Translation, Cultural Adaptation and Turkish ValidationNCT05214755
Translation, Cross-Cultural Adaptation and Turkish Validation of the 25-Question Geriatric Locomotive Function Scale
An observational study of Translation, Cultural Adaptation and Turkish Validation, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
25-question Geriatric Locomotive Function Scale (GLFS-25) is a patient-reported outcome measure consisting of 25 questions that evaluates locomotive functions and locomotive syndrome risk in elderly individuals. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Translation, Cultural Adaptation and Turkish Validation
- How many people
- 264 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 1 May 2021
- 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: Elderly people who are over the age of 65 and can answer the questionnaire on their own or with the help of their relatives.
Who may be able to join
- over the age of 65
- who can answer the questionnaire on their own or with the help of their relatives
Who cannot join
- unable to walk without the assistance of another person
- having a brain disease or severe cardiovascular, pulmonary or renal disease
- having a history of lower extremity and/or spine fractures in the last 6 months
- were treated for acute trauma
Trial locations and contacts
1 site in 1 country.
About this study
25-question Geriatric Locomotive Function Scale (GLFS-25) is a patient-reported outcome measure consisting of 25 questions that evaluates locomotive functions and locomotive syndrome risk in elderly individuals.
The purpose of this study was to translate and cross-culturally adapt the English version of the GLFS-25 into Turkish and to investigate the reliability and validity of the translated version of the scale.
Read the detailed description
Aging is an inevitable process that begins after birth and continues until the death of the individual, affecting the person mentally and physically. Approximately 21% of elderly individuals requiring care have locomotive organ disorders involving the bone, joint, muscle and nervous system. 25-question Geriatric Locomotive Function Scale (GLFS-25), developed by Japanese researchers in 2012, is a patient-reported outcome measure consisting of 25 questions that evaluates locomotive functions and locomotive syndrome risk in elderly individuals. This scale provides an advantage in terms of locomotive ability and early detection of locomotive syndrome in the elderly. In addition, the scale provides the opportunity to decrease number of needing for hospital care of elderly individuals by early detection of locomotive functions and the risk of locomotive syndrome. Before a patient-reported outcome measure can be used in a society other than the one in which it was developed, it must be translated and culturally adapted. The GLFS-25 have been translated to different cultural settings and into many languages, including Brazilian, Iranian and Chinese. Data obtained from the culturally adapted versions contribute to a better understanding of the tools measurement properties. The studies reported that translated versions of GLFS-25 reliable and valid in older adults for functional assessment. Therefore, a Turkish version of the GLFS-25 would likely be that would be helpful in the functional state management and risk factor analyzes for locomotive syndrome of the Turkish older adult population. The purpose of this study was to translate and cross-culturally adapt the English version of the GLFS-25 into Turkish and to investigate the reliability and validity of the translated version of the scale.
- Keywords
- Elderly, Turkish, GLFS-25, Function, Reliability, Validity
What is being measured
The primary outcome is the main question the study is designed to answer.
25-question Geriatric Locomotive Function Scale (GLFS-25)
GLFS-25 is an assessment tool developed for evaluate locomotive functions in elderly individuals. This scale consists of a self-reported questionnaire with 25 items that are easily understood by the elderly, and each item is graded from 0 to 4 points. The final score is determined by the sum of all items ranging from 0 to 100.
Measured: Baseline
Secondary outcomes (5)
25-question Geriatric Locomotive Function Scale (GLFS-25)
GLFS-25 is an assessment tool developed for evaluate locomotive functions in elderly individuals. This scale consists of a self-reported questionnaire with 25 items that are easily understood by the elderly, and each item is graded from 0 to 4 points. The final score is determined by the sum of all items ranging from 0 to 100.
Measured: Within a 7-to-14-day period after the first assessment
Katz Index
The scale consists of 6 questions evaluating washing, dressing, toilet, continence, transfer and feeding activities. For activities, 'dependent' is evaluated with 0 point and 'independent' is evaluated with 1 point. Six points indicate complete independence, 0 point complete dependence.
Measured: Baseline
Lawton Index
This index includes 8 activities: the ability to use a phone, shopping, using public transport, meal preparation, doing daily housework, traveling, the responsibility for using medication and the ability to handle finance. The scoring scale is 0 and 1, and the sum of the scores is varied from 0 to 8 points.
