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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. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Jméno: Ayşe KAYALI VATANSEVER, Asst. Prof. Dr.
Telefonní číslo: +905529382360
E-mail: ayse.vatansever@bakircay.edu.tr

Studijní místa

Turecko (Türkiye)
- - Izmir, Turecko (Türkiye)
    - Nábor
    - Ege University Faculty of Medicine, Department of Pediatric Surgery
    - Kontakt:
      
      Ayşe KAYALI VATANSEVER, Asst. Prof. Dr.
      
      Telefonní číslo: +905529382360
      
      E-mail: ayse.vatansever@bakircay.edu.tr
    - Kontakt:
      
      Dilek Bayraktar, Asst. Prof. Dr.
      
      Telefonní číslo: +905377265535
      
      E-mail: dilekbayraktar8@gmail.com
- Bornova
  - Izmir, Bornova, Turecko (Türkiye), 35100
    - Zatím nenabíráme
    - Ege university
    - Kontakt:
      
      Dilek BAYRAKTAR, Dr. PT
      
      Telefonní číslo: +905377265535
      
      E-mail: dilekbayraktar8@gmail.com

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

Dítě
Dospělý

Přijímá zdravé dobrovolníky

Ano

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Počet skupin / kohort

Kohorty a intervence

Skupina / kohorta
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Resting Pelvic Floor Muscle Activity (µV) Časové okno: 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) Časové okno: 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) Časové okno: 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 Časové okno: 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 Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Functional Capacity Časové okno: 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) Časové okno: Baseline (at study entry)	Continence status will be assessed using the Kelly Continence Score.	Baseline (at study entry)
Walking Speed (km/h) Časové okno: Baseline (at study entry)	Walking speed will be assessed using the Materialise Motion Footscan® v9 Scientific.	Baseline (at study entry)
Cadence (steps/min) Časové okno: Baseline (at study entry)	Cadence will be assessed using the Materialise Motion Footscan® v9 Scientific.	Baseline (at study entry)
Step Length (cm) Časové okno: Baseline (at study entry)	Step length will be assessed using the Materialise Motion Footscan® v9 Scientific.	Baseline (at study entry)
Subtalar Joint Flexion (degrees) Časové okno: Baseline (at study entry)	Subtalar joint flexion will be assessed using the Materialise Motion Footscan® v9 Scientific.	Baseline (at study entry)
Foot Type Classification Časové okno: 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) Časové okno: 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) Časové okno: 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 Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Izmir Bakircay University

Spolupracovníci

Ege University

Vyšetřovatelé

Vrchní vyšetřovatel: Ayşe KAYALI VATANSEVER, Asst. Prof. Dr., Bakırçay University
Ředitel studie: Dilek BAYRAKTAR, Dr. PT, Ege university
Ředitel studie: Ahmet ÇELİK, Prof. Dr., Ege university
Ředitel studie: Mustafa Orkan ERGÜN, Prof. Dr., Ege university
Ředitel studie: Sena ÖZDEMİR, Bakırçay University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

7. července 2026

Primární dokončení (Odhadovaný)

7. července 2027

Dokončení studie (Odhadovaný)

7. července 2027

Termíny zápisu do studia

První předloženo

6. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

21. července 2026

První zveřejněno (Aktuální)

27. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)