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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 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

95

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Turquía (Türkiye)
      • Izmir, Turquía (Türkiye)
        • Reclutamiento
        • Ege University Faculty of Medicine, Department of Pediatric Surgery
        • Contacto:
        • Contacto:
    • Bornova
      • Izmir, Bornova, Turquía (Türkiye), 35100
        • Aún no reclutando
        • Ege university
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Resting Pelvic Floor Muscle Activity (µV)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Functional Capacity
Periodo de tiempo: 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)
Periodo de tiempo: Baseline (at study entry)
Continence status will be assessed using the Kelly Continence Score.
Baseline (at study entry)
Walking Speed (km/h)
Periodo de tiempo: Baseline (at study entry)
Walking speed will be assessed using the Materialise Motion Footscan® v9 Scientific.
Baseline (at study entry)
Cadence (steps/min)
Periodo de tiempo: Baseline (at study entry)
Cadence will be assessed using the Materialise Motion Footscan® v9 Scientific.
Baseline (at study entry)
Step Length (cm)
Periodo de tiempo: Baseline (at study entry)
Step length will be assessed using the Materialise Motion Footscan® v9 Scientific.
Baseline (at study entry)
Subtalar Joint Flexion (degrees)
Periodo de tiempo: Baseline (at study entry)
Subtalar joint flexion will be assessed using the Materialise Motion Footscan® v9 Scientific.
Baseline (at study entry)
Foot Type Classification
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Izmir Bakircay University

Colaboradores

Ege University

Investigadores

  • Investigador principal: Ayşe KAYALI VATANSEVER, Asst. Prof. Dr., Bakırçay University
  • Director de estudio: Dilek BAYRAKTAR, Dr. PT, Ege university
  • Director de estudio: Ahmet ÇELİK, Prof. Dr., Ege university
  • Director de estudio: Mustafa Orkan ERGÜN, Prof. Dr., Ege university
  • Director de estudio: Sena ÖZDEMİR, Bakırçay University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

7 de julio de 2026

Finalización primaria (Estimado)

7 de julio de 2027

Finalización del estudio (Estimado)

7 de julio de 2027

Fechas de registro del estudio

Enviado por primera vez

6 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de julio de 2026

Publicado por primera vez (Actual)

27 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 2728

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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