Multiple SclerosisNCT07202780
The Relationship Between Mechanical Properties of Respiratory and Lower Extremity Muscles and Other Parameters in Multiple Sclerosis
An observational study of Multiple Sclerosis and Breath Tests, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
Multiple sclerosis (MS) is a chronic inflammatory disease characterised by deterioration in the mechanics of the lower extremities and respiratory muscles and a decrease in respiratory function. Fatigue and depression are among the most common symptoms. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Breath Tests, MyotonPRO
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 Apr 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Having been diagnosed with MS according to the revised McDonald criteria followed at the Neurology Outpatient Clinic of Sanko University Hospital
Who may be able to join
- Having been diagnosed with MS according to the revised McDonald criteria followed at the Neurology Outpatient Clinic of Sanko University Hospital,
- Being between 18 and 50 years of age,
- Not having had an attack in the last 6 months,
- Having an EDSS score of 4.5 or below,
- To have given consent for the study.
Who cannot join
- History of lower extremity surgery within the last 12 months,
- To have undergone physiotherapy within the last 6 months,
- Presence of current trauma or fracture involving the lower extremities,
- Presence of another neuro-musculoskeletal or pulmonary disease besides MS,
- Inability to cooperate with measurements and demonstrate compliance,
- Having received pulse steroid therapy or botulinum toxin/phenol injection within the last 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Examination of the Relationship Between Mechanical Properties of Respiratory and Lower Extremity Muscles, Respiratory Function, Fatigue, and Anxiety-Depression in Patients With Multiple Sclerosis
Multiple sclerosis (MS) is a chronic inflammatory disease characterised by deterioration in the mechanics of the lower extremities and respiratory muscles and a decrease in respiratory function. Fatigue and depression are among the most common symptoms. The aim of this study is to investigate the potential effect of the mechanical properties of the lower extremity and respiratory muscles on respiratory function, fatigue, and anxiety-depression. The sample will consist of 29 MS patients who meet the inclusion and exclusion criteria and volunteer to participate in the study. The sociodemographic data of the individuals will be recorded. Subsequently, the Pulmonary Dysfunction Index (PDI), Modified Medical Research Council Scale (mMRC), Expanded Disability Status Scale (EDSS), Fatigue Severity Scale (FSS), and Hospital Anxiety and Depression Scale (HADS) will be administered to the individuals. The mechanical properties of the accessory respiratory and lower extremity muscles will be recorded using a digital palpation device, and respiratory function and respiratory muscle strength values will be recorded using a portable spirometer. Lower extremity function and strength will be assessed using the 30-second sit-to-stand test. At the end of the study, the level of association between the mechanical properties of the auxiliary respiratory and lower extremity muscles and respiratory function, respiratory muscle strength, fatigue, and depression will be evaluated. The SPSS software package will be used for data analysis. A significance level of p˂0.05 will be accepted. Furthermore, this study will determine the relationship between the mechanical properties of respiratory and lower extremity muscles in MS and provide a different perspective on the clinical management of the disease.
Read the detailed description
Multiple sclerosis (MS) is a chronic inflammatory disease characterised by demyelination and axonal degeneration in the central nervous system, leading to various motor and sensory impairments. Symptoms are classified as cognitive, sensory, and motor, with the most common symptoms including loss of muscle control, muscle weakness, abnormal muscle tone, ataxia, depression, and fatigue. These impairments frequently affect balance and gait, leading to the disabling consequences of the disease. The muscle groups most affected in individuals with MS are the lower extremities, which exhibit significant reductions in muscle strength and function. Research shows that in the early stages of MS, muscle strength in the lower extremities can decrease by approximately 25% compared to healthy controls, with marked deficiencies in muscle activation and increased fatigue. Studies have shown that quadriceps strength is significantly reduced, which can lead to difficulties in walking and maintaining balance. Furthermore, in MS patients, the coactivation patterns of lower limb muscles during walking change, indicating a compensatory mechanism in response to decreased muscle strength. This coactivation can lead to inefficient movement patterns, further exacerbating fatigue and functional limitations.
