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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 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Studiesteder

Tyrkiet (Türkiye)
- - Izmir, Tyrkiet (Türkiye)
    - Rekruttering
    - Ege University Faculty of Medicine, Department of Pediatric Surgery
    - Kontakt:
      
      Ayşe KAYALI VATANSEVER, Asst. Prof. Dr.
      
      Telefonnummer: +905529382360
      
      E-mail: ayse.vatansever@bakircay.edu.tr
    - Kontakt:
      
      Dilek Bayraktar, Asst. Prof. Dr.
      
      Telefonnummer: +905377265535
      
      E-mail: dilekbayraktar8@gmail.com
- Bornova
  - Izmir, Bornova, Tyrkiet (Türkiye), 35100
    - Ikke rekrutterer endnu
    - Ege university
    - Kontakt:
      
      Dilek BAYRAKTAR, Dr. PT
      
      Telefonnummer: +905377265535
      
      E-mail: dilekbayraktar8@gmail.com

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Barn
Voksen

Tager imod sunde frivillige

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Resting Pelvic Floor Muscle Activity (µV) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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 Tidsramme: 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 Tidsramme: 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)

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Izmir Bakircay University

Samarbejdspartnere

Ege University

Efterforskere

Ledende efterforsker: Ayşe KAYALI VATANSEVER, Asst. Prof. Dr., Bakırçay University
Studieleder: Dilek BAYRAKTAR, Dr. PT, Ege university
Studieleder: Ahmet ÇELİK, Prof. Dr., Ege university
Studieleder: Mustafa Orkan ERGÜN, Prof. Dr., Ege university
Studieleder: Sena ÖZDEMİR, Bakırçay University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. juli 2026

Primær færdiggørelse (Anslået)

7. juli 2027

Studieafslutning (Anslået)

7. juli 2027

Datoer for studieregistrering

Først indsendt

6. april 2026

Først indsendt, der opfyldte QC-kriterier

21. juli 2026

Først opslået (Faktiske)

27. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)