Clinical trial NCT05371678: Comparison of Two Interventions in Children with Functional Constipation
Official title: Comparison of Therapeutic Motor Control Interventions and Conventional Treatment in Children with Functional Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation - Functional
Pediatric
Keywords: constipation
biofeedback
rehabilitation
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 36
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Vancouver Non-Neurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome Questionnaire- symptom assessment
timeFrame: Eight weeks
measure: 7-day bowel diary (symptom assessment)
timeFrame: Eight weeks
Secondary outcomes:
measure: Spinal Posture
timeFrame: Eight weeks
measure: Spinal Mobility
timeFrame: Eight weeks
measure: Trunk flexor muscle endurance test
timeFrame: Eight weeks
measure: Trunk extensor muscle endurance test
timeFrame: Eight weeks
measure: Trunk right lateral bridge test
timeFrame: Eight weeks
measure: Trunk left lateral bridge test
timeFrame: Eight weeks
measure: Physical activity level (pedometer)
timeFrame: Eight weeks
measure: Physical activity level (questionnaire)
timeFrame: Eight weeks
measure: Evaluation of subjective perception of improvement
timeFrame: Eight weeks
measure: Evaluation of compliance with lifestyle changes
timeFrame: Eight weeks
measure: Evaluation of compliance with breathing exercises
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Faculty of Health Sciences Bolu Abant İzzet Baysal University
Study officials:
affiliation: Bolu Abant İzzet Baysal University
name: Nuriye Ozengin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bolu Abant İzzet Baysal University
name: Büşra İnal, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: