Multiple SclerosisNCT06777134
Relationship Between Pelvic Floor Dysfunctions and Lower Limb Strength and Activation in MS Patients
An observational study of Multiple Sclerosis and Pelvic Floor Dysfunction, run by Berivan Beril Kılıç at 1 site in Turkey (Türkiye).
Trial summary
we aim to investigate the relationship between pelvic floor dysfunctions, core endurance, hip external rotation muscle strength, and tibialis posterior and tibialis anterior muscle activation in patients diagnosed with MS Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Multiple Sclerosis, Pelvic Floor Dysfunction
- What is being tested?
- Assessment of pelvic floor dysfunction, The Quality of Life Assessment and Core endurance assessment
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 10 Jan 2027
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: It is planned to include 73 patients who applied to Bakırköy Prof. Dr. Mazhar Osman Mental and Nervous Diseases Training and Research Hospital Neurology Clinic and who were diagnosed with definite Multiple Sclerosis according to McDonald Diagnostic Criteria with EDSS level between 0-4.
Who may be able to join
- EDSS score between 0 and 4.0
- Having access to the internet via a high-speed smartphone or computer
- Scoring at least 21 points on the MoCA
- Having a score of Stage 3 or higher on the Functional Ambulation Scale.
Who cannot join
- Having hearing or vision problems.
- Participating in any exercise program.
- Having accompanying other neurological, cardiovascular, or orthopedic disorders.
- A history of an MS relapse or medication change within the last 6 months.
- Being in a physical condition that prevents participation in exercises.
- Comorbid conditions that negatively affect oxygen transport (e.g., severe anemia, peripheral artery disease, etc.)
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
Biruni University
Istanbul, Istanbul, 34103
Beril Kılıç, 05069496158, fztbkilic@gmail.com
About this study
Official title: Relationship Between Pelvic Floor Dysfunctions and Core Endurance, Hip Rotation Muscle Strength, Tibialis Anterior and Tibialis Posterior Muscle Activation in Patients With Multiple Sclerosis
we aim to investigate the relationship between pelvic floor dysfunctions, core endurance, hip external rotation muscle strength, and tibialis posterior and tibialis anterior muscle activation in patients diagnosed with MS
- Conditions
- Multiple Sclerosis, Pelvic Floor Dysfunction
- Being tested
- Assessment of pelvic floor dysfunction, The Quality of Life Assessment, Core endurance assessment, Hip strength assessment, Tibialis posterior muscle activation
- Keywords
- pelvic floor, multiple sclerosis, core endurance, tibialis anterior, tibialis posterior, electromyography
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of pelvic floor dysfunctionOther
Pelvic floor dysfunctions in patients with multiple sclerosis will be assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20). The scale is designed to assess all symptoms related to pelvic floor disorders and the severity of the distress they cause. The PFDI-20 consists of 3 subscales and 20 items, with each item rated on a scale from 0 (none) to 4 (quite a bit). To determine the scale scores, the average of the responses for each item in the subscales is multiplied by 25, resulting in a subscale score ranging from 0 to 100, and a total score ranging from 0 to 300. The Turkish validity and reliability of the scale were conducted by Çelenay et al.
The Quality of Life AssessmentOther
The quality of life of the patients will be assessed using the Multiple Sclerosis International Quality of Life Questionnaire. The questionnaire consists of 31 questions and 9 subscales. The lowest score that can be obtained from the scale is 0, the highest score is 124, and a high score indicates a low quality of life. The subscales of the questionnaire include daily living activities, psychological well-being, relationships with friends, symptoms, relationships with family, relationships with the healthcare system, emotional and sexual life, coping, and rejection. The Turkish validation of the questionnaire has been conducted.
Core endurance assessmentOther
Core endurance in patients will be assessed using McGill's core endurance tests Trunk Flexor Test: Patients sit at a 60° trunk angle with knees bent, arms crossed, and feet stabilized. Time holding the position is recorded.
