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Fear of Fall Related Factors in Chronic Stroke

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04844476
Enrollment
50
Registered
2021-04-14
Start date
2021-01-15
Completion date
2022-02-01
Last updated
2022-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fall, Stroke

Keywords

Stroke, hemiplegia, falls, fear, posture

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.

Interventions

None listed

Sponsors

Izmir Katip Celebi University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fear of falling1 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

MeasureTime frameDescription
Posture1 day (All patients will be evaluated once.)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.
Functional Independence1 day (All patients will be evaluated once.)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.
Balance1 day (All patients will be evaluated once.)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
Hemiplegia stage1 day (All patients will be evaluated once.)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.
Ambulatory status1 day (All patients will be evaluated once.)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.
Spasticity1 day (All patients will be evaluated once.)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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026