Multiple SclerosisNCT07370935
Trunk Stability, Balance, and Fatigue in Minimally to Moderately Disabled People With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Cappadocia University.
Trial summary
The goal of this observational study is to investigate the relationship between trunk stability and balance, mobility, upper limb performance, and fatigue in people with multiple sclerosis (MS) with minimal to moderate disability levels. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Measurements
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 26 Jan 2026to 26 Dec 2026
- 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: The study sample will consist of adult men and women aged 18-65 years with a confirmed diagnosis of multiple sclerosis living in Ankara.
Who may be able to join
- The diagnosis of multiple sclerosis was confirmed by a neurologist.
- Expanded Disability Status Scale (EDSS) score between 0 and 4
- Age between 18 and 65 years
- Accepting participation in the study voluntarily
Who cannot join
- An MS attack within the last three months
- Pregnancy
- Presence of cardiovascular, pulmonary, or orthopedic conditions that would prevent participation in exercise
- A disease that can affect the immune system, such as infection or cancer
- Additional neurological disease
About this study
Official title: The Relationship Between Trunk Stability, Balance, Mobility, Upper Limb Performance, and Fatigue in Minimally to Moderately Disabled People With Multiple Sclerosis
The goal of this observational study is to investigate the relationship between trunk stability and balance, mobility, upper limb performance, and fatigue in people with multiple sclerosis (MS) with minimal to moderate disability levels.
The main questions it aims to answer are:
Read more
- Is trunk stability associated with balance, mobility, upper limb performance, and fatigue in people with multiple sclerosis with minimal to moderate disability?
- Do balance, mobility, upper limb performance, and fatigue differ between minimally and moderately disabled people with multiple sclerosis?
Participants with a diagnosis of multiple sclerosis and Expanded Disability Status Scale (EDSS) scores ≤2 (minimally disabled) and 2.5-4 (moderately disabled) will be included in the study.
Participants will undergo standardized clinical assessments to evaluate trunk stability, balance, mobility, upper limb performance, and fatigue during a single assessment session. No intervention will be applied as part of the study, and all measurements will reflect participants' current functional status.
- Conditions
- Multiple Sclerosis
- Being tested
- Measurements
- Keywords
- multiple sclerosis, balance, mobility, fatigue
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeasurementsOther
No intervention. Participants will be assessed observationally for trunk stability, balance, mobility, upper limb performance, and fatigue using standardized clinical tests.
What is being measured
The primary outcome is the main question the study is designed to answer.
The Prone Bridge Test
The prone bridge test was used to assess core muscle endurance. In this test, the individuals were asked to raise their bodies in a prone position, supporting themselves on their forearms and toes with their elbows flexed, maintaining this position for as long as possible. When the individual was unable to maintain the position, the test was terminated. The score was the total time in seconds to complete the task. In the study, the test was repeated twice, and the longer duration was recorded.
Measured: Single assessment at the time of enrollment
The Side-bridge Test
The side-bridge test was used to assess core muscle endurance. The individuals were positioned in a straight line, lying on their left or right side with their legs fully extended. The individuals were asked to lift their body on forearms and toes, and maintain this position for as long as possible. When the individual was unable to maintain the position, the test was terminated. The score was the total time in seconds to complete the task. In the study, the test was performed twice, and the longer duration was recorded.
Measured: Single assessment at the time of enrollment
The Trunk Flexor Test
The trunk flexor test was used to assess core muscle endurance. The individuals were positioned in a sit-up position with their back resting against a wedge angled at 60° from the floor. After the wedge was removed, they were asked to maintain this position for as long as possible. When the individual was unable to maintain the position, the test was terminated. The score was the total time in seconds to complete the task. In the study, the test was repeated twice, and the longer duration was recorded.
Measured: Single assessment at the time of enrollment
The Biering-Sorensen Test
The Biering-Sorensen test was used to assess core muscle endurance. In this test, the individuals were asked to lie prone on a workout bench, aligning their anterior superior iliac spine with the edge of the bench, allowing the upper body to extend over the edge. An assisting partner secured the individuals' knees, hips, and pelvis. The individuals were instructed to fold their arms across their chest and to hold this position for as long as possible. When the individual was unable to maintain the position, the test was terminated. The score was the total time in seconds to complete the task. In the study, the test was performed twice, and the longer duration was recorded.
Measured: Single assessment at the time of enrollment
The Sit-ups Test
The sit-ups test was used to assess core muscle strength. The test began when the individuals were instructed to ''go'', and they were asked to lift their upper body off the floor, raising the lower corner of the scapula. The score was recorded as the number of repetitions completed in 30 seconds. In the study, the test was performed twice, and the highest number of repetitions was recorded.
