- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07788859
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
Recruiting
Conditions
Intervention / Treatment
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
Observational
Enrollment (Estimated)
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
- Name: EMEL TAŞVURAN HORATA, PhD
- Phone Number: 05547759663
- Email: ethorata@gmail.com
Study Contact Backup
- Name: Hakan POLAT, PhD
- Phone Number: +905386487265
- Email: fzthakanpolat@gmail.com
Study Locations
-
-
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Gaziantep, Turkey (Türkiye)
- Recruiting
- SANKO University
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-
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
- 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 |
Intervention / Treatment |
|---|---|
|
Patients with Multiple Sclerosis
Patients with Multiple Sclerosis aged between 18-65 years
|
For the intra-rater reliability analysis, three DTUG protocols will be evaluated at 7- to 10-day intervals.
For the inter-rater reliability analysis, three DTUG protocols will be administered to the same patient by two different physical therapists.
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
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.
Investigators
- 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)
March 16, 2026
Primary Completion (Estimated)
September 14, 2026
Study Completion (Estimated)
September 14, 2026
Study Registration Dates
First Submitted
August 24, 2026
First Submitted That Met QC Criteria
August 24, 2026
First Posted (Actual)
August 27, 2026
Study Record Updates
Last Update Posted (Actual)
August 27, 2026
Last Update Submitted That Met QC Criteria
August 24, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.