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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 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

95

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Turkije (Türkiye)
      • Izmir, Turkije (Türkiye)
        • Werving
        • Ege University Faculty of Medicine, Department of Pediatric Surgery
        • Contact:
        • Contact:
    • Bornova
      • Izmir, Bornova, Turkije (Türkiye), 35100
        • Nog niet aan het werven
        • Ege university
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Resting Pelvic Floor Muscle Activity (µV)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Izmir Bakircay University

Medewerkers

Ege University

Onderzoekers

  • Hoofdonderzoeker: Ayşe KAYALI VATANSEVER, Asst. Prof. Dr., Bakırçay University
  • Studie directeur: Dilek BAYRAKTAR, Dr. PT, Ege university
  • Studie directeur: Ahmet ÇELİK, Prof. Dr., Ege university
  • Studie directeur: Mustafa Orkan ERGÜN, Prof. Dr., Ege university
  • Studie directeur: Sena ÖZDEMİR, Bakırçay University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

7 juli 2026

Primaire voltooiing (Geschat)

7 juli 2027

Studie voltooiing (Geschat)

7 juli 2027

Studieregistratiedata

Eerst ingediend

6 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 juli 2026

Eerst geplaatst (Werkelijk)

27 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

21 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 2728

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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