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

Diastasis Recti Abdominis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05897255
• Other study ID #: FUI/CTR/2023/7
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 11, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2023
• Source: Foundation University Islamabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diastasis Recti Abdominis
• Diastasis, Muscle

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Foundation University Islamabad	Islamabad	Federal

Sponsors (1)

Lead Sponsor	Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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