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Fear of Fall Related Factors in Chronic Stroke

3 апреля 2022 г. обновлено: Nese Olmez Sarikaya, Izmir Katip Celebi University

Relationship Between Fear of Falling and Balance, Posture, Spasticity and Functional Independence in Chronic Stroke Patients

Some stroke survivors develop a fear of falling(FoF) which may exist with or without a prior fall. Fear of fall can be defined as decreased perceived self efficacy or confidence in maintaining balance while completing regular activities. FoF may impair rehabilitation and recovery. Determination of FoF related factors will help to identify interventions needed to decrease FoF. Mostly fear of fall related factors have been studied in acute stroke patients, limited data are available for patients with chronic stroke. The objective of this study is to evaluate frequency of FoF in chronic(>6 months) stroke patients and investigate relationship between FoF and balance, posture,spasticity and activities of daily living. The Turkish Version of the Modified Falls Efficacy Scale was used to measure FoF. Also a single-item dichotomous question "Are you afraid of falling? (Yes/No)" will be asked.

Обзор исследования

Статус

Завершенный

Условия

Подробное описание

In this observational study, chronic(>6 months) stroke patients who admitted to Physical Medicine and Rehabilitation outpatient clinic, older than 50 years old will be included. Sociodemographic and medical data including patients' age, gender, height, weight, body mass index, contact information, marital status, educational status, plegia side, stroke etiology, time after stroke, accompanying diseases, medications used, fear of falling (yes/no), history of falling (yes/no), and the use of walking aids will be recorded. In the evaluation of patients, Brunnstrom Hemiplegia Recovery Staging, Functional Ambulation Classification (FAC), Mini Mental State Examination(MMSE),Turkish Version of Modified Falls Efficacy Scale(MFES), Berg Balance Scale(BBS), Postural Assessment Scale for Stroke Patient Turkish Version (PASS-Turk), Modified Ashworth Scale (MAS), Modified Barthel Activities of Daily Living Index will be used. Fear of falling will be evaluated by the same researcher using the MFES. Also a question " Are you afraid of falling? (Yes/No)" will be asked. The patients will be divided into two groups as Group 1 =MFES<5 and Group2 =MFES ≥5. Balance, posture, ambulation status, spasticity, daily living activities and Brunnstrom staging will be compared between two groups. Correlation between MFES and balance, posture and activities of daily living will be studied.

Тип исследования

Наблюдательный

Регистрация (Действительный)

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Турция
- - İzmir, Турция, 35150
    - Izmir Katip Celebi University

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

50 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Метод выборки

Вероятностная выборка

Исследуемая популяция

Chronic stroke patients, admitted to Izmir Katip Celebi University Ataturk Training and Research Hospital Physical Medicine and Rehabilitation outpatient clinic, aged 50 and older.

Описание

Inclusion Criteria:

Patients aged 50 and over
More than 6 months after the stroke
Able to follow 3-digit orders
Able to approve the consent form in writing
Patients with a score of 23 and above on the Mini-Mental State Test will be included

Exclusion Criteria:

Bed-dependent, wheelchair-dependent patients
Patients diagnosed with Alzheimer's, Dementia
Patients who are cardiovascularly unstable
Patients with diseases that affect balance (such as Parkinson's disease, Cerebral trauma, Meniere, ear infection, Benign paroxysmal positional vertigo, Multiple sclerosis) and those who use drugs that disrupt the balance

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Fear of falling Временное ограничение: 1 day (All patients will be evaluated once.)	Fear of falling will be measured by Turkish Version of Modified Falls Efficacy Scale(MFES). It is a 14-question scale that evaluates patients' fear of falling and their self-confidence in performing daily living activities.	1 day (All patients will be evaluated once.)

Вторичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Balance Временное ограничение: 1 day (All patients will be evaluated once.)	Balance will be measured by Berg Balance Scale. It consists of 14 sub-measurements. Each parameter will be evaluated by scoring between 0-4 and the total score will be revealed. Patients with a total score of 0-20 were associated with high fall risk, 21-40 moderate fall risk, 41-56 low risk	1 day (All patients will be evaluated once.)
Posture Временное ограничение: 1 day (All patients will be evaluated once.)	Posture will be measured by Postural assessment scale for stroke patients (PASS-Turk). In the scale, there are a total of 12 parameters, 5 parameters related to maintaining posture and 7 parameters related to posture change. Each parameter will be scored between 0-3 points and the result will be the PASS-Turk Total score.	1 day (All patients will be evaluated once.)
Functional Independence Временное ограничение: 1 day (All patients will be evaluated once.)	Functional independence will be measured by Modified Barthel Activities of Daily Living Index. It is an index that evaluates the parameters of transfer, ambulation, going up and down stairs, feeding, dressing, personal care, bathing, sitting and standing on the toilet, urine continence, stool continence and collects patients in 5 groups according to these parameter scores. In these groups evaluated between 1 and 5, 1; While it was evaluated as insufficient to do business, 5; it is evaluated completely independently.	1 day (All patients will be evaluated once.)
Spasticity Временное ограничение: 1 day (All patients will be evaluated once.)	Spasticity will be measured by Modified Ashworth Scale. The shoulder girdle, elbow, hand, hip girdle, knee and ankle-ankle joints are scored as 0/1/1 + / 2/3/4 according to the spasticity scale by evaluating the right and left sides separately with speed-dependent passive stretching.	1 day (All patients will be evaluated once.)
Hemiplegia stage Временное ограничение: 1 day (All patients will be evaluated once.)	Hemiplegia stage will be measured by Brunnstrom Hemiplegia Recovery Staging. This staging consists of 3 sub-headings: Upper extremity, Hand, and lower extremity. Upper extremity is evaluated from stage 1 to stage 7, hand and lower extremity from stage 1 to stage 6.	1 day (All patients will be evaluated once.)
Ambulatory status Временное ограничение: 1 day (All patients will be evaluated once.)	Ambulatory status will be measured by Functional Ambulation Classification. Classification is evaluated between stage 0 and stage 5. Stage 5 refers to walking fully independently at any speed and on the ground.	1 day (All patients will be evaluated once.)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Izmir Katip Celebi University

Следователи

Учебный стул: Nese Olmez Sarikaya, Prof, Izmir Katip Celebi University
Главный следователь: Bekir Tetik, MD, Izmir Katip Celebi University

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

15 января 2021 г.

Первичное завершение (Действительный)

1 февраля 2022 г.

Завершение исследования (Действительный)

1 февраля 2022 г.

Даты регистрации исследования

Первый отправленный

13 апреля 2021 г.

Впервые представлено, что соответствует критериям контроля качества