NCT07234513

Brief Summary

The research is a cross-sectional study and was planned to determine which diabetes mellitus symptoms related to physical competence have a greater impact on balance in patients with diabetes mellitus

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 3, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2019

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

September 23, 2025

Last Update Submit

November 16, 2025

Conditions

Keywords

Diabetes MellitusDynamic BalancePhysical ActivityExertionUrinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • Dynamic balance

    Four-Step Square Test (FSST): Two strips were placed perpendicular to each other on the floor to create 4 squares. At the start of the test, the patient stood on square 1 facing square 2. The stepping sequence was as follows: 2-3-4-1-4-3-2-1. Participants were instructed to complete the sequence as fast as possible, without touching the canes or strips, and to ensure that both feet fully contacted the ground in each square. If the participant failed to complete the sequence correctly, lost balance, or touched the cane, the test was repeated. The total time required to complete the test was recorded

    7 months

Secondary Outcomes (4)

  • International Physical Activity Questionnaire-Long Form (IPAQ-LF)

    7 months

  • 6-Minute Walking Test (6MWT)

    7 months

  • Modified Borg Scale (MBS)

    7 months

  • International Urinary Incontinence Consultation Questionnaire-Short Form (ICIQ-UI SF)

    7 months

Study Arms (1)

1

There will be only one group in the study.

Diagnostic Test: There will be no intervention in the study. Only descriptive tests will be used.

Interventions

There will be no intervention in the study. Only descriptive tests will be used.

1

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Diabetes Mellitus

You may qualify if:

  • having Diabetes MEllitus
  • having a Mini Mental Test (MMT) score ≥ 24

You may not qualify if:

  • the presence of comorbid conditions that could affect balance, such as lower extremity injuries, musculoskeletal surgery, diabetic neuropathy, orthopedic, neurological and cardiovascular diseases, and hearing or vision problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suleyman Demirel University

Isparta, 32200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes MellitusMotor ActivityUrinary Incontinence

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehaviorUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • ÇETİŞLİ KORKMAZ

    Pamukkale University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 23, 2025

First Posted

November 18, 2025

Study Start

December 3, 2018

Primary Completion

July 13, 2019

Study Completion

July 7, 2025

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations