Multiple SclerosisNCT07815990
Aerobic Fitness in Multiple Sclerosis: The Relationship Between Balance and Sensory Dual-Tasking
An observational study of Multiple Sclerosis, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2026to 15 May 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Süleyman Demirel Üniversitesi Araştırma ve Uygulama Hastanesi
Isparta, 32260
Aleyna Özdamar Yücel, MSc, +90 507 950 74 57, aleynayucel@sdu.edu.tr
Mehmet DURAY, Assoc. Prof., +90 506 473 11 65, mehmetduray@sdu.edu.tr
About this study
Official title: The Effect of Aerobic Fitness on Balance-Related Sensory Dual-Task Performance in Patients With Multiple Sclerosis
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.
Read more
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.
Read the detailed description
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).
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Aerobic Capacity, Dual-Task Performance, Postural Control, Dynamic Balance
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (6)
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.
Measured: Day 1
Dual Task Performance Test: Standing (Static Balance) Tasks
- 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.
Measured: Day 1
Dual Task Performance Test: Walking (Dynamic Balance) Tasks
- 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.
Measured: Day 1
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.
Measured: Day 1
Activity-Specific Balance Confidence Scale
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.
Measured: Day 1
Modified Fatigue Impact Scale
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start15 Sep 2026
- Primary completion15 Jan 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleyna Özdamar Yücel, Suleyman Demirel University
- Investigators
- MELİKE DOĞAN ÜNLÜ, NEUROLOGIST ASSOCIATE PROFESSO, Study director, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815990
- Sponsor's protocol ID
- SüleymanDU-126/9
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data for the primary and secondary objectives of the research will be compared after they are received.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aerobic Fitness on Balance-Related Sensory Dual-Task Performance in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07815990
- Acronym / sponsor ID
- SüleymanDU-126/9
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Aerobic Capacity, Dual-Task Performance, Postural Control, Dynamic Balance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
6-Minute Walk Test
Time frame: Day 1
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.
6 secondary outcomes
Timed 25-Step Walking Test
Time frame: Day 1
Dual Task Performance Test: Standing (Static Balance) Tasks
Time frame: Day 1
Dual Task Performance Test: Walking (Dynamic Balance) Tasks
Time frame: Day 1
Berg Balance Scale
Time frame: Day 1
Activity-Specific Balance Confidence Scale
Time frame: Day 1
Modified Fatigue Impact Scale
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No. The data for the primary and secondary objectives of the research will be compared after they are received.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MELİKE DOĞAN ÜNLÜ, NEUROLOGIST ASSOCIATE PROFESSO study director
Suleyman Demirel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ALEYNA OZDAMAR YUCEL, MSc (+90 507 950 74 57, aleynayucel@sdu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Minute Walk Test (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.