Trunk Extensor Test: Patients lie prone with the pelvis stabilized, lift the upper body above table level, and hold. Time is recorded until the body drops.
Lateral Trunk Test: In a modified side plank (knees bent, elbow support), patients lift hips off the mat. Time is recorded until hips lower or extra support is needed.
Hip strength assessmentOther
The assessment of hip strength will specifically focus on the hip adductor and hip external rotator muscle strength. Both muscle groups are considered to be associated with the pelvic floor. Among the hip external rotators, the piriformis muscle functions as an internal stabilizer for the hip joint, while the obturator internus muscle shares fascial connections with the pelvic floor, playing a significant role in pelvic floor function. MR and EMG studies have demonstrated that the levator ani and gluteus maximus muscles are morphologically and functionally connected, and that the contraction of hip adductor and gluteal muscles facilitates the synergistic contraction of pelvic floor muscles. Based on this information, a handheld dynamometer will be used to measure the strength of the two muscle groups planned for evaluation. Measurements will be performed three times, and the average value will be recorded.
Tibialis posterior muscle activationOther
The NeuroTrac Myoplus Pro (Quintet, Bergen, Norway) EMG device will be used for the superficial EMG analysis of the posterior tibialis muscle. During the assessment, single-use 30 x 30 mm round adhesive electrodes will be placed on the reference points. The active electrode will be positioned at the exact midpoint between the tibial tuberosity and the medial malleolus (32,33); the passive electrode will be placed 4 cm distal; and the reference electrode will be placed on the lateral malleolus.
The patient will be asked to perform isometric plantar flexion + inversion movement of the ankle against resistance for 10 seconds. The ankle isometric contractions will be performed in 3 repetitions, with a 20-second rest period between contractions. As a result of the assessment, parameters related to the muscle's strength, total work, and resting tone will be recorded in microvolts; the maximal voluntary contraction will be recorded as a percentage.
Tibialis anterior muscle activationOther
The NeuroTrac Myoplus Pro (Quintet, Bergen, Norway) EMG device will be used for the superficial EMG analysis of the tibialis anterior muscle. During the assessment, single-use 30 x 30 mm round adhesive electrodes will be placed on the reference points. The active electrode will be positioned on the muscle body of the tibialis anterior, the passive electrode will be placed 4 cm distal, and the reference electrode will be placed on the lateral malleolus (34,35).
The patient will be asked to perform isometric ankle dorsiflexion against resistance for 10 seconds. The ankle isometric contractions will be performed in 3 repetitions, with a 20-second rest period between contractions. As a result of the assessment, parameters related to the muscle's strength, total work, and resting tone will be recorded in microvolts; the maximal voluntary contraction will be recorded as a percentage.
| Study group | Role | What they receive |
|---|---|---|
| patients with multiple sclerosis | Not described Receives: Other: Assessment of pelvic floor dysfunction; Other: The Quality of Life Assessment; Other: Core endurance assessment; Other: Hip strength assessment; Other: Tibialis posterior muscle activation; Other: Tibialis anterior muscle activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor muscle dysfunction
Pelvic floor dysfunctions in patients with multiple sclerosis will be assessed using the Pelvic Floor Distress Inventory-20. The scale is designed to assess all symptoms related to pelvic floor disorders and the severity of the distress they cause. It consists of 3 subscales and 20 items, with each item rated on a scale from 0 (none) to 4 (quite a bit). To determine the scale scores, the average of the responses for each item in the subscales is multiplied by 25, resulting in a subscale score ranging from 0 to 100, and a total score ranging from 0 to 300. The Turkish validity and reliability of the scale were conducted.
Measured: baseline
Secondary outcomes (13)
Qualitf of life
The quality of life of the patients will be assessed using the Multiple Sclerosis International Quality of Life Questionnaire. The questionnaire consists of 31 questions and 9 subscales. The subscales of the questionnaire include daily living activities, psychological well-being, relationships with friends, symptoms, relationships with family, relationships with the healthcare system, emotional and sexual life, coping, and rejection. An increase in the total score obtained from the scale indicates better quality of life. The Turkish validation of the questionnaire has been conducted.