Fatigue is another important symptom associated with MS and affects both voluntary and involuntary muscle contractions. Approximately 65% of individuals with MS report fatigue, and 40% describe fatigue as the most disabling symptom. However, despite the prevalence of fatigue in MS, its exact mechanisms remain unclear. It has been suggested that there may be a correlation between fatigue and increased central arousal to compensate for reduced central activation, and depression has also been reported as a factor that increases fatigue. Fatigue is not only a result of muscle weakness but also involves central mechanisms that impair motor control and muscle activation.
Disability in MS is associated with reduced mobility, abnormal gait mechanics, impaired balance and muscle weakness, as well as cognitive and autonomic dysfunction. These impairments typically reduce functional capacity, increase fatigue, reduce independence in activities of daily living, and consequently increase the risk of secondary diseases such as coronary heart disease, diabetes, and obesity. Therefore, a good understanding of fatigue and the mechanical properties of muscle in these patients may play an important role in disease progression.
MS can affect the trunk and respiratory muscles as well as the lower extremities. Factors affecting respiratory function include muscle weakness, changes in muscle tone, motor coordination disorders, and postural abnormalities. In addition, MS can affect the centres responsible for respiratory function, leading to clinically significant changes in respiratory control. It has been reported that respiratory muscle weakness can be observed even in the early stages of MS. These studies highlight the complex effect of MS on respiratory function and respiratory muscle weakness.
In summary, MS is a multi-faceted disease that can affect the muscles of the lower extremities, particularly the quadriceps, as well as the trunk and respiratory muscles. These impairments can lead to significant functional limitations, affecting the mobility and overall quality of life of individuals with MS and potentially worsening the progression of the disease. Therefore, it is important to understand this condition well and take it into account in clinical management. However, lower limb and respiratory muscle mechanics, respiratory function, fatigue, and depression levels in individuals with MS have not been comprehensively investigated. Therefore, the aim of this study is to investigate the potential relationship between lower limb and respiratory muscle mechanics, respiratory function, fatigue, and anxiety-depression in individuals with MS.
Research Hypotheses:
H0: The mechanical properties of the respiratory and lower extremity muscles in individuals with multiple sclerosis have no effect on respiratory function, fatigue, and depression levels.
H1: The mechanical properties of the respiratory and lower extremity muscles in individuals with multiple sclerosis have an effect on respiratory function, fatigue, and depression levels.
This study will be conducted jointly by the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, SANKO University, and the Department of Neurology, Faculty of Medicine, SANKO University. MS patients who apply to the Neurology Outpatient Clinic of SANKO University Hospital and meet the inclusion criteria will be included in the study. Patients included in the study will be evaluated at the SANKO University Department of Physiotherapy and Rehabilitation Research Laboratory.
The study data were collected using the Case Report Form (CRF), Pulmonary Dysfunction Index (PDI), Modified Medical Research Council Scale (mMRC), Expanded Disability Status Scale (EDSS), Fatigue Severity Scale (FSS), and Hospital Anxiety and Depression Scale (HADS). Data contained in the Data Collection Form (DCF) will be obtained using the 30-second sit-to-stand functional assessment test (30sSTT) and laboratory measurement devices including the MyotonPro® digital palpation device (Myoton AS, Estonia) and a portable spirometer (Cosmed, Pony Fx, Rome, Italy).
The study data were collected using the Case Report Form (CRF), Pulmonary Dysfunction Index (PDI), Modified Medical Research Council Scale (mMRC), Expanded Disability Status Scale (EDSS), Fatigue Severity Scale (FSS), and Hospital Anxiety and Depression Scale (HADS). Data contained in the Data Collection Form (DCF) will be obtained using the 30-second sit-to-stand functional assessment test (30sSTT) and laboratory measurement devices including the MyotonPro® digital palpation device (Myoton AS, Estonia) and a portable spirometer (Cosmed, Pony Fx, Rome, Italy).
