Effect of High Intensity Focused Electromagnetic Field on Postnatal Diastasis Recti

Обзор

This study will be conducted to investigate the effect of high-intensity focused electromagnetic field on postnatal diastasis recti.

Подробное описание

Rectus diastasis is a prevalent condition that can have adverse health implications for women during both the antenatal and postnatal periods of pregnancy. Diastasis rectus abdominis (DRA) has been found to affect between 30% and 70% of pregnant women, and the increased inter rectus diastasis (IRD) can persist separated in the immediate postpartum period in 35% to 60% of women.

The contraction of all abdominal muscles reduces the abdominal horizontal diameter in such a way that a horizontal force will be generated, producing the approximation of both rectus abdominis muscles, particularly at umbilical level. So, increasing the abdominal muscles strength have proven to bring the left and right sides of the rectus diastasis together, convert the abdomen into a rigid cylinder and minimize the additional stress on the trunk or back.

High-intensity focused electromagnetic technology induces a rapidly changing magnetic field that triggers supramaximal abdominal muscle contractions, not achievable voluntarily. In response, the abdominal muscles grow and strengthen, which lead to a tighter abdomen; thus, increasing the strength and the contour of the abdominal muscles.

To date, few investigations have been conducted to evaluate the effects of high-intensity focused electromagnetic field on changes in the abdominal subcutaneous fat, thickness and separation. But, till now there is no previous study investigated its effect on diastasis recti in postnatal women. Hence, the present study will be conducted to examine the effect of high-intensity focused electromagnetic field on diastasis recti in postnatal women which is anticipated to offer significant benefits to medical service organizations and contribute to the expanding knowledge base of physical therapists in the scientific domain.

Вмешательства

• Другое A program of abdominal exercises
  All women in both groups will be adhered to a program of abdominal strengthening exercise that includes static abdominal, abdominal crunch, and external oblique exercises. Each exercise will be repeated 15 times and will be increased by five repetitions each week throughout the study period, with total time of 20 minutes/ session, 3 times weekly for 8 weeks.
• Устройство High-intensity focused electromagnetic field
  High-intensity focused electromagnetic field will be administered only to the experimental group, targeting the abdominal region for 30 minutes per session, twice weekly for 8 weeks. Sessions will be performed in the supine position, with the applicator centered over the umbilicus and secured to prevent movement. Stimulation intensity will start at 0% and be gradually increased to achieve strong yet tolerable muscle contractions, guided by continuous visual monitoring and patient feedback to ens

Первичные конечные точки

• Inter-recti distance (IRD) 3 cm above the umbilicus [Срок оценки: 8 weeks]
• Inter-recti distance at the level of the umbilicus [Срок оценки: 8 weeks]
• Inter-recti distance 3 cm below the umbilicus [Срок оценки: 8 weeks]
• Right rectus abdominis muscle thickness [Срок оценки: 8 weeks]
• Left rectus abdominis muscle thickness [Срок оценки: 8 weeks]
• Right external oblique muscle thickness [Срок оценки: 8 weeks]
• Left external oblique muscle thickness [Срок оценки: 8 weeks]

Вторичные конечные точки (2)

• one-minute sit-up test [Срок оценки: 8 weeks]
• Inventory of Functional Status After Childbirth (IFSAC) questionnaire [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• Postnatal women (6 months after delivery) having diastasis recti (separation between the two recti more than 2.5cm at the level of umbilicus) diagnosed and referred from the obstetrician.
• Multiparous women (2-3) times delivered vaginally with or without episiotomy.
• Their ages will range from 25 -35 years old.
• Their BMI will be less than 30 kg/cm2.
• All women will be of sedentary lifestyle.
• They will be clinically and medically stable when attending the study.

Критерии исключения

• Cardiac disorders.
• Active cancer.
• Medical condition contraindicating the application of an electromagnetic field as epilepsy or having metal implants
• Abdominal or back surgery.
• Abdominal hernia.
• History of abnormal pregnancy, uterine fibroid or polyhydramnios during pregnancy.
• Neurological disorders as multiple sclerosis, stroke and spinal lesion.
• Musculoskeletal diseases such as fractures and muscle strains which may affect their physical activity.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07442487 · P.T.REC/012/005282

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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