Measured: Baseline
Core endurance -trunk flexor endurance
Core endurance will be assessed using McGill's tests:
Trunk Flexor Test: Patients sit at a 60° trunk angle with knees bent, arms crossed, and feet stabilized. Time holding the position is recorded.
Measured: baseline
Core endurance -trunk extansor endurance
Core endurance will be assessed using McGill's tests:
Trunk Extensor Test: Patients lie prone with the pelvis stabilized, lift the upper body above table level, and hold. Time is recorded until the body drops.
Measured: baseline
Core endurance - lateral flexor endurance
Core endurance will be assessed using McGill's tests:
Lateral Trunk Test: In a modified side plank (knees bent, elbow support), patients lift hips off the mat. Time is recorded until hips lower or extra support is needed.
Measured: baseline
Hip strength
The assessment of hip strength will specifically focus on the hip adductor and hip external rotator muscle strength. Both muscle groups are considered to be associated with the pelvic floor. Among the hip external rotators, the piriformis muscle functions as an internal stabilizer for the hip joint, while the obturator internus muscle shares fascial connections with the pelvic floor, playing a significant role in pelvic floor function. MR and EMG studies have demonstrated that the levator ani and gluteus maximus muscles are morphologically and functionally connected, and that the contraction of hip adductor and gluteal muscles facilitates the synergistic contraction of pelvic floor muscles. Based on this information, a handheld dynamometer will be used to measure the strength of the two muscle groups planned for evaluation. Measurements will be performed three times, and the average value will be recorded.
Measured: baseline
tibialis posterior muscle activation - peak torque
The NeuroTrac Myoplus Pro (Quintet, Bergen, Norway) electromyography (EMG) device will be used for the superficial EMG analysis of the posterior tibialis muscle. During the assessment, single-use 30 x 30 mm round adhesive electrodes will be placed on the reference points. The active electrode will be positioned at the exact midpoint between the tibial tuberosity and the medial malleolus; the passive electrode will be placed 4 cm distal; and the reference electrode will be placed on the lateral malleolus.
The patient will be asked to perform isometric plantar flexion + inversion movement of the ankle against resistance for 10 seconds. The ankle isometric contractions will be performed in 3 repetitions, with a 20-second rest period between contractions. As a result of the assessment, peak torque will be recorded in microvolts.
Measured: baseline
tibialis posterior muscle activation - work avarage
The NeuroTrac Myoplus Pro (Quintet, Bergen, Norway) electromyography (EMG) device will be used for the superficial EMG analysis of the posterior tibialis muscle. During the assessment, single-use 30 x 30 mm round adhesive electrodes will be placed on the reference points. The active electrode will be positioned at the exact midpoint between the tibial tuberosity and the medial malleolus; the passive electrode will be placed 4 cm distal; and the reference electrode will be placed on the lateral malleolus.
The patient will be asked to perform isometric plantar flexion + inversion movement of the ankle against resistance for 10 seconds. The ankle isometric contractions will be performed in 3 repetitions, with a 20-second rest period between contractions. As a result of the assessment, work avarage will be recorded in microvolts.
Measured: baseline
tibialis posterior muscle activation - percentage of maximal voluntary contractions
The NeuroTrac Myoplus Pro (Quintet, Bergen, Norway) electromyography (EMG) device will be used for the superficial EMG analysis of the posterior tibialis muscle. During the assessment, single-use 30 x 30 mm round adhesive electrodes will be placed on the reference points. The active electrode will be positioned at the exact midpoint between the tibial tuberosity and the medial malleolus; the passive electrode will be placed 4 cm distal; and the reference electrode will be placed on the lateral malleolus.
