Constipation - FunctionalNCT05371678
Comparison of Two Interventions in Children with Functional Constipation
A study testing Conventional treatment in people with Constipation - Functional and Pediatric, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Constipation - Functional, Pediatric
- What is being tested?
- Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Apr 2022to 5 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Voluntary participation in the research
- Fulfill the diagnostic criteria for functional constipation (Rome IV)
Who cannot join
- Having neurological diseases
- Having chronic diseases
- Having previous orthopedic surgery or trauma
- Presence of organic pathology underlying constipation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Sciences Bolu Abant İzzet Baysal University
Bolu, Bolu, 14300
About this study
Official title: Comparison of Therapeutic Motor Control Interventions and Conventional Treatment in Children with Functional Constipation
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.
Read the 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.
- Conditions
- Constipation - Functional, Pediatric
- Being tested
- Therapeutic motor control interventions, Conventional treatment
- Keywords
- constipation, biofeedback, rehabilitation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic motor control interventionsOther
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 treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Therapeutic motor control interventions |
| 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. Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vancouver Non-Neurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome Questionnaire- symptom assessment
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.
Measured: Eight weeks
7-day bowel diary (symptom assessment)
The bowel histories of the children (frequency of defecation, fecal incontinence, feeling urgency defecations...) will be evaluated with a 1-week bowel diary.
Measured: Eight weeks
Secondary outcomes (11)
Spinal Posture
Spinal posture evaluations of children will be perform with the Spinal Mouse, which is a computer-assisted and non-invasive electromechanical device. Spinal posture evaluations will be perform in standing upright position. After taking the evaluation position, the Spinal Mouse device will be moved by sliding down through all spinal processes starting from the C7 spinal process to the S3 spinal process. Relevant parameters in standing upright position [thoracic curvature angle (from T1 to T12), lumbar curvature angle (from T12 to S1), sacrum-hip angle (difference between the sacral angle and the vertical), inclination angle (angle formed by the vertical and a line joining C7 to sacrum)] were recorded by the Spinal Mouse device via bluetooth and will be analyzed.
Measured: Eight weeks
Spinal Mobility
Spinal mobility evaluations of children will be perform with the Spinal Mouse, which is a computer-assisted and non-invasive electromechanical device. Spinal posture and mobility evaluations will be perform in 3 different positions: standing upright, maximum flexion and maximum extension. After taking the evaluation position, the Spinal Mouse device will be moved by sliding down through all spinal processes starting from the C7 spinal process to the S3 spinal process. Relevant parameters in standing upright position [thoracic curvature angle (from T1 to T12), lumbar curvature angle (from T12 to S1), sacrum-hip angle (difference between the sacral angle and the vertical), inclination angle (angle formed by the vertical and a line joining C7 to sacrum)] were recorded by the Spinal Mouse device via bluetooth and will be analyzed.
Measured: Eight weeks
Trunk flexor muscle endurance test
In the trunk flexor endurance test, the child is in a long sitting position on the treatment bed. At this time, the trunk is supported by a wedge in 60° flexion and knees and hips flexed 90°, arms crossed in front of the chest. The feet are fixed to the bed with a belt. The wedge supporting the trunk is retracted by 10 cm and the child tries to maintain his position as much as possible. The test is terminated when the child's trunk touches the wedge or the test time exceeds 300 seconds.
Measured: Eight weeks
Trunk extensor muscle endurance test
In the trunk extensor endurance test, the child lies in the prone position with his hips at the edge of the treatment bed. Pelvis, hips and knees are fixed to the treatment bed with belts. The child tries to keep it in a horizontal body position as much as possible by crossing his arms in front of his body. This test is terminated when the child cannot maintain the horizontal position or the test time exceeds 300 seconds.
Measured: Eight weeks
Trunk right lateral bridge test
In the right bridge trunk endurance test, the test begins when the child's knees are extended and the upper foot is placed in front of the lower foot in the right side lying position. The child's upper arm is holding the other shoulder. The child carries his/her body weight with his/her lower elbow and feet, and he/she should keep his/her torso in a straight line as much as possible throughout the test. The test is terminated when this side lying position is disturbed or the hip touches the treatment bed or the test time exceeds 300 seconds.
Measured: Eight weeks
Trunk left lateral bridge test
In the left bridge trunk endurance test, the test begins when the child's knees are extended and the child's upper foot is placed in front of the lower foot in the left side lying position. The child's upper arm is holding the other shoulder. The child carries his/her body weight with his/her lower elbow and feet, and he/she should keep his/her torso in a straight line as much as possible throughout the test. The test is terminated when this side lying position is disturbed or the hip touches the treatment bed or the test time exceeds 300 seconds.
