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StrokeNCT04844476

Fear of Fall Related Factors in Chronic Stroke

An observational study of Stroke and Fall, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Stroke, Fall
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Jan 2021to 1 Feb 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Izmir Katip Celebi University

    Izmir, 35150

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Conditions
Stroke, Fall
Keywords
Stroke, hemiplegia, falls, fear, posture
Medical subject headings
Stroke, Hemiplegia

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 day (All patients will be evaluated once.)

Secondary outcomes (6)

  1. Balance

    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

    Measured: 1 day (All patients will be evaluated once.)

  2. Posture

    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.

    Measured: 1 day (All patients will be evaluated once.)

  3. Functional Independence

    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.

    Measured: 1 day (All patients will be evaluated once.)

  4. Spasticity

    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.

    Measured: 1 day (All patients will be evaluated once.)

  5. Hemiplegia stage

    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.

    Measured: 1 day (All patients will be evaluated once.)

  6. Ambulatory status

    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.

    Measured: 1 day (All patients will be evaluated once.)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2021
  2. Study start15 Jan 2021
  3. Primary completion1 Feb 2022
  4. Study completion1 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04844476
Sponsor's protocol ID
Fearoffallstroke
Status last verified
Apr 2022
First submitted
13 Apr 2021
Last updated
5 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Fall, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fear of falling (time frame: 1 day (All patients will be evaluated once.)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04844476.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.

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