Healthy individuals of the same age group will be included in the study. The results of healthy individuals will be compared with the results of MS patients.
- Conditions
- Multiple Sclerosis, Breath Tests, MyotonPRO
- Keywords
- multiple skleroz, breath test, myoton pro
- 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 |
|---|---|---|
| multiple sclerosis people | Individuals diagnosed with MS were included | |
| healthy individuals | healthy individuals were included |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Neurological Disability Level:
The neurological disability level of individuals with MS will be determined using the Expanded Disability Status Scale (EDSS), a widely used scale. Developed by Kurke, it has been the most commonly used method for measuring disability in the field of MS for many years. The EDSS is used to measure the level of disability in MS. The validity and reliability of the EDSS in Turkish, particularly when used in conjunction with other scales to comprehensively assess disability in the context of MS, has been demonstrated in various studies. The EDSS is a 20-stage disease severity scale ranging from 0 (normal) to 10 (death due to MS).
Measured: 1 year
Fatigue Severity Scale
The Fatigue Severity Scale (FSS) was first developed by Krupp et al. (1989). This scale was specifically designed to assess the severity of fatigue in patients with MS and other chronic conditions. Its validity and reliability in Turkish-speaking MS patients were demonstrated by Armutlu et al. (2007). The FSS consists of nine items that assess the impact of fatigue on daily functioning and overall quality of life, with responses measured on a seven-point Likert scale. In the self-administered version of the scale, each item is scored from 1 to 7 (1 = strongly disagree, 7 = strongly agree), and the total score is calculated as the average of the nine items. The lower the total score, the less fatigue is present. A commonly used cut-off value in clinical practice is a total score of 36 or higher, indicating significant fatigue.
Measured: 1 year
The Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) will be used to assess depression. Developed by Zigmond et al. (1983), this scale consists of 14 questions, seven measuring anxiety and seven measuring depression. A four-point Likert-type scale is used to answer each question. Each item is scored between 0 and 3, and the total score is calculated as the average of the seven items. The scale has been adapted into Turkish, and as a result of the validity and reliability study, the cut-off score for the anxiety subscale was found to be 10/11, and the cut-off score for the depression subscale was found to be 7/8. In our study, each HADS score for anxiety and depression will be considered as follows: 0-7 = normal, 8-10 = borderline abnormal, 11-21 = abnormal.
Measured: 1 year
myoton pro
The muscles of the patients' lower extremities, including the Rectus Femoris, Vastus Lateralis, Vastus Medialis, Biceps Femoris, Semitendinosus, Gastrocnemius Medialis, and Gastrocnemius Lateralis, as well as the auxiliary respiratory muscles, including the Sternocleidomastoideus, M. Upper Trapezius, M. Pectoralis Major, M. Serratus Anterior, M. Rectus Abdominis, and M. External Oblique Abdominis will be assessed using the MyotonPro® (Myoton AS, Estonia) digital palpation device.
Measured: 1 year
Assessment of Lower Limb Functionality and Muscle Strength
The 30-second sit-to-stand test (30s-OKT) will be used to measure lower limb functionality and muscle strength. The test, developed by Jones et al. (1999), is a functional assessment test. The 30sOKT has been validated as an effective measure of lower extremity strength, particularly in patients with MS, and has shown strong correlations with other functional assessments such as the Timed Up and Go (TUG) test and the 5-repetition sit-to-stand test (5STS). In our country, Özkeskin et al. (2023) applied this test to patients with MS and reported that the test-retest reliability was excellent (ICC > 0.80) and the concurrent validity (r > 0.05) was strong. Prior to the test, patients will rest for 30 minutes, and the physiotherapist administering the test will demonstrate how the test is performed to the patient. Patients will be seated upright on an armless chair (approximately 43 cm high) with their back against the wall, their
Measured: 1 years
Assessment of Respiratory Muscle Strength:
In clinical practice, respiratory muscle strength is assessed based on the principle of measuring the pressure difference between inspiration and expiration. Maximal voluntary inspiratory (PImax) and expiratory (PEmax) pressures (MIP and MEP) are the most commonly used non-invasive methods for measuring respiratory muscle strength (ATS/ERS, 2022). Black and Hyatt (1969) stated that this technique can be used for health checks in patients and athletes of all ages. Pressure is measured by performing maximal inspiration (Müller manoeuvre) and expiration (Valsalva manoeuvre) through the mouth. The manoeuvre is typically performed at residual volume (RV) for MIP and total lung capacity (TLC) for MEP (Cotes et al., 2006; Ruppel, 2009). In our study, patients' intraoral pressure measurements will be taken using a Cosmed Pony FX model device (Italy).
