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CompletedNCT06061887Updated Sep 29, 2023

Factors Associated With Recurrent Falls in Stroke Patients

An observational study in Fall and Stroke, sponsored by Bozyaka Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-09-29.

Sponsored by Bozyaka Training and Research Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
147
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The goal of this observational study is to learn about the recurrent falls in patients with acute stroke. The main question[s] it aims to answer are:

  • what is the frequency of recurrent falls
  • which factors are associated with recurrent falls in patients with acute stroke.

Participants will be evaluated in terms of

  • frequency of recurrent falls within the six months after stroke
  • fear of falling
  • the stroke severity (Canadian Neurological Scale),
  • ambulation level (Functional Ambulation Classification),
  • functional disability (Functional Independence Scale)
  • Postural control and balance
  • functional status (Modified Rankin Scale)
Read the detailed description

Falling is common in stroke patients both in the hospital and at home after discharge. As a result, physical problems such as fractures and psychological problems such as fear of falling, limitation of physical activity and social isolation occur. Identifying the factors that cause falls after stroke will contribute to the recovery process by preventing complications by taking the necessary precautions and increasing the patient's participation in rehabilitation. This study was planned to determine the frequency of falls in patients with acute stroke and to determine the risk factors associated with recurrent falls within the first six months after stroke.

02

Conditions studied

  • Fall
  • Stroke

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03

In context

Stroke

7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's enrollment of 147 is close to the median of 160 across 1,729 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Bozyaka Training and Research Hospital is the lead sponsor of 51 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients aged 18 and over, hospitalized in the neurology service with the diagnosis of acute stroke

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Having an acute stroke over the age of 18
  2. To have a cognitive situation to understand and answer questions

Exclusion criteria

Exclusion Criteria:

  1. Patients with bilateral hemiplegia
  2. Patients without motor involvement
  3. Those with a history of stroke
  4. Patients with severe cognitive impairment
  5. Patients in need of intensive care
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
147 participants (actual)
Patient registry
No

Interventions

  • OtherFall evaluation

    Evaluation of the frequency of falls in patients with acute stroke and determining the risk factors associated with recurrent falls within the first six months after stroke

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What researchers measure

Primary outcomes

  1. Frequency of fall

    The frequency of recurrent falls were were determined by questioning the patients.

    Time frame: Six month

Secondary outcomes

  1. Factors related with recurrent falls

    Poor postural control, number of falls,fear of falling, functional disability, ambulation level of the patients will be evaluated.

    Time frame: Six month

07

Study locations

1 site
  • University of Health Sciences Turkey
    Izmir, Turkey (Türkiye)
08

References and documents

Publications

  • Samuelsson CM, Hansson PO, Persson CU. Determinants of Recurrent Falls Poststroke: A 1-Year Follow-up of the Fall Study of Gothenburg. Arch Phys Med Rehabil. 2020 Sep;101(9):1541-1548. doi: 10.1016/j.apmr.2020.05.010. Epub 2020 Jun 1. PubMed 32497600 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2021 to primary completion in Feb 2023, 22 months.

Of 787 non-industry observational studies under Stroke, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 101. This study's 22 months is below that.

Counting every sponsor, half of 833 studies reached it within 41 months; a quarter within 18 and three quarters within 92.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 8, 2023
First posted
Sep 29, 2023
StartActual
Mar 31, 2021
Primary completionActual
Feb 28, 2023
CompletionActual
Mar 28, 2023
Last update
Sep 29, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06061887
Lead sponsor
Bozyaka Training and Research Hospital
Responsible party
Altınay Göksel Karatepe (Professor, Bozyaka Training and Research Hospital) — Principal investigator
First posted
Sep 29, 2023
Start date
Mar 31, 2021
Primary completion
Feb 28, 2023
Completion
Mar 28, 2023
Last update
Sep 29, 2023

Study contacts

Altınay Göksel Karatepe, MD
principal investigator · Saglik Bilimleri Universitesi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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