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다발성 경화증이있는 여성의 골반 바닥에 대한 척추 안정화의 영향

2026년 9월 25일 업데이트: Gözde TEKİN, Abant Izzet Baysal University

다발성 경화증 및 요로 증상이있는 여성의 코어 안정성, 비뇨기 증상 및 골반 바닥 근육 기능에 대한 골반 바닥에 중점을 둔 척추 안정화 운동의 효과에 대한 조사

The purpose of this study was to investigate the effects of spinal stabilization exercises focusing on the pelvic floor on core stability, urinary symptoms and pelvic floor muscle function in women with Multiple Sclerosis and lower urinary tract symptoms. Participants will be randomly assigned to a control group that receives pelvic floor muscle exercises only or an experimental group that receives both pelvic floor muscle exercises and spinal stabilization exercise focused on the pelvic floor. Outcome measures will be assessed pre- and post-intervention using validated instruments.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

In multiple sclerosis (MS), disruption of the neural pathways responsible for bladder control leads to the development of lower urinary tract symptoms (LUTS). These symptoms, observed in approximately 32-96% of individuals with MS, have a significant negative impact on quality of life. Conservative management of LUTS includes lifestyle modifications, bladder training, and pelvic floor muscle training (PFMT). Although the effectiveness of PFMT has been demonstrated, there is no standardized protocol regarding exercise type or duration, indicating a gap in the literature concerning the identification of the most effective approach. Moreover, existing studies emphasize that the effective contraction of pelvic floor muscles requires the simultaneous activation of deep core muscles, particularly the transversus abdominis. This suggests that pelvic floor rehabilitation without the involvement of abdominal muscles may be insufficient. Spinal stabilization exercises target deep core muscles to enhance neuromuscular control, strength, and endurance. Recently, "spinal stabilization exercises focusing on the pelvic floor" have emerged as a promising strategy in the management of urinary incontinence. However, research on trunk control in individuals with MS remains limited and primarily focuses on neurological symptoms, with minimal attention given to LUTS and pelvic floor function.

This study is designed as a prospective, randomized controlled trial to evaluate the effects of spinal stabilization exercises focusing on the pelvic floor, delivered in addition to PFMT, on core stability, urinary symptoms, and pelvic floor muscle function in women with MS and LUTS. Eligible participants who consent to join the study will be randomly allocated into two groups using block randomization. The control group will receive PFMT alone, while the experimental group will receive PFMT combined with spinal stabilization exercises focusing on the pelvic floor . Both interventions will be delivered three times per week for eight weeks. Primary and secondary outcomes will be assessed using validated objective and subjective tools at baseline and post-intervention.

연구 유형

중재적

등록 (실제)

49

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Bolu
      • Merkez, Bolu, 터키 (Türkiye), 14030
        • Bolu Abant İzzet Baysal University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

Inclusion Criteria:

  • Female participants aged between 18 and 65 years
  • Being diagnosed with Multiple Sclerosis by a specialist neurologist and having lower urinary system symptoms [Overactive Bladder-V8 scale score ≥ 9 and having at least two of the lower urinary system symptoms (urinary incontinence, nocturia, daytime urination frequency >8, storage symptoms such as sudden feeling of tightness, intermittent urination, slow urine flow and emptying symptoms such as incomplete emptying)
  • Being in the mild or moderate stage of the disease (Expanded Disability Status Scale (EDSS) score ˂ 6
  • No relapse experienced within the past month
  • Scoring 24 or above on the Mini-Mental State Examination (MMSE)
  • Being literate
  • Willingness to voluntarily participate in the study
  • Ability to perform voluntary pelvic floor muscle contractions
  • No changes in medical treatment within the past three months
  • Ability to understand and cooperate with the assessments and interventions involved in the study

Exclusion Criteria:

  • Diagnosis of one or more neurological disorders other than Multiple Sclerosis
  • Body mass index (BMI) ≥ 30
  • Diagnosis of overflow urinary incontinence
  • History of antimuscarinic medication use
  • Presence of advanced pelvic organ prolapse (stage ≥ 2)
  • Active urinary tract infection
  • History of cesarean section or vaginal delivery within the past 6 months
  • Diagnosis of any other neurological condition that may cause urinary incontinence
  • History of urological or gynecological surgery
  • History of malignancy
  • Currently pregnant or not sexually active (coitus negative)
  • Participation in exercise training or physical therapy for lower urinary tract symptoms within the past 6 months

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Pelvic floor muscle exercises

Pelvic floor muscle exercises will be taught with an innovative approach based on the principles of finding, feeling, forcing, following and functional training of the pelvic floor muscles. Pelvic floor muscle exercises will be applied as 3 sets in the first 2 weeks, 4 sets in the 3rd and 4th weeks, 5 sets in the 5th and 6th weeks, and finally 6 sets in the 7th and 8th weeks. Individuals will continue their pelvic floor muscle exercises as a home program.

Pelvic floor muscle exercises will be taught with an innovative approach based on the principles of finding, feeling, forcing, following and functional training of the pelvic floor muscles. Pelvic floor muscle exercises will be applied as 3 sets in the first 2 weeks, 4 sets in the 3rd and 4th weeks, 5 sets in the 5th and 6th weeks, and finally 6 sets in the 7th and 8th weeks. Individuals will continue their pelvic floor muscle exercises as a home program.

실험적: Spinal stabilization exercises focusing on the pelvic floor + Pelvic floor muscle exercises

Spinal stabilization exercises focusing on the pelvic floor will be administered under physiotherapist supervision three times per week for eight weeks. Each session will consist of 5 minutes of warm-up, 30 minutes of pelvic floor-focused spinal stabilization exercises, and 5 minutes of cool-down. Stabilization and posture training will be provided at the outset, including instruction on identifying the neutral position of the spine to ensure proper posture. Correct pelvic floor muscle contraction and abdominal bracing techniques will be demonstrated. The exercise program will comprise three phases: static (weeks 1-2), dynamic (weeks 3-5), and functional (weeks 6-8). Throughout all exercises, participants will maintain a neutral spine position and abdominal bracing, with contractions held for 5-10 seconds and repeated 10 times. Additionally, participants will be instructed to continue pelvic floor exercises as a home program on non-supervised days.

This program consists of 3 phases: 30 minutes of spinal stabilization exercises focusing on the pelvic floor, 5 minutes of warm-up and 5 minutes of cool-down exercises.The exercises will consist of 3 phases: static, dynamic and functional phases. Individuals will perform static phase exercises for the first 2 weeks, then dynamic phase exercises in the 3rd and 5th weeks and finally functional phase exercise in the 6th and 8th weeks. Individuals will be asked to maintain neutral spine position and abdominal bracing during pelvic floor muscle contraction during all exercises. Individuals will maintain the contraction for 5-10 seconds for 10 repetitions in each position in all phases.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Evaluation of Urinary Symptoms
기간: 8 week

Urinary symptoms will be assessed with the International Incontinence Questionnaire Short Form. The International Incontinence Questionnaire Short Form consists of a total of six questions. The total score is obtained by summing the scores of questions 3, 4 and 5. Scores that can be obtained from the scale vary between 0-21; a low score indicates that urinary incontinence affects quality of life a little, while a high score indicates that it affects it a lot.

8 week
Evaluation of Bladder Functions
기간: 8 week

A bladder diary will be used to assess bladder function for lower urinary tract symptoms. Patients will be asked to complete a 24-hour bladder diary on three non-consecutive days. Average day-night voiding frequency, voiding volume and number of urinary incontinence will be calculated by averaging the three daily urinary diaries.

8 week

2차 결과 측정

결과 측정
측정값 설명
기간
Evaluation of the degree of urinary symptoms
기간: 8 week

Overactive Bladder-Version8 will be used to assess the degree of lower urinary system symptoms due to overactive bladder. The score to be obtained from the scale ranges from "0" the best to "40" the worst. If the total score on the scale is more than 8, the subjects are considered to have possible lower urinary tract symptoms.

8 week
Evaluation of Pelvic Floor Muscle Function
기간: 8 week

Pelvic floor muscle function will be evaluated with the 632 Myomed biofeedback device. The pressure probe and device will be disinfected in each individual before the application and the probe will be used with a condom to ensure the hygiene of the individual. During the assessment, the pressure probe will be inserted intravaginally while the individual is supine, knees bent and slightly apart. Assessment results will be recorded in hectopascal.

