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Comparison of Two Interventions in Children with Functional Constipation

A

Abant Izzet Baysal University

Status

Completed

Conditions

Constipation - Functional
Pediatric

Treatments

Other: Conventional treatment
Other: Therapeutic motor control interventions

Study type

Interventional

Funder types

Other

Identifiers

NCT05371678
AIBU-FTR-BI

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

4 to 18 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

36 participants in 2 patient groups

Therapeutic motor control interventions
Active Comparator group
Description:
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.
Treatment:
Other: Therapeutic motor control interventions
Conventional treatment
Active Comparator group
Description:
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.
Treatment:
Other: Conventional treatment

Trial contacts and locations

1

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Central trial contact

Büşra İnal, M.Sc.; Nuriye Ozengin, Ph.D.

Data sourced from clinicaltrials.gov

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