Examination of Biomechanical Characteristics of Linea Alba in Diastasis Recti Patients

Not yet recruiting

• Conditions: Separated Recti Abdominis
• Interventions: Device: Ultrasonography; Device: The MyotonPRO Device

• Registration Number: NCT06492603
• Lead Sponsor: South Valley University

Brief Summary

Diastasis recti is an increased distance between the rectus abdominis muscles at the midline caused by weakness in the anterior abdominal wall.

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 Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-01
• Study First Posted: 2024-07-09
• Last Update Submitted: 2025-03-09
• Last Update Posted: 2025-03-12
• Study Start: 2025-05-20
• Primary Completion: 2025-12-20
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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 35 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 35 years old.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
20 Women in the Postpartum Diastasis Recti Group	The MyotonPRO Device	-
20 Women in the Control Group (Postpartum Without Diastasis Recti)	The MyotonPRO Device	-
20 Women in the Postpartum Diastasis Recti Group	Ultrasonography	-
20 Women in the Control Group (Postpartum Without Diastasis Recti)	Ultrasonography	-

Primary Outcome Measures

Name	Time	Method
Linea Alba Elasticity	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
Linea Alba Creep	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
Linea Alba Stiffness	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