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The Relationship Between Pelvic Floor Dysfunction and Quality of Life, Functional Capacity, Gait Parameters, and Static Balance in Children With Defecation Disorders

The Relationship Between Pelvic Floor Dysfunction and Quality of Life, Functional Capacity, Gait Parameters, and Static Balance in Children With Defecation Disorders

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07727837
Enrollment
95
Registered
2026-07-27
Start date
2026-07-07
Completion date
2027-07-07
Last updated
2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Defecation Disorders, Pelvic Floor Dysfunction

Keywords

Defecation disorders, Functional constipation, Children, Balance, Gait, Quality of Life

Brief 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.

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.

Interventions

None listed

Sponsors

Izmir Bakircay University
Lead SponsorOTHER
Ege University
CollaboratorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Resting Pelvic Floor Muscle Activity (µV)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)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)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 ScoreBaseline (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 ScoreBaseline (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.

Secondary

MeasureTime frameDescription
Functional CapacityBaseline (at study entry)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)Baseline (at study entry)Continence status will be assessed using the Kelly Continence Score.
Walking Speed (km/h)Baseline (at study entry)Walking speed will be assessed using the Materialise Motion Footscan® v9 Scientific.
Cadence (steps/min)Baseline (at study entry)Cadence will be assessed using the Materialise Motion Footscan® v9 Scientific.
Step Length (cm)Baseline (at study entry)Step length will be assessed using the Materialise Motion Footscan® v9 Scientific.
Subtalar Joint Flexion (degrees)Baseline (at study entry)Subtalar joint flexion will be assessed using the Materialise Motion Footscan® v9 Scientific.
Foot Type ClassificationBaseline (at study entry)Foot type will be classified as pes planus, pes cavus, or neutral using the Materialise Motion Footscan® v9 Scientific.
Center of Pressure Path Length (mm)Baseline (at study entry)Static balance will be assessed using the Materialise Motion Footscan® v9 Scientific. Center of pressure (COP) path length will be recorded.
Mean Center of Pressure Velocity (mm/s)Baseline (at study entry)Static balance will be assessed using the Materialise Motion Footscan® v9 Scientific. Mean center of pressure (COP) velocity will be recorded.
Static Plantar Pressure DistributionBaseline (at study entry)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.

Countries

Turkey (Türkiye)

Contacts

CONTACTAyşe KAYALI VATANSEVER, Asst. Prof. Dr.
ayse.vatansever@bakircay.edu.tr+905529382360
PRINCIPAL_INVESTIGATORAyşe KAYALI VATANSEVER, Asst. Prof. Dr.

Bakırçay University

STUDY_DIRECTORDilek BAYRAKTAR, Dr. PT

Ege University

STUDY_DIRECTORAhmet ÇELİK, Prof. Dr.

Ege University

STUDY_DIRECTORMustafa Orkan ERGÜN, Prof. Dr.

Ege University

STUDY_DIRECTORSena ÖZDEMİR

Bakırçay University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026