The patient will be asked to perform isometric plantar flexion + inversion movement of the ankle against resistance for 10 seconds. The ankle isometric contractions will be performed in 3 repetitions, with a 20-second rest period between contractions. As a result of the assessment, maximal voluntary contractions will be recorded in percentage
Measured: baseline
tibialis posterior muscle activation - rest tone
The NeuroTrac Myoplus Pro (Quintet, Bergen, Norway) electromyography (EMG) device will be used for the superficial EMG analysis of the posterior tibialis muscle. During the assessment, single-use 30 x 30 mm round adhesive electrodes will be placed on the reference points. The active electrode will be positioned at the exact midpoint between the tibial tuberosity and the medial malleolus; the passive electrode will be placed 4 cm distal; and the reference electrode will be placed on the lateral malleolus.
The patient will be asked to perform isometric plantar flexion + inversion movement of the ankle against resistance for 10 seconds. The ankle isometric contractions will be performed in 3 repetitions, with a 20-second rest period between contractions. As a result of the assessment, rest tone will be recorded in microvolts.
Measured: baseline
tibialis anterior muscle activation - peak torque
The NeuroTrac Myoplus Pro (Quintet, Bergen, Norway) electromyography (EMG) device will be used for the superficial EMG analysis of the tibialis anterior muscle. During the assessment, single-use 30 x 30 mm round adhesive electrodes will be placed on the reference points. The active electrode will be positioned on the muscle body of the tibialis anterior, the passive electrode will be placed 4 cm distal, and the reference electrode will be placed on the lateral malleolus.
The patient will be asked to perform isometric ankle dorsiflexion against resistance for 10 seconds. The ankle isometric contractions will be performed in 3 repetitions, with a 20-second rest period between contractions. As a result of the assessment, peak torque will be recorded in microvolts.
Measured: baseline
tibialis anterior muscle activation - work avarage
The NeuroTrac Myoplus Pro (Quintet, Bergen, Norway) electromyography (EMG) device will be used for the superficial EMG analysis of the tibialis anterior muscle. During the assessment, single-use 30 x 30 mm round adhesive electrodes will be placed on the reference points. The active electrode will be positioned on the muscle body of the tibialis anterior, the passive electrode will be placed 4 cm distal, and the reference electrode will be placed on the lateral malleolus.
The patient will be asked to perform isometric ankle dorsiflexion against resistance for 10 seconds. The ankle isometric contractions will be performed in 3 repetitions, with a 20-second rest period between contractions. As a result of the assessment, work average will be recorded in microvolts.
Measured: baseline
tibialis anterior muscle activation - percentage of maximal voluntarily contractions
The NeuroTrac Myoplus Pro (Quintet, Bergen, Norway) electromyography (EMG) device will be used for the superficial EMG analysis of the tibialis anterior muscle. During the assessment, single-use 30 x 30 mm round adhesive electrodes will be placed on the reference points. The active electrode will be positioned on the muscle body of the tibialis anterior, the passive electrode will be placed 4 cm distal, and the reference electrode will be placed on the lateral malleolus.
The patient will be asked to perform isometric ankle dorsiflexion against resistance for 10 seconds. The ankle isometric contractions will be performed in 3 repetitions, with a 20-second rest period between contractions. As a result of the assessment, maximal voluntary contractions will be recorded in percentage.
Measured: baseline
tibialis anterior muscle activation - rest tone
The NeuroTrac Myoplus Pro (Quintet, Bergen, Norway) electromyography (EMG) device will be used for the superficial EMG analysis of the tibialis anterior muscle. During the assessment, single-use 30 x 30 mm round adhesive electrodes will be placed on the reference points. The active electrode will be positioned on the muscle body of the tibialis anterior, the passive electrode will be placed 4 cm distal, and the reference electrode will be placed on the lateral malleolus.
The patient will be asked to perform isometric ankle dorsiflexion against resistance for 10 seconds. The ankle isometric contractions will be performed in 3 repetitions, with a 20-second rest period between contractions. As a result of the assessment, rest tone will be recorded in microvolts.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Jan 2025
- Primary completion10 Dec 2026 (estimated)
- Study completion10 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Berivan Beril Kılıç
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Berivan Beril Kılıç, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777134
- Sponsor's protocol ID
- 05-14
- Status last verified
- Feb 2026
- First submitted
- 4 Jan 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
İstek, A. (2009) Kronik Pelvik Ağrı Şikayeti Olan Hastalarda Posterior Tibial Sinir Uyarısı Tedavisinin (Nöromodülasyon) Yaşam Kalitesi Üzerine Etkisi
İri, S.G. (2022) Üriner İnkontinansı Olan Kadınlarda Pelvik Taban Sağlığı Eğitimi Ve Egzersiz Programının Etkinliğinin Araştırılması
İpeker Karagöz, F. (2022) Kadınlarda Stres Üriner İnkontinans Şiddetinin İnsülin Benzeri Büyüme Faktörü-1 Ve Kor Stabilizasyonu Üzerine Etkisinin İncelenmesi
YAVAŞ, İpek, Özge ERTEKİN, and Turhan KAHRAMAN. "Multipl Sklerozlu Bireylerde Üriner Semptomlar, Bağırsak Semptomları ve Cinsel İşlev Bozukluğunun Tedavisinde Pelvik Taban Kas Eğitimi: Geleneksel Derleme." Turkiye Klinikleri Journal of Health Sciences/Türkiye Klinikleri Sağlık Bilimleri Dergisi 9.2 (2024).
Yavaş, İ. (2021). Multipl sklerozlu bireylerde telerehabilitasyon temelli pelvik taban kas eğitiminin üriner inkontinans, cinsel işlev bozukluğu ve yaşam kalitesi üzerine etkisi
Yıldız, H.C. (2018). Multipl Skleroz bireylerinde, mesane fonksiyonlarının etkilenim şiddetine göre yorgunluk, düşme, yaşam kalitesi ve pelvik taban kas kuvvetinin karşılaştırması
Gumus H, Akpinar Z, Yilmaz H. Effects of multiple sclerosis on female sexuality: a controlled study. J Sex Med. 2014 Feb;11(2):481-6. doi: 10.1111/jsm.12397. Epub 2013 Dec 2.
PubMed 24299569Nuri YILDIRIM, Niyazi AŞKAR (2017) Chronic Pelvic Floor Dysfunction Kadın Hastalıkları ve Doğum AD, Ege Üniversitesi Tıp Fakültesi, İzmir Turkiye Klinikleri J Gynecol Obst-Special Topics. 2017;10(2):210-4. https://www.turkiyeklinikleri.com/
Chaudhry SR, Nahian A, Chaudhry K. Anatomy, Abdomen and Pelvis, Pelvis. 2023 Jul 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482258/
PubMed 2948917310.2174/1874943701003010110
Murley GS, Buldt AK, Trump PJ, Wickham JB. Tibialis posterior EMG activity during barefoot walking in people with neutral foot posture. J Electromyogr Kinesiol. 2009 Apr;19(2):e69-77. doi: 10.1016/j.jelekin.2007.10.002. Epub 2007 Nov 28.
PubMed 18053742Semple R, Murley GS, Woodburn J, Turner DE. Tibialis posterior in health and disease: a review of structure and function with specific reference to electromyographic studies. J Foot Ankle Res. 2009 Aug 19;2:24. doi: 10.1186/1757-1146-2-24.
PubMed 19691828Bo K, Stien R. Needle EMG registration of striated urethral wall and pelvic floor muscle activity patterns during cough, Valsalva, abdominal, hip adductor, and gluteal muscle contractions in nulliparous healthy females. Neurourol Urodyn. 1994;13(1):35-41. doi: 10.1002/nau.1930130106.
PubMed 8156073McGill SM, Childs A, Liebenson C. Endurance times for low back stabilization exercises: clinical targets for testing and training from a normal database. Arch Phys Med Rehabil. 1999 Aug;80(8):941-4. doi: 10.1016/s0003-9993(99)90087-4.
