EldersNCT05035329
Turkish Version of Lower Extremity Functional Scale in Elders
An observational study of Elders, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted in order to analyze the validity and reliability, and psychometric properties of the Turkish version of the Lower Extremity Functional Scale (LEFS-T) in elder adults. The LEFS was translated and cross-culturally adapted to Turkish. Totally 214 elders were included in the study. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elders
- What is being tested?
- Outcome measurements
- How many people
- 214 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Oct 2017to 20 Oct 2019
- How long will I take part?
- 7 Days
- 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: This study included 65 years old and elder adults.
Who may be able to join
- Being 65 years old and older, and ability to speak and read Turkish fluently.
Who cannot join
- Having neurological, cognitive, and communication problems that can affect the lower extremity functionality severely, and elder adults who cannot answer questionnaires due to inability to understand.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University
Denizli, Kınıklı/Pamukkale, 20070
About this study
Official title: Validity and Reliability of Turkish Version of Lower Extremity Functional Scale in Elders
This study was conducted in order to analyze the validity and reliability, and psychometric properties of the Turkish version of the Lower Extremity Functional Scale (LEFS-T) in elder adults. The LEFS was translated and cross-culturally adapted to Turkish. Totally 214 elders were included in the study. The LEFS-T, Five-Times-Sit-to-Stand Test (FTSTS), and Falls Efficacy Scale International (FES-I) were applied to all older adults. Item-total correlations of factors and Cronbach alpha internal consistency coefficients were determined to examine the reliability. The relationship between the LEFS-T, FTSTS, and FES-I was analyzed. Exploratory (EFA) and confirmatory factor analysis (CFA) were used for construct validity. Spearman Correlation Analysis was used for concurrent validity. Davis technique was used to calculate the content validity index. Floor and ceiling effect were calculated. It has been concluded that the LEFS-T has good psychometric qualities and can be recommended as a choice of measurement tool to assess self-reported physical functioning in elder adults.
Read the detailed description
Purpose: This study was conducted in order to analyze the validity and reliability, and psychometric properties of the Turkish version of the Lower Extremity Functional Scale (LEFS-T) in elder adults.
Method: The LEFS was translated and cross-culturally adapted to Turkish. Totally 214 elders were included in the study. The LEFS-T, Five-Times-Sit-to-Stand Test (FTSTS), and Falls Efficacy Scale International (FES-I) were applied to all older adults. Item-total correlations of factors and Cronbach alpha internal consistency coefficients were determined to examine the reliability. The relationship between the LEFS-T, FTSTS, and FES-I was analyzed. Exploratory and confirmatory factor analysis were used for construct validity. Spearman Correlation Analysis was used for concurrent validity. Davis technique was used to calculate the content validity index. Floor and ceiling effect were calculated.
- Conditions
- Elders
- Being tested
- Outcome measurements
- Keywords
- elders, Lower Extremity Functional Scale, validity, reliability, Turkish version
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outcome measurementsOther
Outcome measurements were applied.
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Extremity Functional Scale
The Lower Extremity Functional Scale was translated and cross-culturally adapted to Turkish. Items are scored as a 5-point Likert Scale (0 = extreme difficulty/ unable to perform an activity, 4 = no difficulty). The highest total score of 80 indicates that the person has a high functional level.
Measured: seven days
Five-Times-Sit-to-Stand Test
The elders were instructed to stand from a standard chair five consecutive times as fast as possible.The duration of the test was recorded in terms of seconds. Less duration means better performance.
Measured: seven days
Falls Efficacy Scale International
The Prevention of Falls Network Europe developed the Falls Efficacy Scale International to assess people's fear of falling during daily living activities. The items score between 1 (not at all concerned) to 4 (very concerned).
Measured: seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start21 Oct 2017
- Primary completion11 Jun 2018
- Study completion20 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EldersStudies 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
- Cross-sectional
- Enrolment
- 214 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güzin Kara, Pamukkale University
- Investigators
- Güzin Kara, PhD, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035329
- Sponsor's protocol ID
- E-60116787-020-29008
- Status last verified
- Sep 2021
- First submitted
- 3 Aug 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
PubMed 10201543Cacchio A, De Blasis E, Necozione S, Rosa F, Riddle DL, di Orio F, De Blasis D, Santilli V. The Italian version of the lower extremity functional scale was reliable, valid, and responsive. J Clin Epidemiol. 2010 May;63(5):550-7. doi: 10.1016/j.jclinepi.2009.08.001. Epub 2009 Nov 12.
