Fear of Fall Related Factors in Chronic Stroke
3. April 2022 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
50
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
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İzmir, Truthahn, 35150
- Izmir Katip Celebi University
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
50 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
Chronic stroke patients, admitted to Izmir Katip Celebi University Ataturk Training and Research Hospital Physical Medicine and Rehabilitation outpatient clinic, aged 50 and older.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Fear of falling
Zeitfenster: 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.)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Balance
Zeitfenster: 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
|
1 day (All patients will be evaluated once.)
|
|
Posture
Zeitfenster: 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
Zeitfenster: 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.)
|
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Spasticity
Zeitfenster: 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.)
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Hemiplegia stage
Zeitfenster: 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.)
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Ambulatory status
Zeitfenster: 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.)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienstuhl: Nese Olmez Sarikaya, Prof, Izmir Katip Celebi University
- Hauptermittler: Bekir Tetik, MD, Izmir Katip Celebi University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
15. Januar 2021
Primärer Abschluss (Tatsächlich)
1. Februar 2022
Studienabschluss (Tatsächlich)
1. Februar 2022
Studienanmeldedaten
Zuerst eingereicht
13. April 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
13. April 2021
Zuerst gepostet (Tatsächlich)
14. April 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
5. April 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
3. April 2022
Zuletzt verifiziert
1. April 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Fearoffallstroke
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
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Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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