Comparison of Two Interventions in Children with Functional Constipation

NCT05371678 | Completed

• 1 other identifier: AIBU-FTR-BI
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study; to compare the effects of therapeutic motor control interventions and conventional treatment in children with functional constipation on symptoms, spinal posture and mobility and trunk muscles endurance.

Conditions

Constipation - Functional; Pediatric

Keywords

constipation; biofeedback; rehabilitation

Outcome Measures

Primary Outcomes (2)

• Vancouver Non-Neurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome Questionnaire- symptom assessment

  Vancouver Non-Neurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome Questionnaire was developed in 2009. The questionnaire consists of 14-item. Each question is 5-Likert type, and the last question is not added to the scoring. The total score ranges from 0 to 52 and increasing score means an increase in symptom severity.

  Eight weeks

• 7-day bowel diary (symptom assessment)

  The bowel histories of the children (frequency of defecation, fecal incontinence, feeling urgency defecations...) will be evaluated with a 1-week bowel diary.

  Eight weeks

Secondary Outcomes (11)

• Spinal Posture

  Eight weeks

• Spinal Mobility

  Eight weeks

• Trunk flexor muscle endurance test

  Eight weeks

• Trunk extensor muscle endurance test

  Eight weeks

• Trunk right lateral bridge test

  Eight weeks

Study Arms (2)

Therapeutic motor control interventions

ACTIVE COMPARATOR

Treatment duration will be 8 weeks. Therapeutic motor control intervention therapy sessions will be 2 days a week. Therapeutic motor control intervention will include education about defecation and physiology, dietary advices, core stabilization exercises, pelvic floor muscle training with surface Electromyographic-Biofeedback and breathing exercises. In the first session education and dietary advices will be given to patient. Dietary advices will be given by dietitian. Two surface electromyographic electrodes will be applied on external anal sphincter muscle position.

Other: Therapeutic motor control interventions

Conventional treatment

ACTIVE COMPARATOR

Treatment duration will be 8 weeks. Conventional treatment will include education about defecation and physiology, dietary advices and laxative therapy. In the first session education and dietary advices will be given to patient. Dietary advices will be given by dietitian. Laxative therapy will be given by pediatric surgery.

Other: Conventional treatment

Interventions

Therapeutic motor control interventions OTHER

Treatment duration will be 8 weeks, two sessions a week. Each session will take approximately 60 minutes. This intervention includes education, dietary advices, core stabilization exercises and pelvic floor muscle training with surface Electromyographic-Biofeedback. In the education will be taught to the child and their parents in the first session. Dietary advices will be given by specialist dietitian. Core stabilization exercises will be performed 2 days a week with a physiotherapist and the session will be approximately 50 minutes. Diaphragmatic breathing will be taught to children in breathing exercises. The pelvic floor muscles exercises will be do by surface Electromyographic-Biofeedback. The Electromyographic-Biofeedback teaches the child how to relax the external anal sphincters with visual and auditory feedback techniques.The child will learn to relax the pelvic floor muscles during defecation by monitoring the recorded electromyographic activity.

Therapeutic motor control interventions

Conventional treatment OTHER

Treatment duration will be 8 weeks. This intervention includes education, dietary advices and laxative therapy. In the education will be taught to the child and their parents in the first session. Dietary advices will be given by specialist dietitian. Laxative therapy will be adjusted at different doses according to the child's age and weight. Laxative therapy will be administered to children by a specialist doctor.

Conventional treatment

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Voluntary participation in the research
• Fulfill the diagnostic criteria for functional constipation (Rome IV)

You may not qualify if:

• Having neurological diseases
• Having chronic diseases
• Having previous orthopedic surgery or trauma
• Presence of organic pathology underlying constipation.

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Faculty of Health Sciences Bolu Abant İzzet Baysal University

Bolu, Bolu, 14300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nuriye Ozengin, Ph.D.

  Bolu Abant İzzet Baysal University

  PRINCIPAL INVESTIGATOR

• Büşra İnal, M.Sc.

  Bolu Abant İzzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Children will be divided into two intervention groups by randomization method. Randomization method will be made with a computer program (Random Allocation Software version 2.0) stratified according to age and gender.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: comparison of therapeutic motor control interventions which include education, dietary advice, core stabilization exercises, pelvic floor muscle training with surface Electromyographic, and breathing exercises and conventional treatment which include education, dietary advice and laxative therapy

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 12, 2022
• Study Start: April 18, 2022
• Primary Completion: November 5, 2024
• Study Completion: November 5, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)