FallNCT06061887
Factors Associated With Recurrent Falls in Stroke Patients
An observational study of Fall and Stroke, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- What is being tested?
- Fall evaluation
- How many people
- 147 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Mar 2021to 28 Mar 2023
- 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 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients aged 18 and over, hospitalized in the neurology service with the diagnosis of acute stroke
Who may be able to join
- Having an acute stroke over the age of 18
- To have a cognitive situation to understand and answer questions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
- Being tested
- Fall evaluation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fall evaluationOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of fall
The frequency of recurrent falls were were determined by questioning the patients.
Measured: 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.
Measured: Six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start31 Mar 2021
- Primary completion28 Feb 2023
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Altınay Göksel Karatepe, Bozyaka Training and Research Hospital
- Investigators
- Altınay Göksel Karatepe, MD, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061887
- Sponsor's protocol ID
- 117
- Status last verified
- Sep 2023
- First submitted
- 8 Mar 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Falls in Stroke Patients and Factors Associated With Recurrent Falls
- ClinicalTrials.gov ID
- NCT06061887
- Acronym / sponsor ID
- 117
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 and over, hospitalized in the neurology service with the diagnosis of acute stroke
Key inclusion criteria (2 listed)
- Having an acute stroke over the age of 18
- To have a cognitive situation to understand and answer questions
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fall evaluationEvaluation 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 | Other | – |
Primary outcome
Frequency of fall
Time frame: Six month
The frequency of recurrent falls were were determined by questioning the patients.
1 secondary outcome
Factors related with recurrent falls
Time frame: Six month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Results publication: PubMed 32497600Samuelsson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Altınay Göksel Karatepe, MD principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fall and Stroke, run by Bozyaka Training and Research Hospital 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 2 inclusion and 5 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 29 Sep 2023. 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?
Frequency of fall (time frame: Six month). 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 NCT06061887, which also lists 1 linked publication.
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 29 Sep 2023.