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The Effects of Core Stability Training in Chronic Stroke Patients

29 de octubre de 2021 actualizado por: Sefa Gümrük Aslan, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

The Effects of Core Stability Training on Functional Ability and Muscle Thickness in Chronic Stroke Patients

The purpose of this study is to assess effects of core stability training on functional ability, balance, gait, motor functions, quality of lite and core muscle thickness of chronic stroke patients.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

After being informed about the study all the patients giving written informed consent were assessed. At the beginning the eligible patients were randomized into two groups: core stability and conventional therapy group. The therapy programs were performed 5 times a week for 45 min over a period of 3 weeks. Patients were assessed twice: before and after treatment.

Tipo de estudio

Intervencionista

Inscripción (Actual)

50

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

  • Pavo
      • Ankara, Pavo
        • Gaziler Physical Medicine and Rehabilitation Education and Research 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

18 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • First onset
  • Stroke duration from 6 months to 2 years
  • With ability to cooperate
  • Independent ambulation or ambulation with assistive device

Exclusion Criteria:

  • Uncooperative
  • Neglect syndrome
  • Surgical history of abdominal and hip region
  • Drugs that affect neuromuscular control
  • Other neurological disorders
  • Serious diseases, unstable medical condition
  • BMI ≥ 35

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: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Core stability group
Patients were performed therapy 5 times a week for 45 min over a period of 3 weeks. The therapy session takes 45 min; 15 min of the session was core stability training, remaining 30 min were conventional therapy.
Otro: Core stability training
The core stability training were performed 5 days a week for 15 min over a period of 3 weeks. The conventional therapy were performed 5 days a week for 30 min (remaining time of each session) over a period of 3 weeks. Duration of each session was 45 min.
Comparador activo: Conventional therapy group
Patients were performed therapy 5 times a week for 45 min over a period of 3 weeks. The therapy session takes 45 min of conventional therapy.
Otro: Conventional therapy
The conventional therapy were performed 5 days a week for 45 min over a period of 3 weeks. Duration of each session was 45 min

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline score of Berg Balance Scale at week 3
Periodo de tiempo: Baseline and week 3 (after treatment)
Berg Balance Scale is reliable and valid tool to assess balance and functional mobility. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
Baseline and week 3 (after treatment)
Change from baseline score of Motricity Index Scale for lower extremity at week 3
Periodo de tiempo: Baseline and week 3 (after treatment)
The Motricity Index was used to measure strength in upper and lower extremities after stroke. Assessing lower extremity strength is a 3 item list with each item consisting of a six point scale ranging from 0 to 33 (0, 9, 14, 19, 25, 33).
Baseline and week 3 (after treatment)
Change from baseline score of Trunk Control Test at week 3
Periodo de tiempo: Baseline and week 3 (after treatment)
Trunk Control Test assess four simple aspect of trunk movement. Total score range: 0 to 100.
Baseline and week 3 (after treatment)
Change from baseline score of 6 Minute Walk Test (6MWT) at week 3
Periodo de tiempo: Baseline and week 3 (after treatment)
6MWT is valid and reliable test to assess walking capacity of stroke patients. The distance that a patient can walk within six minutes is evaluated.
Baseline and week 3 (after treatment)
Change from baseline score of Functional Independence Measure (FIM) at week 3
Periodo de tiempo: Baseline and week 3 (after treatment)
FIM is valid and reliable scale to assess and grade the functional status of a person based on the level of assistance he or she requires. FIM is an 18-item, seven-level, ordinal scale intended to be sensitive to changes over the course of a comprehensive inpatient medical rehabilitation program.
Baseline and week 3 (after treatment)
Change from baseline score of Trunk Impairment Scale (TIS) at week 3
Periodo de tiempo: Baseline and week 3 (after treatment)
TIS is a tool to assess static and dynamic sitting balance and trunk coordination in a sitting position. On the static and dynamic sitting balance and coordination subscales the maximal scores that can be attained are 7, 10 and 6 points.
Baseline and week 3 (after treatment)
Change from baseline score of Timed Up and Go Test (TUG) at week 3
Periodo de tiempo: Baseline and week 3 (after treatment)
TUG test is an assessment tool for measuring mobility in stroke patients. The TUG times a patient standing from a chair, walking 3 metres and returning to sit down.
Baseline and week 3 (after treatment)
Change from baseline score of Stroke Specific Quality of Life Scale (SS-QOL) at week 3
Periodo de tiempo: Baseline and week 3 (after treatment)
SS-QOL is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. Patients must respond to each question of the SS-QOL with reference to the past week. It is a self-report scale containing 49 items. Items are rated on a 5-point Likert scale.
Baseline and week 3 (after treatment)
Change from baseline measurements Core muscle thickness at week 3
Periodo de tiempo: Baseline and week 3 (after treatment)
Thickness of five core muscles (rectus abdominis, external oblique, internal oblique, transversus abdominis, multifidus and gluteus medius) are measured by ultrasound. Paretic and nonparetic side of each patient are assessed twice (at baseline and after treatment).
Baseline and week 3 (after treatment)

Colaboradores e Investigadores

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

Patrocinador

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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)

19 de junio de 2019

Finalización primaria (Actual)

1 de octubre de 2021

Finalización del estudio (Actual)

1 de octubre de 2021

Fechas de registro del estudio

Enviado por primera vez

20 de octubre de 2021

Primero enviado que cumplió con los criterios de control de calidad

29 de octubre de 2021

Publicado por primera vez (Actual)

9 de noviembre de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de noviembre de 2021

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

29 de octubre de 2021

Última verificación

1 de octubre de 2021

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 23 (SIME)

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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