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Clinical Trials/NCT05371678
NCT05371678
Completed
N/A

Comparison of Therapeutic Motor Control Interventions and Conventional Treatment in Children with Functional Constipation

Abant Izzet Baysal University1 site in 1 country36 target enrollmentApril 18, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Constipation - Functional
Sponsor
Abant Izzet Baysal University
Enrollment
36
Locations
1
Primary Endpoint
Vancouver Non-Neurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome Questionnaire- symptom assessment
Status
Completed
Last Updated
last year

Overview

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.

Detailed Description

Constipation is a very common problem in children. The pathophysiology of pediatric constipation is multifactorial and not fully understood. Constipation is a problem characterized by infrequent, difficult, often painful defecation and involuntary leakage of stool. It has been reported in the literature that the prevalence of constipation in children is 30%. It has been determined that approximately 96% of children with constipation have functional constipation. 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.

Registry
clinicaltrials.gov
Start Date
April 18, 2022
End Date
November 5, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

nuriye ozengin

Associate Professor

Abant Izzet Baysal University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: Eight weeks

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.

7-day bowel diary (symptom assessment)

Time Frame: Eight weeks

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

Secondary Outcomes

  • Spinal Posture(Eight weeks)
  • Trunk flexor muscle endurance test(Eight weeks)
  • Spinal Mobility(Eight weeks)
  • Trunk extensor muscle endurance test(Eight weeks)
  • Trunk right lateral bridge test(Eight weeks)
  • Trunk left lateral bridge test(Eight weeks)
  • Physical activity level (pedometer)(Eight weeks)
  • Evaluation of compliance with lifestyle changes(Eight weeks)
  • Evaluation of subjective perception of improvement(Eight weeks)
  • Physical activity level (questionnaire)(Eight weeks)
  • Evaluation of compliance with breathing exercises(Eight weeks)

Study Sites (1)

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