- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT05182411
Validity and Reliability of Turkish Version Leg Activity Measure
Patient-filled scales minimize the burden of data collection for clinicians in a clinical setting.
Therefore, Leg activity measure, a new self-report measure of active and passive function in the leg, has been developed.
Leg activity measure consists of three parts. The first part includes passive functions, the second part includes active functions, and the third part includes the assessment of quality of life.
It is a valid and reliable test in adult neurological patients with lower extremity spasticity. It can be used in the evaluation of the active and passive functions of the results of the clinicians' interventions by making the cultural adaptation of the Turkish language and examining its validity and reliability. We think that it will be important to determine the limitations in activity, participation and daily living activities and to evaluate their reflections.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Spasticity is a common symptom resulting from stroke, brain trauma, and degenerative brain diseases. Spasticity, known as rate-dependent resistance to passive movement, prevents many activities of daily living. Lower extremity spasticity, on the other hand, hinders joint movements and complicates mobility, transfer and passive activities of caregivers.
Goals for the treatment of spasticity often focus on active function improvements in walking, standing, and moving from different sitting positions. However, improvements in passive function tasks and symptom management are often equally important to patients. Active function is the use of the limb to directly perform a task. Passive fonskyion is care of the affected extremity, usually performed by the person himself, but may require assistance from another person.
There is a need for instruments with demonstrable measurement properties that can reflect a clinically significant change in practice. Outcomes developed for treatments such as botulinum toxin and physical interventions for spasticity aimed at improving any aspect of functional performance (active and passive function) should ideally reflect real-life function as opposed to simply observed tasks in the clinical setting.
Leg activity measure filled by the patient consists of three parts. The first part includes passive functions, the second part includes active functions, and the third part includes the assessment of quality of life.
It is a valid and reliable test in adult neurological patients with lower extremity spasticity. It can be used in the evaluation of the active and passive functions of the results of the clinicians' interventions by making the cultural adaptation of the Turkish language and examining its validity and reliability.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Kahramanmaraş, Турция
- Kahramanmaras Sutcu Imam University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- 1 or more spasticity in at least one muscle according to the Modified Ashworth Scale
- Be between the ages of 18-65
- Volunteering to participate in the study
Exclusion Criteria:
- Under 18 years old, over 65 years old
- History of trauma in the last 1 year
- Having alcohol and substance abuse
- Having a pregnancy
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
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Patients with spasticity
adult neurological patients with spasticities in their lower extremities
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Turkish version of Leg Activity Measure Rivearmead Mobility Index Nottingham Health Profile Functional Independence Measures
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Turkish version of Leg Activity Measure
Временное ограничение: First day
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Leg activity measure consists of three parts.
The first part includes passive functions, the second part includes active functions, and the third part includes the assessment of quality of life.
The questions in each section are scored between 0-4.
An increase in the score indicates that the activity could not be performed.
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First day
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Turkish version of Leg Activity Measure
Временное ограничение: 2 weeks later
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Leg activity measure consists of three parts.
The first part includes passive functions, the second part includes active functions, and the third part includes the assessment of quality of life.
The questions in each section are scored between 0-4.
An increase in the score indicates that the activity could not be performed.
|
2 weeks later
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
The Rivermead Mobility Index
Временное ограничение: First day
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The Rivermead Mobility Index is appropriate for a range of disabilities that include anything from being bedridden to being able to run
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First day
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Nottingham Health Profile (NHP)
Временное ограничение: First day
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The NHP is a patient-reported questionnaire. Respondents tick yes or no boxes to answer questions about their health and its effects on their daily life. The questionnaire is divided into two parts. The first parts comprises 38 questions in six categories: sleep, physical mobility, energy, pain, emotional reactions, and social isolation. The second part of the NHP is made up of seven statements about areas of life that are commonly affected by health: paid employment, jobs around the house, social life, personal relationships, sex life, hobbies and interests, and holidays |
First day
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The Functional Independence Measure (FIM)
Временное ограничение: First day
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The Functional Independence Measure (FIM) is an instrument that was developed as a measure of disability for a variety of populations and is not specific to any diagnosis. The FIM instrument includes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. |
First day
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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
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
Дополнительные соответствующие термины MeSH
- Заболевания центральной нервной системы
- Заболевания нервной системы
- Заболевания иммунной системы
- Демиелинизирующие аутоиммунные заболевания, ЦНС
- Аутоиммунные заболевания нервной системы
- Демиелинизирующие заболевания
- Аутоиммунные заболевания
- Раны и травмы
- Травма, нервная система
- Заболевания спинного мозга
- Рассеянный склероз
- Травмы спинного мозга
Другие идентификационные номера исследования
- ipekkkirmaci
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. .
Клинические исследования assessment
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Centre Francois BaclesseЗавершенный
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University of CataniaUniversity of Roma La Sapienza; Hospital General Universitario Santa Lucia; Klinik...Еще не набираютРассеянный склерозИталия