NCT07815990

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Sep 2026

Shorter than P25 for all trials

Status
not yet recruiting

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 Progress11%
Sep 2026May 2027

First Submitted

Initial submission to the registry

September 7, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

September 15, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2027

Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 7, 2026

Last Update Submit

September 14, 2026

Conditions

Keywords

Multiple SclerosisAerobic CapacityDual-Task PerformancePostural ControlDynamic Balance

Outcome Measures

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.

    Day 1

Secondary Outcomes (6)

  • Timed 25-Step Walking Test

    Day 1

  • Dual Task Performance Test: Standing (Static Balance) Tasks

    Day 1

  • Dual Task Performance Test: Walking (Dynamic Balance) Tasks

    Day 1

  • Berg Balance Scale

    Day 1

  • Activity-Specific Balance Confidence Scale

    Day 1

  • +1 more secondary outcomes

Study Arms (2)

Those with High Aerobic Fitness: Joint Clinical and Dual Duty Protocol

Data will be collected once 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 (MCIET), the Activity-Specific Balance Confidence Scale (ASBCS), and the Modified Fatigue Impact Scale (MFIS).

Individuals with Low Aerobic Fitness: Joint Clinical and Dual Duty Protocol

Data will be collected once 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 (MCIET), the Activity-Specific Balance Confidence Scale (ASBCS), and the Modified Fatigue Impact Scale (MFIS).

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • MELİKE DOĞAN ÜNLÜ, NEUROLOGIST ASSOCIATE PROFESSO

    Suleyman Demirel University

    STUDY DIRECTOR

Central Study Contacts

ALEYNA OZDAMAR YUCEL, MSc

CONTACT

MEHMET DURAY, associate professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, MSc

Study Record Dates

First Submitted

September 7, 2026

First Posted

September 11, 2026

Study Start

September 15, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

May 15, 2027

Last Updated

September 17, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

The data for the primary and secondary objectives of the research will be compared after they are received.