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临床试验/NCT04844476
NCT04844476已完成不适用

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

Izmir Katip Celebi University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Fear of falling

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Fear of falling

时间窗: 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.

次要结局

  • Balance(1 day (All patients will be evaluated once.))
  • Ambulatory status(1 day (All patients will be evaluated once.))
  • Posture(1 day (All patients will be evaluated once.))
  • Functional Independence(1 day (All patients will be evaluated once.))
  • Spasticity(1 day (All patients will be evaluated once.))
  • Hemiplegia stage(1 day (All patients will be evaluated once.))

研究者

发起方
Izmir Katip Celebi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nese Olmez Sarikaya

Professor Doctor

Izmir Katip Celebi University

研究点 (1)

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