Geriatric IndividualsNCT07277751
Validity and Reliability of the L Test in Geriatric Individuals
An observational study of Geriatric Individuals and Geriatric, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
Age-related declines in mobility, gait speed, balance, and functional independence are major determinants of morbidity and fall risk among older adults. Widely used functional mobility assessments-such as the Timed Up and Go Test (TUG) and the 10-Meter Walk Test (10MWT)-provide valuable information but do not fully… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geriatric Individuals, Geriatric
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2025to 21 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: As explained in the section on inclusion criteria: ≥65 years, able to understand instructions, able to walk independently (with or without minimal assistive device), MMSE (Mini Mental State Examination) ≥24, no acute medical condition
Who may be able to join
- ≥65 years
- Able to understand instructions
- Able to walk independently (with or without minimal assistive device)
- MMSE (Mini Mental State Examination) ≥24
- No acute medical condition
Who cannot join
- Lower-limb surgery within 6 months
- Diagnosed neurological or cardiopulmonary disease
- Visual or auditory impairments preventing safe assessment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hasan Kalyoncu University Medical Research and Application Center
Gaziantep
About this study
Official title: Investigating the Validity and Reliability of the L Test in Geriatric Individuals
Age-related declines in mobility, gait speed, balance, and functional independence are major determinants of morbidity and fall risk among older adults. Widely used functional mobility assessments-such as the Timed Up and Go Test (TUG) and the 10-Meter Walk Test (10MWT)-provide valuable information but do not fully capture the multidimensional motor tasks required in daily life, such as turning, directional changes, sit-to-stand transitions, and combined mobility tasks. The L Test, originally developed as an expanded form of TUG, includes turning, curved-path walking and a longer walking distance, and may therefore offer a more comprehensive assessment of functional mobility. Although previous studies have demonstrated high test-retest reliability and significant correlations with TUG in clinical populations such as Parkinson's disease and chronic conditions, evidence regarding the reliability and validity of the L Test in healthy geriatric individuals is lacking. This study aims to address this gap by evaluating the psychometric properties of the L Test in older adults.
Purpose: The purposes of the study are to: Evaluate the test-retest reliability of the L Test in geriatric individuals. Determine its concurrent validity by examining relationships with TUG and 10MWT. Calculate measurement error indices including Standard Error of Measurement (SEM) and Minimal Detectable Change (MDC).
Read more
Hypotheses H1: The L Test is a valid assessment tool for older adults. H2: The L Test demonstrates acceptable test-retest reliability (ICC ≥ 0.70). H3: The L Test shows a strong correlation with TUG (r ≥ 0.50). H4: The L Test shows a strong correlation with 10MWT (r ≥ 0.50).
Study Design: A cross-sectional methodological study with repeated measures (test-retest) one week apart.
Participants: Target population: Adults aged ≥65 years who can independently ambulate at least 10 meters.
Sample size: 58 participants based on power analysis; increased to 70 to compensate for potential attrition.
Sampling: Simple random sampling.
Inclusion Criteria:
≥65 years of age Mini-Mental State Examination ≥24 Able to walk 10 meters independently Voluntary participation
Exclusion Criteria:
Lower limb surgery within the past 6 months Diagnosed cardiovascular, neurological, or pulmonary disease Visual or auditory impairments affecting test safety
Procedures Participants will complete: L Test, Timed Up and Go Test (TUG), 10-Meter Walk Test (10MWT; normal and fast speed). One week later, all assessments will be repeated under the same conditions.
Outcome Measures: Primary: L Test time (seconds)
Secondary:TUG time, 10MWT time (normal and fast pace), SEM and MDC values. Pearson correlation with TUG and 10MWT
Statistical Analysis:
Test-retest reliability: ICC Concurrent validity: Pearson correlation coefficient Measurement error: SEM, MDC Significance level: p < 0.05
Ethical Considerations: All tests conducted by trained physiotherapists. Continuous supervision to minimize fall risk. Written informed consent obtained. Participants may withdraw at any time. Confidentiality ensured
Expected Outcomes: The study is expected to:
Provide normative data for the L Test in the geriatric population Demonstrate the test's psychometric robustness Support the clinical use of the L Test for functional mobility screening Contribute to physiotherapy and geriatric rehabilitation literature
Read the detailed description
Background Functional mobility declines significantly with aging due to sarcopenia, reduced neuromuscular coordination, impaired balance, and slower gait speed. These changes contribute to increased fall risk, reduced independence, and diminished quality of life in older adults. Accurate assessment tools are essential for identifying early functional deterioration, planning individualized rehabilitation interventions, and monitoring clinical outcomes.
