The Relationship Between Pelvic Floor Dysfunction and Quality of Life, Functional Capacity, Gait Parameters, and Static Balance in Children With Defecation Disorders
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Pelvic Floor Dysfunction, Defecation Disorders. Базовые параметры: 6 лет — 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Turkey (Türkiye)
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
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.
Первичные конечные точки
- Resting Pelvic Floor Muscle Activity (µV) [Срок оценки: Baseline (at study entry)]
- Pelvic Floor Muscle Maximum Voluntary Contraction (µV) [Срок оценки: Baseline (at study entry)]
- Pelvic Floor Muscle Activity During Straining (µV) [Срок оценки: Baseline (at study entry)]
- Pediatric Quality of Life Inventory (PedsQL™ 4.0) Child Self-Report Total Score [Срок оценки: Baseline (at study entry)]
- Pediatric Quality of Life Inventory (PedsQL™ 4.0) Parent Proxy-Report Total Score [Срок оценки: Baseline (at study entry)]
Вторичные конечные точки (10)
- Functional Capacity [Срок оценки: Baseline (at study entry)]
- Anal Continence (Kelly Continence Score) [Срок оценки: Baseline (at study entry)]
- Walking Speed (km/h) [Срок оценки: Baseline (at study entry)]
- Cadence (steps/min) [Срок оценки: Baseline (at study entry)]
- Step Length (cm) [Срок оценки: Baseline (at study entry)]
- Subtalar Joint Flexion (degrees) [Срок оценки: Baseline (at study entry)]
- Foot Type Classification [Срок оценки: Baseline (at study entry)]
- Center of Pressure Path Length (mm) [Срок оценки: Baseline (at study entry)]
- Mean Center of Pressure Velocity (mm/s) [Срок оценки: Baseline (at study entry)]
- Static Plantar Pressure Distribution [Срок оценки: Baseline (at study entry)]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Turkey (Türkiye) · 2 центра
- Ege University — Izmir
- Ege University Faculty of Medicine, Department of Pediatric Surgery — Izmir
Идентификаторы
NCT: NCT07727837 · 2728