Fear of Fall Related Factors in Chronic Stroke

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Fall

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey, 35150
    • Izmir Katip Celebi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear of falling	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.)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance	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	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	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	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	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	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.)

Collaborators and Investigators

• Sponsor: Izmir Katip Celebi University
• Investigators: Study Chair: Nese Olmez Sarikaya, Prof, Izmir Katip Celebi University; Principal Investigator: Bekir Tetik, MD, Izmir Katip Celebi University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 3, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Stroke; falls; hemiplegia; fear; posture
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Fearoffallstroke

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No