Commonly used functional tests such as the TUG and 10MWT measure important aspects of mobility; however, they do not fully represent the complexity of real-life movement patterns. Daily activities often require multidirectional walking, pivoting, turning, and completing longer paths that challenge balance and coordination.
The L Test is a modification of the TUG and incorporates: Sit-to-stand, straight walking, turning, extended pathway walking, returning and sitting. This structure more closely resembles real-world functional mobility demands. Previous studies in clinical groups, including Parkinson's disease and chronic obstructive pulmonary disease, have demonstrated strong reliability (ICC > 0.90) and significant correlations with TUG and gait speed tests. However, no studies have systematically examined the psychometric properties of the L Test among healthy older adults.
Given the progressive aging of the population and the increasing need for precise mobility assessments, establishing the reliability and validity of the L Test in geriatric individuals is clinically important.
Objectives: The primary objective is to determine the test-retest reliability of the L Test. Secondary objectives include: Determining concurrent validity against TUG and 10MWT Calculating measurement error (SEM, MDC) Contributing to clinical decision-making by identifying cutoff values for functional mobility.
Study Design and Setting: This is a single-center, observational methodological study conducted at: Hasan Kalyoncu University Medical Research and Application Center, Gaziantep, Türkiye.
Participants will be assessed twice at a one-week interval to evaluate test-retest reliability and measurement consistency.
Participants and Sample Size: A total of 70 participants will be recruited.
Inclusion Criteria
≥65 years Able to understand instructions Able to walk independently (with or without minimal assistive device) MMSE ≥24 No acute medical condition
Exclusion Criteria:
Lower-limb surgery within 6 months Diagnosed neurological or cardiopulmonary disease Visual or auditory impairments preventing safe assessment.
Study Procedures
- Informed Consent and Baseline Assessments: Participants will receive verbal and written explanations about the study. After informed consent: Demographic data will be recorded.Height, weight, BMI, chronic diseases, use of assistive devices documented
- Functional Tests:All tests will be administered by trained physiotherapists. L Test Procedure:Starting seated in a standard chair. Standing up upon instruction. Walking 3 m straight. Turning left and walking 7 m. Returning via the same route. Sitting down again. Total distance: 20 m. Time recorded using a stopwatch
TUG Test:Standing from a chair. Walking 3 m, turning, returning, and sitting. Time recorded.
10MWT: Walking a 14-m walkway (10-m timed zone). Three trials at normal and fast speed. Average used for analysis
- Retesting: The full test battery will be repeated 1 week later under identical conditions.
Outcome Measures
Primary Outcome:
L Test completion time (seconds) Secondary Outcomes TUG time 10MWT time SEM MDC Correlation between L Test and other mobility tests.
Data Management and Analysis: Data will be stored securely with coded identifiers, complying with national data protection regulations.
Statistical Analysis Plan:
ICC (2,1) for test-retest reliability Pearson correlation for concurrent validity SEM = SD × √(1 - ICC) MDC = SEM × 1.96 × √2 Descriptive statistics for demographic variables p < 0.05 considered statistically significant
Ethics, Safety, and Monitoring:
Ethical approval has been obtained All procedures follow the Declaration of Helsinki Trained physiotherapists will supervise tests to prevent falls Participants may withdraw at any time Adverse events (if any) will be documented and reported
Expected Impact This study is expected to: Provide the first comprehensive psychometric evaluation of the L Test in healthy older adults. Offer clinicians a valid and reliable tool for mobility screening. Support risk stratification for falls and mobility limitations. Guide clinical decision-making in geriatric rehabilitation.