Measurements were performed in a sitting position with a nose clip. The Valsalva and Müller manoeuvr
Measured: 1 year
A Spirometry Test (SFT)
involves the measurement of dynamic lung volumes and capacities over time during forced inspiration and expiration (Bartu-Saryal and Ulubay, 2012). In our study, SFT measurements will be performed using a Cosmed Pony FX model (Italy) portable spirometer.
Patients will be informed about the PFT in advance, in accordance with measurement standards. To enable comparison with standard values, patients' gender, age, height, weight, and ethnicity (e.g., Caucasian) will be entered into the device. Tests will be performed in a seated position. At least 3 tests will be performed on each patient, and measurements will not be continued for cases that fail to perform the manoeuvre successfully after 8 tests. During the test, subjects will be asked to take 3-4 normal breaths and then take a deep inspiration, followed by a rapid and forceful expiration to expel all air (ATS/ERS, 2005). After three successful tests, the test with the highest sum of FVC and FEV1, as recommend
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Jan 2025
- Primary completion1 Aug 2025
- Study completion1 Apr 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
- Other
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Bağcı, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202780
- Sponsor's protocol ID
- Burcu3
- Status last verified
- Oct 2025
- First submitted
- 16 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Relationship Between Mechanical Properties of Respiratory and Lower Extremity Muscles, Respiratory Function, Fatigue, and Anxiety-Depression in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07202780
- Acronym / sponsor ID
- Burcu3
- Conditions
- Multiple Sclerosis, Breath Tests, MyotonPRO
- Keywords
- multiple skleroz, breath test, myoton pro
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 2 Oct 2025 (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.
Multiple sclerosis (MS) is a chronic inflammatory disease characterised by deterioration in the mechanics of the lower extremities and respiratory muscles and a decrease in respiratory function. Fatigue and depression are among the most common symptoms. The aim of this study is to investigate the potential effect of the mechanical properties of the lower extremity and respiratory muscles on respiratory function, fatigue, and anxiety-depression. The sample will consist of 29 MS patients who meet the inclusion and exclusion criteria and volunteer to participate in the study. The sociodemographic data of the individuals will be recorded. Subsequently, the Pulmonary Dysfunction Index (PDI), Modified Medical Research Council Scale (mMRC), Expanded Disability Status Scale (EDSS), Fatigue Severity Scale (FSS), and Hospital Anxiety and Depression Scale (HADS) will be administered to the individuals. The mechanical properties of the accessory respiratory and lower extremity muscles will be recorded using a digital palpation device, and respiratory function and respiratory muscle strength values will be recorded using a portable spirometer. Lower extremity function and strength will be assessed using the 30-second sit-to-stand test. At the end of the study, the level of association between the mechanical properties of the auxiliary respiratory and lower extremity muscles and respiratory function, respiratory muscle strength, fatigue, and depression will be evaluated. The SPSS software package will be used for data analysis. A significance level of p˂0.05 will be accepted. Furthermore, this study will determine the relationship between the mechanical properties of respiratory and lower extremity muscles in MS and provide a different perspective on the clinical management of the disease.
