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Clinical Trials/NCT05371678
NCT05371678CompletedNot Applicable

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

Abant Izzet Baysal University1 site in 1 country36 target enrollmentStarted: April 18, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
1
Primary Endpoint
Vancouver Non-Neurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome Questionnaire- symptom assessment

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

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.

Eligibility Criteria

Ages
4 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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.

Intervention: Therapeutic motor control interventions (Other)

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.

Intervention: Conventional treatment (Other)

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

nuriye ozengin

Associate Professor

Abant Izzet Baysal University

Study Sites (1)

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