Dissemination Plan Results will be submitted to: Peer-reviewed journals, National and international physiotherapy and geriatric conferences. Participants may request a summary of the study results.
- Conditions
- Geriatric Individuals, Geriatric
- Keywords
- Geriatric assessment, Aged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric Individuals | ≥65 years Able to understand instructions Able to walk independently (with or without minimal assistive device) MMSE ≥24 (Mini Mental State Examination) No acute medical condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
L Test Procedure
Starting seated in a standard chair. Standing up upon instruction. Walking 3 m straight. Turning left and walking 7 m. Returning via the same route. Sitting down again. Total distance: 20 m. Time recorded using a stopwatch.
The L-test has far less well-established normative data and validated cut-offs for older adults than TUG or gait speed. Several recent reviews note a lack of age-specific reference values or consensus study-based cut-off scores for older community-dwelling adults. Because of this limited evidence base, the L-test is useful for within-person change (reliability, MDC) but less suitable for population screening using a single universal cut-off.
Measured: one week
Secondary outcomes (2)
Time Up and Go (TUG) Test
Standing from a chair. Walking 3 m, turning, returning, and sitting. Time recorded.
A frequently cited threshold for increased fall risk in community-dwelling older adults is ≈13.5 seconds. This value is often used as a screening cut-off for elevated fall risk.< 10-12 s: general indicator of normal to good functional mobility for many community-dwelling older adults (younger/healthier seniors often complete in 8-10 s).12-13.5 s: transitional zone - many studies treat this range as the threshold for increased fall risk or functional limitation. > 20 s (or substantially higher): often indicates significant mobility limitation, need for mobility aid and high fall/hospitalization risk (context dependent).
Measured: one week
10 Metre Walking Test (10 MWT)
Walking a 14-m walkway (10-m timed zone). Three trials at normal and fast speed. Average used for analysis.
< 0.8 m/s - commonly referenced threshold associated with increased health risk, reduced community ambulation and higher risk of adverse outcomes. < 0.7 m/s - associated in some reports with increased risk of hospitalization and dependency in older adults. 0.4-0.8 m/s - interpreted as limited community ambulation (below 0.4 m/s is usually household ambulation only). These bands are commonly used for functional classification. ≥ 1.0 m/s - often taken as the threshold associated with safe and independent community mobility and lower risk of adverse outcomes.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start22 Oct 2025
- Primary completion21 Mar 2026 (estimated)
- Study completion21 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric IndividualsStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nail Abidin Yaraşır, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277751
- Sponsor's protocol ID
- HasanKU-FTR-NAY-01
- Status last verified
- Nov 2025
- First submitted
- 29 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are not shared due to ethical principles. Should your work be published as a scientific paper, the data may be available from the relevant publication. Data may also be shared upon request for inclusion in a meta-analysis or systematic review study.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Validity and Reliability of the L Test in Geriatric Individuals
- ClinicalTrials.gov ID
- NCT07277751
- Acronym / sponsor ID
- HasanKU-FTR-NAY-01
- Conditions
- Geriatric Individuals, Geriatric
- Keywords
- Geriatric assessment, Aged
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 21 Mar 2026 (estimated)
- Study completion
- 21 Apr 2026 (estimated)
- First posted
- 11 Dec 2025 (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.
Age-related declines in mobility, gait speed, balance, and functional independence are major determinants of morbidity and fall risk among older adults. Widely used functional mobility assessments-such as the Timed Up and Go Test (TUG) and the 10-Meter Walk Test (10MWT)-provide valuable information but do not fully capture the multidimensional motor tasks required in daily life, such as turning, directional changes, sit-to-stand transitions, and combined mobility tasks. The L Test, originally developed as an expanded form of TUG, includes turning, curved-path walking and a longer walking distance, and may therefore offer a more comprehensive assessment of functional mobility. Although previous studies have demonstrated high test-retest reliability and significant correlations with TUG in clinical populations such as Parkinson's disease and chronic conditions, evidence regarding the reliability and validity of the L Test in healthy geriatric individuals is lacking. This study aims to address this gap by evaluating the psychometric properties of the L Test in older adults.
