NCT07186998

Brief Summary

Motor problems and cognitive deficits affecting walking and balance are frequently observed in individuals with MS. As a result of problems occurring in the motor and sensory systems, walking becomes less automatic and greater use is made of cognitive capacity. In addition to deficits in the motor system, individuals with MS experience reduced attention capacity and executive function dysfunction. Walking dysfunction is observed in approximately 85% of MS patients from the early stages, and MS patients report that walking dysfunction significantly limits their daily lives. Gait disorders in individuals with MS are generally characterised by reduced walking speed, shortened stride length, increased double support phase, shortened single support period, cadence changes, and progressively shorter walking distance. MS patients may exhibit variability in walking parameters even in the very early stages. This variability provides information about the extent to which they are at risk of balance impairment and falls. Cognitive impairments are among the most common symptoms of MS. Approximately 65% of individuals with MS report cognitive deficits that emerge in the early stages of the disease. In previous years, motor and cognitive impairments were commonly studied independently of each other. Recently, however, there has been a focus on researching the simultaneous performance of motor and cognitive tasks and revealing the interaction between the two. Performing two actions, motor and cognitive, at the same time can lead to a decrease in performance in one or both actions. This decrease in performance is called Cognitive-Motor Matching. It is usually assessed using dual-task activities that involve motor (walking, balance task) and cognitive tasks (counting backwards, word generation), and the dual-task cost (DTC) is calculated by taking the percentage change in dual-task performance compared to single-task performance. As daily living activities do not involve isolated motor or cognitive tasks, it is recommended in clinical practice and research that both tasks be examined together to calculate the dual-task cost. Many studies evaluating dual-task performance in individuals with MS have reported that individuals with high disability levels, in particular, show greater dual-task cost than healthy individuals. This increase in motor and cognitive dual-task cost in individuals with MS has been shown to be associated with an increased risk of falling. Therefore, it has been stated that it should be included in routine clinical assessments and that intervention studies involving dual-task activities are needed. Dual task impairment in MS may be due to impaired attention, fatigue, and reduced memory capacity or general cognitive functions not related to the use of different strategies. Studies investigating the effect of dual tasks on walking in individuals with MS have reported that dual tasks increase step length, sway phase duration, and double support period, while decreasing walking speed. In the literature, dual tasks have been assessed using tests such as walking on a straight path, tandem walking, and backward walking. Gait assessment has generally been evaluated in a straightforward, simple, and easy manner, such as the Timed Up and Go (TUG) test, the 10-metre walk test, and the 6-minute walk test. Based on this information, we aimed to evaluate dual tasks using the L test, which is a more complex and potentially challenging test. The L test is a modification of the Timed Up and Go test that extends the walking distance to 6 to 20 metres and requires participants to make turns both clockwise and counterclockwise. The L test is a modified form of the TUG test. The walking path is L-shaped. The L test is a more comprehensive test than the TUG test because it involves a greater walking distance and turning activity in both directions. This test indirectly assesses dynamic balance during walking and turning activities. The L test evaluates the fundamental components of functional mobility, such as balance, transfer, walking, and turning. Based on this information, we aimed to assess the applicability of the L test in individuals with multiple sclerosis to evaluate both cognitive and more complex motor skills during single and dual tasks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 15, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 15, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2025

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

September 15, 2025

Last Update Submit

September 15, 2025

Conditions

Keywords

multiple sklerozyürümegeçerlilikgüvenirlilik

Outcome Measures

Primary Outcomes (3)

  • The timed up-and-go test:

    This test assesses walking speed and turning ability over a specified distance on a flat surface. At the start of the test, individuals sit on a chair. A distance of 3 metres is marked out in front of them. Upon the "start" command, they stand up from their seat, walk 3 metres, turn around, walk back, and sit down. The time taken from the "start" command until they are fully seated is recorded in seconds. A shorter time indicates good functional mobility.

    1 years

  • L test:

    This test indirectly assesses walking speed and dynamic balance during walking and turning activities. It is a modified version of the TUG test. The walking path is L-shaped. The L test is more comprehensive than the TUG test as it involves a greater walking distance and turning activities in both directions. The L test assesses the fundamental components of functional mobility, such as balance, transfer, walking, and turning. During the test, the individual stands up from a chair, walks 3 metres, turns right, walks 7 metres, then turns back and walks along the same path to sit down on the chair. The measured distance is recorded in metres.

    1 years

  • Timed 25-step walking test

    This test is performed to assess mobility and leg function by recording walking speed over a specified straight distance. Individuals are asked to walk 7.62 metres at their maximum speed on a flat surface in a safe manner. If necessary, individuals are permitted to use walking aids. Participants are asked to walk three times. The average of the times is recorded

    1 years

Eligibility Criteria

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

Patients presenting with multiple sclerosis at the SANKO University Sani Konukoğlu Application and Research Hospital Neurology Outpatient Clinic

You may qualify if:

  • Individuals aged 18-65
  • Volunteers participating in the study
  • Individuals with an Expanded Disability Status Scale (EDSS) score ≤ 4.

You may not qualify if:

  • Pregnant or within the first 3 months postpartum,
  • Who have received corticosteroid treatment within the last month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanko Unıversıty

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
Physiotherapy and Rehabilitation Department, Assistant Professor

Study Record Dates

First Submitted

September 15, 2025

First Posted

September 22, 2025

Study Start

December 15, 2024

Primary Completion

April 15, 2025

Study Completion

August 15, 2025

Last Updated

September 22, 2025

Record last verified: 2025-09

Locations