PubMed 10453772Simeoni M, Auquier P, Fernandez O, Flachenecker P, Stecchi S, Constantinescu C, Idiman E, Boyko A, Beiske A, Vollmer T, Triantafyllou N, O'Connor P, Barak Y, Biermann L, Cristiano E, Atweh S, Patrick D, Robitail S, Ammoury N, Beresniak A, Pelletier J; MusiQol study group. Validation of the Multiple Sclerosis International Quality of Life questionnaire. Mult Scler. 2008 Mar;14(2):219-30. doi: 10.1177/1352458507080733. Epub 2007 Oct 17.
PubMed 17942521
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Pelvic Floor Dysfunctions and Core Endurance, Hip Rotation Muscle Strength, Tibialis Anterior and Tibialis Posterior Muscle Activation in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06777134
- Acronym / sponsor ID
- 05-14
- Conditions
- Multiple Sclerosis, Pelvic Floor Dysfunction
- Keywords
- pelvic floor, multiple sclerosis, core endurance, tibialis anterior, tibialis posterior, electromyography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Berivan Beril KılıçUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 10 Jan 2027 (estimated)
- First posted
- 15 Jan 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.
we aim to investigate the relationship between pelvic floor dysfunctions, core endurance, hip external rotation muscle strength, and tibialis posterior and tibialis anterior muscle activation in patients diagnosed with MS
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with multiple sclerosis | – | Other: Assessment of pelvic floor dysfunction, Other: The Quality of Life Assessment, Other: Core endurance assessment, Other: Hip strength assessment, Other: Tibialis posterior muscle activation, Other: Tibialis anterior muscle activation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is planned to include 73 patients who applied to Bakırköy Prof. Dr. Mazhar Osman Mental and Nervous Diseases Training and Research Hospital Neurology Clinic and who were diagnosed with definite Multiple Sclerosis according to McDonald Diagnostic Criteria with EDSS level between 0-4.
Key inclusion criteria (4 listed)
- EDSS score between 0 and 4.0
- Having access to the internet via a high-speed smartphone or computer
- Scoring at least 21 points on the MoCA
- Having a score of Stage 3 or higher on the Functional Ambulation Scale.
Key exclusion criteria (6 listed)
- Having hearing or vision problems.
- Participating in any exercise program.
- Having accompanying other neurological, cardiovascular, or orthopedic disorders.
- A history of an MS relapse or medication change within the last 6 months.
- Being in a physical condition that prevents participation in exercises.
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 |
|---|---|---|
| Assessment of pelvic floor dysfunctionPelvic floor dysfunctions in patients with multiple sclerosis will be assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20). The scale is designed to assess all symptoms related to pelvic floor disorders and the severity of the distress they cause. The PFDI-20 consists of 3 subscales and 20 items, with each item rated on a scale from 0 (none) to 4 (quite a bit). To determine the scale scores, the average of the responses for each item in the subscales is multiplied by 25, resulting in a subscale score ranging from 0 to 100, and a total score ranging from 0 to 300. The Turkish validity and reliability of the scale were conducted by Çelenay et al. | Other | patients with multiple sclerosis |
| The Quality of Life AssessmentThe quality of life of the patients will be assessed using the Multiple Sclerosis International Quality of Life Questionnaire. The questionnaire consists of 31 questions and 9 subscales. The lowest score that can be obtained from the scale is 0, the highest score is 124, and a high score indicates a low quality of life. The subscales of the questionnaire include daily living activities, psychological well-being, relationships with friends, symptoms, relationships with family, relationships with the healthcare system, emotional and sexual life, coping, and rejection. The Turkish validation of the questionnaire has been conducted. | Other | patients with multiple sclerosis |
| Core endurance assessmentCore endurance in patients will be assessed using McGill's core endurance tests Trunk Flexor Test: Patients sit at a 60° trunk angle with knees bent, arms crossed, and feet stabilized. Time holding the position is recorded. Trunk Extensor Test: Patients lie prone with the pelvis stabilized, lift the upper body above table level, and hold. Time is recorded until the body drops. Lateral Trunk Test: In a modified side plank (knees bent, elbow support), patients lift hips off the mat. Time is recorded until hips lower or extra support is needed. | Other | patients with multiple sclerosis |