Purpose: The purposes of the study are to: Evaluate the test-retest reliability of the L Test in geriatric individuals. Determine its concurrent validity by examining relationships with TUG and 10MWT. Calculate measurement error indices including Standard Error of Measurement (SEM) and Minimal Detectable Change (MDC).
Hypotheses H1: The L Test is a valid assessment tool for older adults. H2: The L Test demonstrates acceptable test-retest reliability (ICC ≥ 0.70). H3: The L Test shows a strong correlation with TUG (r ≥ 0.50). H4: The L Test shows a strong correlation with 10MWT (r ≥ 0.50).
Study Design: A cross-sectional methodological study with repeated measures (test-retest) one week apart.
Participants: Target population: Adults aged ≥65 years who can independently ambulate at least 10 meters.
Sample size: 58 participants based on power analysis; increased to 70 to compensate for potential attrition.
Sampling: Simple random sampling.
Inclusion Criteria:
≥65 years of age Mini-Mental State Examination ≥24 Able to walk 10 meters independently Voluntary participation
Exclusion Criteria:
Lower limb surgery within the past 6 months Diagnosed cardiovascular, neurological, or pulmonary disease Visual or auditory impairments affecting test safety
Procedures Participants will complete: L Test, Timed Up and Go Test (TUG), 10-Meter Walk Test (10MWT; normal and fast speed). One week later, all assessments will be repeated under the same conditions.
Outcome Measures: Primary: L Test time (seconds)
Secondary:TUG time, 10MWT time (normal and fast pace), SEM and MDC values. Pearson correlation with TUG and 10MWT
Statistical Analysis:
Test-retest reliability: ICC Concurrent validity: Pearson correlation coefficient Measurement error: SEM, MDC Significance level: p < 0.05
Ethical Considerations: All tests conducted by trained physiotherapists. Continuous supervision to minimize fall risk. Written informed consent obtained. Participants may withdraw at any time. Confidentiality ensured
Expected Outcomes: The study is expected to:
Provide normative data for the L Test in the geriatric population Demonstrate the test's psychometric robustness Support the clinical use of the L Test for functional mobility screening Contribute to physiotherapy and geriatric rehabilitation literature
Detailed description
Background Functional mobility declines significantly with aging due to sarcopenia, reduced neuromuscular coordination, impaired balance, and slower gait speed. These changes contribute to increased fall risk, reduced independence, and diminished quality of life in older adults. Accurate assessment tools are essential for identifying early functional deterioration, planning individualized rehabilitation interventions, and monitoring clinical outcomes.
Commonly used functional tests such as the TUG and 10MWT measure important aspects of mobility; however, they do not fully represent the complexity of real-life movement patterns. Daily activities often require multidirectional walking, pivoting, turning, and completing longer paths that challenge balance and coordination.
The L Test is a modification of the TUG and incorporates: Sit-to-stand, straight walking, turning, extended pathway walking, returning and sitting. This structure more closely resembles real-world functional mobility demands. Previous studies in clinical groups, including Parkinson's disease and chronic obstructive pulmonary disease, have demonstrated strong reliability (ICC > 0.90) and significant correlations with TUG and gait speed tests. However, no studies have systematically examined the psychometric properties of the L Test among healthy older adults.
Given the progressive aging of the population and the increasing need for precise mobility assessments, establishing the reliability and validity of the L Test in geriatric individuals is clinically important.
Objectives: The primary objective is to determine the test-retest reliability of the L Test. Secondary objectives include: Determining concurrent validity against TUG and 10MWT Calculating measurement error (SEM, MDC) Contributing to clinical decision-making by identifying cutoff values for functional mobility.
Study Design and Setting: This is a single-center, observational methodological study conducted at: Hasan Kalyoncu University Medical Research and Application Center, Gaziantep, Türkiye.
Participants will be assessed twice at a one-week interval to evaluate test-retest reliability and measurement consistency.
Participants and Sample Size: A total of 70 participants will be recruited.
