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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02096445
Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke
9 de junio de 2017 actualizado por: Roger Gassert
The aim of this project is to clinically evaluate a novel robot-assisted therapeutic approach to train sensorimotor hand function after stroke.
It combines the profound experience of the clinic Hildebrand in neurocognitive therapy - involving brain and mind in the task and training both the motor and the sensory system - with the advanced haptic robotic technology of the Rehabilitation Engineering Lab at the Swiss Federal Institute of Technology Zurich (ETH Zurich), allowing unmet interaction with the hand through the simulation of virtual objects with various mechanical properties.
In a randomized controlled clinical trial, 10 sub-acute stroke patients will receive four weeks of robotic therapy sessions, integrated seamlessly into their daily rehabilitation program, while 10 other patients will receive conventional therapy.
The investigators will assess baseline performance in an initial clinical and robotic assessment, with another assessment at the end of the four-week period, and in follow-ups four weeks and six months later.
The contents of the patient-tailored robotic therapy sessions will match those of the conventional therapy as closely as possible.
This study will demonstrate the feasibility of including robotic therapy of hand function into the daily rehabilitation program, and investigate the acceptance from patients and therapists.
The investigators expect increased training intensity during the robotic therapy session compared to conventional sessions with similar contents, as well as novel insights into the recovery process of both the motor and the sensory system during the four weeks of therapy, through advanced robotic assessments integrated into the training sessions.
This project is a first step towards making such robotic therapy available to patients as integration into the conventional individual therapy program (e.g. for self-training), and towards transferring this technology to the home environment.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
34
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Ticino
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Brissago, Ticino, Suiza, 6614
- Clinica Hildebrand Centro di riabilitazione Brissago
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 90 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- age between 18-90 years old
- hemisyndrome (central paralysis of the upper extremity, and all degrees of weakness: M0 - M5 on the paresis scale) as a result of a first stroke
- sub-acute lesion not more than 6 weeks post ictus
Exclusion Criteria:
- insufficient state of consciousness
- severe aphasia
- severe cognitive deficits
- severe pathologies of the upper extremity of traumatic or rheumatic nature
- severe pain in the affected arm
- Patients with pacemakers and other active implants
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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 |
|---|---|
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Experimental: Robot group
Receive robot-assisted neurocognitive therapy instead of conventional neurocognitive therapy. (4 x 45 min/week) |
2 degrees-of-freedom hand rehabilitation robot to train fine motor skills during grasping and forearm rotation.
Otros nombres:
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Comparador activo: Control group
Receive dose-matched conventional neurocognitive therapy
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Use sensory perception (tactile, proprioception but not vision!) to solve a by the therapist guided (passive) or patient controlled (active) therapy task, e.g.
discrimination/identification of different spring resistances, sponges, different sized blocks, etc.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Motor impairment of the upper limb
Periodo de tiempo: Change from Baseline in motor impairment of the upper limb at 4 weeks
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Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points)
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Change from Baseline in motor impairment of the upper limb at 4 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Motor impairment of the upper limb
Periodo de tiempo: Change from Baseline in motor impairment of the upper limb at 8 weeks
|
Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points)
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Change from Baseline in motor impairment of the upper limb at 8 weeks
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Motor impairment of the upper limb
Periodo de tiempo: Change from Baseline in motor impairment of the upper limb at 6 months
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Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points)
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Change from Baseline in motor impairment of the upper limb at 6 months
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Functional improvement in dexterity
Periodo de tiempo: Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks
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Functional improvement in dexterity is assessed with the Box and Block Test
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Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks
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Functional improvement in dexterity
Periodo de tiempo: Change from Baseline in functional improvement of dexterity of the upper limb at 8 weeks
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Functional improvement in dexterity is assessed with the Box and Block Test
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Change from Baseline in functional improvement of dexterity of the upper limb at 8 weeks
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Functional improvement in dexterity
Periodo de tiempo: Change from Baseline in functional improvement of dexterity of the upper limb at 6 months
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Functional improvement in dexterity is assessed with the Box and Block Test
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Change from Baseline in functional improvement of dexterity of the upper limb at 6 months
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Spasticity level of the upper limb
Periodo de tiempo: Change from Baseline in spasticity level of the upper limb at 4 weeks
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Spasticity level is measured with the Modified Ashworth Scale
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Change from Baseline in spasticity level of the upper limb at 4 weeks
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Spasticity level of the upper limb
Periodo de tiempo: Change from Baseline in spasticity level of the upper limb at 8 weeks
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Spasticity level is measured with the Modified Ashworth Scale
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Change from Baseline in spasticity level of the upper limb at 8 weeks
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Spasticity level of the upper limb
Periodo de tiempo: Change from Baseline in spasticity level of the upper limb at 6 months
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Spasticity level is measured with the Modified Ashworth Scale
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Change from Baseline in spasticity level of the upper limb at 6 months
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Tactile and proprioceptive sensory function of the upper limb
Periodo de tiempo: Change from Baseline in Tactile and proprioceptive sensory function of the upper limb at 4 weeks
