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临床试验/NCT06909448
NCT06909448尚未招募不适用

Effect of Capacitive and Resistive Radiofrequency on Postpartum Diastasis Recti

Cairo University0 个研究点目标入组 80 人开始时间: 2025年4月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
Ultrasound

研究概览

简要总结

To evaluate the effect of capacitive and resistive radiofrequency on postpartum rectus abdominis diastasis.

详细描述

Eighty females postpartum with rectus diastasis will be included in this study; they will be recruited the outpatient clinic at El Mahalla Al Kobra (The first author's pervious workplace) and will be referred by obstetric and genecology physicians. Patients will be assigned into two groups.

Group A: It will include 40 patients participating in abdominal belt. Group B: It will include 40 patients participating in abdominal belt plus TECAR therapy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Postpartum women (7 days after delivery) having diastasis recti (separation between the two recti more than 2.5cm at the level of umbilicus).
  • •Multiparous women (2-3) times delivered vaginally with or without episiotomy.
  • •Their age will be ranged from 20 -35 years old.
  • •Their BMI will be less than 30 kg/cm2.

排除标准

  • •Any participant will be excluded if she meets one or more of the following criteria:
  • •Postpartum women will be excluded from the study if they have:
  • •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 muscle strains, severe knee osteoarthritis which may affect their physical activity.

研究组 & 干预措施

control group

Active Comparator

It will be consisted of 40 postpartum women who will only wear abdominal belt for 14 weeks.

干预措施: abdominal belt (Device)

study group

Active Comparator

will wear the same abdominal belt for 6 weeks then participating in TECAR therapy 3 sessions /week for 8 weeks.

干预措施: abdominal belt (Device)

study group

Active Comparator

will wear the same abdominal belt for 6 weeks then participating in TECAR therapy 3 sessions /week for 8 weeks.

干预措施: TECAR therapy (Device)

结局指标

主要结局

Ultrasound

时间窗: 14 week

The distance between the recti muscles at 3 levels will be measured at the beginning and again at the end of the study duration, i.e., 8 weeks. The desired measurement locations will be marked with a water-soluble pen: 4.5 cm above the umbilicus, at the midpoint, and 4.5 cm below the umbilicus. The measurements will be performed at rest and during contraction. Each woman will be asked to lie in a crock lying position, crossing the arms over the chest and raising the head until the spine of the scapulae will be off the table surface. The women will maintain a partial curl-up while the examiner palpates the medial borders of the right and left rectus abdominis muscle bellies at the marked location. With the linear transducer, it will be positioned transversely along the linea alba in the direction of the muscles and adjusted to perceived inert recti distance width. Three trials will be taken for each assessment, and the mean will be recorded. (Khandale \& Hande, 2016).

trunk flexors strength and endurance

时间窗: 14 week

Trunk flexion strength will be graded from zero to five using Daniels and Worthingham's procedure (Hislop et al., 2013) as follows: Grades: (Hislop et al., 2013). Grade 5 (Normal) Patient complete ROM until inferior angle of the scapulae are off table (weight of arms serves as resistance). Grade 4 (Good) Patient complete ROM until inferior angle of the scapulae are off table. Resistance of arms is reduced in the cross-chest position. Grade 3 (Fair) Patient complete ROM and lifts trunk until inferior angle of the scapulae are off table with arms at side. Grade 2 (Poor) Patient is unable to clear the inferior angle of the scapula from the table Grade 1 (Trace) No depression of the rib cage but visible or palpable contraction occurs. Grade 0 (Zero) No activity Patient Positioning: Grade 5 (Normal): Supine with fingertips lightly touching the back of the head. For grade 4: Supine with arms crossed over chest. For grade 3: Supine with arms at side. For grade 0 to 2: Supine with arms at

Assessment of functional status

时间窗: 14 week

All participating women with diastasis recti in both groups (A\&B) will be asked to fill the Inventory of functional status after childbirth questionnaire before and after the end of the study program.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Gamil Omar

assistant lecturer

Cairo University

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