Comparison of Two Interventions in Children with Functional Constipation
NCT ID: NCT05371678
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2022-04-18
2024-11-05
Brief Summary
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Detailed Description
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It has been shown in the literature that children with functional constipation had a protrusion in the abdomen compared to healthy children, and their ability to actively relax their trunks decreased. Thus, it has been suggested that children with functional constipation may have reduced trunk muscle and/or endurance or muscle control. As a result of this study, they recommend that the treatment of these children should focus on awareness and education about trunk muscles, defecation and correction of sitting position.
According to the Cochrane systematic review published in 2016, physiotherapy and rehabilitation methods in bladder and bowel dysfunction are generally divided into two as education and specific methods. Specific methods are therapeutic motor control methods, manual therapy techniques (abdominal classical massage) and electrotherapy.
The use of therapeutic motor control methods in the treatment of constipation in children is quite new, and there is a need for innovative studies in this field in the literature.
The conventional treatment in children with functional constipation is education and laxatives.
In the light of this information, in this study considered that therapeutic motor control methods (core stabilization exercises, Electromyographic-Biofeedback therapy and breathing exercises) may have an effect on the symptoms of children with constipation. The primary aim of this study is to compare the effectiveness of therapeutic motor control methods and conventional treatment on constipation symptoms in children with functional constipation.
Children will be divided into 2 groups with the randomization program. Educational training, breathing exercises, dietary recommendations, core stabilization exercises and Electromyographic-Biofeedback therapy will be applied to the first group. The 2nd group is the control group and this group will receive routine treatment. Group 2 will receive laxative therapy by a specialist doctor along with educational training, dietary recommendations.
The duration of treatment will be 8 weeks. All children will be evaluated before and after 8 weeks of treatment. The first group will be treated by a physiotherapist in 2 sessions a week for 8 weeks. Each session will take approximately 60 minutes. Group 2 will receive routine treatment for 8 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Therapeutic motor control interventions
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.
Therapeutic motor control interventions
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.
Conventional treatment
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.
Conventional treatment
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.
Interventions
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Therapeutic motor control interventions
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.
Conventional treatment
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.
Eligibility Criteria
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Inclusion Criteria
* Fulfill the diagnostic criteria for functional constipation (Rome IV)
Exclusion Criteria
* Having chronic diseases
* Having previous orthopedic surgery or trauma
* Presence of organic pathology underlying constipation.
4 Years
18 Years
ALL
No
Sponsors
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Abant Izzet Baysal University
OTHER
Responsible Party
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nuriye ozengin
Associate Professor
Principal Investigators
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Nuriye Ozengin, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Bolu Abant İzzet Baysal University
Büşra İnal, M.Sc.
Role: PRINCIPAL_INVESTIGATOR
Bolu Abant İzzet Baysal University
Locations
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Faculty of Health Sciences Bolu Abant İzzet Baysal University
Bolu, Bolu, Turkey (Türkiye)
Countries
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Other Identifiers
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AIBU-FTR-BI
Identifier Type: -
Identifier Source: org_study_id