| Hip strength assessmentThe assessment of hip strength will specifically focus on the hip adductor and hip external rotator muscle strength. Both muscle groups are considered to be associated with the pelvic floor. Among the hip external rotators, the piriformis muscle functions as an internal stabilizer for the hip joint, while the obturator internus muscle shares fascial connections with the pelvic floor, playing a significant role in pelvic floor function. MR and EMG studies have demonstrated that the levator ani and gluteus maximus muscles are morphologically and functionally connected, and that the contraction of hip adductor and gluteal muscles facilitates the synergistic contraction of pelvic floor muscles. Based on this information, a handheld dynamometer will be used to measure the strength of the two muscle groups planned for evaluation. Measurements will be performed three times, and the average value will be recorded. | Other | patients with multiple sclerosis |
| Tibialis posterior muscle activationThe NeuroTrac Myoplus Pro (Quintet, Bergen, Norway) EMG device will be used for the superficial EMG analysis of the posterior tibialis muscle. During the assessment, single-use 30 x 30 mm round adhesive electrodes will be placed on the reference points. The active electrode will be positioned at the exact midpoint between the tibial tuberosity and the medial malleolus (32,33); the passive electrode will be placed 4 cm distal; and the reference electrode will be placed on the lateral malleolus. The patient will be asked to perform isometric plantar flexion + inversion movement of the ankle against resistance for 10 seconds. The ankle isometric contractions will be performed in 3 repetitions, with a 20-second rest period between contractions. As a result of the assessment, parameters related to the muscle's strength, total work, and resting tone will be recorded in microvolts; the maximal voluntary contraction will be recorded as a percentage. | Other | patients with multiple sclerosis |
| Tibialis anterior muscle activationThe NeuroTrac Myoplus Pro (Quintet, Bergen, Norway) EMG device will be used for the superficial EMG analysis of the tibialis anterior muscle. During the assessment, single-use 30 x 30 mm round adhesive electrodes will be placed on the reference points. The active electrode will be positioned on the muscle body of the tibialis anterior, the passive electrode will be placed 4 cm distal, and the reference electrode will be placed on the lateral malleolus (34,35). The patient will be asked to perform isometric ankle dorsiflexion against resistance for 10 seconds. The ankle isometric contractions will be performed in 3 repetitions, with a 20-second rest period between contractions. As a result of the assessment, parameters related to the muscle's strength, total work, and resting tone will be recorded in microvolts; the maximal voluntary contraction will be recorded as a percentage. | Other | patients with multiple sclerosis |
Primary outcome
Pelvic floor muscle dysfunction
Time frame: baseline
Pelvic floor dysfunctions in patients with multiple sclerosis will be assessed using the Pelvic Floor Distress Inventory-20. The scale is designed to assess all symptoms related to pelvic floor disorders and the severity of the distress they cause. It consists of 3 subscales and 20 items, with each item rated on a scale from 0 (none) to 4 (quite a bit). To determine the scale scores, the average of the responses for each item in the subscales is multiplied by 25, resulting in a subscale score ranging from 0 to 100, and a total score ranging from 0 to 300. The Turkish validity and reliability of the scale were conducted.
13 secondary outcomes
Qualitf of life
Time frame: Baseline
Core endurance -trunk flexor endurance
Time frame: baseline
Core endurance -trunk extansor endurance
Time frame: baseline
Core endurance - lateral flexor endurance
Time frame: baseline
Hip strength
Time frame: baseline
tibialis posterior muscle activation - peak torque
Time frame: baseline
tibialis posterior muscle activation - work avarage
Time frame: baseline
tibialis posterior muscle activation - percentage of maximal voluntary contractions
Time frame: baseline
tibialis posterior muscle activation - rest tone
Time frame: baseline
tibialis anterior muscle activation - peak torque
Time frame: baseline
tibialis anterior muscle activation - work avarage
Time frame: baseline
tibialis anterior muscle activation - percentage of maximal voluntarily contractions
Time frame: baseline
tibialis anterior muscle activation - rest tone
Time frame: baseline
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 20 Feb 2026.
