- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07462338
Validity and Reliability of Timed Up and Go Test in Dual-Task Conditions for Multiple Sclerosis Patients
Validity and Reliability of Timed Up and Go Test in Dual-Task Conditions in Patients With Multiple Sclerosis
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.
Study Overview
Status
Conditions
Detailed Description
This study investigates the validity and reliability of the Timed Up and Go (TUG) test under dual-task conditions in patients with Multiple Sclerosis (MS). MS is a chronic neurological disease that affects motor and cognitive functions, often leading to walking difficulties, balance problems, and increased risk of falls.
Volunteers with MS will be recruited from the Neurological Rehabilitation Unit at SANKO University. Eligible participants will perform the TUG test in three conditions:
Single-task TUG: normal TUG without additional tasks.
Cognitive dual-task TUG (kSKYT): performing TUG while counting backwards in threes or generating words starting with a specific letter.
Motor dual-task TUG (mSKYT): performing TUG while carrying a small ball on a tray.
Participants' demographic and clinical data, including age, sex, height, weight, MS duration, EDSS score, and history of falls, will be recorded. TUG tests will be conducted by two physiotherapists and repeated after one week to assess test-retest reliability and inter-rater reliability.
Convergent validity will be evaluated by comparing dual-task TUG results with single-task TUG, 25-step walking test, Mini-BESTest, and a dual-task questionnaire. Known-groups validity will be assessed by comparing results between MS patients who have fallen and those who have not.
All data will be coded and stored confidentially. The study is observational, with no experimental interventions, and each assessment session will take approximately 25-30 minutes.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Gaziantep
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Gaziantep, Gaziantep, Turkey (Türkiye), 27090
- Sanko Unıversıty
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Sit-to-Stand and Walk Test (SKYT)
Time Frame: 1 week
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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
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1 week
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Dual-task SKYT tests
Time Frame: one weeks
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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
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one weeks
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The 25-step walk test (S25AYT)
Time Frame: one weeks
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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
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one weeks
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Dual-task questionnaire
Time Frame: one weeks
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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.
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one weeks
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Mini-BESTest
Time Frame: one weeks
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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.
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one weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- hakanpolat16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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