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NCT Number: NCT07815990

Aerobic Fitness in Multiple Sclerosis: The Relationship Between Balance and Sensory Dual-Tasking

The aim of this study is to comparatively examine the effect of aerobic fitness levels on walking and balance performance, sensory dual-task (proprioceptive and vestibular) performance, balance confidence, and fatigue levels in individuals diagnosed with MS.

Research hypotheses H1: MS patients with high aerobic fitness exhibit superior walking speed and balance performance compared to MS patients with low aerobic fitness.

H2: In sensory dual-task tests involving proprioceptive and vestibular manipulations (BOSU ball, soft surface, and head movements synchronized with a metronome), MS patients with high aerobic fitness demonstrate better performance than the group with low aerobic fitness.

H3: MS patients with high aerobic fitness report higher levels of balance confidence compared to the group with low aerobic fitness.

H4: Perceived fatigue is greater in MS patients with low aerobic fitness compared to the group with high aerobic fitness.

H5: There is a significant relationship between aerobic capacity levels and sensory dual-task performance, balance confidence, and fatigue severity in MS patients.

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Key information

About this study

The study will be conducted on volunteer patients diagnosed with multiple sclerosis by a specialist physician in the Department of Neurology of Isparta Süleyman Demirel University Hospital. All stages of the study will be conducted at Isparta Süleyman Demirel University. Informed consent form will be obtained from all patients participating in the study.The research protocol consists of two main phases. In Phase 1, "Basic Assessment and Grouping," participants' aerobic fitness will be determined using the 6-Minute Walk Test (6MWT). Based on the walking distance results, the sample will be divided into two groups: "Group 1: Those with High Aerobic Fitness" and "Group 2: Those with Low Aerobic Fitness."In Phase 2, the "Joint Clinical and Dual Task Protocol," data will be collected using a Personal Information Form, the Timed 25-Step Walk Test (T25WWT), the Timed Up and Walk Test (TUWT), the Berg Balance Scale (BBS), the Modified Clinical Sensory Interaction Test (MCIT), the Activity-Specific Balance Confidence Scale (ASBCS), and the Modified Fatigue Impact Scale (MFIS).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having been diagnosed with Relapsing-Remitting or Progressive MS.
  • Being between 18-65 years of age.
  • Having an Expanded Disability Status Scale score between 1.5-5.
  • Being able to walk independently or with a unilateral assistive device.
  • Having full cooperation and orientation, and a cognitive level to understand given commands: Mini Mental Test score of 24 or higher.

Exclusion criteria

  • Having experienced an MS relapse or received acute corticosteroid treatment within the last 3 months.
  • Having an additional neurological, orthopedic, or rheumatological condition unrelated to MS that may affect balance and walking.
  • Having severe cardiovascular or respiratory disease that may make aerobic fitness assessment risky.
  • Having significant vision or hearing loss that would impede understanding test instructions.
  • Experiencing significant pain during measurements.
  • Having cognitive impairment that would prevent understanding or answering questions - scoring below 24 on the Minimental Test.

Treatment and study plan

Primary outcomes

  1. 6-Minute Walk Test

    Time frame: once

    Participants' aerobic fitness, walking endurance, and functional exercise capacity will be assessed using the 6DKYT. Participants are asked to walk for 6 minutes at their own determined maximum safe pace in a 30-meter straight corridor, and the total distance covered is recorded in meters.

Secondary outcomes

  1. Timed 25-Step Walking Test

    Time frame: once

    To assess participants' baseline walking performance and speed, the Z25AYT, a subtest of the universal Multiple Sclerosis Functional Composite Battery, will be administered. Participants will be asked to walk a distance of 25 steps (approximately 7.62 meters) as quickly and safely as possible, and the elapsed time will be measured with a stopwatch and recorded in seconds.

  2. Dual Task Performance Test: Standing (Static Balance) Tasks

    Time frame: once

    • Proprioceptive Task: The goal is to restrict/modify the proprioceptive inputs from the participant's support surface. For this purpose, the participant is asked to stand on an unstable surface (BOSU ball) to examine the effect of uncertainty in deep sensory inputs on static postural control.
    • Vestibular Task: The participant's proprioceptive inputs are stabilized by having them stand on a hard, stable surface. The role of the vestibular system in balance is assessed by having the participant stand while making rhythmic head movements (accompanied by a metronome). Thus, by manipulating the inputs from the vestibular apparatus, the stability of static balance, excluding visual and somatosensory inputs, is measured.
  3. Dual Task Performance Test: Walking (Dynamic Balance) Tasks

    Time frame: once

    • Vestibular Task (GKST + Head Movement): During the standard GKST, participants will be asked to perform rhythmic head movements to the accompaniment of a metronome to assess the effect of the vestibular system on mobility.
    • Proprioceptive Task (GKST + Soft Surface): To manipulate ground proprioception, the standard GKST protocol will be repeated on a soft foam surface of a specific density instead of a hard surface. This method will record walking stability and task completion time under conditions where proprioceptive feedback is limited.
  4. Berg Balance Scale

    Time frame: once

    Participants' objective balance and fall risk will be measured using the BDI (Brain Stability Inventory). The scale consists of 14 different functional balance tasks, including sitting, standing, reaching, and turning, and is evaluated on a scale of 0-56 points. Lower scores indicate an increased risk of falls.

  5. Activity-Specific Balance Confidence Scale

    Time frame: once

    The 16-item Fall Fear and Balance Confidence Scale (FDSS) will be administered to assess fall fear and balance confidence during daily living activities. The FDSS consists of 16 items scored between 0 and 100. Each item asks the individual to rate their confidence in their ability to maintain their balance without falling during a specific activity, on a scale of 0 (not confident at all) to 100 (completely confident). The total score is calculated by taking the arithmetic mean of all items, resulting in a value between 0 and 100. A higher total score indicates that the individual has high balance confidence and reduced fall fear during daily living activities.

  6. Modified Fatigue Impact Scale

    Time frame: once

    To assess the impact of fatigue on physical, cognitive, and psychosocial functions, a 21-item fatigue risk assessment scale will be used. The fatigue risk assessment scale consists of 21 items that inquire about fatigue experiences over the past four weeks. Each item evaluates the impact of fatigue on daily life using a Likert-type scale ranging from 0 (never) to 4 (always). The total score obtainable from the scale ranges from 0 to 84. An increase in the total score indicates a greater negative impact of fatigue on the patient's physical, cognitive, and psychosocial functions, and a greater impact on quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

ALEYNA OZDAMAR YUCEL, MSc

CONTACT

[email protected]

+90 507 950 74 57

MEHMET DURAY, associate professor

CONTACT

[email protected]

+90 506 473 11 65

Sponsors and collaborators

Lead sponsor

Suleyman Demirel University

Other

Registry information

Official study title

The Effect of Aerobic Fitness on Balance-Related Sensory Dual-Task Performance in Patients With Multiple Sclerosis

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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