NCT06053879

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

September 11, 2023

Last Update Submit

April 15, 2024

Conditions

Fecal Incontinence in Children

Outcome Measures

Primary Outcomes (1)

  • EMG biofeedback assessment for contraction of anus and puborectalis muscle

    EMG biofeedback assessment for degree ofanal contraction in cases with faecal incontinence post Posterior Sagittal Anorectoplasty

    12 weeks

Study Arms (1)

Biofeedback electrical stimulation

EXPERIMENTAL

Biofeedback electrical stimulation

Other: Biofeedback electrical stimulation

Interventions

Biofeedback electrical stimulationOTHER

biofeedback stimulation for faecal incontinence post Posterior Sagittal Anorectoplasty

Also known as: Biofeedback
Biofeedback electrical stimulation

Eligibility Criteria

Age10 Years - 13 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Neuromuscular or musculoskeletal disorders
  • Behavioural disorders
  • Psychological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Badr university in cairo

Badr, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Interventions

Biofeedback, Psychology

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
biofeedback stimulation for faecal incontinence post Posterior Sagittal Anorectoplasty
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: pretest post test
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for women health

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 26, 2023

Study Start

May 10, 2023

Primary Completion

September 5, 2023

Study Completion

September 5, 2023

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)