NCT07107620

Brief Summary

The aim of this study is to compare the dual task performances of individuals with and without type 2 diabetes. Thus, it will be concluded whether having type 2 diabetes affects dual task performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
Last Updated

August 6, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

June 28, 2025

Last Update Submit

August 4, 2025

Conditions

Keywords

Type II Diabetes MellitusDual-taskCognition

Outcome Measures

Primary Outcomes (2)

  • 10 meter walk test

    The dual task cost was calculated to measure dual task performance by applying the 10-meter walking test as single and dual tasks. This cost will be calculated as follows: (Dual task performance-single task performance)/ single task performance x100

    one day

  • time up go test

    The dual task cost was calculated to measure dual task performance by applying the time up go test as single and dual tasks. This cost will be calculated as follows: (Dual task performance-single task performance)/ single task performance x100

    one day

Secondary Outcomes (2)

  • Stroop test

    one day

  • Dual task survey

    one day

Study Arms (2)

type II diabetes mellitus group

Dual task tests were applied to the group with type 2 diabetes mellitus

Diagnostic Test: one taskDiagnostic Test: dual task

Healthy group

Dual task tests were administered to the healthy group

Diagnostic Test: one taskDiagnostic Test: dual task

Interventions

one taskDIAGNOSTIC_TEST

Single task tests consist of measuring walking times with normal walking (easy), walking with a 50% reduction in the base of support measured between the medial malleoli (medium difficulty) and tandem walking (difficult) tasks while applying the 10 meter walk test and time up go tests.

Healthy grouptype II diabetes mellitus group
dual taskDIAGNOSTIC_TEST

Dual task consists of single task plus tests of carrying glasses of water or counting backwards from a given number.

Healthy grouptype II diabetes mellitus group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals who have had diabetes for at least 1 year and are over 50 years of age and their matched healthy controls constitute the study sample.

You may qualify if:

  • Having been diagnosed with Type II DM (for the Type II diabetes group)
  • Being 50 years old or older
  • Being a native Turkish speaker

You may not qualify if:

  • Not being able to read and write,
  • Having communication problems,
  • Having a score below 24 points on the Standardized Mini-Mental Test,
  • Having one of the neurological diseases that will affect the study such as Parkinson's, stroke, etc.,
  • Having upper and/or lower extremity surgery in the last year or having a surgical history that will affect walking,
  • Having retinopathy, foot ulcers, and severe sensory impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University hospital

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Suat EREL, professor

    Pamukkale University Faculty of Health Sciences

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 28, 2025

First Posted

August 6, 2025

Study Start

September 1, 2022

Primary Completion

March 1, 2023

Study Completion

June 1, 2023

Last Updated

August 6, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations