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Combined Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Upper Arm Training in Subacute Stroke Patients

14 de marzo de 2019 actualizado por: Yonsei University

Combined Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Upper Arm Training in Subacute Stroke Patients : Randomized Controlled Trial

This study was designed to establish the clinical evidence for effect of Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of subacute stroke patients.

  • Purpose : to elucidate the effect of Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of stroke patients compared to conventional occupational therapy
  • Subjects : total 99 patients with stroke whose upper limb functions are impaired
  • Intervention : 4 weeks of therapy (5 days per week)
  • Studies : upper limb functional assessment (FMA, MFT, WMFT), computerized motion analysis
  • Evaluation plan : 1) pre-intervention, 2) post-2 weeks of intervention, 3) post-4 weeks of intervention, 4) 4 weeks after end of intervention

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

108

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

  • Corea, república de
      • Seoul, Corea, república de, 03722
        • Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine

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

20 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Upper FMA 7-38
  • Hemiplegic patients within 6months after stroke onset
  • male or female, 20 years older

Exclusion Criteria:

  • Patients with cognitive impairment who are unable to comply with protocol-required procedure
  • Quadriplegic or double hemiplegic patients
  • Patients with musculoskeletal disease, peripheral nerve disease in upper extremity
  • Patients with lower motor neuron disease
  • Patients who cannot perform rTMS
  • Pregnant woman

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: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Robot and rTMS
Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation group(intervention group 1)
Dispositivo: Armeo and rTMS

The Armeo, a robot with a spring mechanism allowing adjustable arm weight support, can generate assistive forces of up to 66N in flexion/extension and up to 30N for the arm and forearm respectively. This robot integrates seven angle sensors and one pressure sensor that allow direct interaction between the motion of the patient's arm and the associated therapy software. rTMS is a magnetic method used to stimulate small regions of the brain.

The Robot and rTMS group will receive the robot-assisted upper arm training and rTMS for 5 times per week, for 4 weeks. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.

Otros nombres:
  • Estimulación magnética transcraneal repetitiva (rTMS)
  • Robot-Assisted upper arm training(Armeo)
Experimental: Robot
Robot-Assisted upper arm training group(intervention group2)
Dispositivo: Armeo
The Armeo, a robot with a spring mechanism allowing adjustable arm weight support, can generate assistive forces of up to 66N in flexion/extension and up to 30N for the arm and forearm respectively. This robot integrates seven angle sensors and one pressure sensor that allow direct interaction between the motion of the patient's arm and the associated therapy software. The Robot group will receive the robot-assisted upper arm training for 30 minutes daily 5 times per week, for 4 weeks. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.
Otros nombres:
  • Robot-Assisted upper arm training(Armeo)
Comparador activo: Conventional
Conventional training group(control group)
Otro: Control group
The conventional group will receive occupational therapy for 30 minutes daily 5 times per week, for 4 weeks instead of Robot or rTMS. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.
Otros nombres:
  • conventional training

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Fugl-Meyer Assessment (FMA)
Periodo de tiempo: 1 minute before the first intervention
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
1 minute before the first intervention
Fugl-Meyer Assessment (FMA)
Periodo de tiempo: 2 weeks after the first intervention
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
2 weeks after the first intervention
Fugl-Meyer Assessment (FMA)
Periodo de tiempo: 4 weeks after the first intervention
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
4 weeks after the first intervention
Fugl-Meyer Assessment (FMA)
Periodo de tiempo: 4 weeks after the final intervention
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
4 weeks after the final intervention

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Wolf motor function test
Periodo de tiempo: 1 minute before the first intervention
The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
1 minute before the first intervention
Wolf motor function test
Periodo de tiempo: 2 weeks after the first intervention
The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
2 weeks after the first intervention
Wolf motor function test
Periodo de tiempo: 4 weeks after the first intervention
The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
4 weeks after the first intervention
Wolf motor function test
Periodo de tiempo: 4 weeks after the final intervention
The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
4 weeks after the final intervention
Manual Function test
Periodo de tiempo: 1 minute before the first intervention
The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
1 minute before the first intervention
Manual Function test
Periodo de tiempo: 2 weeks after the first intervention
The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
2 weeks after the first intervention
Manual Function test
Periodo de tiempo: 4 weeks after the first intervention
The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
4 weeks after the first intervention
Manual Function test
Periodo de tiempo: 4 weeks after the final intervention
The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
4 weeks after the final intervention
Kinematic data of computerized 3D motion analysis
Periodo de tiempo: 1 minute before the first intervention
D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
1 minute before the first intervention
Kinematic data of computerized 3D motion analysis
Periodo de tiempo: 2 weeks after the first intervention
D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
2 weeks after the first intervention
Kinematic data of computerized 3D motion analysis
Periodo de tiempo: 4 weeks after the first intervention
D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
4 weeks after the first intervention
Kinematic data of computerized 3D motion analysis
Periodo de tiempo: 4 weeks after the final intervention
D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
4 weeks after the final intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Yonsei University

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)

18 de junio de 2015

Finalización primaria (Actual)

26 de junio de 2018

Finalización del estudio (Actual)

26 de junio de 2018

Fechas de registro del estudio

Enviado por primera vez

30 de enero de 2017

Primero enviado que cumplió con los criterios de control de calidad

1 de febrero de 2017

Publicado por primera vez (Estimar)

3 de febrero de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de marzo de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

14 de marzo de 2019

Última verificación

1 de marzo de 2019

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1-2014-0083

Plan de datos de participantes individuales (IPD)

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INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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