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The Relationship Between Pelvic Floor Dysfunction and Quality of Life, Functional Capacity, Gait Parameters, and Static Balance in Children With Defecation Disorders

21 июля 2026 г. обновлено: AYŞE KAYALI VATANSEVER, Izmir Bakircay University

Defecation disorders are common in children and may adversely affect pelvic floor function, gait, balance, functional capacity, and health-related quality of life. Although pelvic floor dysfunction is considered an important component of defecation disorders, its relationship with gait characteristics, plantar pressure distribution, static balance, functional capacity, and health-related quality of life has not been fully investigated in children.

The aim of this study is to investigate the relationship between pelvic floor function and gait parameters, plantar pressure distribution, static balance, functional capacity, and health-related quality of life in children with defecation disorders. Pelvic floor function will be evaluated using surface electromyography and the Kelly Continence Score. Gait parameters, plantar pressure distribution, static balance, functional capacity, and health-related quality of life will be assessed using validated and standardized assessment methods.

Обзор исследования

Статус

Рекрутинг

Условия

Подробное описание

Defecation disorders are among the most common gastrointestinal disorders in children and are associated with impaired pelvic floor function, reduced functional capacity, altered gait characteristics, balance impairments, and decreased health-related quality of life. Despite the recognized role of pelvic floor dysfunction in children with defecation disorders, the relationship between pelvic floor function and physical performance outcomes has not been comprehensively investigated.

This observational study aims to evaluate the relationship between pelvic floor function and gait parameters, plantar pressure distribution, static balance, functional capacity, and health-related quality of life in children with defecation disorders.

Eligible participants will undergo a comprehensive baseline assessment. Demographic and clinical characteristics, including age, sex, anthropometric measurements, medical history, and defecation characteristics, will be recorded. Defecation disorders will be evaluated according to the Rome IV diagnostic criteria.

Pelvic floor function will be assessed using surface electromyography and the Kelly Continence Score. Functional capacity, gait parameters, plantar pressure distribution, static balance, and health-related quality of life will be evaluated using validated assessment methods. The relationships between pelvic floor function and the clinical and functional outcome measures will be analyzed.

Тип исследования

Наблюдательный

Регистрация (Оцененный)

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Имя: Ayşe KAYALI VATANSEVER, Asst. Prof. Dr.
Номер телефона: +905529382360
Электронная почта: ayse.vatansever@bakircay.edu.tr

Места учебы

Турция (Туркие)
- - Izmir, Турция (Туркие)
    - Рекрутинг
    - Ege University Faculty of Medicine, Department of Pediatric Surgery
    - Контакт:
      
      Ayşe KAYALI VATANSEVER, Asst. Prof. Dr.
      
      Номер телефона: +905529382360
      
      Электронная почта: ayse.vatansever@bakircay.edu.tr
    - Контакт:
      
      Dilek Bayraktar, Asst. Prof. Dr.
      
      Номер телефона: +905377265535
      
      Электронная почта: dilekbayraktar8@gmail.com
- Bornova
  - Izmir, Bornova, Турция (Туркие), 35100
    - Еще не набирают
    - Ege university
    - Контакт:
      
      Dilek BAYRAKTAR, Dr. PT
      
      Номер телефона: +905377265535
      
      Электронная почта: dilekbayraktar8@gmail.com

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

Ребенок
Взрослый

Принимает здоровых добровольцев

Да

Метод выборки

Невероятностная выборка

Исследуемая популяция

The study will include children aged 6-18 years diagnosed with a defecation disorder according to Rome IV clinical criteria. Participants must have a history of constipation or fecal incontinence for at least 3 months, cognitive and auditory abilities to follow simple commands, and written consent from their parent or guardian. Children with orthopedic, neurological, or sensory impairments that prevent participation, or with recent surgery or significant neurological disease, will be excluded.

Описание

Inclusion Criteria:

Being between 6 and 18 years of age
Diagnosed with a defecation disorder by a pediatric surgeon according to Rome IV clinical criteria
Having a history of constipation or fecal incontinence lasting at least 3 months
Cognitive and auditory abilities sufficient to understand and follow simple verbal commands
Written consent provided by the child's parent or legal guardian

Exclusion Criteria:

Having orthopedic or neurological conditions that would impair lower extremity movements or walking
History of surgery within the last 6 months
History of neurological disorders (e.g., cerebral palsy, epilepsy, neuromuscular diseases)
Having visual or hearing impairments severe enough to prevent participation in the study

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Количество групп / когорт

Когорты и вмешательства

Группа / когорта
Children with Defecation Disorders Children aged 6-18 years diagnosed with defecation disorders according to the Rome IV criteria. Participants will undergo assessments of pelvic floor function, continence status, gait parameters, plantar pressure distribution, static balance, functional capacity, and health-related quality of life.