Measured: Eight weeks
Physical activity level (pedometer)
Physical activity level will be assessed by pedometer. Step counts of children will be recorded with the pedometer for a total of 4 days, 2 days on weekdays and 2 days on weekends. The pedometer will be fixed on the hips of the children.
Measured: Eight weeks
Physical activity level (questionnaire)
Physical activity level will be assessed by questionnaire.The physical activity questionnaire for children (PAQ-C) will assess physical activity the ages of 8-14 years.The total score of the PAQ-C consists of the first 9 items. A score of 1 means low level of physical activity, while a score of 5 means high physical activity. PAQ for Adolescents (PAQ-A) is a questionnaire designed to evaluate the physical activity of students aged 14-20 attending secondary education during the last 7 days of the school term.A score of '1' corresponds to low-intensity physical activity and a score of '5' corresponds to high-intensity physical activity, but the last question is not included in the scoring. The total score is obtained by calculating the average score of all questions.
Measured: Eight weeks
Evaluation of subjective perception of improvement
The Global Perceived Impact scale will be used to evaluate children after treatment (week 8). Children will be asked to rate the extent to which their complaints have improved on a 4-item Likert-type scale. Description of scores; '1' would be 'worsened', '2' would be 'unchanged', '3' would be 'better', '4' would be 'completely healed'
Measured: Eight weeks
Evaluation of compliance with lifestyle changes
After the treatment (8th week), the degree of compliance of the children with the recommendations for lifestyle changes will be evaluated with the Visual Analog Scale. Children will be asked to mark the point that best describes them on a vertical line 10 cm long. The distance of the marked point to the '0' point will be measured with a ruler and recorded in cm. On this scale, the '0' point will be defined as 'Never (0%) I Have Not Complied' and the '10' point will be defined as 'I Have Fully (100%) Compliance'.
Measured: Eight weeks
Evaluation of compliance with breathing exercises
After the treatment, the degree of compliance of the children in Group 1 towards breathing exercises will be evaluated with the Visual Analog Scale. Children will be asked to mark the point that best describes them on a vertical line 10 cm long. The distance of the marked point to the '0' point will be measured with a ruler and recorded in cm. On this scale, the '0' point will be defined as 'Never (0%) I Have Not Complied' and the '10' point will be defined as 'I Have Fully (100%) Compliance'.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start18 Apr 2022
- Primary completion5 Nov 2024
- Study completion5 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation - FunctionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nuriye ozengin, Abant Izzet Baysal University
- Investigators
- Nuriye Ozengin, Ph.D., Principal investigator, Abant Izzet Baysal UniversityBüşra İnal, M.Sc., Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371678
- Sponsor's protocol ID
- AIBU-FTR-BI
- Status last verified
- Jul 2024
- First submitted
- 26 Apr 2022
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Therapeutic Motor Control Interventions and Conventional Treatment in Children with Functional Constipation
- ClinicalTrials.gov ID
- NCT05371678
- Acronym / sponsor ID
- AIBU-FTR-BI
- Conditions
- Constipation - Functional, Pediatric
- Keywords
- constipation, biofeedback, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 5 Nov 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Therapeutic motor control interventions | Active comparator | Other: Therapeutic motor control interventionsTreatment 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. |
| Conventional treatment | Active comparator | Other: Conventional treatmentTreatment 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. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Voluntary participation in the research
- Fulfill the diagnostic criteria for functional constipation (Rome IV)
Key exclusion criteria (4 listed)
- Having neurological diseases
- Having chronic diseases
- Having previous orthopedic surgery or trauma
- Presence of organic pathology underlying constipation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic motor control interventionsTreatment 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. | Other | Therapeutic motor control interventions |
| Conventional treatmentTreatment 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. | Other | Conventional treatment |
Primary outcome
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.
11 secondary outcomes
Spinal Posture
Time frame: Eight weeks
Spinal Mobility
Time frame: Eight weeks
Trunk flexor muscle endurance test
Time frame: Eight weeks
Trunk extensor muscle endurance test
Time frame: Eight weeks
Trunk right lateral bridge test
Time frame: Eight weeks
Trunk left lateral bridge test
Time frame: Eight weeks
Physical activity level (pedometer)
Time frame: Eight weeks
Physical activity level (questionnaire)
Time frame: Eight weeks
Evaluation of subjective perception of improvement
Time frame: Eight weeks
Evaluation of compliance with lifestyle changes
Time frame: Eight weeks
Evaluation of compliance with breathing exercises
Time frame: Eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuriye Ozengin, Ph.D. principal investigator
Abant Izzet Baysal University
Büşra İnal, M.Sc. principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional treatment in people with Constipation - Functional and Pediatric, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vancouver Non-Neurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome Questionnaire- symptom assessment (time frame: Eight weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.