About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Other
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
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.
Anal Continence (Kelly Continence Score)
Continence status will be assessed using the Kelly Continence Score.
Walking Speed (km/h)
Walking speed will be assessed using the Materialise Motion Footscan® v9 Scientific.
Cadence (steps/min)
Cadence will be assessed using the Materialise Motion Footscan® v9 Scientific.
Sponsors and contacts
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Izmir Bakircay University
Lead sponsor
Ege University
Collaborator