An observational study in Pelvic Floor Dysfunction and Defecation Disorders, sponsored by Izmir Bakircay University. Recruiting at 2 sites in Turkey (Türkiye). Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Izmir Bakircay University · Observational
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.
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.
Izmir Bakircay University is the lead sponsor of 73 studies on the registry; 17 are open to participants now.
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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.
Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (at study entry)
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.
Time frame: Baseline (at study entry)
Anal Continence (Kelly Continence Score)
Continence status will be assessed using the Kelly Continence Score.
Time frame: Baseline (at study entry)
Walking Speed (km/h)
Walking speed will be assessed using the Materialise Motion Footscan® v9 Scientific.
Time frame: Baseline (at study entry)
Cadence (steps/min)
Cadence will be assessed using the Materialise Motion Footscan® v9 Scientific.
Time frame: Baseline (at study entry)
Step Length (cm)
Step length will be assessed using the Materialise Motion Footscan® v9 Scientific.
Time frame: Baseline (at study entry)
Subtalar Joint Flexion (degrees)
Subtalar joint flexion will be assessed using the Materialise Motion Footscan® v9 Scientific.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (at study entry)
Plan to share: No
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Izmir Bakircay University