Detailed description
Multiple sclerosis (MS) is a chronic inflammatory disease characterised by demyelination and axonal degeneration in the central nervous system, leading to various motor and sensory impairments. Symptoms are classified as cognitive, sensory, and motor, with the most common symptoms including loss of muscle control, muscle weakness, abnormal muscle tone, ataxia, depression, and fatigue. These impairments frequently affect balance and gait, leading to the disabling consequences of the disease. The muscle groups most affected in individuals with MS are the lower extremities, which exhibit significant reductions in muscle strength and function. Research shows that in the early stages of MS, muscle strength in the lower extremities can decrease by approximately 25% compared to healthy controls, with marked deficiencies in muscle activation and increased fatigue. Studies have shown that quadriceps strength is significantly reduced, which can lead to difficulties in walking and maintaining balance. Furthermore, in MS patients, the coactivation patterns of lower limb muscles during walking change, indicating a compensatory mechanism in response to decreased muscle strength. This coactivation can lead to inefficient movement patterns, further exacerbating fatigue and functional limitations.
Fatigue is another important symptom associated with MS and affects both voluntary and involuntary muscle contractions. Approximately 65% of individuals with MS report fatigue, and 40% describe fatigue as the most disabling symptom. However, despite the prevalence of fatigue in MS, its exact mechanisms remain unclear. It has been suggested that there may be a correlation between fatigue and increased central arousal to compensate for reduced central activation, and depression has also been reported as a factor that increases fatigue. Fatigue is not only a result of muscle weakness but also involves central mechanisms that impair motor control and muscle activation.
Disability in MS is associated with reduced mobility, abnormal gait mechanics, impaired balance and muscle weakness, as well as cognitive and autonomic dysfunction. These impairments typically reduce functional capacity, increase fatigue, reduce independence in activities of daily living, and consequently increase the risk of secondary diseases such as coronary heart disease, diabetes, and obesity. Therefore, a good understanding of fatigue and the mechanical properties of muscle in these patients may play an important role in disease progression.
MS can affect the trunk and respiratory muscles as well as the lower extremities. Factors affecting respiratory function include muscle weakness, changes in muscle tone, motor coordination disorders, and postural abnormalities. In addition, MS can affect the centres responsible for respiratory function, leading to clinically significant changes in respiratory control. It has been reported that respiratory muscle weakness can be observed even in the early stages of MS. These studies highlight the complex effect of MS on respiratory function and respiratory muscle weakness.
In summary, MS is a multi-faceted disease that can affect the muscles of the lower extremities, particularly the quadriceps, as well as the trunk and respiratory muscles. These impairments can lead to significant functional limitations, affecting the mobility and overall quality of life of individuals with MS and potentially worsening the progression of the disease. Therefore, it is important to understand this condition well and take it into account in clinical management. However, lower limb and respiratory muscle mechanics, respiratory function, fatigue, and depression levels in individuals with MS have not been comprehensively investigated. Therefore, the aim of this study is to investigate the potential relationship between lower limb and respiratory muscle mechanics, respiratory function, fatigue, and anxiety-depression in individuals with MS.
Research Hypotheses:
H0: The mechanical properties of the respiratory and lower extremity muscles in individuals with multiple sclerosis have no effect on respiratory function, fatigue, and depression levels.
H1: The mechanical properties of the respiratory and lower extremity muscles in individuals with multiple sclerosis have an effect on respiratory function, fatigue, and depression levels.
This study will be conducted jointly by the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, SANKO University, and the Department of Neurology, Faculty of Medicine, SANKO University. MS patients who apply to the Neurology Outpatient Clinic of SANKO University Hospital and meet the inclusion criteria will be included in the study. Patients included in the study will be evaluated at the SANKO University Department of Physiotherapy and Rehabilitation Research Laboratory.
The study data were collected using the Case Report Form (CRF), Pulmonary Dysfunction Index (PDI), Modified Medical Research Council Scale (mMRC), Expanded Disability Status Scale (EDSS), Fatigue Severity Scale (FSS), and Hospital Anxiety and Depression Scale (HADS). Data contained in the Data Collection Form (DCF) will be obtained using the 30-second sit-to-stand functional assessment test (30sSTT) and laboratory measurement devices including the MyotonPro® digital palpation device (Myoton AS, Estonia) and a portable spirometer (Cosmed, Pony Fx, Rome, Italy).
