NCT05127291

Brief Summary

The aim of the study is to examine the effect of dual-task performance on hand functions in individuals with Type 2 Diabetes Mellitus. It is planned to reach at least 100 participants during the data collection phase of the study. Demographic information, plasma glucose levels, and HbA1C levels of the participants included in the study will be recorded. The upper extremity problems of the participants will be recorded. Minnesota Manual Dexterity Test will be used to evaluate upper extremity functions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable type-2-diabetes

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

First Submitted

Initial submission to the registry

November 9, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
1.5 years until next milestone

Study Start

First participant enrolled

May 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

September 5, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

November 9, 2021

Last Update Submit

September 1, 2023

Conditions

Type 2 Diabetes

Keywords

type 2 diabetesdual-taskhand functions

Outcome Measures

Primary Outcomes (2)

  • The Minnesota Dexterity Test

    The test consists of two parts, "placing" and "turning". The patient is instructed to put disks to the holes and the test time uses as a score, in the placing test. In the turning test, the patient is instructed to turn the disks before putting the holes. The test time is recorded. The test will perform with and without dual-task and the dual-task effect will calculate.

    30 minutes

  • Dual-task effect

    Each patient is going to be instructed to perform The Minnesota Dexterity Test with and without dual-task. Firstly, patients are going to perform the two parts of the test without dual-task. Secondly, patients are going to perform two parts of the test while counting down 3 by 3 from a random three-digit number. The percentage of difference is going to calculate as the dual-task effect.

    30 minutes

Study Arms (2)

Study Group

EXPERIMENTAL

Patients with type 2 diabetes mellitus

Other: Dual-task

Control Group

OTHER

People without type 2 diabetes and prediabetes

Other: Dual-task

Interventions

Dual-taskOTHER

In the study, both groups are going to evaluate with and without dual-task. The dual-task will be counting back down 3 by 3 from a three-digit number.

Control GroupStudy Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having been diagnosed with type 2 diabetes mellitus for at least 5 years for study group, having no diagnosed type 2 diabetes mellitus or prediabetes for control group,
  • Being able to count down 3 by 3 from a three-digit number,
  • Volunteer to take part in the study.

You may not qualify if:

  • History of traumatic or inflammatory injury in the upper extremity,
  • History of involving the upper extremity in the last year,
  • Having rheumatological/inflammatory arthritis or deformity,
  • Having a deformity caused by osteoarthritis in the upper extremity,
  • Having a neurological problem affecting the upper extremity,
  • Getting 23 points or less on the Mini-Mental Test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, 43100, 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

  • Eda O Okur, Doctorate

    Kutahya Health Sciences University

    PRINCIPAL INVESTIGATOR

  • Ismail Okur, Doctorate

    Kutahya Health Sciences University

    STUDY DIRECTOR

  • Turkan Pasali Kilit, Doctorate

    Kutahya Health Sciences University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Proffessor

Study Record Dates

First Submitted

November 9, 2021

First Posted

November 19, 2021

Study Start

May 20, 2023

Primary Completion

August 20, 2023

Study Completion

August 30, 2023

Last Updated

September 5, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)