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

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

Overview

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

Interventions

• Other Assessment of pelvic floor dysfunction
  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
• Other The Quality of Life Assessment
  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
• Other Core endurance assessment
  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 reco
• Other Hip strength assessment
  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 an
• Other Tibialis posterior muscle activation
  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.
• Other Tibialis anterior muscle activation
  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 perfo

Primary outcome measures

• Pelvic floor muscle dysfunction [Time frame: baseline]

Secondary outcome measures (12)

• 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]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Turkey (Türkiye) · 1 center

• Biruni University — Istanbul

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. PMID 24299569
• 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/

Identifiers

NCT: NCT06777134 · 05-14

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