NCT07462338

Brief Summary

his study aims to examine the validity and reliability of the Timed Up and Go (TUG) test in patients with Multiple Sclerosis (MS) under dual-task conditions, where participants perform both a motor and a cognitive task at the same time. MS affects movement, balance, and cognitive functions, which can lead to difficulties in walking and increased risk of falls. In this study, volunteers with MS will be asked to perform the TUG test in different conditions: Single-task TUG: walking, standing up, and sitting down without additional tasks. Cognitive dual-task TUG: performing TUG while doing a cognitive task, such as counting backwards or word generation. Motor dual-task TUG: performing TUG while carrying a small object on a tray. Participants' demographic and clinical information will be recorded, and tests will be repeated to evaluate the reliability of the measurements. The results will help determine if the TUG test can reliably assess both motor and cognitive performance in MS patients. The study is observational, and no experimental treatment will be given. Participation involves only performing tests and answering questions, taking approximately 25-30 minutes per session. All collected data will be kept confidential.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2026

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

28 days

First QC Date

March 4, 2026

Last Update Submit

March 4, 2026

Conditions

Keywords

multiple sclerosisreliability and validitydual task

Outcome Measures

Primary Outcomes (5)

  • Sit-to-Stand and Walk Test (SKYT)

    SKYT is a test that assesses an individual's functional mobility, balance, and walking performance, including sitting, standing up, walking, turning, and sitting back down. The participant is asked to walk 3 metres and

    1 week

  • Dual-task SKYT tests

    Dual-task SKYT tests will consist of three different dual-task SKYT tests: two cognitive dual-task SKYT tests (cSKYT) and one motor dual-task SKYT test (mSKYT). The cognitive task parameters of the cSKYT will be numerical processing

    one weeks

  • The 25-step walk test (S25AYT)

    This is a standardised test used to assess walking speed and functional mobility in MS patients, performed by walking a distance of 7.62 metres as quickly and safely as possible. The test has been reported to have high rel

    one weeks

  • Dual-task questionnaire

    The questionnaire was originally developed to assess individuals with neurological injury or disease and is used to evaluate the frequency of difficulties experienced in daily activities involving dual tasks. The questionnaire consists of 10 items, and each question is rated on a 5-point scale (0 = 'never' to 4 = 'very often' or N/A = 'not applicable'). The resulting score is the average score per question (questionnaire score = total questionnaire score/10). Its validity and reliability in the Turkish MS population have been demonstrated.

    one weeks

  • Mini-BESTest

    A test frequently used in neurological disease populations that assesses the dynamic components of balance control. Participants are asked to perform various balance tasks (e.g., postural responses, sensorimotor strategies, dynamic walking). Studies conducted in MS patients have demonstrated that the Mini-BESTest has high reliability and validity in the Turkish neurological population, including MS.

    one weeks

Study Arms (1)

Multiple Sclerosis Patients Observed for Dual-Task TUG Test

This cohort includes volunteers diagnosed with Multiple Sclerosis (MS) who will participate in observational assessments of functional mobility using the Timed Up and Go (TUG) test under single-task and dual-task conditions. No experimental interventions will be applied. Participants will perform cognitive and motor dual-tasks simultaneously with the TUG test to evaluate walking, balance, and functional mobility. Demographic and clinical data, including age, sex, MS duration, EDSS score, and fall history, will be recorded. The cohort will be assessed by trained physiotherapists to determine test-retest and inter-rater reliability, as well as validity of the dual-task TUG test.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

multiple sclerosis

You may qualify if:

  • Diagnosed with Multiple Sclerosis (MS).
  • Age 18 years or older.
  • EDSS score low to moderate (able to walk without assistive devices).
  • Willing to provide informed consent.
  • Able to perform Timed Up and Go (TUG) test.

You may not qualify if:

  • Severe cognitive impairment preventing understanding of instructions.
  • Recent MS relapse (within the past 30 days).
  • Use of walking aids that interfere with TUG test performance.
  • Other neurological or musculoskeletal conditions affecting walking or balance.
  • Any condition that makes participation unsafe, according to the investigato

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanko Unıversıty

Gaziantep, Gaziantep, 27090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dırector

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 10, 2026

Study Start

February 15, 2026

Primary Completion

March 15, 2026

Study Completion

April 1, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations