Dual-Task Effects on Hand Functions in Type 2 Diabetes Mellitus

September 1, 2023 updated by: Eda Ozge OKUR, Kutahya Health Sciences University

The Effect of Dual-Task on Hand Functions in Individuals With Type 2 Diabetes Mellitus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is aimed to evaluate the effect of dual-task performance on hand functions in individuals with Type 2 Diabetes Mellitus. The study will conduct in the Internal Medicine Clinic of Kutahya Health Sciences University Evliya Celebi Training and Research Hospital. Approval for the study was granted by the Clinical Research Ethics Committee of Kutahya Health Sciences University and written informed consent forms will be obtained from all the participants. This study is planned to reach at least 50 participants with type 2 diabetes mellitus for the study group and 50 participants without diabetes for the control group. The participants will be questioned about their eligibility for the inclusion criteria. The demographic and descriptive data of the participants will be recorded. Minnesota Manual Dexterity Test will be used to evaluate upper extremity functions. The test will be performed with and without the dual-task. Counting backward from a random three-digit number 3 by 3 will be used for the dual-task. The effect of dual-task will calculate using the difference between the completion time of both tests for both groups.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kutahya, Turkey, 43100
        • Kutahya Health Sciences University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
Patients with type 2 diabetes mellitus
Other: Dual-task
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.
Other: Control Group
People without type 2 diabetes and prediabetes
Other: Dual-task
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Minnesota Dexterity Test
Time Frame: 30 minutes
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
Time Frame: 30 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kutahya Health Sciences University

Investigators

  • Principal Investigator: Eda O Okur, Doctorate, Kutahya Health Sciences University
  • Study Director: Ismail Okur, Doctorate, Kutahya Health Sciences University
  • Study Director: Turkan Pasali Kilit, Doctorate, Kutahya Health Sciences University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2023

Primary Completion (Actual)

August 20, 2023

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

November 9, 2021

First Submitted That Met QC Criteria

November 9, 2021

First Posted (Actual)

November 19, 2021

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T2DM-Dualtask

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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