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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorIzmir Bakircay University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 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.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

95 Participants
are grouped into 1 trial group
Group A: Children with Defecation Disorders

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (at study entry)
2

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.

Time frame
Baseline (at study entry)
3

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.

Time frame
Baseline (at study entry)
4

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.

Time frame
Baseline (at study entry)

Secondary outcomes

1

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.

Time frame
Baseline (at study entry)
2

Anal Continence (Kelly Continence Score)

Continence status will be assessed using the Kelly Continence Score.

Time frame
Baseline (at study entry)
3

Walking Speed (km/h)

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

Time frame
Baseline (at study entry)
4

Cadence (steps/min)

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

Time frame
Baseline (at study entry)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Izmir Bakircay University

Lead sponsor

Ege University

Collaborator