Measured: Single assessment at the time of enrollment
The Modified Push-ups Test
The modified push-ups test was used to assess core muscle strength. The individuals were positioned on their hands and knees with hands shoulder-width apart and elbows fully extended. They dropped their hips and moved their hands forward until they created a straight line and a straight back from the knees to the hips to the shoulders. During the test, the individuals were asked to maintain this straight position while lowering their upper body until their elbows were bent to 90°, then pushing back up to the starting position. The score was recorded as the number of repetitions completed in 30 seconds. In the study, the test was performed twice, and the highest number of repetitions was recorded.
Measured: Single assessment at the time of enrollment
The Postural Stability Test
The Postural Stability Test was assessed with The Biodex-Biosway Portable Balance System (Biodex Medical System Inc., Shirley, NY, USA). The test evaluates static balance by assessing the individual's ability to maintain their center of gravity over the support surface while standing. During the test, the individuals were asked to stand as still as possible. The test duration was 30 seconds and a total stability index score was calculated. The stability index scores range from 0 to 4, with lower scores indicating good postural stability.
Measured: Single assessment at the time of enrollment
The Limits of Stability Test
The Limits of Stability Test was assessed with The Biodex-Biosway Portable Balance System (Biodex Medical System Inc., Shirley, NY, USA). During the test, the individuals were asked to move their bodies toward target points displayed on the screen without lifting their feet and then return to the center point. During this movement, they were instructed to move as quickly and accurately as possible. The test results in a total percentage score. A lower score indicates decreased stability limits.
Measured: Single assessment at the time of enrollment
The Modified Sensory Organization Test
The Modified Sensory Organization Test (MSOT) was assessed with the Biodex-Biosway Portable Balance System (Biodex Medical System Inc., Shirley, NY, USA). In the test, by selectively disrupting visual and somatosensory inputs, it is determined which sensory inputs the individual relies on the most to maintain postural stability. The MSOT was performed under four conditions in the study: eyes open on a firm surface, eyes closed on a firm surface, eyes open on a soft surface, and eyes closed on a soft surface. The individuals were instructed to maintain their balance in all conditions. The test duration was 30 seconds for each condition. The sway index scores were calculated at the end of the test. The sway index scores range from 0 to 4, with lower sway index scores indicating decreased postural sway.
Measured: Single assessment at the time of enrollment
The Activities-specific Balance Confidence Scale
The Activities-specific Balance Confidence Scale (ABC) evaluates balance confidence in daily living activities and includes 16 activities related to balance. Participants were asked to rate their perceived safety while performing these activities and their perceived risk of falling on a scale from 0 (completely unsafe) to 100 (completely safe). The total score is calculated by dividing the score by 16 and ranges from 0 to 100. Scores closer to zero indicate greater balance impairment and a higher risk of falls.
Measured: Single assessment at the time of enrollment
The 6-Minute Walk Test
Walking performance and functional exercise capacity were assessed using the Six-Minute Walk Test (6-MWT). Participants were instructed to walk at the highest speed they felt safe in a 30-meter straight pathway for six minutes. The score was the total walking distance in meters at the end of the test.
Measured: Single assessment at the time of enrollment
The Timed Up and Go Test
Functional mobility was assessed by the Timed Up and Go Test (TUG). During the test, the individuals were asked to get up from the chair, walk 3 meters, turn around, walk back to the chair, and sit down. The score was the total time in seconds to complete the task. In the study, the test was repeated three times, and the average time was recorded.
Measured: Single assessment at the time of enrollment
The Five Times Sit-to-Stand Test
Lower extremity functional muscle strength was assessed by the Five Times Sit-to-Stand Test. The individuals were seated in a standard chair with arm support of 43-45 cm height, with their arms crossed on their chests. When the command "Start" was given, individuals were asked to stand up as quickly as possible and sit down and stand up 5 times. The score was the total time in seconds to complete the task. In the study, the test was repeated twice and the shortest time was recorded.
Measured: Single assessment at the time of enrollment
Secondary outcomes (3)
The Nine-Hole Peg Test
Upper extremity performance was assessed using the Nine-Hole Peg Test (9-HPT). The 9-HPT consists of a pegboard with 9 holes and 9 wooden pegs. Individuals were asked to place and remove all 9 pegs one at a time as fast as possible. The score was the total time in seconds to complete the task. In the study, the test was repeated twice for each extremity, and the average time was recorded for each side.
Measured: Single assessment at the time of enrollment
The Fatigue Severity Scale
The Fatigue Severity Scale (FSS) assesses the severity of fatigue in the last month. It consists of 9 items, and the items are scored from 1 (strongly disagree) to 7 (strongly agree). The mean of the nine item scores is used as the FSS score. The scores that can be obtained from the test are between 1 and 7, and high scores indicate the presence of fatigue.
