Clinical trial NCT04844476: Fear of Fall Related Factors in Chronic Stroke
Official title: Relationship Between Fear of Falling and Balance, Posture, Spasticity and Functional Independence in Chronic Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Fall
Keywords: Stroke
hemiplegia
falls
fear
posture
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: Fear of falling
timeFrame: 1 day (All patients will be evaluated once.)
Secondary outcomes:
measure: Balance
timeFrame: 1 day (All patients will be evaluated once.)
measure: Posture
timeFrame: 1 day (All patients will be evaluated once.)
measure: Functional Independence
timeFrame: 1 day (All patients will be evaluated once.)
measure: Spasticity
timeFrame: 1 day (All patients will be evaluated once.)
measure: Hemiplegia stage
timeFrame: 1 day (All patients will be evaluated once.)
measure: Ambulatory status
timeFrame: 1 day (All patients will be evaluated once.)
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Katip Celebi University
Study officials:
affiliation: Izmir Katip Celebi University
name: Nese Olmez Sarikaya, Prof
role: STUDY_CHAIR
affiliation: Izmir Katip Celebi University
name: Bekir Tetik, MD
role: PRINCIPAL_INVESTIGATOR
References: