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Biofeedback Intervention in Rehabilitation of Adolescence With Posterior Sagittal Anorectoplasty

Primary Purpose

Fecal Incontinence in Children

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Biofeedback electrical stimulation
Sponsored by
Badr University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence in Children

Eligibility Criteria

10 Years - 13 Years (Child)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Badr university in cairo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biofeedback electrical stimulation

Arm Description

Biofeedback electrical stimulation

Outcomes

Primary Outcome Measures

biofeedback assessment for degree of contraction of anus and puborectalis muscle
biofeedback assessment for degree of anal contraction in cases with faecal incontinence post Posterior Sagittal Anorectoplasty

Secondary Outcome Measures

Full Information

First Posted
September 11, 2023
Last Updated
September 22, 2023
Sponsor
Badr University
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1. Study Identification

Unique Protocol Identification Number
NCT06053879
Brief Title
Biofeedback Intervention in Rehabilitation of Adolescence With Posterior Sagittal Anorectoplasty
Official Title
Biofeedback Intervention in Rehabilitation of Adolescence With Posterior Sagittal Anorectoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
September 5, 2023 (Actual)
Study Completion Date
September 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Badr University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence in Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
pretest post test
Masking
None (Open Label)
Masking Description
biofeedback stimulation for faecal incontinence post Posterior Sagittal Anorectoplasty
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biofeedback electrical stimulation
Arm Type
Experimental
Arm Description
Biofeedback electrical stimulation
Intervention Type
Other
Intervention Name(s)
Biofeedback electrical stimulation
Other Intervention Name(s)
Biofeedback
Intervention Description
biofeedback stimulation for faecal incontinence post Posterior Sagittal Anorectoplasty
Primary Outcome Measure Information:
Title
biofeedback assessment for degree of contraction of anus and puborectalis muscle
Description
biofeedback assessment for degree of anal contraction in cases with faecal incontinence post Posterior Sagittal Anorectoplasty
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reham A Elkalla, PHD
Organizational Affiliation
Lecturer of PT for surgery and burn
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mostafa S Ali, PHD
Organizational Affiliation
Ass.Prof. of PT for paediatric
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Radwa S Mahmoud, PHD
Organizational Affiliation
Ass.Prof. of PT for paediatric
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Noha A Abd el rahman, PHD
Organizational Affiliation
lecturer of PT for women health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Badr university in cairo
City
Badr
State/Province
Cairo
ZIP/Postal Code
002
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Biofeedback Intervention in Rehabilitation of Adolescence With Posterior Sagittal Anorectoplasty

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