The study data were collected using the Case Report Form (CRF), Pulmonary Dysfunction Index (PDI), Modified Medical Research Council Scale (mMRC), Expanded Disability Status Scale (EDSS), Fatigue Severity Scale (FSS), and Hospital Anxiety and Depression Scale (HADS). Data contained in the Data Collection Form (DCF) will be obtained using the 30-second sit-to-stand functional assessment test (30sSTT) and laboratory measurement devices including the MyotonPro® digital palpation device (Myoton AS, Estonia) and a portable spirometer (Cosmed, Pony Fx, Rome, Italy).
Healthy individuals of the same age group will be included in the study. The results of healthy individuals will be compared with the results of MS patients.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multiple sclerosis people | – | –Individuals diagnosed with MS were included |
| healthy individuals | – | –healthy individuals were included |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Having been diagnosed with MS according to the revised McDonald criteria followed at the Neurology Outpatient Clinic of Sanko University Hospital
Key inclusion criteria (5 listed)
- Having been diagnosed with MS according to the revised McDonald criteria followed at the Neurology Outpatient Clinic of Sanko University Hospital,
- Being between 18 and 50 years of age,
- Not having had an attack in the last 6 months,
- Having an EDSS score of 4.5 or below,
- To have given consent for the study.
Key exclusion criteria (6 listed)
- History of lower extremity surgery within the last 12 months,
- To have undergone physiotherapy within the last 6 months,
- Presence of current trauma or fracture involving the lower extremities,
- Presence of another neuro-musculoskeletal or pulmonary disease besides MS,
- Inability to cooperate with measurements and demonstrate compliance,
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
Assessment of Neurological Disability Level:
Time frame: 1 year
The neurological disability level of individuals with MS will be determined using the Expanded Disability Status Scale (EDSS), a widely used scale. Developed by Kurke, it has been the most commonly used method for measuring disability in the field of MS for many years. The EDSS is used to measure the level of disability in MS. The validity and reliability of the EDSS in Turkish, particularly when used in conjunction with other scales to comprehensively assess disability in the context of MS, has been demonstrated in various studies. The EDSS is a 20-stage disease severity scale ranging from 0 (normal) to 10 (death due to MS).
Fatigue Severity Scale
Time frame: 1 year
The Fatigue Severity Scale (FSS) was first developed by Krupp et al. (1989). This scale was specifically designed to assess the severity of fatigue in patients with MS and other chronic conditions. Its validity and reliability in Turkish-speaking MS patients were demonstrated by Armutlu et al. (2007). The FSS consists of nine items that assess the impact of fatigue on daily functioning and overall quality of life, with responses measured on a seven-point Likert scale. In the self-administered version of the scale, each item is scored from 1 to 7 (1 = strongly disagree, 7 = strongly agree), and the total score is calculated as the average of the nine items. The lower the total score, the less fatigue is present. A commonly used cut-off value in clinical practice is a total score of 36 or higher, indicating significant fatigue.
The Hospital Anxiety and Depression Scale
Time frame: 1 year
The Hospital Anxiety and Depression Scale (HADS) will be used to assess depression. Developed by Zigmond et al. (1983), this scale consists of 14 questions, seven measuring anxiety and seven measuring depression. A four-point Likert-type scale is used to answer each question. Each item is scored between 0 and 3, and the total score is calculated as the average of the seven items. The scale has been adapted into Turkish, and as a result of the validity and reliability study, the cut-off score for the anxiety subscale was found to be 10/11, and the cut-off score for the depression subscale was found to be 7/8. In our study, each HADS score for anxiety and depression will be considered as follows: 0-7 = normal, 8-10 = borderline abnormal, 11-21 = abnormal.
myoton pro
Time frame: 1 year
The muscles of the patients' lower extremities, including the Rectus Femoris, Vastus Lateralis, Vastus Medialis, Biceps Femoris, Semitendinosus, Gastrocnemius Medialis, and Gastrocnemius Lateralis, as well as the auxiliary respiratory muscles, including the Sternocleidomastoideus, M. Upper Trapezius, M. Pectoralis Major, M. Serratus Anterior, M. Rectus Abdominis, and M. External Oblique Abdominis will be assessed using the MyotonPro® (Myoton AS, Estonia) digital palpation device.
