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Active, not recruiting Observational

GYKO-Based L-Test Reliability in Parkinson's Disease

NCT07327346 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2025-12-01
Last updated
2026-01-21

Condition(s) studied

Parkinson Disease

Investigational drug(s) / intervention(s)

GYKO-Based Postural Sway Assessment

GYKO-Based Postural Sway Assessment: This procedure involves obtaining postural sway parameters using the GYKO inertial measurement device during the Time Up and Go (TUG) test and L-Test. No therapeutic intervention is applied. Time Up and Go Test: Timed Up and Go (TUG) is a standardized functional mobility test used to assess dynamic balance and gait performance. Participants are instructed to stand up from a standard-height chair, walk 3 meters, turn around, walk back to the chair, and sit down. The total time to complete the task (in seconds) is recorded. Higher times indicate reduced mobility. L Test: Time (in seconds) to complete the L-Test of Functional Mobility. The test requires participants to stand up from a chair, walk 3 m, execute a 90° turn, walk another 7 m, perform a 180° turn, and return along the same path (total walking distance ≈ 20 m). The task ends when the participant sits back down. The total time to complete the task (in seconds) is recorded. Higher times indicate reduced mobility.

Study summary

This study aims to investigate the interrater and test-retest reliability of GYKO-based postural sway measurements collected during the L-Test and Timed Up and Go (TUG) test in individuals with Parkinson's disease (Hoehn \& Yahr stages 1-3). Two independent raters will perform GYKO-based assessments of the L-Test and TUG with a 20-minute interval. Participants will return one week later to repeat the same procedures for test-retest reliability. Concurrent validity will be examined using the Berg Balance Scale.

Eligibility

Sex
ALL
Min age
50 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of idiopathic Parkinson's disease * Hoehn \& Yahr stage 1-3 * Ability to walk independently with or without an assistive device * Ability to follow verbal instructions * Age 50-85 Exclusion Criteria: * Other neurological, vestibular, or musculoskeletal disorders affecting balance * Deep brain stimulation (DBS) implant * Severe visual or auditory impairment

Primary outcome measure(s)

  • Interrater Reliability of GYKO-Based Postural Sway Parameters — Day 1
    Interrater reliability of postural sway will be evaluated using a composite set of parameters derived from GYKO inertial sensor data collected during the Timed Up and Go (TUG) and L-Test procedures. Measurements will be obtained independently by two raters on the same day. The composite postural sway outcome includes ellipsoid area, displacement-related parameters in the mediolateral and anteroposterior directions, and velocity-related parameters. Although individual variables are expressed in different units, all parameters collectively represent a single postural control construct. Interrater reliability will be assessed using the intraclass correlation coefficient (ICC 2,1) with 95% confidence intervals.
  • Test-Retest Reliability of GYKO-Based Postural Sway Parameters — 1 week
    Test-retest reliability of postural sway will be assessed using a composite set of parameters derived from GYKO inertial sensor data collected during the Timed Up and Go (TUG) and L-Test procedures. Participants will be re-evaluated after a 1-week interval. The composite postural sway outcome includes ellipsoid area, mediolateral and anteroposterior displacement parameters, and velocity-related parameters, representing a single postural control construct. Test-retest reliability will be analyzed using the intraclass correlation coefficient (ICC 3,1) with 95% confidence intervals. Paired t-tests will be used to examine differences between test and retest measurements.

Trial sites (1)

FacilityCityRegionStatus
Hasan Kalyoncu University Gaziantep Şahinbey
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07327346 on ClinicalTrials.gov ↗ ← All trials in Turkey