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

Primary Purpose

Rectus Diastasis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
low caloric diet regimen
ultrasound cavitation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectus Diastasis focused on measuring Ultrasound Cavitation, Static Balance, Dynamic Balance

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Asmaa Maher Ahmed ZahranRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

low caloric diet regimn

ultrasound cavitation for 30 minutes, twice per week for eight weeks and low caloric diet regimn

Arm Description

patients will follow low caloric diet regimn (1600: 2000 Kcal/ day), 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.

ultrasound cavitation, Dae Yang, Mabel 6, frequency (50: 60) Hz, power consumption 150 W, power input AC (100: 230) V, hand probe diameter 8.0 cm, serial number DY73-15037, produced by DAEYANG MEDICAL company, made in Korea. the device will be applied for 30 minutes on the abdominal area, twice per week for eight weeks. low caloric diet regimn patients will follow low caloric diet regimn (1600: 2000 Kcal/ day), 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.

Outcomes

Primary Outcome Measures

Abdominal subcutaneous fat thickness
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
Inter recti distance
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

Secondary Outcome Measures

Static and dynamic postural balance
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 both static and dynamic postural balance for all patients
Lumbar lordotic angle
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

Full Information

First Posted
May 26, 2023
Last Updated
September 19, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05900856
Brief Title
Effect of Ultrasound Cavitation on Static and Dynamic Balance in Obese Postnatal Women With Diastasis Recti
Official Title
Effect of Ultrasound Cavitation on Static and Dynamic Balance in Obese Postnatal Women With Diastasis Recti
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2023 (Actual)
Primary Completion Date
August 9, 2023 (Actual)
Study Completion Date
September 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectus Diastasis
Keywords
Ultrasound Cavitation, Static Balance, Dynamic Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
ultrasound cavitation and low caloric diet regimen
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low caloric diet regimn
Arm Type
Experimental
Arm Description
patients will follow low caloric diet regimn (1600: 2000 Kcal/ day), 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.
Arm Title
ultrasound cavitation for 30 minutes, twice per week for eight weeks and low caloric diet regimn
Arm Type
Experimental
Arm Description
ultrasound cavitation, Dae Yang, Mabel 6, frequency (50: 60) Hz, power consumption 150 W, power input AC (100: 230) V, hand probe diameter 8.0 cm, serial number DY73-15037, produced by DAEYANG MEDICAL company, made in Korea. the device will be applied for 30 minutes on the abdominal area, twice per week for eight weeks. low caloric diet regimn patients will follow low caloric diet regimn (1600: 2000 Kcal/ day), 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.
Intervention Type
Other
Intervention Name(s)
low caloric diet regimen
Other Intervention Name(s)
hypocaloric diet (1600: 2000 Kcal/ day)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
ultrasound cavitation
Other Intervention Name(s)
Dae Yang, Mabel 6, serial number DY73-15037, produced by DAEYANG MEDICAL company
Intervention Description
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
Primary Outcome Measure Information:
Title
Abdominal subcutaneous fat thickness
Description
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
Time Frame
up to eight weeks
Title
Inter recti distance
Description
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
Time Frame
up to eight weeks
Secondary Outcome Measure Information:
Title
Static and dynamic postural balance
Description
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 both static and dynamic postural balance for all patients
Time Frame
up to eight weeks
Title
Lumbar lordotic angle
Description
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
Time Frame
up to eight weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
obese postnatal women with rectus diastasis
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asmaa zahran, lecturer
Phone
01006620136
Email
asmaamaher500500@gmail.com
Facility Information:
Facility Name
Asmaa Maher Ahmed Zahran
City
Giza
ZIP/Postal Code
12511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asmaa Zahran, lecturer
Phone
01006620136
Email
asmaamaher500500@gmail.com
First Name & Middle Initial & Last Name & Degree
asmaa zahran, lecturer

12. IPD Sharing Statement

Learn more about this trial

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

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