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Validity and Reliability of the Modified Four Square Step Test in Multiple Sclerosis Patients

18 de abril de 2022 actualizado por: Zekiye İpek KATIRCI KIRMACI, Kahramanmaras Sutcu Imam University

Investigation of Validity and Reliability of the Modified Four Square Step Test in Multiple Sclerosis Patients

Balance disorder is common in people with MS. As the disease worsens, it is associated with impaired balance, difficulty walking, decreased mobility, and an increased risk of falling. Given the prevalence and clinical significance of balance dysfunction in individuals with MS, the assessment of balance has become an important focus in MS clinical practice and research. The Four Square Step Test is a standard clinical measure used to assess dynamic standing balance. It is a timed test in which the individual is instructed to step rapidly forward, backward, and to the right and left over a low obstacle (a cane). The test assesses the ability to quickly change direction of movement and is a timed test involving the use of assistive devices.

In the modified four-square stepping test, the floor is divided into four equal squares with tape instead of a cane. Performing the test with tape, instead of patients at risk of being stuck with a cane, will ensure its applicability to a wider patient population.

The aim of the study is to examine the validity and reliability of the modified four-frame stepping test in MS patients.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Multiple sclerosis (MS) is a progressive disease of the central nervous system characterized by demyelination and destruction of motor and sensory axons. As the disease worsens, it is associated with impaired balance, difficulty walking, decreased mobility, and an increased risk of falling. The prevalence of balance dysfunction in individuals with MS and Given its clinical relevance, the assessment of balance has become an important focus in MS clinical practice and research.The Four Square Step Test is a standard clinical measure used to assess dynamic standing balance.The individual rapidly forwards over a low obstacle (a cane), is a timed test in which instructed to step backward and to the right and left.The four-frame stepping test was developed to document deficiencies in stance balance, predict falls, assess self-perceived limitations in walking, and compare changes in standing balance following exercise training. Compared to other standardized tests, scoring is not dependent on the subjectivity of the examiner, can be administered by a person with minimal training, and requires minimal time, space, and equipment. In the modified four-square stepping test, the floor is divided into four equal squares with tape instead of a cane. Performing the test with tape, instead of patients at risk of being stuck with a cane, will ensure its applicability to a wider patient population.

Tipo de estudio

De observación

Inscripción (Anticipado)

50

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.

Estudio Contacto

  • Nombre: Zekiye İpek KATIRCI KIRMACI
  • Número de teléfono: +90 544 261 82 85
  • Correo electrónico: ipekkatirci@hotmail.com

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 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

N/A

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Multiple Sclerosis Patients

Descripción

Inclusion Criteria:

  • Having an EDSS score of 4 and below,
  • Being between the ages of 18-65
  • Willingness to participate in the study

Exclusion Criteria:

  • Being pregnant or within the first 3 months after giving birth,
  • Receiving corticosteroid therapy in the last 1 month,
  • Using drugs that will affect walking in the last 1 month

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Multiple sclerosis patient
First day, first evaluator will perform all tests, and second day, second evaluator will perform Modified Four Square Step Test.
Modified Four Square Step Test, Berg Balance Scale, Dynamic Gait Index ,Activity-Specific Balance Confidence Scale

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Modified Four Square Step Test
Periodo de tiempo: First day
The square drawn on the floor is divided by tape into 4 equal parts. The number 1 is written in the lower right corner, and the number 4 is written clockwise. With the start command, individuals are asked to step on the numbers in order. First of all, he is asked to take a step forward (to the number 1 and 2), then to the left (to the number 3), then to the back (to the number 4). Then he is asked to take steps from 4 to 1 again. Time is saved
First day
Modified Four Square Step Test
Periodo de tiempo: second day
The square drawn on the floor is divided by tape into 4 equal parts. The number 1 is written in the lower right corner, and the number 4 is written clockwise. With the start command, individuals are asked to step on the numbers in order. First of all, he is asked to take a step forward (to the number 1 and 2), then to the left (to the number 3), then to the back (to the number 4). Then he is asked to take steps from 4 to 1 again. Time is saved
second day

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Balanza de Berg
Periodo de tiempo: Primer día
Es una escala de 14 ítems que mide la capacidad de mantener el equilibrio mientras se realizan tareas funcionales. Cada ítem se puntúa entre 0 y 4. El equilibrio se considera bueno si la puntuación total es de 45 o más.
Primer día
Dynamic Gait Index
Periodo de tiempo: First day
It consists of 8 walking activities: normal walking, fast-slow walking, walking with horizontal and vertical head movements, walking by jumping from the disabled floor and walking around the obstacle, and turning 360 degrees abruptly on command, going up and down the stairs. During these 8 activities, the patient's performance is scored between 0-3 (0=severe, 3=normal) and the total score is recorded.
First day
Activity-Specific Balance Confidence Scale
Periodo de tiempo: First day
It is a scale that evaluates how confidently people can do 16 activities outside and inside the home. Activities are scored between 0 (unsafe) and 100 (completely confident). A score is obtained by dividing the total score by 16. A higher score indicates greater confidence.
First day

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 (Anticipado)

15 de mayo de 2022

Finalización primaria (Anticipado)

15 de julio de 2022

Finalización del estudio (Anticipado)

15 de agosto de 2022

Fechas de registro del estudio

Enviado por primera vez

15 de diciembre de 2021

Primero enviado que cumplió con los criterios de control de calidad

6 de enero de 2022

Publicado por primera vez (Actual)

10 de enero de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

19 de abril de 2022

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

18 de abril de 2022

Última verificación

1 de abril de 2022

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. .

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