NCT07327346

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

December 8, 2025

Last Update Submit

January 20, 2026

Conditions

Keywords

parkinson diseasebalancepostural swayinterrater reliabilitytest-retest reliabilitvalidity

Outcome Measures

Primary Outcomes (2)

  • Interrater Reliability of GYKO-Based Postural Sway Parameters

    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.

    Day 1

  • Test-Retest Reliability of GYKO-Based Postural Sway Parameters

    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.

    1 week

Secondary Outcomes (3)

  • Validity of GYKO Postural Sway Parameters with Functional Mobility (TUG and L-Test)

    Day 1

  • Relationship Between Postural Sway and Balance Performance (Berg Balance Scale)

    Day 1

  • L test and TUG Completion Time

    1 week

Study Arms (1)

Parkinson's disease group

Parkinson's disease patients with stage 1-3 hoehn yahr

Other: GYKO-Based Postural Sway Assessment

Interventions

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.

Parkinson's disease group

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals aged 50-85 years with idiopathic Parkinson's disease (Hoehn \& Yahr stages 1-3) who can walk independently and participate in TUG, L-Test, and GYKO assessments.

You may qualify if:

  • 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

You may not qualify if:

  • Other neurological, vestibular, or musculoskeletal disorders affecting balance
  • Deep brain stimulation (DBS) implant
  • Severe visual or auditory impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Şahinbey, 27000, Turkey (Türkiye)

Location

Related Publications (2)

  • Haas B, Clarke E, Elver L, Gowman E, Mortimer E, Byrd E. The reliability and validity of the L-test in people with Parkinson's disease. Physiotherapy. 2019 Mar;105(1):84-89. doi: 10.1016/j.physio.2017.11.218. Epub 2017 Dec 5.

    PMID: 29395266BACKGROUND
  • Zampieri C, Salarian A, Carlson-Kuhta P, Aminian K, Nutt JG, Horak FB. The instrumented timed up and go test: potential outcome measure for disease modifying therapies in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2010 Feb;81(2):171-6. doi: 10.1136/jnnp.2009.173740. Epub 2009 Sep 2.

    PMID: 19726406BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Büşra Akıncı, MSc

    Hasan Kalyonuc University

    STUDY CHAIR
  • Günseli Usgu, Assoc. Prof.

    Hasan Kalyoncu University

    STUDY DIRECTOR
  • Saadet Nur Çörekçioğlu, P.T.

    Hasan Kalyoncu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

December 8, 2025

First Posted

January 8, 2026

Study Start

December 1, 2025

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations