Diastasis Recti AbdominisNCT05897255
Effects of SEMG Biofeedback With Core Muscle Strengthening Exercises and Kinesiotaping on Diastasis Recti in Post-partum Women
A study testing Surface EMG Biofeedback in people with Diastasis Recti Abdominis, run by Foundation University Islamabad at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Diastasis Recti Abdominis
- What is being tested?
- Surface EMG Biofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Aug 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Surface EMG Biofeedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface EMG BiofeedbackDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Surface EMG Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start11 Aug 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastasis Recti AbdominisStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Group Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ujala Afzal, Principal investigator, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897255
- Sponsor's protocol ID
- FUI/CTR/2023/7
- Status last verified
- May 2023
- First submitted
- 31 May 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of SEMG Biofeedback With Core Muscle Strengthening Exercises and Kinesiotaping on Diastasis Recti in Post-partum Women
- ClinicalTrials.gov ID
- NCT05897255
- Acronym / sponsor ID
- FUI/CTR/2023/7
- Conditions
- Diastasis Recti Abdominis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Parallel Group Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Device: Surface EMG BiofeedbackIn 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. |
| Experimental Group A | Experimental | Device: Surface EMG BiofeedbackIn 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. |
| Experimental Group B | Experimental | Device: Surface EMG BiofeedbackIn 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Having skin sensitivity to taping
- Open abdominal wounds
- Abdominal skin diseases
- Abdominal hernia
- Other abdominal or back surgical history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surface EMG BiofeedbackSurface 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. | Device | Control Group, Experimental Group A, Experimental Group B |
Primary outcome
Inter Rectus Distance between rectus abdominis muscles.
Time frame: 6 weeks
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.
2 secondary outcomes
Abdominal Strength and core stability will be assessed by Mc Gill torso muscular endurance test battery.
Time frame: 6 weeks
Quality of life will be measured by SF-36
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ujala Afzal principal investigator
Foundation University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surface EMG Biofeedback in people with Diastasis Recti Abdominis, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter Rectus Distance between rectus abdominis muscles. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.