Stroke Clinical Trial - Fear of Fall Related Factors in Chronic Stroke

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Fall
Stroke

Clinical Trial Details

NCT number	NCT04844476
Study type	Observational
Source	Izmir Katip Celebi University
Contact
Status	Completed
Phase
Start date	January 15, 2021
Completion date	February 1, 2022

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.