NCT07586553

Brief Summary

This observational study aims to investigate the validity and reliability of the Figure-of-8 Walk Test (8FWT) in individuals with Motoric Cognitive Risk Syndrome (MCRS). The study will evaluate test-retest reliability, measurement error (SEM, MDC), and construct validity by examining the relationship between 8FWT performance and functional mobility measures. The findings are expected to provide evidence for the clinical applicability of 8FWT in assessing dynamic balance, gait performance, and cognitive-motor interaction in older adults.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress50%
Apr 2026Jul 2026

Study Start

First participant enrolled

April 7, 2026

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 1, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2026

Expected
Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

21 days

First QC Date

May 1, 2026

Last Update Submit

May 7, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Figure-of-8 Walk Test completion time

    Time required to complete the Figure-of-8 Walk Test will be recorded in seconds.

    Baseline

  • Figure-of-8 Walk Test number of steps

    The number of steps taken during the Figure-of-8 Walk Test will be recorded.

    Baseline

  • Figure-of-8 Walk Test walking speed

    Walking speed during the Figure-of-8 Walk Test will be calculated in meters per second.

    Baseline

Secondary Outcomes (4)

  • Timed Up and Go Test completion time

    Baseline

  • Test-retest reliability of the Figure-of-8 Walk Test

    Baseline and 7 days after baseline

  • Standard Error of Measurement of the Figure-of-8 Walk Test

    Baseline and 7 days after baseline

  • Minimal Detectable Change of the Figure-of-8 Walk Test

    Baseline and 7 days after baseline

Study Arms (1)

Motoric Cognitive Risk Syndrome Group

Community-dwelling older adults aged 65 years and above diagnosed with Motoric Cognitive Risk Syndrome who will undergo functional mobility and gait assessments.

Other: Assessment Protocol

Interventions

Participants will undergo a series of non-invasive assessments including the Figure-of-8 Walk Test (8FWT) and Timed Up and Go (TUG) test to evaluate gait performance, dynamic balance, and cognitive-motor interaction. No therapeutic intervention will be applied.

Motoric Cognitive Risk Syndrome Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will include community-dwelling older adults aged 65 years and above diagnosed with Motoric Cognitive Risk Syndrome (MCRS) and living in Balıkesir, Turkey. Participants will be recruited from individuals attending the Tazelenme University Coordination Unit. All participants will be able to walk independently and have sufficient cognitive and physical capacity to complete the assessment protocol.

You may qualify if:

  • Aged 65 years or older Presence of subjective cognitive complaints Gait speed ≤ 0.8 m/s (4-meter walk test) Able to walk independently without assistive devices No clinical diagnosis of dementia Able to understand and follow test instructions

You may not qualify if:

  • Mini-Mental State Examination (MMSE) score \< 24 Neurological diseases affecting gait (e.g., stroke, Parkinson's disease, multiple sclerosis) Severe musculoskeletal conditions affecting walking Lower extremity surgery within the last 6 months Severe visual or hearing impairment that interferes with testing Dependence on assistive walking devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balikesir University

Balıkesir, Bigadiç, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • Montero-Odasso M, Verghese J, Beauchet O, Hausdorff JM. Gait and cognition: a complementary approach to understanding brain function and the risk of falling. J Am Geriatr Soc. 2012 Nov;60(11):2127-36. doi: 10.1111/j.1532-5415.2012.04209.x. Epub 2012 Oct 30.

    PMID: 23110433BACKGROUND
  • Huang, Z., Zheng, R., He, M., & Wang, J. (2024). Motoric cognitive risk syndrome and incident dementia: A systematic review and meta-analysis. International Journal of Geriatric Psychiatry, 39(2), e6055. https://doi.org/10.1002/gps.6055

    BACKGROUND
  • Kong HH, Shin K, Yang DS, Gu HY, Joo HS, Shon HC. Digital assessment of walking ability: Validity and reliability of the automated figure-of-eight walk test in older adults. PLoS One. 2025 Feb 10;20(2):e0316612. doi: 10.1371/journal.pone.0316612. eCollection 2025.

    PMID: 39928640BACKGROUND
  • Coyle PC, Perera S, Shuman V, VanSwearingen J, Brach JS. Development and Validation of Person-Centered Cut-Points for the Figure-of-8-Walk Test of Mobility in Community-Dwelling Older Adults. J Gerontol A Biol Sci Med Sci. 2020 Nov 13;75(12):2404-2411. doi: 10.1093/gerona/glaa035.

    PMID: 32006022BACKGROUND
  • Hess RJ, Brach JS, Piva SR, VanSwearingen JM. Walking skill can be assessed in older adults: validity of the Figure-of-8 Walk Test. Phys Ther. 2010 Jan;90(1):89-99. doi: 10.2522/ptj.20080121. Epub 2009 Dec 3.

    PMID: 19959654BACKGROUND

MeSH Terms

Interventions

Nursing Assessment

Intervention Hierarchy (Ancestors)

Nursing ProcessComprehensive Health CarePatient Care ManagementHealth Services Administration

Central Study Contacts

Ebru Tekin, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 1, 2026

First Posted

May 14, 2026

Study Start

April 7, 2026

Primary Completion

April 28, 2026

Study Completion (Estimated)

July 8, 2026

Last Updated

May 14, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations