The Relationship Between Pelvic Floor Dysfunction and Quality of Life, Functional Capacity, Gait … (NCT07727837) | Clinical Trial Compass
RecruitingNot Applicable
The Relationship Between Pelvic Floor Dysfunction and Quality of Life, Functional Capacity, Gait Parameters, and Static Balance in Children With Defecation Disorders
Turkey (Türkiye)95 participantsStarted 2026-07-07
Plain-language summary
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.
Who can participate
Age range
6 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is measuring pelvic floor muscle activity in children with defecation disorders, would my child need to undergo any uncomfortable or invasive muscle activity testing, and how is that typically done in kids their age?
2This trial is listed as Phase NA, which suggests it's an observational study rather than a treatment trial — does that mean my child wouldn't receive any new therapy, and if so, how might participating still benefit them compared to just continuing standard care?
3The study measures both the child's own quality-of-life report and a parent proxy report using the PedsQL tool — how much time and how many visits would my child and I need to commit to in order to participate?
4Since the trial is looking at the relationship between pelvic floor dysfunction and things like walking patterns and balance, would my child need any additional physical assessments beyond what they'd normally have for their defecation disorder?
5Given that this appears to be a research study rather than an active treatment, are there standard treatment options for my child's defecation disorder that I should consider starting now, regardless of whether we decide to participate in this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Resting Pelvic Floor Muscle Activity (µV)
Timeframe: Baseline (at study entry)
2
Pelvic Floor Muscle Maximum Voluntary Contraction (µV)
Timeframe: Baseline (at study entry)
3
Pelvic Floor Muscle Activity During Straining (µV)
Timeframe: Baseline (at study entry)
4
Pediatric Quality of Life Inventory (PedsQL™ 4.0) Child Self-Report Total Score
Timeframe: Baseline (at study entry)
5
Pediatric Quality of Life Inventory (PedsQL™ 4.0) Parent Proxy-Report Total Score