Skip to main content
OpenTrials
Completed

NCT Number: NCT05900856

Effect of Ultrasound Cavitation on Static and Dynamic Balance in Obese Postnatal Women With Diastasis Recti

the aim of this study is to investigate the efficacy of ultrasound cavitation on static and dynamic balance in obese postnatal women with diastasis recti

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

25 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Asmaa Maher Ahmed Zahran

Giza, 12511, Egypt

About this study

Rectus diastasis defined as the widening of the linea alba by more than 2 cm at the midline. A great proportion of pregnant women are complaining from rectus diastasis during pregnancy reaching 100% of all women that may continue for years after delivery in 66% of women, and do not return to the first state automatically. This occurs due to a combination of physiologic, hormonal and mechanical factors, leading to reduction of abdominal muscle functional strength, increased low back pain out of increased lumbar hyperlordosis and postural instability, which may seriously disable woman from taking care of her baby, perform her daily activities. Weight gain is one of the predisposing factors that increases the possibility of developing rectus diastasis postpartum. Being obese increases liability to have rectus diastasis as carrying excess abdominal fats puts greater pressure against linea alba and can develop or aggravate symptoms for both men and women. This massively displaces the center of gravity anteriorly, disturbs body balance, increases joint loads and influences negatively pelvis posture leading to increased anterior pelvic tilt with subsequent exaggerated lumbar hyperlordosis. Ultrasound cavitation is the most revolutionary method that destroys excess body fat through creating microbubbles and releasing energy that breaks down fat cells. This trial has two groups: one will be treated by low caloric diet regimen only and the second one will be treated by ultrasound cavitation in addition to low caloric diet regimen for eight weeks

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All women had a diastasis recti more than 2.5 cm and less than 4 cm in supra umbilical region.
  • Their ages were ranged from 25: 35 years.
  • Their BMI was more than 30 Kg/ m2.
  • All women were with lumbar hyperlordosis.
  • All women were multipara.
  • Their mode of delivery was normal vaginal delivery.
  • They were selected from 2: 5 months postnatal.

Exclusion criteria

  • Previous cesarean section.
  • Previous abdominal and/ or back operation.
  • Spinal disorders.
  • Abdominal skin diseases.
  • Serious diseases such as heart disease, pace maker, uncontrolled diabetes or hypertension, autoimmune disease, malignancy, gastric ulcer, liver or renal failure and any other contraindication for body sculpting-weight loss.

Treatment and study plan

low caloric diet regimen

Other

lipids approximately (20: 35%) of total caloric intake, protein approximately (10: 35%) of total caloric intake and high complexed carbohydrate intake approximately (45: 65%) of total caloric intake (with increased fiber-rich whole grain breads, cereals, fruits and vegetables), for eight weeks.

Other names: hypocaloric diet (1600: 2000 Kcal/ day)

ultrasound cavitation

Device

patients will assume standing position, the abdominal area will be divided vertically into 2 equal sections, right and left segment, extending bilaterally from the line stretching between the mid axilla above and the iliac crest below, and upward from center of diaphragm to the midpoint extending between two iliac crest below, then from supine lying position the cavitation head will be applied on each abdominal segment for 15 minutes with total treatment time 30 minutes twice per week for eight weeks

Other names: Dae Yang, Mabel 6, serial number DY73-15037, produced by DAEYANG MEDICAL company

Primary outcomes

  1. Static postural balance

    Time frame: up to eight weeks

    The Biodex Balance System SD (model: TP-3040-15, DC input: 19V-6.32A, connected to computer software version 4.0.06, 2017, serial number: R712010010, made in Taiwan) will be used to measure overall stability index of static postural balance for all patients

  2. Dynamic postural balance

    Time frame: up to eight weeks

    The Biodex Balance System SD (model: TP-3040-15, DC input: 19V-6.32A, connected to computer software version 4.0.06, 2017, serial number: R712010010, made in Taiwan) will be used to measure overall stability index of dynamic postural balance for all patients

Secondary outcomes

  1. Abdominal subcutaneous fat thickness

    Time frame: up to eight weeks

    Ultrasound imaging unit (Mindary DP10, linear probe, with 10 MHz frequency, serial number: bn- 75013216, made in China) will be used to measure abdominal subcutaneous fat thickness at the umbilical level from supine lying position for all patients

  2. Inter recti distance

    Time frame: up to eight weeks

    Ultrasound imaging unit (Mindary DP10, convex probe, with 5 MHz frequency, serial number: bn- 75013216, made in China) will be used to measure resting inter recti distance 2.5 cm above the upper margin of umbilicus from crock lying position for all patients

  3. Lumbar lordotic angle

    Time frame: up to eight weeks

    Spinal mouse (MEDIMOUSE) IDIAG M360 pro, pc-Software, 7.4.0., serial number: *112D2A24*, made in Switzerland) will be used to measure lumbar lordotic angle from standing position

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 13, 2023
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.