Pelvic Floor DysfunctionNCT07727837
The Relationship Between Pelvic Floor Dysfunction and Quality of Life, Functional Capacity, Gait Parameters, and Static Balance in Children With Defecation Disorders
An observational study of Pelvic Floor Dysfunction and Defecation Disorders, run by Izmir Bakircay University at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Dysfunction, Defecation Disorders
- Type of treatment
- Injection or infusion
- How many people
- 95 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 7 Jul 2026to 7 Jul 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Not yet recruiting
Ege University
Izmir, Bornova, 35100
Dilek BAYRAKTAR, Dr. PT, +905377265535, dilekbayraktar8@gmail.com
- Recruiting
Ege University Faculty of Medicine, Department of Pediatric Surgery
Izmir
Ayşe KAYALI VATANSEVER, Asst. Prof. Dr., +905529382360, ayse.vatansever@bakircay.edu.tr
Dilek Bayraktar, Asst. Prof. Dr., +905377265535, dilekbayraktar8@gmail.com
About this study
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.
Read the 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.
- Conditions
- Pelvic Floor Dysfunction, Defecation Disorders
- Keywords
- Defecation disorders, Functional constipation, Children, Balance, Gait, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (at study entry)
Secondary outcomes (10)
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.
Measured: Baseline (at study entry)
Anal Continence (Kelly Continence Score)
Continence status will be assessed using the Kelly Continence Score.
Measured: Baseline (at study entry)
Walking Speed (km/h)
Walking speed will be assessed using the Materialise Motion Footscan® v9 Scientific.
Measured: Baseline (at study entry)
Cadence (steps/min)
Cadence will be assessed using the Materialise Motion Footscan® v9 Scientific.
Measured: Baseline (at study entry)
Step Length (cm)
Step length will be assessed using the Materialise Motion Footscan® v9 Scientific.
Measured: Baseline (at study entry)
Subtalar Joint Flexion (degrees)
Subtalar joint flexion will be assessed using the Materialise Motion Footscan® v9 Scientific.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (at study entry)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start7 Jul 2026
- Primary completion7 Jul 2027 (estimated)
- Study completion7 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 95 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Principal investigator, AYŞE KAYALI VATANSEVER, Izmir Bakircay University
- Investigators
- Ayşe KAYALI VATANSEVER, Asst. Prof. Dr., Principal investigator, Bakırçay UniversityDilek BAYRAKTAR, Dr. PT, Study director, Ege UniversityAhmet ÇELİK, Prof. Dr., Study director, Ege UniversityMustafa Orkan ERGÜN, Prof. Dr., Study director, Ege UniversitySena ÖZDEMİR, Study director, Bakırçay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727837
- Sponsor's protocol ID
- 2728
- Status last verified
- Jul 2026
- First submitted
- 6 Apr 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Pelvic Floor Dysfunction and Quality of Life, Functional Capacity, Gait Parameters, and Static Balance in Children With Defecation Disorders
- ClinicalTrials.gov ID
- NCT07727837
- Acronym / sponsor ID
- 2728
- Conditions
- Pelvic Floor Dysfunction, Defecation Disorders
- Keywords
- Defecation disorders, Functional constipation, Children, Balance, Gait, Quality of Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- 7 Jul 2027 (estimated)
- Study completion
- 7 Jul 2027 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resting Pelvic Floor Muscle Activity (µV)
Time frame: Baseline (at study entry)
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)
Time frame: Baseline (at study entry)
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)
Time frame: Baseline (at study entry)
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
Time frame: Baseline (at study entry)
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.
Pediatric Quality of Life Inventory (PedsQL™ 4.0) Parent Proxy-Report Total Score
Time frame: Baseline (at study entry)
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.
10 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayşe KAYALI VATANSEVER, Asst. Prof. Dr. principal investigator
Bakırçay University
Dilek BAYRAKTAR, Dr. PT study director
Ege University
Ahmet ÇELİK, Prof. Dr. study director
Ege University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Dysfunction and Defecation Disorders, run by Izmir Bakircay University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşe KAYALI VATANSEVER, Asst. Prof. Dr. (+905529382360, ayse.vatansever@bakircay.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Pelvic Floor Muscle Activity (µV) (time frame: Baseline (at study entry)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.