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

NCT ID: NCT05897255

Last Updated: 2023-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-11
• Study Completion Date: 2023-06-30

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.

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.

Conditions

Diastasis Recti Abdominis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Surface EMG Biofeedback

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Surface EMG Biofeedback

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Surface EMG Biofeedback

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Foundation University Islamabad

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ujala Afzal

Role: PRINCIPAL_INVESTIGATOR

Foundation University Islamabad

Locations

Foundation University Islamabad

Islamabad, Federal, Pakistan

Countries

Pakistan

Other Identifiers

FUI/CTR/2023/7

Identifier Type: -

Identifier Source: org_study_id