros nombres:
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Sin intervención: Control group
The control group is treated with conventional therapy.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Fugl-Meyer test upper limb section
Periodo de tiempo: Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks
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Stroke specific, performance based impairment index.
Applied to determine disease severity and describe motor recovery.
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Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks
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Medical research council score
Periodo de tiempo: Change from baseline Medical research council score at 8 weeks and 12 weeks
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Muscle strength assessment
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Change from baseline Medical research council score at 8 weeks and 12 weeks
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Active range of motion of the elbow joint
Periodo de tiempo: Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks
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The maximum range of motion to flexion and extension of the elbow joint that the person can achieve independently
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Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks
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Passive range of motion of the elbow joint
Periodo de tiempo: Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks
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The maximum range of motion to flexion and extension of the elbow joint of the test person that can be achieved by the assessor.
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Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks
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Modified Ashworth Scale
Periodo de tiempo: Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks
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Spasticity measurement
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Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
ABILHAND questionnaire
Periodo de tiempo: Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks
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Questionnaire-based assessment of manual ability
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Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks
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Functional independence measure
Periodo de tiempo: Change from baseline Functional independence measure score at 8 weeks and 12 weeks
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Assessment of physical and cognitive disability, focusing on the burden of care.
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Change from baseline Functional independence measure score at 8 weeks and 12 weeks
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Stroke impact scale
Periodo de tiempo: Change from baseline Stroke impact scale score at 8 weeks and 12 weeks
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Questionnaire evaluating how stroke has impacted the person's health and life.
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Change from baseline Stroke impact scale score at 8 weeks and 12 weeks
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Intrinsic motivation inventory
Periodo de tiempo: Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks
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Multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments.
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Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lore Van de Perre, MSc, Thomas More Kempen
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IWT120278
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