Fear of Fall Related Factors in Chronic Stroke
3 april 2022 bijgewerkt door: Nese Olmez Sarikaya, Izmir Katip Celebi University
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
50
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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-
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İzmir, Kalkoen, 35150
- İzmir Katip Çelebi University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
50 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
Chronic stroke patients, admitted to Izmir Katip Celebi University Ataturk Training and Research Hospital Physical Medicine and Rehabilitation outpatient clinic, aged 50 and older.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Fear of falling
Tijdsspanne: 1 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.
|
1 day (All patients will be evaluated once.)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Balance
Tijdsspanne: 1 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
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1 day (All patients will be evaluated once.)
|
|
Posture
Tijdsspanne: 1 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.
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1 day (All patients will be evaluated once.)
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Functional Independence
Tijdsspanne: 1 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.
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1 day (All patients will be evaluated once.)
|
|
Spasticity
Tijdsspanne: 1 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.
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1 day (All patients will be evaluated once.)
|
|
Hemiplegia stage
Tijdsspanne: 1 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.
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1 day (All patients will be evaluated once.)
|
|
Ambulatory status
Tijdsspanne: 1 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.
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1 day (All patients will be evaluated once.)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie stoel: Nese Olmez Sarikaya, Prof, İzmir Katip Çelebi University
- Hoofdonderzoeker: Bekir Tetik, MD, İzmir Katip Çelebi University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
15 januari 2021
Primaire voltooiing (Werkelijk)
1 februari 2022
Studie voltooiing (Werkelijk)
1 februari 2022
Studieregistratiedata
Eerst ingediend
13 april 2021
Eerst ingediend dat voldeed aan de QC-criteria
13 april 2021
Eerst geplaatst (Werkelijk)
14 april 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
5 april 2022
Laatste update ingediend die voldeed aan QC-criteria
3 april 2022
Laatst geverifieerd
1 april 2022
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Fearoffallstroke
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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