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NCT Number: NCT07727837

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

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.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ege University, Izmir, Bornova, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Functional Capacity

    Time frame: Baseline (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.

  2. Anal Continence (Kelly Continence Score)

    Time frame: Baseline (at study entry)

    Continence status will be assessed using the Kelly Continence Score.

  3. Walking Speed (km/h)

    Time frame: Baseline (at study entry)

    Walking speed will be assessed using the Materialise Motion Footscan® v9 Scientific.

  4. Cadence (steps/min)

    Time frame: Baseline (at study entry)

    Cadence will be assessed using the Materialise Motion Footscan® v9 Scientific.

  5. Step Length (cm)

    Time frame: Baseline (at study entry)

    Step length will be assessed using the Materialise Motion Footscan® v9 Scientific.

  6. Subtalar Joint Flexion (degrees)

    Time frame: Baseline (at study entry)

    Subtalar joint flexion will be assessed using the Materialise Motion Footscan® v9 Scientific.

  7. Foot Type Classification

    Time frame: Baseline (at study entry)

    Foot type will be classified as pes planus, pes cavus, or neutral using the Materialise Motion Footscan® v9 Scientific.

  8. Center of Pressure Path Length (mm)

    Time frame: 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.

  9. Mean Center of Pressure Velocity (mm/s)

    Time frame: 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.

  10. Static Plantar Pressure Distribution

    Time frame: Baseline (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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayşe KAYALI VATANSEVER, Asst. Prof. Dr.

CONTACT

[email protected]

+905529382360

Sponsors and collaborators

Lead sponsor

Izmir Bakircay University

Other

Collaborators

  • Ege University

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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