- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06492603
Examination of Biomechanical Characteristics of Linea Alba in Diastasis Recti Patients
Examination of Linea Alba Biomechanical and Viscoelastic Characteristics in Patients Diagnosed With Diastasis Recti Using Ultrasound
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Most healthcare providers agree that in diastasis rectus abdominis there is a weakness, thinning, and widening of the linea alba and weakness of the associated abdominal musculature.
Ultrasonography is regarded as the most accurate method for measuring the IRD and its results are consistent with the data derived from palpation, calipers, and intraoperative measurements.
The MyotonPRO Device is used for the non-invasive measurement of Device is for the non-invasive measurement of biomechanical and viscoelastic properties of superficial soft biological tissues. Skeletal muscles or tendons can be measured at different regions, at full rest or in contraction.
This study aims to assess the biomechanical and viscoelastic properties of the Linea Alba in patients who are diagnosed with diastasis rectus abdominis by ultrasonography.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mohamed G Shehata, Lecturer
- Phone Number: 01014397608
- Email: dr_m.gamal1987@svu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Postpartum Mothers who delivered by a cesarean section.
- Postpartum Mothers with a BMI below 30 or a Waist-hip ratio below 1.
- Postpartum Mothers above 18 years old and those below 40 years old.
Exclusion Criteria:
- Postpartum Mothers who delivered by a vaginal delivery.
- Postpartum Mothers who had hernias in the abdominal region or laparotomy.
- Postpartum Mothers with a BMI over 30 or a Waist-hip ratio over 1.
- Postpartum Mothers below 18 years old and those above 40 years old.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
20 Women in the Postpartum Diastasis Recti Group
|
Ultrasound is an assessment device that uses high-energy sound waves to look at either superficial tissues like linea alba and/or organs inside the body.
The sound waves make echoes that form pictures of the tissues and organs on a computer screen (sonogram).
The MyotonPro is a portable device for measuring biomechanical and viscoelastic properties in superficial soft tissues
|
|
20 Women in the Control Group (Postpartum Without Diastasis Recti)
|
Ultrasound is an assessment device that uses high-energy sound waves to look at either superficial tissues like linea alba and/or organs inside the body.
The sound waves make echoes that form pictures of the tissues and organs on a computer screen (sonogram).
The MyotonPro is a portable device for measuring biomechanical and viscoelastic properties in superficial soft tissues
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Linea Alba Stiffness
Time Frame: Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum
|
It is a Biomechanical Characteristic of the Linea Alba
|
Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum
|
|
Linea Alba Elasticity
Time Frame: Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum
|
It is a Biomechanical Characteristic of the Linea Alba
|
Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum
|
|
Linea Alba Creep
Time Frame: Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum
|
It is a Viscoelastic Characteristic of the Linea Alba
|
Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Diastasis Recti
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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