Measured: Baseline
Visual Analogue Scale (VAS)
The VAS assesses pain status on a 10 cm chart, with 0 points defined as "no pain" and 10 points as "terrible pain".
Measured: Baseline
Geriatric Depression Scale
Geriatric Depression Scale is a 30-item scale that evaluates the level of depression in elderly individuals. Questions 1,5,7,9,15,19,21,28,29 and 30 in the scale are evaluated with 0 point for 'yes' and 1 point for 'no'. The total scoring is 30 points, and individuals who score 14 are reported to have a high risk of depression.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start1 Dec 2020
- Primary completion1 Apr 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Translation, Cultural Adaptation and Turkish ValidationStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Aksan Sadıkoğlu, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214755
- Sponsor's protocol ID
- IstanbulAU2022
- Status last verified
- Aug 2022
- First submitted
- 17 Jan 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation, Cross-Cultural Adaptation and Turkish Validation of the 25-Question Geriatric Locomotive Function Scale
- ClinicalTrials.gov ID
- NCT05214755
- Acronym / sponsor ID
- IstanbulAU2022
- Keywords
- Elderly, Turkish, GLFS-25, Function, Reliability, Validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 31 Jan 2022 (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.
25-question Geriatric Locomotive Function Scale (GLFS-25) is a patient-reported outcome measure consisting of 25 questions that evaluates locomotive functions and locomotive syndrome risk in elderly individuals.
The purpose of this study was to translate and cross-culturally adapt the English version of the GLFS-25 into Turkish and to investigate the reliability and validity of the translated version of the scale.
Detailed description
Aging is an inevitable process that begins after birth and continues until the death of the individual, affecting the person mentally and physically. Approximately 21% of elderly individuals requiring care have locomotive organ disorders involving the bone, joint, muscle and nervous system. 25-question Geriatric Locomotive Function Scale (GLFS-25), developed by Japanese researchers in 2012, is a patient-reported outcome measure consisting of 25 questions that evaluates locomotive functions and locomotive syndrome risk in elderly individuals. This scale provides an advantage in terms of locomotive ability and early detection of locomotive syndrome in the elderly. In addition, the scale provides the opportunity to decrease number of needing for hospital care of elderly individuals by early detection of locomotive functions and the risk of locomotive syndrome. Before a patient-reported outcome measure can be used in a society other than the one in which it was developed, it must be translated and culturally adapted. The GLFS-25 have been translated to different cultural settings and into many languages, including Brazilian, Iranian and Chinese. Data obtained from the culturally adapted versions contribute to a better understanding of the tools measurement properties. The studies reported that translated versions of GLFS-25 reliable and valid in older adults for functional assessment. Therefore, a Turkish version of the GLFS-25 would likely be that would be helpful in the functional state management and risk factor analyzes for locomotive syndrome of the Turkish older adult population. The purpose of this study was to translate and cross-culturally adapt the English version of the GLFS-25 into Turkish and to investigate the reliability and validity of the translated version of the scale.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Elderly people who are over the age of 65 and can answer the questionnaire on their own or with the help of their relatives.
Key inclusion criteria (2 listed)
- over the age of 65
- who can answer the questionnaire on their own or with the help of their relatives
Key exclusion criteria (4 listed)
- unable to walk without the assistance of another person
- having a brain disease or severe cardiovascular, pulmonary or renal disease
- having a history of lower extremity and/or spine fractures in the last 6 months
- were treated for acute trauma
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
25-question Geriatric Locomotive Function Scale (GLFS-25)
Time frame: Baseline
GLFS-25 is an assessment tool developed for evaluate locomotive functions in elderly individuals. This scale consists of a self-reported questionnaire with 25 items that are easily understood by the elderly, and each item is graded from 0 to 4 points. The final score is determined by the sum of all items ranging from 0 to 100.
5 secondary outcomes
25-question Geriatric Locomotive Function Scale (GLFS-25)
Time frame: Within a 7-to-14-day period after the first assessment
Katz Index
Time frame: Baseline
Lawton Index
Time frame: Baseline
Visual Analogue Scale (VAS)
Time frame: Baseline
Geriatric Depression Scale
Time frame: Baseline
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 3 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Translation, Cultural Adaptation and Turkish Validation, run by Istanbul Aydın 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 2 inclusion and 4 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 3 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?
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?
25-question Geriatric Locomotive Function Scale (GLFS-25) (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 3 Aug 2022.