Biofeedback Intervention in Rehabilitation of Adolescence With Posterior Sagittal Anorectoplasty

September 22, 2023 updated by: Noha Ahmed Fouad Abd-Elrahman, Badr University
most of children undergo Posterior Sagittal Anorectoplasty Complain from faecal incontinence and faecal soiling which negatively impacts the social life of these children prohibiting their participation with their bears.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

most of children undergo Posterior Sagittal Anorectoplasty Complain from faecal incontinence and faecal soiling which negatively impacts the social life of these children prohibiting their participation with their bears so this study aims prevent faecal incontinence so continue life time without any interference with social life and activities

Study Type

Interventional

Enrollment (Actual)

30

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

  • Egypt
    • Cairo
      • Badr, Cairo, Egypt, 002
        • Badr University in Cairo

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age from 10-13 years old
  • Reliable females
  • Able to understand verbal commands
  • Normal vision and hearing

Exclusion Criteria:

  • Neuromuscular or musculoskeletal disorders
  • Behavioural disorders
  • Psychological 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: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biofeedback electrical stimulation
Other: Biofeedback electrical stimulation
biofeedback stimulation for faecal incontinence post Posterior Sagittal Anorectoplasty
Other Names:
  • Biofeedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biofeedback assessment for degree of contraction of anus and puborectalis muscle
Time Frame: 12 weeks
biofeedback assessment for degree of anal contraction in cases with faecal incontinence post Posterior Sagittal Anorectoplasty
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Badr University

Investigators

  • Principal Investigator: Reham A Elkalla, PHD, Lecturer of PT for surgery and burn
  • Principal Investigator: Mostafa S Ali, PHD, Ass.Prof. of PT for paediatric
  • Principal Investigator: Radwa S Mahmoud, PHD, Ass.Prof. of PT for paediatric
  • Principal Investigator: Noha A Abd el rahman, PHD, lecturer of PT for women health

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)

May 10, 2023

Primary Completion (Actual)

September 5, 2023

Study Completion (Actual)

September 5, 2023

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUC-IACUC-230507-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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