The Relationship Between Pelvic Floor Dysfunction and Quality of Life, Functional Capacity, Gait Parameters, and Static Balance in Children With Defecation Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pelvic Floor Dysfunction, Defecation Disorders. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Resting Pelvic Floor Muscle Activity (µV) [Time frame: Baseline (at study entry)]
- Pelvic Floor Muscle Maximum Voluntary Contraction (µV) [Time frame: Baseline (at study entry)]
- Pelvic Floor Muscle Activity During Straining (µV) [Time frame: Baseline (at study entry)]
- Pediatric Quality of Life Inventory (PedsQL™ 4.0) Child Self-Report Total Score [Time frame: Baseline (at study entry)]
- Pediatric Quality of Life Inventory (PedsQL™ 4.0) Parent Proxy-Report Total Score [Time frame: Baseline (at study entry)]
Secondary outcome measures (10)
- Functional Capacity [Time frame: Baseline (at study entry)]
- Anal Continence (Kelly Continence Score) [Time frame: Baseline (at study entry)]
- Walking Speed (km/h) [Time frame: Baseline (at study entry)]
- Cadence (steps/min) [Time frame: Baseline (at study entry)]
- Step Length (cm) [Time frame: Baseline (at study entry)]
- Subtalar Joint Flexion (degrees) [Time frame: Baseline (at study entry)]
- Foot Type Classification [Time frame: Baseline (at study entry)]
- Center of Pressure Path Length (mm) [Time frame: Baseline (at study entry)]
- Mean Center of Pressure Velocity (mm/s) [Time frame: Baseline (at study entry)]
- Static Plantar Pressure Distribution [Time frame: Baseline (at study entry)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Turkey (Türkiye) · 2 centers
- Ege University — Izmir
- Ege University Faculty of Medicine, Department of Pediatric Surgery — Izmir
Identifiers
NCT: NCT07727837 · 2728