Assessment of Lower Limb Functionality and Muscle Strength
Time frame: 1 years
The 30-second sit-to-stand test (30s-OKT) will be used to measure lower limb functionality and muscle strength. The test, developed by Jones et al. (1999), is a functional assessment test. The 30sOKT has been validated as an effective measure of lower extremity strength, particularly in patients with MS, and has shown strong correlations with other functional assessments such as the Timed Up and Go (TUG) test and the 5-repetition sit-to-stand test (5STS). In our country, Özkeskin et al. (2023) applied this test to patients with MS and reported that the test-retest reliability was excellent (ICC > 0.80) and the concurrent validity (r > 0.05) was strong. Prior to the test, patients will rest for 30 minutes, and the physiotherapist administering the test will demonstrate how the test is performed to the patient. Patients will be seated upright on an armless chair (approximately 43 cm high) with their back against the wall, their
Assessment of Respiratory Muscle Strength:
Time frame: 1 year
In clinical practice, respiratory muscle strength is assessed based on the principle of measuring the pressure difference between inspiration and expiration. Maximal voluntary inspiratory (PImax) and expiratory (PEmax) pressures (MIP and MEP) are the most commonly used non-invasive methods for measuring respiratory muscle strength (ATS/ERS, 2022). Black and Hyatt (1969) stated that this technique can be used for health checks in patients and athletes of all ages. Pressure is measured by performing maximal inspiration (Müller manoeuvre) and expiration (Valsalva manoeuvre) through the mouth. The manoeuvre is typically performed at residual volume (RV) for MIP and total lung capacity (TLC) for MEP (Cotes et al., 2006; Ruppel, 2009). In our study, patients' intraoral pressure measurements will be taken using a Cosmed Pony FX model device (Italy). Measurements were performed in a sitting position with a nose clip. The Valsalva and Müller manoeuvr
A Spirometry Test (SFT)
Time frame: 1 years
involves the measurement of dynamic lung volumes and capacities over time during forced inspiration and expiration (Bartu-Saryal and Ulubay, 2012). In our study, SFT measurements will be performed using a Cosmed Pony FX model (Italy) portable spirometer. Patients will be informed about the PFT in advance, in accordance with measurement standards. To enable comparison with standard values, patients' gender, age, height, weight, and ethnicity (e.g., Caucasian) will be entered into the device. Tests will be performed in a seated position. At least 3 tests will be performed on each patient, and measurements will not be continued for cases that fail to perform the manoeuvre successfully after 8 tests. During the test, subjects will be asked to take 3-4 normal breaths and then take a deep inspiration, followed by a rapid and forceful expiration to expel all air (ATS/ERS, 2005). After three successful tests, the test with the highest sum of FVC and FEV1, as recommend
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 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
RecruitingObservational study
Magnetic Resonance Imaging (MRI) to Evaluate Activity of Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)
Progressive Multifocal Leukoencephalopathy
Recruiting
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
Multiple Sclerosis, Clinically Isolated Syndrome
Active, not recruitingObservational study
A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingPhase 3
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
Relapsing Multiple Sclerosis
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.
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 and Breath Tests, run by Sanko 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: enrolling by invitation, as of the sponsor's last update on 2 Oct 2025. 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?
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?
Assessment of Neurological Disability Level: (time frame: 1 year). The study lists 7 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 2 Oct 2025; AzTrials last refreshed its copy on 26 Oct 2026.