Reliability and Validity of Three DT-TUG Protocols in MS

August 24, 2026 updated by: Emel Taşvuran Horata, Afyonkarahisar Health Sciences University

Comparison of the Reliability and Convergent Validity of Three Dual-Task Timed Up and Go Protocols in People With Multiple Sclerosis

Dual-tasking is performing two different tasks at the same time. For example, singing while cooking. Everyday activities often involve dual-task. In many researches evaluating dual-task performance in individuals with MS, it has been reported that individuals with severe disability, in particular, exhibit greater effort than healthy individuals. This increase in motor and cognitive dual-task performance in individuals with Multiple Sclerosis (MS) is associated with an increased risk of falls. There is a need for standardized, valid, and reliable assessment tools to evaluate dual-task performance in MS. The purpose of this study is to examine and compare the validity and reliability of the dual-task Timed Up and Go test administered using three different protocols.

Study Overview

Status

Status

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

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

Dual-tasking is performing two different tasks at the same time. For example, singing while cooking. Everyday activities often involve dual-task. In many researches evaluating dual-task performance in individuals with MS, it has been reported that individuals with severe disability, in particular, exhibit greater effort than healthy individuals. This increase in motor and cognitive dual-task performance in individuals with MS is associated with an increased risk of falls. There is a need for standardized, valid, and reliable assessment tools to evaluate dual-task performance in MS. The purpose of this study is to examine and compare the validity and reliability of the dual-task Timed Up and Go test (DTUG) administered using three different protocols. To this end, this study will evaluate the validity and reliability of the DTUGs-which consist of three subtasks: counting backward in threes, verbal fluency, and ball-carrying on a tray-and compare their clinical applicability relative to one another. For validity analyses, convergent validity will be assessed. For reliability analyses, intra- and inter-rater reliability will be assessed, and SEM and MDC values will be calculated. Additionally, Bland-Altman plots will be plotted for intra- and inter-rater agreement analyses.

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 (Estimated)

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.
40

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from among individuals who visit the outpatient clinic of the Department of Neurology at SANKO University.

Description

Inclusion Criteria:

  • Having been diagnosed with MS according to the McDonald criteria revised in 2017,
  • Being between the ages of 18 and 65,
  • Having an Expanded Disability Status Scale (EDSS) score between 0 and 5.5,
  • Not requiring any assistive walking devices.

Exclusion Criteria:

  • Pregnancy;
  • Having experienced a relapse within the past three months;
  • The presence of another neurological condition in addition to MS;
  • The presence of a different disorder that could potentially affect gait parameters;
  • The presence of visual, auditory, perceptual, or cognitive impairments severe enough to interfere with the test administration

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.
Patients with Multiple Sclerosis
Patients with Multiple Sclerosis aged between 18-65 years
Other: Intra-rater reliability analysis
For the intra-rater reliability analysis, three DTUG protocols will be evaluated at 7- to 10-day intervals.
Other: Inter-rater reliability analysis
For the inter-rater reliability analysis, three DTUG protocols will be administered to the same patient by two different physical therapists.
Other: Convergent validity
To assess convergent validity, the relationship between the measurements from the three DTUG protocols and the results of other balance and functional mobility tests will be examined.

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
Dual-task Timed up and go test (DTUG)
Time Frame: A single assessment will be administered to all participants at the end of the study. The assessment takes approximately 5 minutes.
The DTUG task will be evaluated in three different ways. The primary task will consist of the Timed Up and Go (TUG) test. The TUG test involves standing up from a chair, walking 3 meters, turning around, and sitting back down. While this test is being administered, secondary tasks will be performed simultaneously, and the time taken to complete the test will be recorded. The secondary tasks consist of a three-count backward counting task, verbal fluency, and a ball-carrying task on a tray.
A single assessment will be administered to all participants at the end of the study. The assessment takes approximately 5 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.
Afyonkarahisar Health Sciences University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emel TAŞVURAN HORATA, PhD, Afyonkarahisar Health Sciences University
  • Study Chair: Hakan POLAT, PhD, Sanko University
  • Study Chair: Meltem UZUN, PhD, Sanko University
  • Study Chair: Suat EREL, PhD, Pamukkale 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.
March 16, 2026

Primary Completion (Estimated)

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 14, 2026

Study Completion (Estimated)

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.
September 14, 2026

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).
August 24, 2026

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.
August 24, 2026

First Posted (Actual)

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.
August 27, 2026

Study Record Updates

Last Update Posted (Actual)

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.
August 27, 2026

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.
August 24, 2026

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.
August 1, 2026

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.
  • 2026/02-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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