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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 julho de 2026 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Descrição detalhada

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 estudo

Observacional

Inscrição (Estimado)

95

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Turquia (Türkiye)
      • Izmir, Turquia (Türkiye)
        • Recrutamento
        • Ege University Faculty of Medicine, Department of Pediatric Surgery
        • Contato:
        • Contato:
    • Bornova
      • Izmir, Bornova, Turquia (Türkiye), 35100
        • Ainda não está recrutando
        • Ege university
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Resting Pelvic Floor Muscle Activity (µV)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários

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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Izmir Bakircay University

Colaboradores

Ege University

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

7 de julho de 2026

Conclusão Primária (Estimado)

7 de julho de 2027

Conclusão do estudo (Estimado)

7 de julho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

6 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de julho de 2026

Primeira postagem (Real)

27 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • 2728

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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