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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diastasis Recti Abdominis
• Intervention / Treatment: Device: Surface EMG Biofeedback

Detailed Description

This study is a Randomized Control Trial in which posr-partum females with diastasis recti will be recruited into a control and two experimental groups. In control group, patients will receive standard conservative treatment, whereas, in first experimental group, participants will receive core strengthening exercises with kinesiotaping; and in second experimental group, core strengthening exercises with kinesiotaping will be assisted by SEMG biofeedback. Patients will be evaluated pre and post-treatment for Inter rectus distance, abdominal strength and quality of life.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Federal
    • Islamabad, Federal, Pakistan, 46000
      • Foundation University Islamabad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; 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; 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.
Experimental: Experimental Group A; 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; 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.
Experimental: Experimental Group B; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal Strength and core stability will be assessed by Mc Gill torso muscular endurance test battery.	The abdominal strength will be assessed by Mc Gill torso muscular endurance battery test. it consists of three endurance tests: trunk flexor, trunk lateral and trunk extensor endurance test. if holding time of these tests is more than 120 sec, core stability is interpreted as excellent.	6 weeks
Quality of life will be measured by SF-36	Short-Form Health Survey (SF36) will be used to measure quality of life. It includes physical function, physical pain, general health status, energy, social function, emotional function, mental health, and indicators of health changes. scores range from 0-100. the lower the score the more disability. the higher the score the less disability.	6 weeks

Collaborators and Investigators

• Sponsor: Foundation University Islamabad
• Investigators: Principal Investigator: Ujala Afzal, Foundation University Islamabad

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2022
• Primary Completion (Estimated): June 30, 2023
• Study Completion (Estimated): June 30, 2023

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations; Diastasis, Muscle
• Other Study ID Numbers: FUI/CTR/2023/7

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No