8 week
Evaluation of pelvic floor muscle strength
기간: 8 week

Vaginal palpation method will be used to measure pelvic floor muscle strength. The assessment will be performed in supine position, with hips and knees flexed and soles of the feet in contact with the bed. After taking the necessary hygiene measures, the physiotherapist will place the index and middle finger intravaginally. The individual will then be asked to pinch the physiotherapist's fingers and pull upwards for pelvic floor muscle contraction. The outcome value will be scored with the Modified Oxford grading system.

8 week
Evaluation of the endurance of the lateral core muscles
기간: 8 week

The lateral bridge test will be used to assess the endurance of the lateral core muscles. Individuals will be asked to place their forearms and feet on the side of one side in a position to carry their body weight, then they will be asked to maintain this position by lifting their hips from the bed. The test will be terminated when the proper posture is broken or the pelvis falls on the bed, and the time from maintaining the proper position to breaking the position will be recorded in seconds. The test will be performed separately on the right and left side.

8 week
Evaluation of the endurance of the anterior core muscles
기간: 8 week

Flexor endurance test will be used to assess the endurance of the anterior core muscles. Individuals will be placed on the bed with their trunk at 60°, knees and hips at 90° flexion and supported by their feet. In this position, the time in seconds will be recorded until they lose 60° of trunk flexion.

8 week
Evaluation of endurance of the posterior core muscles
기간: 8 week

The extensor endurance test will be used to evaluate the endurance of the posterior core muscles. Individuals will lie in a prone position with pelvis, hips and knees supported on the bed and the upper trunk will be positioned on the edge of the bed in a straight, slightly extended position. Individuals will be stabilized by their feet. The test will be terminated when the trunk falls from the horizontal position to flexion and the time in this position will be recorded in seconds.

8 week
Evaluation of Deep Lumbar Muscular Strength
기간: 8 week

Stabilizer Pressure Biofeedback device will be used to assess deep lumbar muscular strength. Individuals will be asked to lie in a prone position and keep their knees in a straight position, their spine straight and their head in a comfortable position. The cushion of the measuring device will be placed under their abdominal area with the air completely deflated. After the manometer needle is set to 70 mm/Hg, the individuals will be asked to contract the transversus abdominous muscles for 5 seconds as taught. The test will be performed for 10 s and 3 repetitions and the average of the results of the 3 tests will be recorded in mm/Hg.

8 week
Evaluation of Quality of Life
기간: 8 week

King Health Questionnaire will be used to assess quality of life. The questionnaire consists of two parts and includes 32 items. . On the complaint severity scale, the best score is "0" and the worst score is "30". In other subsections of the King Health Questionnaire, the best score is "0" and the worst score is "100".

8 week
Evaluation of Subjective Perception of Recovery
기간: 8 week

The Global Perceived Impact scale will be used to assess the subjective perception of improvement after the training. Participants will be asked to rate on a scale of 1 to 9 the extent to which their complaints have improved compared to before the training. The description of the scores is; '1' 'much improved', '2' 'much improved', '3' 'moderately improved', '4' 'slightly improved', '5' 'unchanged', '6' 'slightly worsened', '7' 'moderately worsened', '8' 'much worsened', '9' 'much worsened'.

8 week
Evaluation of Perceived Health Problem
기간: 8 week

The health problem perceived by individuals will be assessed with the Patient-specific complaints instrument. The numbered classification scale-11 (0-10) will be used for scoring. The individual will be asked to give a score between 0-10 for the severity of the problem caused by lower urinary tract symptoms as perceived by the individual. 0 means "no complaint at all" and 10 means "very severe complaint".

8 week
Evaluation of Compliance with Training
기간: 8 week

The compliance of the individuals with the training will be evaluated using a 10-centimeter visual analog scale. At the end of the study, the individuals in the control and experimental groups will be asked to evaluate the training program given to them by marking the place that best expresses themselves on a 10 cm line between 0 (I did not apply the treatment given at all) and 10 (I applied the treatment given completely). The distance between the marked point and the starting point will be recorded.

8 week

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: gözde tekin, Msc, Abant Izzet Baysal University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 6월 30일

기본 완료 (실제)

2026년 1월 23일

연구 완료 (실제)

2026년 1월 23일

연구 등록 날짜

최초 제출

2025년 6월 25일

QC 기준을 충족하는 최초 제출

2025년 7월 10일

처음 게시됨 (실제)

2025년 7월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 25일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • AİBU-FTR-GT-001

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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