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Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC (Medical Center) Nottingham Sensory Assessment
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Change from Baseline in Tactile and proprioceptive sensory function of the upper limb at 4 weeks
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Tactile and proprioceptive sensory function of the upper limb
Periodo de tiempo: Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 8 weeks
|
Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment
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Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 8 weeks
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Tactile and proprioceptive sensory function of the upper limb
Periodo de tiempo: Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 6 months
|
Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment
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Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 6 months
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Neglect
Periodo de tiempo: Change from Baseline in neglect at 4 weeks
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Neglect is assessed with the Albert's test of neglect
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Change from Baseline in neglect at 4 weeks
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Neglect
Periodo de tiempo: Change from Baseline in neglect at 8 weeks
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Neglect is assessed with the Albert's test of neglect
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Change from Baseline in neglect at 8 weeks
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Neglect
Periodo de tiempo: Change from Baseline in neglect at 6 months
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Neglect is assessed with the Albert's test of neglect
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Change from Baseline in neglect at 6 months
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Cognitive impairment
Periodo de tiempo: Change from Baseline in cognitive impairment at 4 weeks
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Cognitive impairment is assessed with the Mini Mental State Examination
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Change from Baseline in cognitive impairment at 4 weeks
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Cognitive impairment
Periodo de tiempo: Change from Baseline in cognitive impairment at 8 weeks
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Cognitive impairment is assessed with the Mini Mental State Examination
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Change from Baseline in cognitive impairment at 8 weeks
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Cognitive impairment
Periodo de tiempo: Change from Baseline in cognitive impairment at 6 months
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Cognitive impairment is assessed with the Mini Mental State Examination
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Change from Baseline in cognitive impairment at 6 months
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Frontal lobe function
Periodo de tiempo: Change from Baseline in frontal lobe function at 4 weeks
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Frontal lobe function is assessed with the Frontal assessment battery
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Change from Baseline in frontal lobe function at 4 weeks
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Frontal lobe function
Periodo de tiempo: Change from Baseline in frontal lobe function at 8 weeks
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Frontal lobe function is assessed with the Frontal assessment battery
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Change from Baseline in frontal lobe function at 8 weeks
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Frontal lobe function
Periodo de tiempo: Change from Baseline in frontal lobe function at 6 months
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Frontal lobe function is assessed with the Frontal assessment battery
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Change from Baseline in frontal lobe function at 6 months
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Aphasia
Periodo de tiempo: Change from Baseline in aphasia at 4 weeks
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Aphasia is assessed with the Aachener Aphasia Test
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Change from Baseline in aphasia at 4 weeks
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Aphasia
Periodo de tiempo: Change from Baseline in aphasia at 8 weeks
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Aphasia is assessed with the Aachener Aphasia Test
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Change from Baseline in aphasia at 8 weeks
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Aphasia
Periodo de tiempo: Change from Baseline in aphasia at 6 months
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Aphasia is assessed with the Aachener Aphasia Test
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Change from Baseline in aphasia at 6 months
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Attention
Periodo de tiempo: Change from Baseline in attention at 4 weeks
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Attention is assessed with the test to identify attention
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Change from Baseline in attention at 4 weeks
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Attention
Periodo de tiempo: Change from Baseline in attention at 8 weeks
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Attention is assessed with the test to identify attention
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Change from Baseline in attention at 8 weeks
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Attention
Periodo de tiempo: Change from Baseline in attention at 6 months
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Attention is assessed with the test to identify attention
|
Change from Baseline in attention at 6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Roger Gassert, Prof. Dr., Rehabilitation Engineering Lab, ETH Zurich
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Metzger JC, Lambercy O, Califfi A, Conti FM, Gassert R. Neurocognitive robot-assisted therapy of hand function. IEEE Trans Haptics. 2014 Apr-Jun;7(2):140-9. doi: 10.1109/TOH.2013.72.
- Ranzani R, Lambercy O, Metzger JC, Califfi A, Regazzi S, Dinacci D, Petrillo C, Rossi P, Conti FM, Gassert R. Neurocognitive robot-assisted rehabilitation of hand function: a randomized control trial on motor recovery in subacute stroke. J Neuroeng Rehabil. 2020 Aug 24;17(1):115. doi: 10.1186/s12984-020-00746-7.
- Metzger JC, Lambercy O, Califfi A, Dinacci D, Petrillo C, Rossi P, Conti FM, Gassert R. Assessment-driven selection and adaptation of exercise difficulty in robot-assisted therapy: a pilot study with a hand rehabilitation robot. J Neuroeng Rehabil. 2014 Nov 15;11:154. doi: 10.1186/1743-0003-11-154.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de abril de 2013
Finalización primaria (Actual)
10 de marzo de 2017
Finalización del estudio (Actual)
9 de junio de 2017
Fechas de registro del estudio
Enviado por primera vez
19 de marzo de 2014
Primero enviado que cumplió con los criterios de control de calidad
21 de marzo de 2014
Publicado por primera vez (Estimar)
26 de marzo de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de junio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
9 de junio de 2017
Última verificación
1 de junio de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CIV-13-02-009921
- 2013-MD-0002 (Otro identificador: Swissmedic)
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. .