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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorSuleyman Demirel University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

This study was planned as a cross-sectional study, and the target population of the research consists of individuals diagnosed with MS and followed up in Isparta province.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

70 Participants
are grouped into 2 trial groups
Group A: Those with High Aerobic Fitness: Joint Clinical and Dual Duty Protocol
Group B: Individuals with Low Aerobic Fitness: Joint Clinical and Dual Duty Protocol

Trial outcomes

Primary outcomes

1

6-Minute Walk Test

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.

Time frame
Day 1

Secondary outcomes

1

Timed 25-Step Walking Test

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.

Time frame
Day 1
2

Dual Task Performance Test: Standing (Static Balance) Tasks

1. 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. 2. 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.

Time frame
Day 1
3

Dual Task Performance Test: Walking (Dynamic Balance) Tasks

1. 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. 2. 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.

Time frame
Day 1
4

Berg Balance Scale

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.

Time frame
Day 1

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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