- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04784026
Dual Task Gait Performance in Pediatric Oncology Patients
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.
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Ожидаемый)
Контакты и местонахождение
Контакты исследования
- Имя: EMEL TAŞVURAN HORATA, PhD
- Номер телефона: 05547759663
- Электронная почта: ethorata@gmail.com
Места учебы
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Afyonkarahisar, Турция, 03030
- Рекрутинг
- Emel Taşvuran Horata
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Контакт:
- Emel TAŞVURAN HORATA, PhD
- Номер телефона: +905547759663
- Электронная почта: ethorata@gmail.com
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Контакт:
- Электронная почта: ethorata@gmail.com
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Главный следователь:
- EMEL TAŞVURAN HORATA, PhD
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Младший исследователь:
- Hamide Nur ÇEVİK ÖZDEMİR, PhD
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Младший исследователь:
- Yunus Emre KUNDAKCI, PhD
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Младший исследователь:
- İbrahim EKER, PhD
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
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.
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: Кейс-контроль
- Временные перспективы: Перспективный
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
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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.
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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.
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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.
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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gait speed
Временное ограничение: 20 minutes
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Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance.
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20 minutes
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cadence
Временное ограничение: 20 minutes
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Cadence is the rate at which a person walk, expressed in steps per minute.
The average cadence is 100 - 115 steps/min.
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20 minutes
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stride length
Временное ограничение: 20 minutes
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Stride length is defined as the distance between successive ground contacts of the same foot.
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20 minutes
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Соавторы и исследователи
Следователи
- Главный следователь: Emel TAŞVURAN HORATA, PhD, Afyonkarahisar Health Science University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 2021/144
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .