NCT06909448

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 3, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

April 6, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2025

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 27, 2025

Last Update Submit

March 27, 2025

Conditions

Keywords

Diastasis recti, radiofrequency therapy, physical exercises, postpartum

Outcome Measures

Primary Outcomes (3)

  • Ultrasound

    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).

    14 week

  • trunk flexors strength and endurance

    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

    14 week

  • Assessment of functional status

    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.

    14 week

Study Arms (2)

control group

ACTIVE COMPARATOR

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

Device: abdominal belt

study group

ACTIVE COMPARATOR

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

Device: abdominal beltDevice: TECAR therapy

Interventions

40 postpartum women will only wear abdominal belt for 14 weeks.

control groupstudy group

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

study group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. 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. 4. Their BMI will be less than 30 kg/cm2.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Mohamed Gamil Omar, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

March 27, 2025

First Posted

April 3, 2025

Study Start

April 6, 2025

Primary Completion

July 7, 2025

Study Completion

August 1, 2025

Last Updated

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share