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Resting Pelvic Floor Muscle Activity (µV) Временное ограничение: Baseline (at study entry)	Resting pelvic floor muscle activity will be quantified using the MyOnyx surface electromyography (sEMG) system. Average onset time and work mean values during the resting phase will be recorded.	Baseline (at study entry)
Pelvic Floor Muscle Maximum Voluntary Contraction (µV) Временное ограничение: Baseline (at study entry)	Pelvic floor muscle activity during maximum voluntary contraction will be quantified using the MyOnyx surface electromyography (sEMG) system. Average onset time and work mean values during maximum voluntary contraction will be recorded.	Baseline (at study entry)
Pelvic Floor Muscle Activity During Straining (µV) Временное ограничение: Baseline (at study entry)	Pelvic floor muscle activity during straining will be quantified using the MyOnyx surface electromyography (sEMG) system. Average onset time and work mean values during straining will be recorded.	Baseline (at study entry)
Pediatric Quality of Life Inventory (PedsQL™ 4.0) Child Self-Report Total Score Временное ограничение: Baseline (at study entry)	Health-related quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL™ 4.0) child self-report form. The total score will be calculated and reported.	Baseline (at study entry)
Pediatric Quality of Life Inventory (PedsQL™ 4.0) Parent Proxy-Report Total Score Временное ограничение: Baseline (at study entry)	Health-related quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL™ 4.0) parent proxy-report form. The total score will be calculated and reported.	Baseline (at study entry)

Вторичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Functional Capacity Временное ограничение: Baseline (at study entry)	Functional capacity will be assessed using the Six-Minute Walk Test (6MWT). The total distance walked in six minutes (meters) will be recorded.	Baseline (at study entry)
Anal Continence (Kelly Continence Score) Временное ограничение: Baseline (at study entry)	Continence status will be assessed using the Kelly Continence Score.	Baseline (at study entry)
Walking Speed (km/h) Временное ограничение: Baseline (at study entry)	Walking speed will be assessed using the Materialise Motion Footscan® v9 Scientific.	Baseline (at study entry)
Cadence (steps/min) Временное ограничение: Baseline (at study entry)	Cadence will be assessed using the Materialise Motion Footscan® v9 Scientific.	Baseline (at study entry)
Step Length (cm) Временное ограничение: Baseline (at study entry)	Step length will be assessed using the Materialise Motion Footscan® v9 Scientific.	Baseline (at study entry)
Subtalar Joint Flexion (degrees) Временное ограничение: Baseline (at study entry)	Subtalar joint flexion will be assessed using the Materialise Motion Footscan® v9 Scientific.	Baseline (at study entry)
Foot Type Classification Временное ограничение: Baseline (at study entry)	Foot type will be classified as pes planus, pes cavus, or neutral using the Materialise Motion Footscan® v9 Scientific.	Baseline (at study entry)
Center of Pressure Path Length (mm) Временное ограничение: Baseline (at study entry)	Static balance will be assessed using the Materialise Motion Footscan® v9 Scientific. Center of pressure (COP) path length will be recorded.	Baseline (at study entry)
Mean Center of Pressure Velocity (mm/s) Временное ограничение: Baseline (at study entry)	Static balance will be assessed using the Materialise Motion Footscan® v9 Scientific. Mean center of pressure (COP) velocity will be recorded.	Baseline (at study entry)
Static Plantar Pressure Distribution Временное ограничение: Baseline (at study entry)	Static plantar pressure distribution will be assessed using the Materialise Motion Footscan® v9 Scientific. Pressure distribution in the forefoot, midfoot, and rearfoot regions of both feet will be recorded.	Baseline (at study entry)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Izmir Bakircay University

Соавторы

Ege University

Следователи

Главный следователь: Ayşe KAYALI VATANSEVER, Asst. Prof. Dr., Bakırçay University
Директор по исследованиям: Dilek BAYRAKTAR, Dr. PT, Ege university
Директор по исследованиям: Ahmet ÇELİK, Prof. Dr., Ege university
Директор по исследованиям: Mustafa Orkan ERGÜN, Prof. Dr., Ege university
Директор по исследованиям: Sena ÖZDEMİR, Bakırçay University

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

7 июля 2026 г.

Первичное завершение (Оцененный)

7 июля 2027 г.

Завершение исследования (Оцененный)

7 июля 2027 г.

Даты регистрации исследования

Первый отправленный

6 апреля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

21 июля 2026 г.

Первый опубликованный (Действительный)

27 июля 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)