AgedNCT06153732
The Foot Posture and Falling Risk in Older People
An observational study of Aged, run by Bahar Anaforoglu Külünkoglu at 1 site in Turkey (Türkiye).
Trial summary
This research will be conducted to examine the relationship between the foot postures and fall risks of elderly individuals living in nursing homes, to identify the factors that most affect the risk of falling, and to inform healthcare professionals working on this subject. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aged
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2023to Dec 2024
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Zonguldak Center, Çaycuma and Kdz, affiliated to the Zonguldak Provincial Directorate of Family and Social Services, participated in the study. Volunteer elderly individuals living in Ereğli İzmirlioğlu Nursing Homes who meet the inclusion criteria will participate in the study.An application will be made to Zonguldak Provincial Directorate of Family and Social Services to conduct this study and the necessary permissions will be obtained. The work will begin after receiving permission approval from the relevant units.
Who may be able to join
- 65 years and older
- Scoring 24 and above from the Mini Mental State Test
- Completing the 8 step up and go test in the Senior Fitness Test Protocol
Who cannot join
- Those who need the use of auxiliary tools in performing daily life activities,
- Those who are in the recovery period of an acute disease,
- Cancer patients known to be life-threatening,
- Cardiovascular problem (previous congestive heart failure, transient ischemic attacks),
- Parkinson's disease,
- Stroke history in the last 6 months
Show all 12Show fewer
- Progressive neuromuscular disease,
- Acute inner ear inflammation and severe hearing loss,
- Those who have lost their eyesight enough to be unable to read the test protocol and see the movements in the test,
- Those who have a fall story in the last year,
- Those who are in a structured exercise program more than three times a week (not physically active),
- Those with chronic orthopedic diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zonguldak Center, Kdz. Ereğli İzmirlioğlu and Çaycuma Nursing Homes
Zonguldak, Center
Ali Osman Yılmaz, +90 (372) 250 08 16, zonguldak@aile.gov.tr
Ayşe TORAMAN KARAGÜLMEZ, Lecturer
About this study
This research will be conducted to examine the relationship between the foot postures and fall risks of elderly individuals living in nursing homes, to identify the factors that most affect the risk of falling, and to inform healthcare professionals working on this subject.
Factors that may increase the risk of falling will be determined from the biomechanical changes that occur in the foot with age. In addition, the results we obtain will contribute to the database to be created in the future to identify factors affecting the risk of falling.
Read the detailed description
The aim of this study is to examine the relationship between foot postures and fall risks of elderly individuals living in nursing homes, to identify the factors that most affect the risk of falling and to inform healthcare professionals on this subject.
Participants included in the research will be grouped in three ways according to their gender, disease status and whether they use medication or not. The disease conditions of the participants will be handled in two ways: direct and indirect disease groups due to falls.
The researchers will evaluate the cognitive status of the participants with the Standardized Mini Mental State Test, balance and fall risks of the participants with the One Leg Standing Test and the 8 Step Up and Go Test and foot postures of the participants with the Foot Posture Index.
A power analysis was conducted to determine the number of participants required for the research. According to the power analysis result; It was found that the minimum number of participants required to be included in the study for one-way analysis of variance with an effect size of 0.3, α= 0.05, and 85% power was 126.
Ethics committee approval for the research was received by the researchers from Ankara Yıldırım Beyazıt University Health Sciences Ethics Committee on 05.01.2020 with research number 2020-600. Later, the researchers made the necessary applications to conduct this study in Karadeniz Ereğli İzmirlioğlu Nursing Home, affiliated with the Zonguldak Provincial Directorate of Family and Social Services.
However, due to the Covid-19 pandemic that affected the whole world, permission approval for the study for the Karadeniz Ereğli İzmirlioğlu Nursing Home was given to the researchers by the Zonguldak Provincial Directorate of Family and Social Services on January 21, 2022. In the preliminary examination conducted by the researchers, it was determined that the number of people required to be included in the study could not be reached from only one nursing home.
For this reason, the researchers again applied to Ankara Yıldırım Beyazıt University Health Sciences Ethics Committee with the request to add new nursing homes to the study.
In order to expand the scope of the research and conduct it in Zonguldak Center and Çaycuma Nursing Homes, a new ethics committee permission was obtained with the decision of Ankara Yıldırım Beyazıt University Health Sciences Ethics Committee dated 09.06.22 and numbered 10/960.
Later, the researchers made the necessary applications to conduct this study in Zonguldak Center and Çaycuma Nursing Homes affiliated with the Zonguldak Provincial Directorate of Family and Social Services.
Permission approval to conduct the study in Zonguldak Center and Çaycuma Nursing Homes was given to the researchers by the Zonguldak Provincial Directorate of Family and Social Services on August 11, 2022. Participants who meet the inclusion and exclusion criteria, aged 65 and over, living in Zonguldak Center and Çaycuma Nursing Home, will be included in the research.
- Conditions
- Aged
- Keywords
- Falls, Aged, Foot
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental State Test
For Individuals; A questionnaire consisting of 2 questions about recording memory, 1 about attention and calculation, 1 about remembering, 6 questions about language, 10 questions about orientation and a maximum total score of 30 will be applied. From the MMDT scores; 28-30 range; high normal, 24-27 range indicates low cognitive function, and 0-23 range indicates impaired cognitive status.
Measured: Baseline
Secondary outcomes (1)
Eight Step Up and Go Test included in the Senior Fitness Test:
It is performed at a distance of 2.44 cm, using a chair with a straight back and no armrest with a seat height of 43.18 cm, a meter, a cone, a stopwatch with an accuracy of 1/10 second. When the individual gets up from the chair with the start command while sitting position, the stopwatch is started with the command. The individual is asked to turn around the cue point at a distance of 2.44 cm as quickly as possible, but without running, and reach the chair again.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start2 Jan 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgedStudies 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
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahar Anaforoglu Külünkoglu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bahar Anaforoglu Külünkoglu, Ankara Yildirim Beyazıt University
- Investigators
- Bahar ANAFOROGLU KULUNKOGLU, Assoc. Prof., Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153732
- Sponsor's protocol ID
- AnkaraYBU
- Status last verified
- Dec 2023
- First submitted
- 23 Nov 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Foot Posture and Falling Risk in Older People
- ClinicalTrials.gov ID
- NCT06153732
- Acronym / sponsor ID
- AnkaraYBU
- Conditions
- Aged
- Keywords
- Falls, Aged, Foot
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Bahar Anaforoglu KülünkogluUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Dec 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.
This research will be conducted to examine the relationship between the foot postures and fall risks of elderly individuals living in nursing homes, to identify the factors that most affect the risk of falling, and to inform healthcare professionals working on this subject.
Factors that may increase the risk of falling will be determined from the biomechanical changes that occur in the foot with age. In addition, the results we obtain will contribute to the database to be created in the future to identify factors affecting the risk of falling.
Detailed description
The aim of this study is to examine the relationship between foot postures and fall risks of elderly individuals living in nursing homes, to identify the factors that most affect the risk of falling and to inform healthcare professionals on this subject.
Participants included in the research will be grouped in three ways according to their gender, disease status and whether they use medication or not. The disease conditions of the participants will be handled in two ways: direct and indirect disease groups due to falls.
The researchers will evaluate the cognitive status of the participants with the Standardized Mini Mental State Test, balance and fall risks of the participants with the One Leg Standing Test and the 8 Step Up and Go Test and foot postures of the participants with the Foot Posture Index.
A power analysis was conducted to determine the number of participants required for the research. According to the power analysis result; It was found that the minimum number of participants required to be included in the study for one-way analysis of variance with an effect size of 0.3, α= 0.05, and 85% power was 126.
Ethics committee approval for the research was received by the researchers from Ankara Yıldırım Beyazıt University Health Sciences Ethics Committee on 05.01.2020 with research number 2020-600. Later, the researchers made the necessary applications to conduct this study in Karadeniz Ereğli İzmirlioğlu Nursing Home, affiliated with the Zonguldak Provincial Directorate of Family and Social Services.
However, due to the Covid-19 pandemic that affected the whole world, permission approval for the study for the Karadeniz Ereğli İzmirlioğlu Nursing Home was given to the researchers by the Zonguldak Provincial Directorate of Family and Social Services on January 21, 2022. In the preliminary examination conducted by the researchers, it was determined that the number of people required to be included in the study could not be reached from only one nursing home.
For this reason, the researchers again applied to Ankara Yıldırım Beyazıt University Health Sciences Ethics Committee with the request to add new nursing homes to the study.
In order to expand the scope of the research and conduct it in Zonguldak Center and Çaycuma Nursing Homes, a new ethics committee permission was obtained with the decision of Ankara Yıldırım Beyazıt University Health Sciences Ethics Committee dated 09.06.22 and numbered 10/960.
Later, the researchers made the necessary applications to conduct this study in Zonguldak Center and Çaycuma Nursing Homes affiliated with the Zonguldak Provincial Directorate of Family and Social Services.
Permission approval to conduct the study in Zonguldak Center and Çaycuma Nursing Homes was given to the researchers by the Zonguldak Provincial Directorate of Family and Social Services on August 11, 2022. Participants who meet the inclusion and exclusion criteria, aged 65 and over, living in Zonguldak Center and Çaycuma Nursing Home, will be included in the research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Zonguldak Center, Çaycuma and Kdz, affiliated to the Zonguldak Provincial Directorate of Family and Social Services, participated in the study. Volunteer elderly individuals living in Ereğli İzmirlioğlu Nursing Homes who meet the inclusion criteria will participate in the study.An application will be made to Zonguldak Provincial Directorate of Family and Social Services to conduct this study and the necessary permissions will be obtained. The work will begin after receiving permission approval from the relevant units.
Key inclusion criteria (3 listed)
- 65 years and older
- Scoring 24 and above from the Mini Mental State Test
- Completing the 8 step up and go test in the Senior Fitness Test Protocol
Key exclusion criteria (12 listed)
- Those who need the use of auxiliary tools in performing daily life activities,
- Those who are in the recovery period of an acute disease,
- Cancer patients known to be life-threatening,
- Cardiovascular problem (previous congestive heart failure, transient ischemic attacks),
- Parkinson's disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mini Mental State Test
Time frame: Baseline
For Individuals; A questionnaire consisting of 2 questions about recording memory, 1 about attention and calculation, 1 about remembering, 6 questions about language, 10 questions about orientation and a maximum total score of 30 will be applied. From the MMDT scores; 28-30 range; high normal, 24-27 range indicates low cognitive function, and 0-23 range indicates impaired cognitive status.
1 secondary outcome
Eight Step Up and Go Test included in the Senior Fitness Test:
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- 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.
Bahar ANAFOROGLU KULUNKOGLU, Assoc. Prof. principal investigator
Ankara Yildirim Beyazıt University
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 Aged, run by Bahar Anaforoglu Külünkoglu 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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 8 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bahar ANAFOROGLU KULUNKOGLU, Assoc. Prof. (+905057421220, anaforoglub@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Mental State Test (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2023.