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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-65
SponsorBerivan Beril Kılıç

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

  • Assessment of pelvic floor dysfunction

    Other intervention

    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 Assessment

    Other intervention

    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 assessment

    Other intervention

    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 assessment

    Other intervention

    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 activation

    Other intervention

    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 activation

    Other intervention

    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.

Treatment groups

73 Participants
are divided into 1 treatment group
Group A: patients with multiple sclerosis6 interventions

Trial outcomes

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.

Time frame
baseline

Secondary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
baseline
3

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.

Time frame
baseline
4

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.

Time frame
baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Berivan Beril Kılıç

Lead sponsor

Biruni University

Sponsor institution