Measured: Single assessment at the time of enrollment
The Fatigue Impact Scale
The Fatigue Impact Scale (FIS) assesses the impact of fatigue on physical, cognitive, and psychosocial functions in the last four weeks. It consists of 40 questions, with responses ranging from 0 (no problem) to 4 (extreme problem). The scores that can be obtained from the test are between 0 and 160, and high scores indicate a greater fatigue effect.
Measured: Single assessment at the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start26 Jan 2026 (estimated)
- Primary completion26 Dec 2026 (estimated)
- Study completion26 Dec 2026 (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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cappadocia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tansu Kus, Cappadocia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370935
- Sponsor's protocol ID
- 25.12
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Trunk Stability, Balance, Mobility, Upper Limb Performance, and Fatigue in Minimally to Moderately Disabled People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07370935
- Acronym / sponsor ID
- 25.12
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, balance, mobility, fatigue
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Cappadocia UniversityUniversity, hospital or other
- Study start
- 26 Jan 2026 (estimated)
- Primary completion
- 26 Dec 2026 (estimated)
- Study completion
- 26 Dec 2026 (estimated)
- First posted
- 27 Jan 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 goal of this observational study is to investigate the relationship between trunk stability and balance, mobility, upper limb performance, and fatigue in people with multiple sclerosis (MS) with minimal to moderate disability levels.
The main questions it aims to answer are:
- Is trunk stability associated with balance, mobility, upper limb performance, and fatigue in people with multiple sclerosis with minimal to moderate disability?
- Do balance, mobility, upper limb performance, and fatigue differ between minimally and moderately disabled people with multiple sclerosis?
Participants with a diagnosis of multiple sclerosis and Expanded Disability Status Scale (EDSS) scores ≤2 (minimally disabled) and 2.5-4 (moderately disabled) will be included in the study.
Participants will undergo standardized clinical assessments to evaluate trunk stability, balance, mobility, upper limb performance, and fatigue during a single assessment session. No intervention will be applied as part of the study, and all measurements will reflect participants' current functional status.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study sample will consist of adult men and women aged 18-65 years with a confirmed diagnosis of multiple sclerosis living in Ankara.
Key inclusion criteria (4 listed)
- The diagnosis of multiple sclerosis was confirmed by a neurologist.
- Expanded Disability Status Scale (EDSS) score between 0 and 4
- Age between 18 and 65 years
- Accepting participation in the study voluntarily
Key exclusion criteria (5 listed)
- An MS attack within the last three months
- Pregnancy
- Presence of cardiovascular, pulmonary, or orthopedic conditions that would prevent participation in exercise
- A disease that can affect the immune system, such as infection or cancer
- Additional neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeasurementsNo intervention. Participants will be assessed observationally for trunk stability, balance, mobility, upper limb performance, and fatigue using standardized clinical tests. | Other | – |
Primary outcome
The Prone Bridge Test
Time frame: Single assessment at the time of enrollment
The prone bridge test was used to assess core muscle endurance. In this test, the individuals were asked to raise their bodies in a prone position, supporting themselves on their forearms and toes with their elbows flexed, maintaining this position for as long as possible. When the individual was unable to maintain the position, the test was terminated. The score was the total time in seconds to complete the task. In the study, the test was repeated twice, and the longer duration was recorded.
The Side-bridge Test
Time frame: Single assessment at the time of enrollment
The side-bridge test was used to assess core muscle endurance. The individuals were positioned in a straight line, lying on their left or right side with their legs fully extended. The individuals were asked to lift their body on forearms and toes, and maintain this position for as long as possible. When the individual was unable to maintain the position, the test was terminated. The score was the total time in seconds to complete the task. In the study, the test was performed twice, and the longer duration was recorded.
The Trunk Flexor Test
Time frame: Single assessment at the time of enrollment
The trunk flexor test was used to assess core muscle endurance. The individuals were positioned in a sit-up position with their back resting against a wedge angled at 60° from the floor. After the wedge was removed, they were asked to maintain this position for as long as possible. When the individual was unable to maintain the position, the test was terminated. The score was the total time in seconds to complete the task. In the study, the test was repeated twice, and the longer duration was recorded.
The Biering-Sorensen Test
Time frame: Single assessment at the time of enrollment
The Biering-Sorensen test was used to assess core muscle endurance. In this test, the individuals were asked to lie prone on a workout bench, aligning their anterior superior iliac spine with the edge of the bench, allowing the upper body to extend over the edge. An assisting partner secured the individuals' knees, hips, and pelvis. The individuals were instructed to fold their arms across their chest and to hold this position for as long as possible. When the individual was unable to maintain the position, the test was terminated. The score was the total time in seconds to complete the task. In the study, the test was performed twice, and the longer duration was recorded.
