Relationship Between Pelvic Floor Dysfunctions and Lower Limb Strength and Activation in MS Patients

NCT06777134 | Recruiting

• 1 other identifier: 05-14
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Multiple Sclerosis; Pelvic Floor Dysfunction

Keywords

pelvic floor; multiple sclerosis; core endurance; tibialis anterior; tibialis posterior; electromyography

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline

Secondary Outcomes (13)

• Qualitf of life

  Baseline

• Core endurance -trunk flexor endurance

  baseline

• Core endurance -trunk extansor endurance

  baseline

• Core endurance - lateral flexor endurance

  baseline

• Hip strength

  baseline

Study Arms (1)

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

Interventions

Assessment of pelvic floor dysfunction OTHER

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.

patients with multiple sclerosis

The Quality of Life Assessment OTHER

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.

patients with multiple sclerosis

Core endurance assessment OTHER

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.

patients with multiple sclerosis

Hip strength assessment OTHER

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.

patients with multiple sclerosis

Tibialis posterior muscle activation OTHER

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.

patients with multiple sclerosis

Tibialis anterior muscle activation OTHER

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.

patients with multiple sclerosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Berivan Beril Kılıç: lead

Study Sites (1)

Biruni University

Istanbul, Istanbul, 34103, Turkey (Türkiye)

RECRUITING

Related Publications (34)

• İstek, A. (2009) Kronik Pelvik Ağrı Şikayeti Olan Hastalarda Posterior Tibial Sinir Uyarısı Tedavisinin (Nöromodülasyon) Yaşam Kalitesi Üzerine Etkisi

  RESULT

• İri, S.G. (2022) Üriner İnkontinansı Olan Kadınlarda Pelvik Taban Sağlığı Eğitimi Ve Egzersiz Programının Etkinliğinin Araştırılması

  RESULT

• İpeker Karagöz, F. (2022) Kadınlarda Stres Üriner İnkontinans Şiddetinin İnsülin Benzeri Büyüme Faktörü-1 Ve Kor Stabilizasyonu Üzerine Etkisinin İncelenmesi

  RESULT

• 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).

  RESULT

• Yavaş, İ. (2021). Multipl sklerozlu bireylerde telerehabilitasyon temelli pelvik taban kas eğitiminin üriner inkontinans, cinsel işlev bozukluğu ve yaşam kalitesi üzerine etkisi

  RESULT

• Yıldız, H.C. (2018). Multipl Skleroz bireylerinde, mesane fonksiyonlarının etkilenim şiddetine göre yorgunluk, düşme, yaşam kalitesi ve pelvik taban kas kuvvetinin karşılaştırması

  RESULT

• Multipl sklerozun kadın cinselliği üzerine etkileri: Kontrollü çalışma Gumus H, Akpınar Z, Yılmaz H. The Journal of Sexual Medicine 11(2) 2014 p:481-485

  RESULT

• Nuri 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/

  RESULT

• 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/

  PMID: 29489173 RESULT

• 10.2174/1874943701003010110

  RESULT

• 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.

  PMID: 18053742 RESULT

• Semple 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.

  PMID: 19691828 RESULT

• Bo 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.

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  PMID: 17942521 RESULT

• Toprak Celenay S, Akbayrak T, Kaya S, Ekici G, Beksac S. Validity and reliability of the Turkish version of the Pelvic Floor Distress Inventory-20. Int Urogynecol J. 2012 Aug;23(8):1123-7. doi: 10.1007/s00192-012-1729-8. Epub 2012 Mar 29.

  PMID: 22456806 RESULT

• Afshari P, Abedi P, Majdinasab N, Tafakh S, Haghighizadeh M. Strengths of pelvic floor muscles in women with multiple sclerosis and its relationship with urinary incontinence and quality of life. Front Neurol. 2025 Jan 13;15:1514157. doi: 10.3389/fneur.2024.1514157. eCollection 2024.

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MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

BERİL KILIÇ, Asst. Prof.

CONTACT

+905069496158; fztbkilic@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 4, 2025
• First Posted: January 15, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): January 10, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

TU (1)