Inclusion Criteria
≥65 years Able to understand instructions Able to walk independently (with or without minimal assistive device) MMSE ≥24 No acute medical condition
Exclusion Criteria:
Lower-limb surgery within 6 months Diagnosed neurological or cardiopulmonary disease Visual or auditory impairments preventing safe assessment.
Study Procedures
- Informed Consent and Baseline Assessments: Participants will receive verbal and written explanations about the study. After informed consent: Demographic data will be recorded.Height, weight, BMI, chronic diseases, use of assistive devices documented
- Functional Tests:All tests will be administered by trained physiotherapists. L Test Procedure:Starting seated in a standard chair. Standing up upon instruction. Walking 3 m straight. Turning left and walking 7 m. Returning via the same route. Sitting down again. Total distance: 20 m. Time recorded using a stopwatch
TUG Test:Standing from a chair. Walking 3 m, turning, returning, and sitting. Time recorded.
10MWT: Walking a 14-m walkway (10-m timed zone). Three trials at normal and fast speed. Average used for analysis
- Retesting: The full test battery will be repeated 1 week later under identical conditions.
Outcome Measures
Primary Outcome:
L Test completion time (seconds) Secondary Outcomes TUG time 10MWT time SEM MDC Correlation between L Test and other mobility tests.
Data Management and Analysis: Data will be stored securely with coded identifiers, complying with national data protection regulations.
Statistical Analysis Plan:
ICC (2,1) for test-retest reliability Pearson correlation for concurrent validity SEM = SD × √(1 - ICC) MDC = SEM × 1.96 × √2 Descriptive statistics for demographic variables p < 0.05 considered statistically significant
Ethics, Safety, and Monitoring:
Ethical approval has been obtained All procedures follow the Declaration of Helsinki Trained physiotherapists will supervise tests to prevent falls Participants may withdraw at any time Adverse events (if any) will be documented and reported
Expected Impact This study is expected to: Provide the first comprehensive psychometric evaluation of the L Test in healthy older adults. Offer clinicians a valid and reliable tool for mobility screening. Support risk stratification for falls and mobility limitations. Guide clinical decision-making in geriatric rehabilitation.
Dissemination Plan Results will be submitted to: Peer-reviewed journals, National and international physiotherapy and geriatric conferences. Participants may request a summary of the study results.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric Individuals | – | –≥65 years Able to understand instructions Able to walk independently (with or without minimal assistive device) MMSE ≥24 (Mini Mental State Examination) No acute medical condition |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- As explained in the section on inclusion criteria: ≥65 years, able to understand instructions, able to walk independently (with or without minimal assistive device), MMSE (Mini Mental State Examination) ≥24, no acute medical condition
Key inclusion criteria (5 listed)
- ≥65 years
- Able to understand instructions
- Able to walk independently (with or without minimal assistive device)
- MMSE (Mini Mental State Examination) ≥24
- No acute medical condition
Key exclusion criteria (3 listed)
- Lower-limb surgery within 6 months
- Diagnosed neurological or cardiopulmonary disease
- Visual or auditory impairments preventing safe assessment
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
L Test Procedure
Time frame: one week
Starting seated in a standard chair. Standing up upon instruction. Walking 3 m straight. Turning left and walking 7 m. Returning via the same route. Sitting down again. Total distance: 20 m. Time recorded using a stopwatch. The L-test has far less well-established normative data and validated cut-offs for older adults than TUG or gait speed. Several recent reviews note a lack of age-specific reference values or consensus study-based cut-off scores for older community-dwelling adults. Because of this limited evidence base, the L-test is useful for within-person change (reliability, MDC) but less suitable for population screening using a single universal cut-off.
2 secondary outcomes
Time Up and Go (TUG) Test
Time frame: one week
10 Metre Walking Test (10 MWT)
Time frame: one week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No. Data are not shared due to ethical principles. Should your work be published as a scientific paper, the data may be available from the relevant publication. Data may also be shared upon request for inclusion in a meta-analysis or systematic review study.
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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 Geriatric Individuals and Geriatric, run by Hasan Kalyoncu 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 11 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
L Test Procedure (time frame: one week). 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 11 Dec 2025.