NCT07180030

Brief Summary

Mobility is a fundamental element of healthy aging. Balance is a necessary function during mobility for all movements throughout life in elderly individuals. Falls due to balance disorders in elderly individuals cause a decrease in the quality of life. Studies in the literature indicate that 13% of individuals aged 65-69 experience falls, and this rate rises to 46% in individuals over 85. Lower extremity muscle volume and strength gradually decrease with aging. This decreased muscle strength directly impacts individuals' activities of daily living.Normal walking speed for elderly individuals is related to balance and overall health performance. However, walking assessments generally focus on walking activities in a forward direction and in a straight line. However, in daily life, we may need to sit on a chair, walk backward to navigate a narrow space, or change direction suddenly due to obstacles or environmental cues. Walking backward requires more complex motor control, and these gait training programs are known to be effective in improving balance and walking skills.Clinically, balance assessments in the elderly persons are commonly measured by using the TUG, 10-meter walk test, functional reach test, 4-square step test, and Berg balance scale. The methods used to assess balance are still not fully standardized. The best test for assessing dynamic balance and fall risk is still up for debate, especially when it comes to elderly individuals who live freely in the community. Further research is needed to determine whether lateral walking tests can identify those at high risk of falling in elderly adults. The purpose of this study was to determine the reliability, validity, and minimal detectable change (MDC) of the Figure-of-8 backward walking test in healthy elderly adults.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

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 Start

First participant enrolled

May 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

9 months

First QC Date

September 5, 2025

Last Update Submit

December 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • figure-of-eight backward walking test

    In the figure-of-eight backward walking (F8BWT) test, participants begin at the midpoint of two cones 1.5 m apart. Participants walk backward, circle both cones, and record the time it takes to return to the starting point. The test is administered by both raters on the first and second days.The assessments will be conducted by two separate specialists(physiotherapists). Individuals' completion times for each activity during the tests will be recorded using a stopwatch. Assessments will be conducted over two days, in two sessions per day. On the first day, in the first session, the first assessor (PT1) will perform the F8BWT twice. In the second session, the second assessor (PT2) will perform the F8BWT twice. The average of the two recorded times will be noted. On the second day of the assessment, the PT2 will begin by performing the F8BWT. PT2 will then perform the F8BWT twice. The average of the two recorded times will be noted.

    On the day 1, in the first session, the first assessor (PT1) will perform the F8BWT twice. In the second session, the second assessor (PT2) will perform the F8BWT twice.

Secondary Outcomes (8)

  • SOCIODEMOGRAPHIC FORM

    On the day1, in the first session, the first assessor (PT1) will record.

  • 8-Figure Walk Test

    On the day1, in the first session, the first assessor (PT1) will record.

  • Timed Up and Go Test (TUG)

    On the first day1, in the first session, the first assessor (PT1) will record.

  • Modified 4-Square Step Test (mFSST)

    On the first day1, in the first session, the first assessor (PT1) will record.

  • 3-Meter Backward Walk Test (3MGYT)

    On the day1, in the first session, the first assessor (PT1) will record.

  • +3 more secondary outcomes

Study Arms (1)

1/study group

Healthy elderly individuals over the age of 65 living in the city center of Kahramanmaraş

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

It is planned to include elderly individuals over 65 years of age residing in the Kahramanmaraş city center in the scope of the research, and healthy elderly individuals over 65 years of age (n=87) who can be reached by random sampling method will be included in the research.

You may qualify if:

  • Healthy elderly individuals over 65 years of age.
  • Elderly individuals who have fluent in Turkish and able to communicate.
  • Elderly individuals who have no cognitive impairment.

You may not qualify if:

  • Elderly individuals who have any neurological problems (Parkinson's, hemiplegia, etc.)
  • Elderly individuals who have any orthopedic problems (fractures, etc., in the last year)
  • Elderly individuals who have a body mass index (BMI) ≥ 40 kg/m2
  • Elderly individuals who havevision problems
  • Elderly individuals who have had any lower extremity surgery in the last year
  • Elderly individuals who use any mobility aids
  • Elderly individuals who refuse to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sütçü imam University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation

Kahramanmaraş, Onikişubat, 46100, Turkey (Türkiye)

RECRUITING

Study Officials

  • hatice adıgüzel tat, Associate Professor

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR
  • Abdülkadir Ertürk, Msc

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR
  • Yusuf Şinasi Kırmacı, Asisstant Prof

    Kahramanmaras Sutcu Imam University

    STUDY CHAIR
  • mehmet göğremiş, Asisstant Prof

    Kahramanmaras Sutcu Imam University

    STUDY CHAIR
  • Mehtap Sönmez, Professor

    Kahramanmaras Sutcu Imam University

    STUDY CHAIR
  • Suat Erel, Professor

    Pamukkale University

    STUDY DIRECTOR
  • Emel Taşvuran Horata

    Sakarya University of Applied Sciences

    STUDY CHAIR

Central Study Contacts

hatice adıgüzel tat, Associate Proffessor

CONTACT

hatice Adiguzel tat, Associate Proffessor

CONTACT

Study Design

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

Study Record Dates

First Submitted

September 5, 2025

First Posted

September 18, 2025

Study Start

May 1, 2025

Primary Completion

January 15, 2026

Study Completion

January 30, 2026

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations