NCT04844476

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

April 13, 2021

Last Update Submit

April 3, 2022

Conditions

Keywords

Strokehemiplegiafallsfearposture

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Balance

    1 day (All patients will be evaluated once.)

  • Posture

    1 day (All patients will be evaluated once.)

  • Functional Independence

    1 day (All patients will be evaluated once.)

  • Spasticity

    1 day (All patients will be evaluated once.)

  • Hemiplegia stage

    1 day (All patients will be evaluated once.)

  • +1 more secondary outcomes

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Celebi University

Izmir, 35150, Turkey (Türkiye)

Location

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nese Olmez Sarikaya, Prof

    Izmir Katip Celebi University

    STUDY CHAIR
  • Bekir Tetik, MD

    Izmir Katip Celebi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

April 13, 2021

First Posted

April 14, 2021

Study Start

January 15, 2021

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

April 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations