Effects of SEMG Biofeedback With Core Muscle Strengthening Exercises and Kinesiotaping on Diastasis Recti in Post-partum Women

NCT05897255 | Unknown

• 1 other identifier: FUI/CTR/2023/7
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Diastasis Rectus Abdominis is quite common during and after pregnancy. Abdominal core strengthening exercises have been proven to be very effective in reducing Inter rectus distance, however, the role of Biofeedback EMG assisted exercises in Diastasis Rectus have been poorly understood.

Conditions

Diastasis Recti Abdominis

Outcome Measures

Primary Outcomes (1)

• Inter Rectus Distance between rectus abdominis muscles.

  We will measure the inter rectus distance by mechanical dial vernier caliper. It normally ranges between1 to 2cm at rest. Measurement of more than 2cm will confirm presence of diastasis rectus abdominis. IRD will be measured by instructing the patient to lie in hook line position, arms down by the side, with one pillow placed beneath the head. The examiner will palpate the medial and lateral borders of the right and left rectus abdominis muscle bellies at the marked locations of 2 cm above, below and at umbilicus levels.

  6 weeks

Secondary Outcomes (2)

• Abdominal Strength and core stability will be assessed by Mc Gill torso muscular endurance test battery.

  6 weeks

• Quality of life will be measured by SF-36

  6 weeks

Study Arms (3)

Control Group

ACTIVE COMPARATOR

In Control group, conventional method to reduce diastasis recti will be provided. Commonly used exercises in the treatment of DRA including abdominal hollowing, curl-ups, sit-ups, pelvic bridging, SLR will be performed by the patients. The conventional exercise program will be given 3days/week for 6 weeks and will include 2 sets of 5 reps of each exercise.

Device: Surface EMG Biofeedback

Experimental Group A

EXPERIMENTAL

In experimental group A, Kinesiotape along with core strengthening exercises will be provided. The core strengthening exercise program will be given 45 minutes of session 3days/week for 6 weeks. Each exercise will have 5-10 repetitions with a period of rest in between to avoid fatigue and muscle spasm.

Device: Surface EMG Biofeedback

Experimental Group B

EXPERIMENTAL

In experimental group B, SEMG biofeedback assisted core strengthening exercises with kinesiotaping will be provided. Surface EMG activity will be recorded from the left and right abdominal muscles while the exercises will be performed in different positions.

Device: Surface EMG Biofeedback

Interventions

Surface EMG Biofeedback DEVICE

Surface EMG activity will be recorded from the left and right abdominal muscles while the exercises will be performed in different positions. Electrical signals in the muscle are measured and displayed on the screen and are amplified into sounds that the patient can hear. This feedback increases patient effort and participation and provides the data and documentation required to measure patient outcomes and quantify progress. Electrical activity from Rectus Abdominis muscle, External Oblique muscle and Transversus Abdominis muscle will be recorded with their specific exercises. SEMG Biofeedback protocol of a series of ten second contractions, each contraction preceded by a ten second rest period will be followed. Starting with shorter work/rest periods as needed to build-up to these intervals are acceptable; for example, starting with 3-second contractions and 6-second rest periods, and then gradually increasing the duration of each.

Control Group; Experimental Group A; Experimental Group B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Post-partum women aged 18-40 years
• Post-partum females from 6 to 24 months
• Diastasis rectus abdominus distance more than 2cm at any of 3 levels
• Primiparous or multiparous
• Spontaneous vaginal delivery and LSCS

You may not qualify if:

• Having skin sensitivity to taping
• Open abdominal wounds
• Abdominal skin diseases
• Abdominal hernia
• Other abdominal or back surgical history
• Any heart or respiratory conditions
• Neurological diseases

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University Islamabad

Islamabad, Federal, 46000, Pakistan

Location

Study Officials

• Ujala Afzal

  Foundation University Islamabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unaware of the type of the intervention they would be receiving.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Group Randomized Control Trial

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 9, 2023
• Study Start: August 11, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: June 9, 2023

Record last verified: 2023-05

Locations

PA (1)