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Biofeedback Intervention in Rehabilitation of Adolescence With Posterior Sagittal Anorectoplasty

Sponsor
Badr University (Other)
Overall Status
Completed
CT.gov ID
NCT06053879
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
3.9
Actual Duration (Months)
7.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Biofeedback electrical stimulation
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Intervention Model Description:
pretest post testpretest post test
Masking:
None (Open Label)
Masking Description:
biofeedback stimulation for faecal incontinence post Posterior Sagittal Anorectoplasty
Primary Purpose:
Treatment
Official Title:
Biofeedback Intervention in Rehabilitation of Adolescence With Posterior Sagittal Anorectoplasty
Actual Study Start Date :
May 10, 2023
Actual Primary Completion Date :
Sep 5, 2023
Actual Study Completion Date :
Sep 5, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Biofeedback electrical stimulation

Biofeedback electrical stimulation

Other: Biofeedback electrical stimulation
biofeedback stimulation for faecal incontinence post Posterior Sagittal Anorectoplasty
Other Names:
  • Biofeedback

    		•

    Outcome Measures

    Primary Outcome Measures

    1. biofeedback assessment for degree of contraction of anus and puborectalis muscle [12 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 13 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Badr university in cairo Badr Cairo Egypt 002

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Noha Ahmed Fouad Abd-Elrahman, lecturer of physical therapy for women health, Badr University
    ClinicalTrials.gov Identifier:
    NCT06053879
    Other Study ID Numbers:
    • BUC-IACUC-230507-20
    First Posted:
    Sep 26, 2023
    Last Update Posted:
    Sep 26, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Fecal Incontinence

    Study Results

    No Results Posted as of Sep 26, 2023