The Relationship Between Pelvic Floor Dysfunction and Quality of Life, Functional Capacity, Gait Parameters, and Static Balance in Children With Defecation Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Resting Pelvic Floor Muscle Activity (µV)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Resting Pelvic Floor Muscle Activity (µV)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Functional Capacity(Baseline (at study entry))
- Anal Continence (Kelly Continence Score)(Baseline (at study entry))
- Walking Speed (km/h)(Baseline (at study entry))
- Cadence (steps/min)(Baseline (at study entry))
- Step Length (cm)(Baseline (at study entry))
- Subtalar Joint Flexion (degrees)(Baseline (at study entry))
- Foot Type Classification(Baseline (at study entry))
- Center of Pressure Path Length (mm)(Baseline (at study entry))
- Mean Center of Pressure Velocity (mm/s)(Baseline (at study entry))
- Static Plantar Pressure Distribution(Baseline (at study entry))
研究者
AYŞE KAYALI VATANSEVER
Asst. Prof. Dr.
Izmir Bakircay University