The Effect of Dual Task On Upper Extremity Functions In Multiple Sclerosis Patients

February 20, 2024 updated by: Eda Ozge OKUR, Kutahya Health Sciences University
The primary aim of this study was to investigate the effect of dual tasking on upper extremity functions in individuals with multiple sclerosis (MS) and compare with healthy controls. Additionally, another aim of our study was to compare the cognitive status, quality of life, fatigue and emotional states of individuals with MS and healthy controls.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study was carried out at Kutahya Health Sciences University Evliya Çelebi Training and Research Hospital. 30 individuals with MS and 30 healthy controls, aged 18-65, were included in the study. In the evaluation, demographic and clinical data were recorded first. The Minnesota Manual Dexterity Test was used to evaluate the upper extremity function of the participants in single and dual task conditions, and the Dual Task Questionnaire was used to evaluate the difficulties experienced during dual tasks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

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
      • Kütahya, 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients having been diagnosed with MS and healthy volunteers

Description

Inclusion Criteria:

  • Having been diagnosed with Multiple Sclerosis for at least 1 year
  • Being between the ages of 18-65
  • Being at least a primary school graduate
  • Volunteering to participate in the study
  • EDSS score between 1 and 6.5

Exclusion Criteria:

  • Patients whose Multiple Sclerosis diagnosis is uncertain
  • Having additional neurological disease that may affect clinical evaluation
  • Having a neurological and/or psychiatric disease that may affect cognitive tests
  • Having had an attack in the last 3 months

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control
healthy volunteers
Other: dual task assessment
The Minnesota Manual Dexterity Test was used to evaluate the upper extremity function of the participants in single and dual task conditions, and the Dual Task Questionnaire was used to evaluate the difficulties experienced during dual tasks. In the dual-task turning test, in addition to the single-task turning test, they were given a cognitive task, the task of counting the months of the year backwards from December to January. The dual-task turning test was continued by changing hands at the end of each turn until the last disk was turned. Meanwhile, verbal fluency and hand errors made while spinning the disc were recorded.
MS
patients with multiple sclerosis
Other: dual task assessment
The Minnesota Manual Dexterity Test was used to evaluate the upper extremity function of the participants in single and dual task conditions, and the Dual Task Questionnaire was used to evaluate the difficulties experienced during dual tasks. In the dual-task turning test, in addition to the single-task turning test, they were given a cognitive task, the task of counting the months of the year backwards from December to January. The dual-task turning test was continued by changing hands at the end of each turn until the last disk was turned. Meanwhile, verbal fluency and hand errors made while spinning the disc were recorded.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Minnesota Manual Dexterity Test
Time Frame: 30 minutes

Upper Extremity Function Evaluation. The Minnesota Manual Dexterity Test basically consists of two subtests, the placement and translation test.

Completing the test faster indicates better dexterity.
30 minutes
Dual Task Questionnaire
Time Frame: 10 minutes

Dual Task Difficulty Evaluation. The survey consists of 10 items and is scored out of 5 points per question.

A higher total score indicates worse dual task performance.
10 minutes
Edinburgh Handedness Questionnaire
Time Frame: 10 minutes
Hand Preference Evaluation. The total scoring is between 100 and -100, individuals with more than 40 points are given right hand; Individuals in this score range from 40 to -40 inclusive are recorded as those who use both hands actively, and individuals with scores of -40 points and below are recorded as left-handed.
10 minutes
Expanded Disability Status Scale
Time Frame: 10 minutes
Disability Status Evaluation. A score of 0 on the scale indicates normal neurological status, while a score of 10 means MS-related death.
10 minutes
Brief International Cognitive Assessment Battery for Multiple Sclerosis
Time Frame: 15 minutes
Cognitive Status Evaluation. BICAMS comprises three tests, the Symbol Digit Modalities Test (SDMT), the learning trials of the California Verbal Learning Test II (CVLT-II), and the Brief Visuospatial Memory Test-Revised (BVMT-R).
15 minutes
Beck Depression Scale
Time Frame: 10 minutes
Emotional Status Evaluation. The lowest score that can be obtained from the scale is 0 and the highest score is 63. According to the resulting total score; It results in absence-mild, mild-moderate, moderate-severe or severe.
10 minutes
Fatigue Impact Scale
Time Frame: 5 minutes
Fatigue Status Evaluation. Each question receives a score between 0 (no problem) and 4 (maximum problem). The highest score is 160, and higher scores indicate fatigue.
5 minutes
Multiple Sclerosis Quality of Life Questionnaire-54
Time Frame: 15 minutes
Quality of Life Status Evaluation. The survey contains 54 questions consisting of 12 sections. Added 18 questions are about; general quality of life (2 items), health stress (4 items), sexual functions and satisfaction (5 items), cognitive functions (4 items), energy (1 item), pain (1 item) and social functions (1 item).
15 minutes

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DTMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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