The Sit-ups Test
Time frame: Single assessment at the time of enrollment
The sit-ups test was used to assess core muscle strength. The test began when the individuals were instructed to ''go'', and they were asked to lift their upper body off the floor, raising the lower corner of the scapula. The score was recorded as the number of repetitions completed in 30 seconds. In the study, the test was performed twice, and the highest number of repetitions was recorded.
The Modified Push-ups Test
Time frame: Single assessment at the time of enrollment
The modified push-ups test was used to assess core muscle strength. The individuals were positioned on their hands and knees with hands shoulder-width apart and elbows fully extended. They dropped their hips and moved their hands forward until they created a straight line and a straight back from the knees to the hips to the shoulders. During the test, the individuals were asked to maintain this straight position while lowering their upper body until their elbows were bent to 90°, then pushing back up to the starting position. The score was recorded as the number of repetitions completed in 30 seconds. In the study, the test was performed twice, and the highest number of repetitions was recorded.
The Postural Stability Test
Time frame: Single assessment at the time of enrollment
The Postural Stability Test was assessed with The Biodex-Biosway Portable Balance System (Biodex Medical System Inc., Shirley, NY, USA). The test evaluates static balance by assessing the individual's ability to maintain their center of gravity over the support surface while standing. During the test, the individuals were asked to stand as still as possible. The test duration was 30 seconds and a total stability index score was calculated. The stability index scores range from 0 to 4, with lower scores indicating good postural stability.
The Limits of Stability Test
Time frame: Single assessment at the time of enrollment
The Limits of Stability Test was assessed with The Biodex-Biosway Portable Balance System (Biodex Medical System Inc., Shirley, NY, USA). During the test, the individuals were asked to move their bodies toward target points displayed on the screen without lifting their feet and then return to the center point. During this movement, they were instructed to move as quickly and accurately as possible. The test results in a total percentage score. A lower score indicates decreased stability limits.
The Modified Sensory Organization Test
Time frame: Single assessment at the time of enrollment
The Modified Sensory Organization Test (MSOT) was assessed with the Biodex-Biosway Portable Balance System (Biodex Medical System Inc., Shirley, NY, USA). In the test, by selectively disrupting visual and somatosensory inputs, it is determined which sensory inputs the individual relies on the most to maintain postural stability. The MSOT was performed under four conditions in the study: eyes open on a firm surface, eyes closed on a firm surface, eyes open on a soft surface, and eyes closed on a soft surface. The individuals were instructed to maintain their balance in all conditions. The test duration was 30 seconds for each condition. The sway index scores were calculated at the end of the test. The sway index scores range from 0 to 4, with lower sway index scores indicating decreased postural sway.
The Activities-specific Balance Confidence Scale
Time frame: Single assessment at the time of enrollment
The Activities-specific Balance Confidence Scale (ABC) evaluates balance confidence in daily living activities and includes 16 activities related to balance. Participants were asked to rate their perceived safety while performing these activities and their perceived risk of falling on a scale from 0 (completely unsafe) to 100 (completely safe). The total score is calculated by dividing the score by 16 and ranges from 0 to 100. Scores closer to zero indicate greater balance impairment and a higher risk of falls.
The 6-Minute Walk Test
Time frame: Single assessment at the time of enrollment
Walking performance and functional exercise capacity were assessed using the Six-Minute Walk Test (6-MWT). Participants were instructed to walk at the highest speed they felt safe in a 30-meter straight pathway for six minutes. The score was the total walking distance in meters at the end of the test.
The Timed Up and Go Test
Time frame: Single assessment at the time of enrollment
Functional mobility was assessed by the Timed Up and Go Test (TUG). During the test, the individuals were asked to get up from the chair, walk 3 meters, turn around, walk back to the chair, and sit down. The score was the total time in seconds to complete the task. In the study, the test was repeated three times, and the average time was recorded.
The Five Times Sit-to-Stand Test
Time frame: Single assessment at the time of enrollment
Lower extremity functional muscle strength was assessed by the Five Times Sit-to-Stand Test. The individuals were seated in a standard chair with arm support of 43-45 cm height, with their arms crossed on their chests. When the command "Start" was given, individuals were asked to stand up as quickly as possible and sit down and stand up 5 times. The score was the total time in seconds to complete the task. In the study, the test was repeated twice and the shortest time was recorded.
3 secondary outcomes
The Nine-Hole Peg Test
Time frame: Single assessment at the time of enrollment
The Fatigue Severity Scale
Time frame: Single assessment at the time of enrollment
The Fatigue Impact Scale
Time frame: Single assessment at the time of enrollment
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 27 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Cappadocia University.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Prone Bridge Test (time frame: Single assessment at the time of enrollment). The study lists 13 primary outcomes in all. 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 27 Jan 2026.