Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-31 @ 9:33 PM
Study NCT ID:
NCT06777134
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-11-25
First Post:
2025-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Pelvic Floor Dysfunctions and Lower Limb Strength and Activation in MS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 73}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-01-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-01-04', 'studyFirstSubmitQcDate': '2025-01-09', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pelvic floor muscle dysfunction', 'timeFrame': 'baseline', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Qualitf of life', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Core endurance -trunk flexor endurance', 'timeFrame': 'baseline', 'description': "Core endurance will be assessed using McGill's tests:\n\nTrunk Flexor Test: Patients sit at a 60° trunk angle with knees bent, arms crossed, and feet stabilized. Time holding the position is recorded."}, {'measure': 'Core endurance -trunk extansor endurance', 'timeFrame': 'baseline', 'description': "Core endurance will be assessed using McGill's tests:\n\nTrunk 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."}, {'measure': 'Core endurance - lateral flexor endurance', 'timeFrame': 'baseline', 'description': "Core endurance will be assessed using McGill's tests:\n\nLateral 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."}, {'measure': 'Hip strength', 'timeFrame': 'baseline', 'description': '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.'}, {'measure': 'tibialis posterior muscle activation - peak torque', 'timeFrame': 'baseline', 'description': '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.\n\nThe 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.'}, {'measure': 'tibialis posterior muscle activation - work avarage', 'timeFrame': 'baseline', 'description': '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.\n\nThe 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.'}, {'measure': 'tibialis posterior muscle activation - percentage of maximal voluntary contractions', 'timeFrame': 'baseline', 'description': '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.\n\nThe 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'}, {'measure': 'tibialis posterior muscle activation - rest tone', 'timeFrame': 'baseline', 'description': '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.\n\nThe 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.'}, {'measure': 'tibialis anterior muscle activation - peak torque', 'timeFrame': 'baseline', 'description': '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.\n\nThe 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.'}, {'measure': 'tibialis anterior muscle activation - work avarage', 'timeFrame': 'baseline', 'description': '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.\n\nThe 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.'}, {'measure': 'tibialis anterior muscle activation - percentage of maximal voluntarily contractions', 'timeFrame': 'baseline', 'description': '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.\n\nThe 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.'}, {'measure': 'tibialis anterior muscle activation - rest tone', 'timeFrame': 'baseline', 'description': '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.\n\nThe 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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pelvic floor', 'multiple sclerosis', 'core endurance', 'tibialis anterior', 'tibialis posterior', 'electromyography'], 'conditions': ['Multiple Sclerosis', 'Pelvic Floor Dysfunction']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'İstek, A. (2009) Kronik Pelvik Ağrı Şikayeti Olan Hastalarda Posterior Tibial Sinir Uyarısı Tedavisinin (Nöromodülasyon) Yaşam Kalitesi Üzerine Etkisi'}, {'type': 'RESULT', 'citation': 'İri, S.G. (2022) Üriner İnkontinansı Olan Kadınlarda Pelvik Taban Sağlığı Eğitimi Ve Egzersiz Programının Etkinliğinin Araştırılması'}, {'type': 'RESULT', 'citation': 'İpeker Karagöz, F. (2022) Kadınlarda Stres Üriner İnkontinans Şiddetinin İnsülin Benzeri Büyüme Faktörü-1 Ve Kor Stabilizasyonu Üzerine Etkisinin İncelenmesi'}, {'type': 'RESULT', 'citation': '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).'