NCT07277751

Brief 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 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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 29, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2026

Completed
Last Updated

December 11, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

November 29, 2025

Last Update Submit

November 29, 2025

Conditions

Keywords

Geriatric assessmentAged

Outcome Measures

Primary Outcomes (1)

  • 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.

    one week

Secondary Outcomes (2)

  • Time Up and Go (TUG) Test

    one week

  • 10 Metre Walking Test (10 MWT)

    one week

Study Arms (1)

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

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • ≥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

You may not qualify if:

  • Lower-limb surgery within 6 months
  • Diagnosed neurological or cardiopulmonary disease
  • Visual or auditory impairments preventing safe assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University Medical Research and Application Center

Gaziantep, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

November 29, 2025

First Posted

December 11, 2025

Study Start

October 22, 2025

Primary Completion

March 21, 2026

Study Completion

April 21, 2026

Last Updated

December 11, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

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.

Locations