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Clinical Trials/NCT04844476
NCT04844476
Completed
N/A

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

Izmir Katip Celebi University1 site in 1 country50 target enrollmentJanuary 15, 2021
ConditionsStrokeFall

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Izmir Katip Celebi University
Enrollment
50
Locations
1
Primary Endpoint
Fear of falling
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2021
End Date
February 1, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Izmir Katip Celebi University
Responsible Party
Principal Investigator
Principal Investigator

Nese Olmez Sarikaya

Professor Doctor

Izmir Katip Celebi University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Fear of falling

Time Frame: 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.

Secondary Outcomes

  • 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.))

Study Sites (1)

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