Fear of Fall Related Factors in Chronic Stroke

NCT ID: NCT04844476

Last Updated: 2022-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-15

Study Completion Date

2022-02-01

Brief Summary

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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

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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.

Conditions

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Stroke Fall

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Izmir Katip Celebi University

OTHER

Sponsor Role lead

Responsible Party

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Nese Olmez Sarikaya

Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nese Olmez Sarikaya, Prof

Role: STUDY_CHAIR

Izmir Katip Celebi University

Bekir Tetik, MD

Role: PRINCIPAL_INVESTIGATOR

Izmir Katip Celebi University

Locations

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Izmir Katip Celebi University

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Fearoffallstroke

Identifier Type: -

Identifier Source: org_study_id

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