}, {'type': 'RESULT', 'citation': 'Yavaş, İ. (2021). Multipl sklerozlu bireylerde telerehabilitasyon temelli pelvik taban kas eğitiminin üriner inkontinans, cinsel işlev bozukluğu ve yaşam kalitesi üzerine etkisi'}, {'type': 'RESULT', 'citation': 'Yıldız, H.C. (2018). Multipl Skleroz bireylerinde, mesane fonksiyonlarının etkilenim şiddetine göre yorgunluk, düşme, yaşam kalitesi ve pelvik taban kas kuvvetinin karşılaştırması'}, {'type': 'RESULT', 'citation': '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'}, {'type': 'RESULT', 'citation': '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/'}, {'pmid': '29489173', 'type': 'RESULT', 'citation': 'Chaudhry SR, Nahian A, Chaudhry K. Anatomy, Abdomen and Pelvis, Pelvis. 2023 Jul 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482258/'}, {'type': 'RESULT', 'citation': '10.2174/1874943701003010110'}, {'pmid': '18053742', 'type': 'RESULT', 'citation': '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': '19691828', 'type': 'RESULT', 'citation': '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': '8156073', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '10453772', 'type': 'RESULT', 'citation': 'McGill 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.'}, {'pmid': '17942521', 'type': 'RESULT', 'citation': "Simeoni 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."}, {'pmid': '22456806', 'type': 'RESULT', 'citation': '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': '39871990', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '10022678', 'type': 'RESULT', 'citation': 'Litwiller SE, Frohman EM, Zimmern PE. Multiple sclerosis and the urologist. J Urol. 1999 Mar;161(3):743-57.'}, {'pmid': '30300239', 'type': 'RESULT', 'citation': 'Oh J, Vidal-Jordana A, Montalban X. Multiple sclerosis: clinical aspects. Curr Opin Neurol. 2018 Dec;31(6):752-759. doi: 10.1097/WCO.0000000000000622.'}, {'pmid': '31987556', 'type': 'RESULT', 'citation': 'Sivakumar R, Jena S. Effect of unstable surface sitting on paretic anterior tibial muscle following stroke. J Bodyw Mov Ther. 2020 Jan;24(1):269-273. doi: 10.1016/j.jbmt.2019.06.001. Epub 2019 Jun 4.'}, {'pmid': '32703614', 'type': 'RESULT', 'citation': 'Marques SAA, Silveira SRBD, Passaro AC, Haddad JM, Baracat EC, Ferreira EAG. Effect of Pelvic Floor and Hip Muscle Strengthening in the Treatment of Stress Urinary Incontinence: A Randomized Clinical Trial. J Manipulative Physiol Ther. 2020 Mar-Apr;43(3):247-256. doi: 10.1016/j.jmpt.2019.01.007. Epub 2020 Jul 21.'}, {'pmid': '34842941', 'type': 'RESULT', 'citation': 'Wang Z, Zhu Y, Han D, Huang Q, Maruyama H, Onoda K. Effect of hip external rotator muscle contraction on pelvic floor muscle function and the piriformis. Int Urogynecol J. 2022 Oct;33(10):2833-2839. doi: 10.1007/s00192-021-05046-9. Epub 2021 Nov 29.'}, {'pmid': '11744914', 'type': 'RESULT', 'citation': 'Barber MD, Kuchibhatla MN, Pieper CF, Bump RC. Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol. 2001 Dec;185(6):1388-95. doi: 10.1067/mob.2001.118659.'}, {'pmid': '22581511', 'type': 'RESULT', 'citation': 'Burton C, Sajja A, Latthe PM. Effectiveness of percutaneous posterior tibial nerve stimulation for overactive bladder: a systematic review and meta-analysis. Neurourol Urodyn. 2012 Nov;31(8):1206-16. doi: 10.1002/nau.22251. Epub 2012 May 11.'}, {'pmid': '36105867', 'type': 'RESULT', 'citation': 'Nipa SI, Sriboonreung T, Paungmali A, Phongnarisorn C. The Effects of Pelvic Floor Muscle Exercise Combined with Core Stability Exercise on Women with Stress Urinary Incontinence following the Treatment of Nonspecific Chronic Low Back Pain. Adv Urol. 2022 Sep 5;2022:2051374. doi: 10.1155/2022/2051374. eCollection 2022.'}, {'pmid': '28676358', 'type': 'RESULT', 'citation': 'Eickmeyer SM. Anatomy and Physiology of the Pelvic Floor. Phys Med Rehabil Clin N Am. 2017 Aug;28(3):455-460. doi: 10.1016/j.pmr.2017.03.003. Epub 2017 May 27.'}, {'pmid': '29489277', 'type': 'RESULT', 'citation': 'Bordoni B, Sugumar K, Leslie SW. Anatomy, Abdomen and Pelvis, Pelvic Floor. 2023 Jul 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482200/'}, {'pmid': '22179160', 'type': 'RESULT', 'citation': "Lucio AC, Perissinoto MC, Natalin RA, Prudente A, Damasceno BP, D'ancona CA. A comparative study of pelvic floor muscle training in women with multiple sclerosis: its impact on lower urinary tract symptoms and quality of life. Clinics (Sao Paulo). 2011;66(9):1563-8. doi: 10.1590/s1807-59322011000900010."