- Results publicationİstek, A. (2009) Kronik Pelvik Ağrı Şikayeti Olan Hastalarda Posterior Tibial Sinir Uyarısı Tedavisinin (Nöromodülasyon) Yaşam Kalitesi Üzerine Etkisi
- Results publicationİri, S.G. (2022) Üriner İnkontinansı Olan Kadınlarda Pelvik Taban Sağlığı Eğitimi Ve Egzersiz Programının Etkinliğinin Araştırılması
- Results publicationİpeker Karagöz, F. (2022) Kadınlarda Stres Üriner İnkontinans Şiddetinin İnsülin Benzeri Büyüme Faktörü-1 Ve Kor Stabilizasyonu Üzerine Etkisinin İncelenmesi
- Results publicationYAVAŞ, İpek, Özge ERTEKİN, and Turhan KAHRAMAN. "Multipl Sklerozlu Bireylerde Üriner Semptomlar, Bağırsak Semptomları ve Cinsel İşlev Bozukluğunun Tedavisinde Pelvik Taban Kas Eğitimi: Geleneksel Derleme." Turkiye Klinikleri Journal of Health Sciences/Türkiye Klinikleri Sağlık Bilimleri Dergisi 9.2 (2024).
- Results publicationYavaş, İ. (2021). Multipl sklerozlu bireylerde telerehabilitasyon temelli pelvik taban kas eğitiminin üriner inkontinans, cinsel işlev bozukluğu ve yaşam kalitesi üzerine etkisi
- Results publicationYıldız, H.C. (2018). Multipl Skleroz bireylerinde, mesane fonksiyonlarının etkilenim şiddetine göre yorgunluk, düşme, yaşam kalitesi ve pelvik taban kas kuvvetinin karşılaştırması
- Results publication: PubMed 24299569Gumus H, Akpinar Z, Yilmaz H. Effects of multiple sclerosis on female sexuality: a controlled study. J Sex Med. 2014 Feb;11(2):481-6. doi: 10.1111/jsm.12397. Epub 2013 Dec 2.
- Results publicationNuri YILDIRIM, Niyazi AŞKAR (2017) Chronic Pelvic Floor Dysfunction Kadın Hastalıkları ve Doğum AD, Ege Üniversitesi Tıp Fakültesi, İzmir Turkiye Klinikleri J Gynecol Obst-Special Topics. 2017;10(2):210-4. https://www.turkiyeklinikleri.com/
- Results publication: PubMed 29489173Chaudhry SR, Nahian A, Chaudhry K. Anatomy, Abdomen and Pelvis, Pelvis. 2023 Jul 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482258/
- Results publication10.2174/1874943701003010110
- Results publication: PubMed 18053742Murley GS, Buldt AK, Trump PJ, Wickham JB. Tibialis posterior EMG activity during barefoot walking in people with neutral foot posture. J Electromyogr Kinesiol. 2009 Apr;19(2):e69-77. doi: 10.1016/j.jelekin.2007.10.002. Epub 2007 Nov 28.
- Results publication: PubMed 19691828Semple R, Murley GS, Woodburn J, Turner DE. Tibialis posterior in health and disease: a review of structure and function with specific reference to electromyographic studies. J Foot Ankle Res. 2009 Aug 19;2:24. doi: 10.1186/1757-1146-2-24.
- Individual participant dataSharing planned: Undecided
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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.
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 Pelvic Floor Dysfunction, run by Berivan Beril Kılıç 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 4 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 20 Feb 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 BERİL KILIÇ, Asst. Prof. (+905069496158, fztbkilic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor muscle dysfunction (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06777134, which also lists 34 linked publications.
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 20 Feb 2026.