- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06061887
Factors Associated With Recurrent Falls in Stroke Patients
September 25, 2023 updated by: Altınay Göksel Karatepe, Bozyaka Training and Research Hospital
Frequency of Falls in Stroke Patients and Factors Associated With Recurrent Falls
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)
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
147
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
İzmir, Turkey
- University of Health Sciences Turkey
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
Patients aged 18 and over, hospitalized in the neurology service with the diagnosis of acute stroke
Description
Inclusion Criteria:
- Having an acute stroke over the age of 18
- To have a cognitive situation to understand and answer questions
Exclusion Criteria:
- Patients with bilateral hemiplegia
- Patients without motor involvement
- Those with a history of stroke
- Patients with severe cognitive impairment
- Patients in need of intensive care
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of fall
Time Frame: Six month
|
The frequency of recurrent falls were were determined by questioning the patients.
|
Six month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Factors related with recurrent falls
Time Frame: Six month
|
Poor postural control, number of falls,fear of falling, functional disability, ambulation level of the patients will be evaluated.
|
Six month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Altınay Göksel Karatepe, MD, Saglik Bilimleri Universitesi
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 31, 2021
Primary Completion (Actual)
February 28, 2023
Study Completion (Actual)
March 28, 2023
Study Registration Dates
First Submitted
March 8, 2023
First Submitted That Met QC Criteria
September 25, 2023
First Posted (Actual)
September 29, 2023
Study Record Updates
Last Update Posted (Actual)
September 29, 2023
Last Update Submitted That Met QC Criteria
September 25, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 117
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.