}, {'pmid': '33671492', 'type': 'RESULT', 'citation': 'Johns JS, Krogh K, Ethans K, Chi J, Queree M, Eng JJ, Spinal Cord Injury Research Evidence Team. Pharmacological Management of Neurogenic Bowel Dysfunction after Spinal Cord Injury and Multiple Sclerosis: A Systematic Review and Clinical Implications. J Clin Med. 2021 Feb 22;10(4):882. doi: 10.3390/jcm10040882.'}, {'pmid': '35859189', 'type': 'RESULT', 'citation': 'Miget G, Tan E, Pericolini M, Chesnel C, Haddad R, Turmel N, Amarenco G, Hentzen C. The Neurogenic Bowel Dysfunction score (NBD) is not suitable for patients with multiple sclerosis. Spinal Cord. 2022 Dec;60(12):1130-1135. doi: 10.1038/s41393-022-00837-3. Epub 2022 Jul 20.'}, {'pmid': '32040860', 'type': 'RESULT', 'citation': 'Aguilar-Zafra S, Del Corral T, Vidal-Quevedo C, Rodriguez-Duran P, Lopez-de-Uralde-Villanueva I. Pelvic floor dysfunction negatively impacts general functional performance in patients with multiple sclerosis. Neurourol Urodyn. 2020 Mar;39(3):978-986. doi: 10.1002/nau.24314. Epub 2020 Feb 10.'}, {'pmid': '683462', 'type': 'RESULT', 'citation': 'Oppenheimer DR. The cervical cord in multiple sclerosis. Neuropathol Appl Neurobiol. 1978 Mar-Apr;4(2):151-62. doi: 10.1111/j.1365-2990.1978.tb00555.x.'}, {'pmid': '18970977', 'type': 'RESULT', 'citation': 'Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.'}, {'pmid': '23544716', 'type': 'RESULT', 'citation': 'Tullman MJ. Overview of the epidemiology, diagnosis, and disease progression associated with multiple sclerosis. Am J Manag Care. 2013 Feb;19(2 Suppl):S15-20.'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* EDSS score between 0 and 4.0\n* Having access to the internet via a high-speed smartphone or computer\n* Scoring at least 21 points on the MoCA\n* Having a score of Stage 3 or higher on the Functional Ambulation Scale.\n\nExclusion Criteria:\n\n* Having hearing or vision problems.\n* Participating in any exercise program.\n* Having accompanying other neurological, cardiovascular, or orthopedic disorders.\n* A history of an MS relapse or medication change within the last 6 months.\n* Being in a physical condition that prevents participation in exercises.\n* Comorbid conditions that negatively affect oxygen transport (e.g., severe anemia, peripheral artery disease, etc.)'}, 'identificationModule': {'nctId': 'NCT06777134', 'briefTitle': 'Relationship Between Pelvic Floor Dysfunctions and Lower Limb Strength and Activation in MS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Biruni University'}, 'officialTitle': 'Relationship Between Pelvic Floor Dysfunctions and Core Endurance, Hip Rotation Muscle Strength, Tibialis Anterior and Tibialis Posterior Muscle Activation in Patients With Multiple Sclerosis', 'orgStudyIdInfo': {'id': '05-14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with multiple sclerosis', 'interventionNames': ['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': [{'name': 'Assessment of pelvic floor dysfunction', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['patients with multiple sclerosis']}, {'name': 'The Quality of Life Assessment', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['patients with multiple sclerosis']}, {'name': 'Core endurance assessment', 'type': 'OTHER', 'description': "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.\n\nTrunk 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.\n\nLateral 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.", 'armGroupLabels': ['patients with multiple sclerosis']}, {'name': 'Hip strength assessment', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['patients with multiple sclerosis']}, {'name': 'Tibialis posterior muscle activation', 'type': 'OTHER', 'description': "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.\n\nThe 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.", 'armGroupLabels': ['patients with multiple sclerosis']}, {'name': 'Tibialis anterior muscle activation', 'type': 'OTHER', 'description': "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).\n\nThe 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.", 'armGroupLabels': ['patients with multiple sclerosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Biruni University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Berivan Beril Kılıç', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Berivan Beril Kılıç', 'investigatorAffiliation': 'Biruni University'}}}}