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Dual Task Gait Performance in Pediatric Oncology Patients

2 de marzo de 2021 actualizado por: Emel Taşvuran Horata, Afyonkarahisar Health Sciences University

Comparison of Single and Dual Task Gait Performance in Pediatric Oncology Patients With Healthy Control Group

Cancer incidence, which is recognized as the leading cause of death in children worldwide, is gradually increasing.

Most studies on children who survive cancer show that the disease and its treatment have side effects and long-term late effects on the musculoskeletal system, physical function, gait and cognitive skills.

Therefore, dual task gait performance, in which cognitive and motor tasks are performed simultaneously, may be affected in pediatric oncology patients. The aim of this study is to compare gait performance in single and dual task conditions in pediatric oncology patients with healthy controls.

Descripción general del estudio

Descripción detallada

Cancer incidence, which is recognized as the leading cause of death in children worldwide, is gradually increasing. About 300,000 children aged 0 to 19 are diagnosed with cancer each year, according to the international study where the International Agency for Research on Cancer collected data on neoplasms (malignant and non-malignant) diagnosed in individuals under 20 years of age between 2001-2010.

Most studies on children who survive cancer show that the disease and its treatment have side effects and long-term late effects on the musculoskeletal system, physical function, gait and cognitive skills. According to the study of Beulertz et al. (2016), active ankle dorsiflexion limitation, gait disturbances and decrease in walking efficiency were observed in all pediatric oncology patients, which have an important role in walking, not limited to children with bone tumors and central nervous system tumors.Intensive chemotherapy (eg methotrexate) and the use of radiation are thought to cause damage to cortical and subcortical white matter, resulting in late effects. Symptoms consistent with attention deficit disorder and mental processing speed, working memory, executive function and memory deficits put cancer survivors at an intellectual and academic disadvantage.

Therefore, dual task gait performance, in which cognitive and motor tasks are performed simultaneously, may be affected in pediatric oncology patients. The aim of this study is to compare gait performance in single and dual task conditions in pediatric oncology patients with healthy controls.

Tipo de estudio

De observación

Inscripción (Anticipado)

40

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: EMEL TAŞVURAN HORATA, PhD
  • Número de teléfono: 05547759663
  • Correo electrónico: ethorata@gmail.com

Ubicaciones de estudio

      • Afyonkarahisar, Pavo, 03030
        • Reclutamiento
        • Emel Taşvuran Horata
        • Contacto:
          • Emel TAŞVURAN HORATA, PhD
          • Número de teléfono: +905547759663
          • Correo electrónico: ethorata@gmail.com
        • Contacto:
        • Investigador principal:
          • EMEL TAŞVURAN HORATA, PhD
        • Sub-Investigador:
          • Hamide Nur ÇEVİK ÖZDEMİR, PhD
        • Sub-Investigador:
          • Yunus Emre KUNDAKCI, PhD
        • Sub-Investigador:
          • İbrahim EKER, PhD

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

6 años a 18 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

In this study, inpatient and outpatient children diagnosed with cancer in Afyonkarahisar Health Sciences University Health Application and Research Center Pediatric Hematology-Oncology Clinics will form the case group of the study.

Healthy children who come to Afyonkarahisar Ege Youth and Sports Club Association to do sports and who have recently registered will form the control group of the research.

Descripción

Inclusion Criteria:

Healthy control group:

  • Being in the age range of 6-18,
  • To be physically, cognitively and mentally healthy,
  • Open to communication enough to understand questions,
  • Speaking and understanding Turkish,
  • Approval has been obtained from the child and his / her family for the study and who agrees to participate in the study,

Case group:

  • Able to walk alone without any walking aid,
  • Open to communication enough to understand questions,
  • Speaking and understanding Turkish,
  • Approval has been obtained from the child and his / her family for the study and who agrees to participate in the study,
  • Children between the ages of 6-18 will be included in the study

Exclusion Criteria:

Healthy control group:

  • Any orthopedic or neurological impairment that would prevent walking;
  • Having any mental disability that prevents cognitive task

Case group:

  • Staying in an isolated room or having risk of infection (neutropenic, etc.),
  • Any orthopedic or neurological impairment that could prevent walking;
  • Having any mental disability that prevents cognitive task,
  • Individuals with malignant hypertension or unstable heart disease (eg congestive heart failure) will not be included in the study.

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

  • Modelos observacionales: Control de caso
  • Perspectivas temporales: Futuro

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Healthy Control Group
Healthy children who come to Afyonkarahisar Ege Youth and Sports Club Association for the purpose of sports, newly registered and between the ages of 6-18 will constitute the control group of the study.
The single walk will be evaluated with a 10-meter walking test and a G-Walk portable device.
The dual task gait, 10-meter walking test and a motor (carrying a full water glass) will be combined with the task and evaluated with the G-Walk portable device.
The dual task gait will be combined with a 10-meter walking test and a cognitive (1-back test) task and evaluated with the G-Walk portable device.
Case Group
The sample of the study will be inpatient and outpatient pediatric patients between the ages of 6-18 who have been diagnosed with cancer in the Pediatric Hematology-Oncology Clinics of Afyonkarahisar Health Sciences University Health Application and Research Center Department of Pediatrics.
The single walk will be evaluated with a 10-meter walking test and a G-Walk portable device.
The dual task gait, 10-meter walking test and a motor (carrying a full water glass) will be combined with the task and evaluated with the G-Walk portable device.
The dual task gait will be combined with a 10-meter walking test and a cognitive (1-back test) task and evaluated with the G-Walk portable device.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
gait speed
Periodo de tiempo: 20 minutes
Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance.
20 minutes
cadence
Periodo de tiempo: 20 minutes
Cadence is the rate at which a person walk, expressed in steps per minute. The average cadence is 100 - 115 steps/min.
20 minutes
stride length
Periodo de tiempo: 20 minutes
Stride length is defined as the distance between successive ground contacts of the same foot.
20 minutes

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Emel TAŞVURAN HORATA, PhD, Afyonkarahisar Health Science 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)

1 de marzo de 2021

Finalización primaria (Anticipado)

20 de marzo de 2023

Finalización del estudio (Anticipado)

20 de marzo de 2023

Fechas de registro del estudio

Enviado por primera vez

2 de marzo de 2021

Primero enviado que cumplió con los criterios de control de calidad

2 de marzo de 2021

Publicado por primera vez (Actual)

5 de marzo de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de marzo de 2021

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

2 de marzo de 2021

Última verificación

1 de marzo de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 2021/144

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

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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