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

Sponsor
Kutahya Health Sciences University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05127291
Collaborator
(none)
100
2
3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Dual-task
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
The Effect of Dual-Task on Hand Functions in Individuals With Type 2 Diabetes Mellitus
Anticipated Study Start Date :
Sep 6, 2022
Anticipated Primary Completion Date :
Sep 6, 2022
Anticipated Study Completion Date :
Dec 6, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The Minnesota Dexterity Test [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.

  2. Dual-task effect [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eda Ozge OKUR, Assistant Proffessor, Kutahya Health Sciences University
ClinicalTrials.gov Identifier:
NCT05127291
Other Study ID Numbers:
  • T2DM-Dualtask
First Posted:
Nov 19, 2021
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eda Ozge OKUR, Assistant Proffessor, Kutahya Health Sciences University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2022