Physical Therapy for Functional Constipation in Children
March 28, 2024 updated by: Amira Hussin Hussin Mohammed, Delta University for Science and Technology
Children diagnosed with functional constipation are subjected to physical therapy combined with conventional treatment
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Gamasa, Egypt, 35712
- Amira Hussin Mohammed
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- children diagnosed as functional constipation.
- aged from 4 to 18 years old
- from both sex
Exclusion Criteria:
- children diagnosed as constipation caused by medicine Bowel surgery, Endocrine and metabolic disorders , Neurological and psychiatric disorders.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control group (A)
conventional treatment by diet regimen and laxatives
|
Polyethylene Glycols syrup (0.7 g/kg daily)
|
|
Experimental: study Group (B)
physical therapy program in addition to conventional treatment by diet regimen and laxatives
|
Polyethylene Glycols syrup (0.7 g/kg daily)
The physical therapy program includes exercises and massage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rome-III criteria
Time Frame: after 6 months of interventions
|
assessment for functional constipation symptoms
|
after 6 months of interventions
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
short form 36 questionnaire
Time Frame: after 6 months of interventions
|
assessment for quality of life
|
after 6 months of interventions
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2022
Primary Completion (Actual)
December 30, 2023
Study Completion (Actual)
December 30, 2023
Study Registration Dates
First Submitted
January 5, 2024
First Submitted That Met QC Criteria
January 5, 2024
First Posted (Actual)
January 17, 2024
Study Record Updates
Last Update Posted (Actual)
March 29, 2024
Last Update Submitted That Met QC Criteria
March 28, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- constipation in children
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.