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

NCT05900856 | Completed

• 1 other identifier: p. t.REC/012/003570
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Rectus Diastasis

Keywords

Ultrasound Cavitation, Static Balance, Dynamic Balance

Outcome Measures

Primary Outcomes (2)

• Static 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 static postural balance for all patients

  up to eight weeks

• 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 dynamic postural balance for all patients

  up to eight weeks

Secondary Outcomes (3)

• Abdominal subcutaneous fat thickness

  up to eight weeks

• Inter recti distance

  up to eight weeks

• Lumbar lordotic angle

  up to eight weeks

Study Arms (2)

low caloric diet regimn

EXPERIMENTAL

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.

Other: low caloric diet regimen

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

EXPERIMENTAL

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.

Other: low caloric diet regimen; Device: ultrasound cavitation

Interventions

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.

Also known as: hypocaloric diet (1600: 2000 Kcal/ day)

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

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

Also known as: Dae Yang, Mabel 6, serial number DY73-15037, produced by DAEYANG MEDICAL company

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

Eligibility Criteria

• Age: 25 Years - 35 Years
• Gender Eligibility Details: obese postnatal women with rectus diastasis
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Asmaa Maher Ahmed Zahran

Giza, 12511, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: ultrasound cavitation and low caloric diet regimen

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 13, 2023
• Study Start: June 9, 2023
• Primary Completion: October 9, 2023
• Study Completion: December 9, 2023
• Last Updated: August 30, 2024

Record last verified: 2024-08

Locations

EG (1)