Multiple SclerosisNCT07788859
Reliability and Validity of Three DT-TUG Protocols in MS
An observational study of Multiple Sclerosis, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Intra-rater reliability analysis, Inter-rater reliability analysis and Convergent validity
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Mar 2026to 14 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from among individuals who visit the outpatient clinic of the Department of Neurology at SANKO University.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
SANKO University
Gaziantep
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Intra-rater reliability analysis, Inter-rater reliability analysis, Convergent validity
- Keywords
- validity, reliability, dual-task, assessment tools, timed up and go test
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-rater reliability analysisOther
For the intra-rater reliability analysis, three DTUG protocols will be evaluated at 7- to 10-day intervals.
Inter-rater reliability analysisOther
For the inter-rater reliability analysis, three DTUG protocols will be administered to the same patient by two different physical therapists.
Convergent validityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Multiple Sclerosis | Patients with Multiple Sclerosis aged between 18-65 years Receives: Other: Intra-rater reliability analysis; Other: Inter-rater reliability analysis; Other: Convergent validity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual-task Timed up and go test (DTUG)
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.
Measured: A single assessment will be administered to all participants at the end of the study. The assessment takes approximately 5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start16 Mar 2026
- Primary completion14 Sep 2026 (estimated)
- Study completion14 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Taşvuran Horata, Afyonkarahisar Health Sciences University
- Investigators
- Hakan POLAT, PhD, Study chair, Sanko UniversityMeltem UZUN, PhD, Study chair, Sanko UniversitySuat EREL, PhD, Study chair, Pamukkale UniversityEmel TAŞVURAN HORATA, PhD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788859
- Sponsor's protocol ID
- 2026/02-1
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Reliability and Convergent Validity of Three Dual-Task Timed Up and Go Protocols in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07788859
- Acronym / sponsor ID
- 2026/02-1
- Conditions
- Multiple Sclerosis
- Keywords
- validity, reliability, dual-task, assessment tools, timed up and go test
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 14 Sep 2026 (estimated)
- Study completion
- 14 Sep 2026 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Multiple Sclerosis | – | Other: Intra-rater reliability analysis, Other: Inter-rater reliability analysis, Other: Convergent validityPatients with Multiple Sclerosis aged between 18-65 years |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from among individuals who visit the outpatient clinic of the Department of Neurology at SANKO University.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-rater reliability analysisFor the intra-rater reliability analysis, three DTUG protocols will be evaluated at 7- to 10-day intervals. | Other | Patients with Multiple Sclerosis |
| Inter-rater reliability analysisFor the inter-rater reliability analysis, three DTUG protocols will be administered to the same patient by two different physical therapists. | Other | Patients with Multiple Sclerosis |
| Convergent validityTo 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. | Other | Patients with Multiple Sclerosis |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Multiple Sclerosis
Active, not recruitingPhase 3
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis (RMS)
RecruitingObservational study
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
Relapsing Multiple Sclerosis, Multiple Sclerosis
RecruitingObservational study
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Primary Progressive Multiple Sclerosis, Primary Progressive MS
RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hakan POLAT, PhD study chair
Sanko University
Meltem UZUN, PhD study chair
Sanko University
Suat EREL, PhD study chair
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EMEL TAŞVURAN HORATA, PhD (05547759663, ethorata@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.