PubMed 19913388
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Turkish Version of Lower Extremity Functional Scale in Elders
- ClinicalTrials.gov ID
- NCT05035329
- Acronym / sponsor ID
- E-60116787-020-29008
- Conditions
- Elders
- Keywords
- elders, Lower Extremity Functional Scale, validity, reliability, Turkish version
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 21 Oct 2017 (actual)
- Primary completion
- 11 Jun 2018 (actual)
- Study completion
- 20 Oct 2019 (actual)
- First posted
- 5 Sep 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.
This study was conducted in order to analyze the validity and reliability, and psychometric properties of the Turkish version of the Lower Extremity Functional Scale (LEFS-T) in elder adults. The LEFS was translated and cross-culturally adapted to Turkish. Totally 214 elders were included in the study. The LEFS-T, Five-Times-Sit-to-Stand Test (FTSTS), and Falls Efficacy Scale International (FES-I) were applied to all older adults. Item-total correlations of factors and Cronbach alpha internal consistency coefficients were determined to examine the reliability. The relationship between the LEFS-T, FTSTS, and FES-I was analyzed. Exploratory (EFA) and confirmatory factor analysis (CFA) were used for construct validity. Spearman Correlation Analysis was used for concurrent validity. Davis technique was used to calculate the content validity index. Floor and ceiling effect were calculated. It has been concluded that the LEFS-T has good psychometric qualities and can be recommended as a choice of measurement tool to assess self-reported physical functioning in elder adults.
Detailed description
Purpose: This study was conducted in order to analyze the validity and reliability, and psychometric properties of the Turkish version of the Lower Extremity Functional Scale (LEFS-T) in elder adults.
Method: The LEFS was translated and cross-culturally adapted to Turkish. Totally 214 elders were included in the study. The LEFS-T, Five-Times-Sit-to-Stand Test (FTSTS), and Falls Efficacy Scale International (FES-I) were applied to all older adults. Item-total correlations of factors and Cronbach alpha internal consistency coefficients were determined to examine the reliability. The relationship between the LEFS-T, FTSTS, and FES-I was analyzed. Exploratory and confirmatory factor analysis were used for construct validity. Spearman Correlation Analysis was used for concurrent validity. Davis technique was used to calculate the content validity index. Floor and ceiling effect were calculated.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- This study included 65 years old and elder adults.
Key inclusion criteria (1 listed)
- Being 65 years old and older, and ability to speak and read Turkish fluently.
Key exclusion criteria (1 listed)
- Having neurological, cognitive, and communication problems that can affect the lower extremity functionality severely, and elder adults who cannot answer questionnaires due to inability to understand.
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 |
|---|---|---|
| Outcome measurementsOutcome measurements were applied. | Other | – |
Primary outcome
Lower Extremity Functional Scale
Time frame: seven days
The Lower Extremity Functional Scale was translated and cross-culturally adapted to Turkish. Items are scored as a 5-point Likert Scale (0 = extreme difficulty/ unable to perform an activity, 4 = no difficulty). The highest total score of 80 indicates that the person has a high functional level.
Five-Times-Sit-to-Stand Test
Time frame: seven days
The elders were instructed to stand from a standard chair five consecutive times as fast as possible.The duration of the test was recorded in terms of seconds. Less duration means better performance.
Falls Efficacy Scale International
Time frame: seven days
The Prevention of Falls Network Europe developed the Falls Efficacy Scale International to assess people's fear of falling during daily living activities. The items score between 1 (not at all concerned) to 4 (very concerned).
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 17 Sep 2021.
- Background: PubMed 10201543Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
- Background: PubMed 19913388Cacchio A, De Blasis E, Necozione S, Rosa F, Riddle DL, di Orio F, De Blasis D, Santilli V. The Italian version of the lower extremity functional scale was reliable, valid, and responsive. J Clin Epidemiol. 2010 May;63(5):550-7. doi: 10.1016/j.jclinepi.2009.08.001. Epub 2009 Nov 12.
- 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.
Güzin Kara, PhD principal investigator
Pamukkale 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 Elders, run by Pamukkale 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 1 inclusion and 1 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 17 Sep 2021. 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?
Lower Extremity Functional Scale (time frame: seven days). The study lists 3 primary outcomes in all. 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 NCT05035329, which also lists 2 linked publications.
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 Sep 2021.