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The Application of Thermal Stimulation on Functional Recovery of Stroke Patients

6 de abril de 2015 actualizado por: Jau-Hong Lin, Professor, Kaohsiung Medical University Chung-Ho Memorial Hospital
In literature review, thermal stimulation (TS) intervention is effective in facilitating upper extremity functional recovery in stroke patients. In addition, several functional MRI studies have indicated that thermal stimuli promoted activation in the premotor and motor cortices of healthy participants. These imply the possibility of TS in cortical reorganization. However, there were no studies exploring the relationship of the TS intervention and cortical reorganization. By the functional recovery of stroke patients, findings of brain image and brain mapping, it could enhance the understanding the TS influences on brain reorganization. Regarding with clinical application of the TS intervention for improving functional performance of upper extremity in participants with stroke, the best parameters of TS intervention in clinical practice have not been decided. Therefore, this five-year study recruited three groups of stroke patients (acute, sub-acute, chronic) undergoing TS intervention with different parameters. Functional scales, kinematic data, brain image were taken in several timelines as outcome measures.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The thermal stimulation (TS) intervention uses the heat and cold apply alternately (~30minutes), and this kind temperature application is common in clinical neuromuscular or sports rehabilitation. Moreover, some studies have proved efficacy of the TS on stroke. However, the best parameters and application on different-stage stroke groups have not been clearly explored. Moreover, in order to discover the TS intervention influences on neuroplasticity, the brain images and the brain mapping are taken in the group A (explained in the below). In addition, the kinematic data was also collected in group A. However, the above-mentioned three examination are optional. Finally, functional recovery measurements (clinical scales) are measured in the three groups.

There are three groups (90 participants in each group) and their respective TS intervention design. In other word, three sub-studies (A, B, C) are under this project. Group A recruited 90 acute stroke (~ 30 days) and the independent variable is temperature of TS intervention. Group B is with sub-acute stroke (3-12 months), undergoing different frequency of TS intervention. Group C targets on participants with chronic stroke (> 1 y/o) and this variation in TS is intensity of TS application (30 mins vs 60 mins/each session).

Tipo de estudio

Intervencionista

Inscripción (Actual)

220

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

  • Taiwán
      • Kaohsiung city, Taiwán, 807
        • Kaohsiung Medical University

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 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. first-ever ischemic stroke;
  2. no severe cognitive impairments and able to follow instructions;
  3. sit on a chair for more than 30 minutes independently.

Exclusion Criteria:

  1. musculoskeletal or cardiac disorders that potentially interferes with experimental tests;
  2. diabetic or sensory impairment that attributable to peripheral vascular disease or neuropathy;
  3. speech disorder or global aphasia;
  4. skin problems at the sites of stimulation;

6.contraindications of heat or ice application.

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 factorial
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Noxious TS in study A
Otro: Noxious TS
hot, cold alternately, noxious TS in study A
Comparador activo: Innocuous TS
Innocuous TS in study A
Otro: Innocuous TS
warm, cool alternately, Innocuious TS in study A
Experimental: High Frequency of Noxious TS
High Frequency of Noxious TS in study B
Otro: High Frequency of Noxious TS
High Frequency of Noxious TS in study B
Comparador activo: Low Frequency of Noxious TS
Low Frequency of Noxious TS in study B
Otro: Low Frequency of Noxious TS
Low Frequency of Noxious TS in study B
Experimental: High Intensity of Noxious TS
High Intensity of Noxious TS in study C
Otro: High Intensity of Noxious TS
High Intensity of Noxious TS in study C
Comparador activo: Low Intensity of Noxious TS
Low Intensity of Noxious TS in study C
Otro: Low Intensity of Noxious TS
Low Intensity of Noxious TS in study C

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Movement performance assessment
Periodo de tiempo: baseline, half time-line of whole intervention period, post-intervention, 1 month follow-up, 6 month follow-up
  • Movement performance assessment by clinical motor assessment scales in upper extremity
  • executed by qualified physiotherapy
  • in study A, B, C
baseline, half time-line of whole intervention period, post-intervention, 1 month follow-up, 6 month follow-up
Brain images
Periodo de tiempo: immediate effects in 3 timeline
  • "intermediate effect of TS" means: pretest of the single TS, then application of this single TS, finally post-test of this TS in the session in the same day
  • immediate effects of intervention in the 1st day and 24th of intervention, six-month follow-up
  • this examination is optional
  • in study A.
  • use regular scan examination of hospital and operated by trained qualified professionals, the attending is consulted
  • This examination can be stopped at any time if participants do not want to perform or feeling unwell
immediate effects in 3 timeline
Mapping of brain cortex
Periodo de tiempo: immediate effect in four timeline
  • "intermediate effect of TS" means: pretest of the single TS, then application of this single TS, finally post-test of this TS in the session in the same day
  • immediate effects of intervention in the 1st day and 24th of intervention, one-month follow-up, six-month follow-up
  • in study A.
  • this examination is optional
  • use equipment of brain mapping and operated under trained staff, the attending is consulted This examination can be stopped at any time if participants do not want to perform or feeling unwell
immediate effect in four timeline
Kinematics measure of upper extremity movement
Periodo de tiempo: four timeline
  • 1st day and 24th of intervention, one-month follow-up, six-month follow-up (This examination is optional)
  • signal emission marks are sticked on surface skin during motion tests

  • this examination is optional

    --in study A.

  • executed by trained qualified physiotherapy
four timeline

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Quality of life
Periodo de tiempo: baseline, post-intervention, 6 month follow-up
  • Quality of life by subjective questionnaires
  • executed by qualified physiotherapy --in study A, B, C.
baseline, post-intervention, 6 month follow-up

Colaboradores e Investigadores

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

Patrocinador

Kaohsiung Medical University Chung-Ho Memorial Hospital

Colaboradores

E-DA Hospital
Kaohsiung Municipal Hsiaokang Hospital

Investigadores

  • Investigador principal: Jau-Hong Lin, Professor, Kaohsiung Medical University

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

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

1 de enero de 2010

Finalización primaria (Actual)

1 de junio de 2014

Finalización del estudio (Actual)

1 de diciembre de 2014

Fechas de registro del estudio

Enviado por primera vez

26 de junio de 2011

Primero enviado que cumplió con los criterios de control de calidad

16 de agosto de 2011

Publicado por primera vez (Estimar)

17 de agosto de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

8 de abril de 2015

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

6 de abril de 2015

Última verificación

1 de abril de 2015

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NHRI-EX99-9907PI

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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