Fall PatientsNCT05072366
Reliability and Validity of the Turkish Version of the Tinetti Fall Efficacy Scale in Older People
An observational study of Fall Patients, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
The Joint International Commission (JCI) defines a fall as an unplanned, abrupt, change of motion towards the ground that may result in physical injury. Falls are among the most obvious reasons for applying to health centers after an involuntary external injury. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall Patients
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Mar 2022to 31 Dec 2022
- How long will I take part?
- 1 Day
- 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: It is planned to conduct a study with elderly inpatients at the Izmir Governor's Private Empathy Care Center. Turkish volunteers aged 65 and over.
Who may be able to join
- Being 65 years old and over,
- Not having a cooperation problem (individuals with a mini mental test score >24),
- Not having communication difficulties or problems
- Voluntarily accepts participation in the research.
Who cannot join
- Those with uncontrollable hypertension, heart disease, cardiac arrhythmia, cardiovascular disease,
- Those who have malignancy and cause malignancy, receive chemotherapy, radiotherapy,
- Those who have any neurological or orthopedic disorder that will disrupt the balance,
- Individuals who are addicted to alcohol and drugs,
- Those who do not accept to participate in the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability and Validity of the Turkish Version of the Tinetti Fall Efficacy Scale in Older People and Comparison With Other Fall Scales
The Joint International Commission (JCI) defines a fall as an unplanned, abrupt, change of motion towards the ground that may result in physical injury. Falls are among the most obvious reasons for applying to health centers after an involuntary external injury. Risk of falls diagnostic tools; It is used to reduce the incidence of falls, to reduce the severity of falls, to increase walking and existing functional status, to determine the factors causing falls and to keep them under control, and to raise awareness of health personnel about falls. This study aims to make the Turkish cultural adaptation of the Tinetti Fall Efficiency Scale, to test the validity and reliability of the factorial structure in elderly individuals. It was planned to determine that it is specific and sensitive. The Fall Efficiency Scale (DAS) was developed based on the definition of this fear as "low perceived self-efficacy in avoiding falls during harmless activities of daily living".
Read the detailed description
Is the fall effectiveness scale an effective scale that determines the fear of falling? To find the answer to this question of which scale is more sensitive when compared to other scales, to ensure the adaptation of the elderly individuals in Turkish society and to raise awareness of the discomforts that can be experienced after falling to the geriatric individual and their surroundings, as a result of this, by enabling those at risk of falling to contact health professionals, preventive rehabilitation and other treatment methods are encouraged. It is aimed to gain public awareness about reducing health expenditures and protecting body integrity.
This thesis study is suitable for the methodological research method that investigates the validity and reliability of a questionnaire. In this study demographic data (age, gender, educational status, occupation, marital status) of individuals will be questioned in the initial evaluations. Height (m), weight (kg) will be recorded and body mass index (BMI) will be determined as body weight/height2 (kg/m2). The drugs used, co-morbidities, backgrounds will be recorded in the socio-demographic information forms of the individuals will be applied. This study aimed to adapt the Tinetti Fall Effectiveness Scale (FES), a tool to measure fear of falling, into Turkish, to demonstrate its validity-reliability and sensitivity to change in elderly individuals, and to compare the Timed Up and Go Test, Fall Risk Self-Assessment Scale, Tinetti Balance, and Gait Assessment and Activity. Together with the Specific Balance Confidence scales, an answer was sought for the question of which is the most effective scale for falling.
In scale studies, taking at least 3 or 5-10 people for each scale item constitutes the sample size. As the Fall Efficiency Scale consisted of 10 items, it was planned to study with 51 individuals.
- Conditions
- Fall Patients
- Keywords
- Falling, Gait, Balance, Geriatrics
What is being measured
The primary outcome is the main question the study is designed to answer.
Socio-demographic Information Form
Demographic data of individuals (age, gender, educational status, occupation, marital status) will be questioned. Height (m), weight (kg) were recorded and body mass index (BMI) will be determined as body weight/height2 (kg/m2). Medications used, additional diseases, backgrounds will be recorded in the socio-demographic information forms of the individuals.
Measured: through study completion, an average of six months
Standardized Mini Mental Test
The scale, which consists of 11 items, gathered under five main headings as orientation, recording memory, attention and calculation, recall and language, is evaluated over a total of 30 points. While the maximum score on this scale is 30, scores below 20 in adults indicate cognitive impairment. The ideal threshold value of MMDT was found to be 24.
Measured: through study completion, an average of six months
Fall Efficacy Scale
Evaluates the activities of daily living in 10 different activities by scoring "on a scale of 1 to 10, where 1 is very confident and 10 is very confident, how sure are you that you can do the following activities without falling?"; A total score above 70 indicates that the person has a fear of falling.
Measured: through study completion, an average of six months
Fall Risk Self-Assessment Scale
It is a scale that evaluates the risk of falling in the elderly. It consists of 13 items assessing the risk of falling in the elderly. The answers are yes (1 point) and no (0 points), and individuals who score 4 points or more from the score are classified as having a high risk of falling.
Measured: through study completion, an average of six months
Activity-Specific Balance Confidence Scale
Individuals were asked 16 questions about how confidently they performed the movements they performed during daily life and were asked to give a score between 0 and 100.
At the end of the test, the scores were summed up and divided by 16 to obtain the individual's ABC score. A high value indicates that the individual feels confident about balance.
Measured: through study completion, an average of six months
Time up and go
A score ≥ 13.5 s indicated a high risk of falling. The patient was asked to get up from the chair he was sitting in, walk 3 meters (at his own walking pace), then go back and sit on the chair again, and the total time spent was recorded. The patient was allowed to use the arm of the chair when getting up from the chair and to use an assistive device during this test.
Measured: through study completion, an average of six months
Tinetti Balance and Gait Test
In the test used to evaluate balance, the walking score is a maximum of 12 points, the balance score is a maximum of 16 points and a total of 28 points. Those who score twenty-six and below are considered to have a problem. Studies have shown that the lower the score, the higher the risk of falling.
Measured: through study completion, an average of six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start31 Mar 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall PatientsStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 51 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melahat Selin DURMUŞ, Kırıkkale University
- Investigators
- Melahat S. DURMUŞ, PT, Study chair, Kırıkkale UniversityMeral SERTEL, Assoc. Prof, Study director, Kırıkkale UniversitySaniye AYDOĞAN, Dr., Study director, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072366
- Sponsor's protocol ID
- KırıkkaleUniversityMSD
- Status last verified
- Aug 2022
- First submitted
- 19 Sep 2021
- Last updated
- 17 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Turkish Version of the Tinetti Fall Efficacy Scale in Older People and Comparison With Other Fall Scales
- ClinicalTrials.gov ID
- NCT05072366
- Acronym / sponsor ID
- KırıkkaleUniversityMSD
- Conditions
- Fall Patients
- Keywords
- Falling, Gait, Balance, Geriatrics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 8 Oct 2021 (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 Joint International Commission (JCI) defines a fall as an unplanned, abrupt, change of motion towards the ground that may result in physical injury. Falls are among the most obvious reasons for applying to health centers after an involuntary external injury. Risk of falls diagnostic tools; It is used to reduce the incidence of falls, to reduce the severity of falls, to increase walking and existing functional status, to determine the factors causing falls and to keep them under control, and to raise awareness of health personnel about falls. This study aims to make the Turkish cultural adaptation of the Tinetti Fall Efficiency Scale, to test the validity and reliability of the factorial structure in elderly individuals. It was planned to determine that it is specific and sensitive. The Fall Efficiency Scale (DAS) was developed based on the definition of this fear as "low perceived self-efficacy in avoiding falls during harmless activities of daily living".
Detailed description
Is the fall effectiveness scale an effective scale that determines the fear of falling? To find the answer to this question of which scale is more sensitive when compared to other scales, to ensure the adaptation of the elderly individuals in Turkish society and to raise awareness of the discomforts that can be experienced after falling to the geriatric individual and their surroundings, as a result of this, by enabling those at risk of falling to contact health professionals, preventive rehabilitation and other treatment methods are encouraged. It is aimed to gain public awareness about reducing health expenditures and protecting body integrity.
This thesis study is suitable for the methodological research method that investigates the validity and reliability of a questionnaire. In this study demographic data (age, gender, educational status, occupation, marital status) of individuals will be questioned in the initial evaluations. Height (m), weight (kg) will be recorded and body mass index (BMI) will be determined as body weight/height2 (kg/m2). The drugs used, co-morbidities, backgrounds will be recorded in the socio-demographic information forms of the individuals will be applied. This study aimed to adapt the Tinetti Fall Effectiveness Scale (FES), a tool to measure fear of falling, into Turkish, to demonstrate its validity-reliability and sensitivity to change in elderly individuals, and to compare the Timed Up and Go Test, Fall Risk Self-Assessment Scale, Tinetti Balance, and Gait Assessment and Activity. Together with the Specific Balance Confidence scales, an answer was sought for the question of which is the most effective scale for falling.
In scale studies, taking at least 3 or 5-10 people for each scale item constitutes the sample size. As the Fall Efficiency Scale consisted of 10 items, it was planned to study with 51 individuals.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- It is planned to conduct a study with elderly inpatients at the Izmir Governor's Private Empathy Care Center. Turkish volunteers aged 65 and over.
Key inclusion criteria (4 listed)
- Being 65 years old and over,
- Not having a cooperation problem (individuals with a mini mental test score >24),
- Not having communication difficulties or problems
- Voluntarily accepts participation in the research.
Key exclusion criteria (5 listed)
- Those with uncontrollable hypertension, heart disease, cardiac arrhythmia, cardiovascular disease,
- Those who have malignancy and cause malignancy, receive chemotherapy, radiotherapy,
- Those who have any neurological or orthopedic disorder that will disrupt the balance,
- Individuals who are addicted to alcohol and drugs,
- Those who do not accept to participate in the research.
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
Socio-demographic Information Form
Time frame: through study completion, an average of six months
Demographic data of individuals (age, gender, educational status, occupation, marital status) will be questioned. Height (m), weight (kg) were recorded and body mass index (BMI) will be determined as body weight/height2 (kg/m2). Medications used, additional diseases, backgrounds will be recorded in the socio-demographic information forms of the individuals.
Standardized Mini Mental Test
Time frame: through study completion, an average of six months
The scale, which consists of 11 items, gathered under five main headings as orientation, recording memory, attention and calculation, recall and language, is evaluated over a total of 30 points. While the maximum score on this scale is 30, scores below 20 in adults indicate cognitive impairment. The ideal threshold value of MMDT was found to be 24.
Fall Efficacy Scale
Time frame: through study completion, an average of six months
Evaluates the activities of daily living in 10 different activities by scoring "on a scale of 1 to 10, where 1 is very confident and 10 is very confident, how sure are you that you can do the following activities without falling?"; A total score above 70 indicates that the person has a fear of falling.
Fall Risk Self-Assessment Scale
Time frame: through study completion, an average of six months
It is a scale that evaluates the risk of falling in the elderly. It consists of 13 items assessing the risk of falling in the elderly. The answers are yes (1 point) and no (0 points), and individuals who score 4 points or more from the score are classified as having a high risk of falling.
Activity-Specific Balance Confidence Scale
Time frame: through study completion, an average of six months
Individuals were asked 16 questions about how confidently they performed the movements they performed during daily life and were asked to give a score between 0 and 100. At the end of the test, the scores were summed up and divided by 16 to obtain the individual's ABC score. A high value indicates that the individual feels confident about balance.
Time up and go
Time frame: through study completion, an average of six months
A score ≥ 13.5 s indicated a high risk of falling. The patient was asked to get up from the chair he was sitting in, walk 3 meters (at his own walking pace), then go back and sit on the chair again, and the total time spent was recorded. The patient was allowed to use the arm of the chair when getting up from the chair and to use an assistive device during this test.
Tinetti Balance and Gait Test
Time frame: through study completion, an average of six months
In the test used to evaluate balance, the walking score is a maximum of 12 points, the balance score is a maximum of 16 points and a total of 28 points. Those who score twenty-six and below are considered to have a problem. Studies have shown that the lower the score, the higher the risk of falling.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- The main test of the thesis to be valid and reliableLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Melahat S. DURMUŞ, PT study chair
Kırıkkale University
Meral SERTEL, Assoc. Prof study director
Kırıkkale University
Saniye AYDOĞAN, Dr. study director
Kırıkkale 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 Fall Patients, run by Kırıkkale 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 4 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: status not confirmed, as of the sponsor's last update on 17 Aug 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?
Results are not available in the source record.
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?
Socio-demographic Information Form (time frame: through study completion, an average of six months). The study lists 7 primary outcomes in all. 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 17 Aug 2022.