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Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation

9 de diciembre de 2019 actualizado por: Lai chien hung, Taipei Medical University Hospital

Investigate the Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation Technology in Persons With Stroke

This study is to investigate the combined effects of repetitive Transcranial Magnetic Stimulation (rTMS) and Augmented Reality (AR) intervention on cortical excitability, balance, gait, activity in individuals with stroke. Forty participants will be recruited in this study. They will be allocated to four group: rTMS and AR group (10), sham rTMS and AR group (10), AR group (10), and conventional physiotherapy group (10).

Descripción general del estudio

Descripción detallada

Participants will be randomized allocated to four groups: rTMS and AR group, sham rTMS and AR group, AR group ,and conventional physiotherapy group in current study. All participants underwent four weeks, 3 sessions per week, and 60 minutes per session training program. Motor evoked potential (MEP), Time up go test (TUG), Berg Balance Scale (BBS), Fugl-Meyer Assessment (FMA), Multi-directional Reach Test (MDRT),The Postural Assessment Scale for Stroke Patients (PASS), and Taiwanese Depression Questionnaires (TDQ) will be assessed before and after intervention in all participants.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

40

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

      • Taipei, Taiwán
        • Reclutamiento
        • Taipei Medical University Hospital

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 a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Cognitive ability is sufficient to understand the nature of study (Mini-Mental State Examination score was above 23).
  2. Participants suffer from unilateral hemiplegia caused by a first-ever stroke.
  3. Participants are stable in medical and psychological condition.

Exclusion Criteria:

  1. Participants have other neurologic problems that can affect balance and walking ability.
  2. Participants take of drugs or have other medical condition that can affect balance and function.
  3. Participants have contraindications for rTMS intervention such as pacemaker, cochlear implants, metal in the brain or skull, open wound of brain, or history of epilepsy.

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
Experimental: rTMS and AR group
Ten participants in group A will undergo repetitive transcranial magnetic stimulation (real, 1 Hz, 15 minutes), follow by a session of augmented reality exercise (45 minutes), 3 days per week for 4 weeks.
rTMS performs 1Hz,15 minutes real rTMS. AR intervention contains weight-shift exercise, strengthening of lower limb and balance training for 45 minutes.
Comparador activo: Sham rTMS and AR group
Ten participants in group B will receive repetitive transcranial magnetic stimulation (sham,1 Hz, 15 minutes), follow by a session of augmented reality exercise (45 minutes), 3 days per week for 4 weeks.
Sham rTMS applies 1Hz, 15 minutes sham rTMS. AR intervention includes weight-shift exercise, strengthening of lower limb and balance training for 45 minutes.
Comparador activo: AR group
Ten participants in group C will undergo augmented reality exercise 60 minutes a day and 3 days per week for four weeks.
AR intervention contains weight-shift exercise, strengthening of lower limb and balance training for 60 minutes.
Comparador activo: Conventional physiotherapy group
Ten participants allocated to the group D will receive conventional physiotherapy 60 minutes a day and 3 days per week for four weeks.
Conventional physiotherapy includes rolling, sitting, balance exercise, standing, overground walking, facilitation of the paretic limbs, and so on for 60 minutes.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change of Time Up Go test (TUG)
Periodo de tiempo: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
The TUG test will ask participants to stand up, walk for 3 m, turn, walk back and sit down as fast as they can during the test, and the time requires for each patient to complete the test is recorded.
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change of Berg Balance Scale (BBS)
Periodo de tiempo: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Participants performed a series of 14 functional balance tasks, including maintaining a quiet stance, sitting-to-standing, shifting weight and reaching, turning in place, standing on one leg, and maintaining a tandem stance. Each task was scored on a 5-point ordinal scale (from 0 to 4). A score of 0 denotes the inability of the participant to perform the task, and a score of 4 denotes that the participant can complete the task based on a preset criterion. The highest possible score is 56.
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Change of Motor evoked potential (MEP)
Periodo de tiempo: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Motor evoked potential (MEP) is recorded from tibialis anterior muscles following direct transcranial magnetic stimulation (TMS) of motor cortex. All TMS is delivered with the participant seated upright on the chair. Both passive and active conditions, participants are instructed to relax their right leg in the seated position. TMS is delivered over the motor cortex (M1) using a concave double cone coil (Magstim Co., United Kingdom) attached to a BiStim magnetic stimulator (Magstim Co., United Kingdom). To locate the optimal site, stimuli are delivered over various points along the M1. The optimal site is the location on the M1 that evoked the greatest MEP amplitude in the bilateral tibialis anterior muscles. The onset latency and onset to peak amplitude will be assessed.
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Change of Fugl-Meyer Assessment (FMA)-Lower extremity
Periodo de tiempo: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Fugl-Meyer Assessment-Lower extremity is used to measure lower-limb recovery in stroke rehabilitation studies.The scale has 6 items ranging from reflex activity to voluntary motor control. Each item further comprises components, with a total of 17. Scoring is done on a 3-point ordinal scale ranges from 0 (no performance) to 2 (faultless performance). The total score range from 0 (no motor function) to 34 (good motor recovery).
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Change of Multi-directional Reach Test (MDRT)
Periodo de tiempo: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Participants will be required to reach in the forward, left and right directions. The test is performed with the participant in standing. It is the measure of the difference, in centimeters, between arm's length with arms at 90° flexion/ abduction and maximal forward, left and right directions reaching respectively, using a fixed base of support. The test uses a centimeters measuring device against a wall at shoulder height.
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Change of The Postural Assessment Scale for Stroke Patients (PASS)
Periodo de tiempo: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
The Postural Assessment Scale for Stroke Patients (PASS) is a postural assessment scale specifically designed to assess and monitor postural control after stroke. It contains 12 four-level items of varying difficulty for assessing ability to maintain or change a given lying, sitting, or standing posture. The PASS consists of 2 sections with a 4-point scale to describe each task. The total score ranges from 0 - 36. A score of 0 denotes the inability of the participant to perform the task, and a score of 3 denotes that the participant can complete the task based on a preset criterion. The highest possible score is 36.
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Change of Taiwanese Depression Questionnaires (TDQ)
Periodo de tiempo: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Taiwanese Depression Questionnaires (TDQ) contains 18 items to screen the situation of depression within a week. The TDQ, which is a 4-point scale with 18 items, is a culturally specific depression self-rating instrument for effective screening of depression in Taiwan and has satisfactory reliability and validity. Subjects are guided to rate each item on a scale from 0 to 3 on the basis of "how often you felt the physical and emotional aspects during the past week". Zero denotes never, three means always. TDQ scores range from 0 to 54.
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups

Colaboradores e Investigadores

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

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)

31 de julio de 2018

Finalización primaria (Anticipado)

30 de octubre de 2020

Finalización del estudio (Anticipado)

30 de diciembre de 2020

Fechas de registro del estudio

Enviado por primera vez

20 de noviembre de 2018

Primero enviado que cumplió con los criterios de control de calidad

20 de noviembre de 2018

Publicado por primera vez (Actual)

23 de noviembre de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de diciembre de 2019

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

9 de diciembre de 2019

Última verificación

1 de diciembre de 2019

Más información

Términos relacionados con este estudio

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. .

Ensayos clínicos sobre rTMS and AR

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