The Relationship Between Pelvic Floor Dysfunction and Quality of Life, Functional Capacity, Gait Parameters, and Static Balance in Children With Defecation Disorders

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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Floor Dysfunction; Defecation Disorders

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 95

Contacts and Locations

• Study Contact: Name: Ayşe KAYALI VATANSEVER, Asst. Prof. Dr.; Phone Number: +905529382360; Email: ayse.vatansever@bakircay.edu.tr

Study Locations

• Turkey (Türkiye)
  • Izmir, Turkey (Türkiye)
    • Recruiting
    • Ege University Faculty of Medicine, Department of Pediatric Surgery
    • Contact: Ayşe KAYALI VATANSEVER, Asst. Prof. Dr.; Phone Number: +905529382360; Email: ayse.vatansever@bakircay.edu.tr
    • Contact: Dilek Bayraktar, Asst. Prof. Dr.; Phone Number: +905377265535; Email: dilekbayraktar8@gmail.com
  • Bornova
    • Izmir, Bornova, Turkey (Türkiye), 35100
      • Not yet recruiting
      • Ege University
      • Contact: Dilek BAYRAKTAR, Dr. PT; Phone Number: +905377265535; Email: dilekbayraktar8@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting Pelvic Floor Muscle Activity (µV)	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)	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)	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	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	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)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Izmir Bakircay University
• Collaborators: Ege University
• Investigators: Principal Investigator: Ayşe KAYALI VATANSEVER, Asst. Prof. Dr., Bakırçay University; Study Director: Dilek BAYRAKTAR, Dr. PT, Ege University; Study Director: Ahmet ÇELİK, Prof. Dr., Ege University; Study Director: Mustafa Orkan ERGÜN, Prof. Dr., Ege University; Study Director: Sena ÖZDEMİR, Bakırçay University

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2026
• Primary Completion (Estimated): July 7, 2027
• Study Completion (Estimated): July 7, 2027

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Balance; Quality of Life; Gait; Children; Functional constipation; Defecation disorders
• Other Study ID Numbers: 2728

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No