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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 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Szczegółowy opis

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 studiów

Obserwacyjny

Zapisy (Szacowany)

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Nazwa: Ayşe KAYALI VATANSEVER, Asst. Prof. Dr.
Numer telefonu: +905529382360
E-mail: ayse.vatansever@bakircay.edu.tr

Lokalizacje studiów

Turcja (Türkiye)
- - Izmir, Turcja (Türkiye)
    - Rekrutacyjny
    - Ege University Faculty of Medicine, Department of Pediatric Surgery
    - Kontakt:
      
      Ayşe KAYALI VATANSEVER, Asst. Prof. Dr.
      
      Numer telefonu: +905529382360
      
      E-mail: ayse.vatansever@bakircay.edu.tr
    - Kontakt:
      
      Dilek Bayraktar, Asst. Prof. Dr.
      
      Numer telefonu: +905377265535
      
      E-mail: dilekbayraktar8@gmail.com
- Bornova
  - Izmir, Bornova, Turcja (Türkiye), 35100
    - Jeszcze nie rekrutacja
    - Ege university
    - Kontakt:
      
      Dilek BAYRAKTAR, Dr. PT
      
      Numer telefonu: +905377265535
      
      E-mail: dilekbayraktar8@gmail.com

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

Dziecko
Dorosły

Akceptuje zdrowych ochotników

Tak

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Liczba grup / kohort

Kohorty i interwencje

Grupa / 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Resting Pelvic Floor Muscle Activity (µV) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Functional Capacity Ramy czasowe: 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) Ramy czasowe: Baseline (at study entry)	Continence status will be assessed using the Kelly Continence Score.	Baseline (at study entry)
Walking Speed (km/h) Ramy czasowe: Baseline (at study entry)	Walking speed will be assessed using the Materialise Motion Footscan® v9 Scientific.	Baseline (at study entry)
Cadence (steps/min) Ramy czasowe: Baseline (at study entry)	Cadence will be assessed using the Materialise Motion Footscan® v9 Scientific.	Baseline (at study entry)
Step Length (cm) Ramy czasowe: Baseline (at study entry)	Step length will be assessed using the Materialise Motion Footscan® v9 Scientific.	Baseline (at study entry)
Subtalar Joint Flexion (degrees) Ramy czasowe: Baseline (at study entry)	Subtalar joint flexion will be assessed using the Materialise Motion Footscan® v9 Scientific.	Baseline (at study entry)
Foot Type Classification Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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 Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Izmir Bakircay University

Współpracownicy

Ege University

Śledczy

Główny śledczy: Ayşe KAYALI VATANSEVER, Asst. Prof. Dr., Bakırçay University
Dyrektor Studium: Dilek BAYRAKTAR, Dr. PT, Ege university
Dyrektor Studium: Ahmet ÇELİK, Prof. Dr., Ege university
Dyrektor Studium: Mustafa Orkan ERGÜN, Prof. Dr., Ege university
Dyrektor Studium: Sena ÖZDEMİR, Bakırçay University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

7 lipca 2026

Zakończenie podstawowe (Szacowany)

7 lipca 2027

Ukończenie studiów (Szacowany)

7 lipca 2027

Daty rejestracji na studia

Pierwszy przesłany

6 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 lipca 2026

Pierwszy wysłany (Rzeczywisty)

27 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)