ExoDoF: exoesqueleto robótico para la rehabilitación motora de las extremidades superiores después de un accidente cerebrovascular
Two decades ago, the projection of recovery of the upper extremity (UE) after a stroke had a very poor prognosis worldwide. Nowadays, thanks to medical advances and early rehabilitation, the prognosis for recovery has improved; however, there is still a limit that no therapy has been able to overcome, related to spontaneous recovery as part of the natural evolution of the pathophysiological process, rather than with the contribution of rehabilitation. Additionally, existing therapies show partial effectiveness on the recovery of UE function, but do not avoid the use of compensatory strategies or alternatives to normal movement. Given this situation, there is an active search for new therapeutic approaches. In this clinical trial the investigators propose a rehabilitation paradigm that promotes the recovery of control of specific planes of movement through the selective restriction of degrees of freedom, simplifying control demands. The investigators sought to test the hypothesis that people with stroke in the early subacute stage and who present alterations in the movement of the upper extremity, a rehabilitation protocol that reduces the degrees of freedom of the UE and trunk, enables greater recovery of the movement of the UE and less use of compensatory movements compared to a protocol without DoF control. The general objective is to demonstrate the effect of training with restriction of the degrees of freedom of UE and trunk, mediated by an exoskeleton and videogames, on the control of the UE.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Pablo Burgos, PhD
- Número de teléfono: 19713314101
- Correo electrónico: pburgos@uchile.cl
Copia de seguridad de contactos de estudio
- Nombre: Juan José Mariman, PhD
- Número de teléfono: +56981928168
- Correo electrónico: juan.mariman@umce.cl
Ubicaciones de estudio
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Santiago, Chile
- Reclutamiento
- Hospital El Carmen
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Contacto:
- Daniel Bustos, PT
- Número de teléfono: +56 9 7754 9193
- Correo electrónico: daniel.bustos.c@usach.cl
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Santiago, Chile
- Reclutamiento
- Hospital Clínico Universidad de Chile
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Contacto:
- Hachi Manzur, Ph.D
- Número de teléfono: +56 9 8192 8168
- Correo electrónico: hemanzur@gmail.com
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Santiago, Chile
- Reclutamiento
- Hospital San José
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Contacto:
- Natalia Gonzalez, PT
- Número de teléfono: +56 9 8154 8009
- Correo electrónico: nataliagonzaleznunes@gmail.com
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Temuco, Chile
- Reclutamiento
- Hospital Dr. Hernán Henríquez Aravena
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Contacto:
- Pablo Hernández, PT
- Número de teléfono: +56 9 7853 9892
- Correo electrónico: klgo.pablohernandez@gmail.com
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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:
- Diagnosis of ischemic or hemorrhagic stroke with zero to twelve weeks of evolution.
- Subjects with alterations in active voluntary movement of ES with Fugl Meyer less than or equal to 50 points. Strength of shoulder abduction and finger extension from palpable contraction (1 in Medical Research Council (MRC) scale for muscle strength).
Exclusion Criteria:
- Cognitive impairment that prevents signing the informed consent, following the instructions and understanding the procedures. (MOCA < 18).
- Inability to perform activities sitting for more than 90 minutes or inability to perform activities without severe pain (VAS > 6) or having limited reach ranges.
- Have severe visual impairment that does not allow to carry out the activities associated with the task.
- Previous stroke with neurological sequelae in the upper extremity.
- Present bilateral sensorimotor alterations.
- Damage to the cerebellum/peduncles described in the radiological report or classic signs of cerebellar damage (Upper extremity SARA items of 2 or more)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: DoF Group
The experimental group with control of the degrees of freedom will receive treatment for 4 weeks using an exoskeleton and also it will be supervised by a physiotherapist.The exoskeleton will restrict the movement of the trunk and upper extremity to leave only the joint free to work in the plane of interest. The training will be selective in an articular plane with biofeedback of movement through videogames and external movement sensors installed in the upper extremity. This movement sensor will allow to interact with the videogames through the movement of the trained movement. |
Training of specific uniarticular and single plane movement of the upper limb through an exoskeleton and videogames that will be supervised by a physiotherapist. |
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Comparador activo: Task Group
The group without control of the degrees of freedom (Task Group) will receive a therapeutic intervention equivalent in dose, but without any restriction of joint movement (without the exoskeleton). Each session will be divided into two parts. In the first part, participants will train with combined planes and in a multi-joint manner with the same video games as DoF Group but with the movement sensor in your hand performing 4 direction movements with the upper limb (horizontal, vertical and diagonals). In the second training part, patients will perform functional tasks: raise and lower your hand on the table, cleaning a table, put cream on the non-paretic arm, hold a bottle, put a piece of bread or something similar in your mouth, wash your face, brush your hair, store items in a basket, brush teeth, wrote and serve water in glass. |
Training of multiarticular upper limb movements (vertical, horizontal and diagonal) through videogames and also training of functional task (raise and lower your hand on the table, cleaning a table, put cream on the non-paretic arm, hold a bottle, put a piece of bread or something similar in your mouth, wash your face, brush your hair, store items in a basket, brush teeth, wrote and serve water in glass). This activities will be supervised by a physiotherapist. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in UE-FMA at the end of the training
Periodo de tiempo: 3 days post training
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Differences between the Upper Extremity Fugl-Meyer Assessment (UE-FMA) at the beginning of the recruitment and at the end of the training |
3 days post training
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Change in UE-FMA at 6 months post stroke
Periodo de tiempo: 180 days post stroke
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Differences between the Upper Extremity Fugl-Meyer Assessment (UE-FMA) at the beginning of the recruitment and at 6 months post stroke |
180 days post stroke
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in ARAT at the end of the training
Periodo de tiempo: 3 days post training
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Differences between the Action Research Arm Test (ARAT) at the beginning of the recruitment and at the end of the training |
3 days post training
|
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Change in ARAT at 6 months post stroke
Periodo de tiempo: 180 days post stroke
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Differences between the Action Research Arm Test (ARAT) at the beginning of the recruitment and at 6 months post stroke |
180 days post stroke
|
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Change in iCoh at the end of the training
Periodo de tiempo: 3 days post training
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Differences between EEG Ipsi-Contralateral Motor Cortex connectivity (iCoh) at the beginning of the training and at the end of the training |
3 days post training
|
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Change in iCoh connectivity at 6 months post stroke
Periodo de tiempo: 180 days post stroke
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Differences between EEG Ipsi-Contralateral Motor Cortex connectivity (iCoh) at the beginning of the training and at 6 months post stroke |
180 days post stroke
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Change in arm kinematics at the end of the training
Periodo de tiempo: 3 days post training
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Differences between arm kinematics (shoulder, elbow, wrist and finger angles during reaching and grasping a glass) at the beginning of the training and at the end of the training |
3 days post training
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Change in arm kinematics at 6 months post stroke
Periodo de tiempo: 180 days post stroke
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Differences between arm kinematics (shoulder, elbow, wrist and finger angles during reaching and grasping a glass) at the beginning of the training and at 6 months post stroke |
180 days post stroke
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Pablo Burgos, PhD, University of Chile
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
- FONDEF IDeA 2023 ID23I104
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
all collected IPD
Marco de tiempo para compartir IPD
After the publication of the clinical trial, for 5 years.
Criterios de acceso compartido de IPD
Based on reasonable request to the project director (Pablo Burgos, pburgos@uchile.cl), the data will be shared.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
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.
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