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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

2026年7月21日 更新者：AYŞE KAYALI VATANSEVER、Izmir Bakircay University

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.

調査の概要

状態

募集

条件

詳細な説明

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.

研究の種類

観察的

入学 (推定)

95

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • トルコ（Türkiye）
      • Izmir、トルコ（Türkiye）
        • 募集
        • Ege University Faculty of Medicine, Department of Pediatric Surgery
        • コンタクト：
        • コンタクト：
    • Bornova
      • Izmir、Bornova、トルコ（Türkiye）、35100
        • まだ募集していません
        • Ege university
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Resting Pelvic Floor Muscle Activity (µV)
時間枠：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.
Baseline (at study entry)
Pelvic Floor Muscle Maximum Voluntary Contraction (µV)
時間枠：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.
Baseline (at study entry)
Pelvic Floor Muscle Activity During Straining (µV)
時間枠：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.
Baseline (at study entry)
Pediatric Quality of Life Inventory (PedsQL™ 4.0) Child Self-Report Total Score
時間枠：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.
Baseline (at study entry)
Pediatric Quality of Life Inventory (PedsQL™ 4.0) Parent Proxy-Report Total Score
時間枠：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.
Baseline (at study entry)

二次結果の測定

結果測定
メジャーの説明
時間枠
Functional Capacity
時間枠：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.
Baseline (at study entry)
Anal Continence (Kelly Continence Score)
時間枠：Baseline (at study entry)
Continence status will be assessed using the Kelly Continence Score.
Baseline (at study entry)
Walking Speed (km/h)
時間枠：Baseline (at study entry)
Walking speed will be assessed using the Materialise Motion Footscan® v9 Scientific.
Baseline (at study entry)
Cadence (steps/min)
時間枠：Baseline (at study entry)
Cadence will be assessed using the Materialise Motion Footscan® v9 Scientific.
Baseline (at study entry)
Step Length (cm)
時間枠：Baseline (at study entry)
Step length will be assessed using the Materialise Motion Footscan® v9 Scientific.
Baseline (at study entry)
Subtalar Joint Flexion (degrees)
時間枠：Baseline (at study entry)
Subtalar joint flexion will be assessed using the Materialise Motion Footscan® v9 Scientific.
Baseline (at study entry)
Foot Type Classification
時間枠：Baseline (at study entry)
Foot type will be classified as pes planus, pes cavus, or neutral using the Materialise Motion Footscan® v9 Scientific.
Baseline (at study entry)
Center of Pressure Path Length (mm)
時間枠：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.
Baseline (at study entry)
Mean Center of Pressure Velocity (mm/s)
時間枠：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.
Baseline (at study entry)
Static Plantar Pressure Distribution
時間枠：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.
Baseline (at study entry)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Izmir Bakircay University

協力者

Ege University

捜査官

  • 主任研究者：Ayşe KAYALI VATANSEVER, Asst. Prof. Dr.、Bakırçay University
  • スタディディレクター：Dilek BAYRAKTAR, Dr. PT、Ege university
  • スタディディレクター：Ahmet ÇELİK, Prof. Dr.、Ege university
  • スタディディレクター：Mustafa Orkan ERGÜN, Prof. Dr.、Ege university
  • スタディディレクター：Sena ÖZDEMİR、Bakırçay University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年7月7日

一次修了 (推定)

2027年7月7日

研究の完了 (推定)

2027年7月7日

試験登録日

最初に提出

2026年4月6日

QC基準を満たした最初の提出物

2026年7月21日

最初の投稿 (実際)

2026年7月27日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月27日

QC基準を満たした最後の更新が送信されました

2026年7月21日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • 2728

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いいえ

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