Diastasis RectiNCT05111483
Effects of Tupler's Technique on Postpartum Diastasis Recti and Strength Recovery of Abdominal Muscles
A study testing Tupler technique and conventional therapy in people with Diastasis Recti, run by Riphah International University at 1 site in Pakistan.
Trial summary
Diastasis rectus is the separation of the muscles along the midline of the abdomen, typically as seen in women after pregnancy. Separation is mostly larger than 2cm width at above, below or level of umbilicus. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Diastasis Recti
- What is being tested?
- Tupler technique and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Aug 2021to 31 Jul 2022
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 20-40 years
- Both Primiparous and Multiparous women
- Diastasis recti more than 2.5cm within 6 weeks or more postpartum
Who cannot join
- Neurological signs, specific spinal pathology (e.g. disc lesions, malignancy, or inflammatory disease) or any other major medical pathology.
- Any complication during pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Diastasis rectus is the separation of the muscles along the midline of the abdomen, typically as seen in women after pregnancy. Separation is mostly larger than 2cm width at above, below or level of umbilicus. With this muscular pathology women do not feel any pain symptom just perceiving symptoms of physical discomfort, abdomen muscle weakness and its bulging. Excess weight of mother or baby and multiple birth pregnancy is the common risk factor for the DRA. Various tools will be used for the diagnosis of DRA such as vernier caliper by using centimeter ruler, diagnostic ultrasonography that give the exact measurement, pressure biofeedback unit which is used to assess the strength of weak muscles, and patient specific functional scale that used to determine the functional limitation and its improvement.
To treat the DRA conservatively, Tupler's technique and conventional physical therapy will be directed. Electrical muscular stimulations will also be given as a baseline before applying both treatments. In Tupler's technique, diastasis rehab splint and Tupler's exercises will be used whereas in conservative physical therapy, scarf tie around abdomen while performing exercises, Respiratory rehabilitation manoeuvre and abdominal muscle exercises will be used. The aim of the study is to find the the effects of Tupler's technique and conventional physical therapy treatment for abdominal muscle strength regaining and in reducing the diastasis recti among females with diastasis recti after their postpartum period. It is a Randomized clinical trial and convenient random sampling is to be used with an inclusion criterion of patients having age between 20-40 years, Both primiparous and multiparous women and Diastasis recti more than 2.5cm within 6 weeks or more postpartum. Patients will be randomly allocated into two groups, Group A will receive Tupler's technique and Group B will receive conventional physical therapy intervention. Total duration of study will be six months. Assessment will be done before and after the treatment. Pressure biofeedback unit, vernier caliper, ultrasound and patient specific functional scale are to be used to measure the outcomes. Data will be assessed by using parametric/non parametric test after completion of study.
- Conditions
- Diastasis Recti
- Being tested
- Tupler technique, conventional therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tupler techniqueOther
The subjects with DRA will receive Tupler's technique treatment plan for 18 weeks in which four steps will be followed.
- Repositioning with diastasis rehab splint :
- Protect the connective tissue
- Tupler's technique exercises (elevators, contractions, standing pelvic tilt, head lifts, leg slides, low back stretch) with 10 repetitions for each exercise.
- Diastasis safe exercises program to maintain the gains
conventional therapyOther
The subjects with DRA will receive conventional physical therapy treatment for 16 weeks in which researcher will follow these steps:
- Tie a scarf around abdomen while performing exercises
- Exercise program for diastasis recti abdominal muscles; sit ups, reverse sit ups, reverse trunk twist and U-seat exercises. (10 repetitions for each exercise)
- Respiratory rehabilitation manoeuvre
| Study group | Role | What they receive |
|---|---|---|
| Tupler's technique | Experimental | The subjects with DRA will receive Tupler's technique treatment plan for 18 weeks in which four steps will be followed.
1. Repositioning with diastasis rehab splint :
2. Protect the connective tissue
3. Tupler's technique exercises (elevators, contractions, standing pelvic tilt, head lifts, leg slides, low back stretch) with 10 repetitions for each exercise.
4. Diastasis safe exercises program to maintain the gains Receives: Other: Tupler technique |
| conventional therapy | Experimental | The subjects with DRA will receive conventional physical therapy treatment for 16 weeks in which researcher will follow these steps:
1. Tie a scarf around abdomen while performing exercises
2. Exercise program for diastasis recti abdominal muscles; sit ups, reverse sit ups, reverse trunk twist and U-seat exercises. (10 repetitions for each exercise)
3. Respiratory rehabilitation manoeuvre Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
strength of muscle
Pressure biofeedback is a tool designed to facilitate muscle re-education by detecting movement of the lumbar spine associated with a deep abdominal contraction in relation to an air-filled reservoir. gauge is attached increase in pressure tell more strength.
Measured: 6 months
Inter-recti distance
through vernier caliper distance will be measured the distance between 2 arms can be checked.
Measured: 6 months
Patient Specific Functional Scale
Patient Specific Functional Scale was developed by Stratford et al 1995 as a self-report outcome measure of function that could be used in patients with varying levels of independence. Scale is from 0 - 10.
In Which "0" represents "unable to perform" and "10" represents "able to perform at prior level"
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start30 Aug 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diastasis RectiStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabiya Noor, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111483
- Sponsor's protocol ID
- REC/RCR&AHS/21/0509
- Status last verified
- Dec 2022
- First submitted
- 27 Oct 2021
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Michalska A, Rokita W, Wolder D, Pogorzelska J, Kaczmarczyk K. Diastasis recti abdominis - a review of treatment methods. Ginekol Pol. 2018;89(2):97-101. doi: 10.5603/GP.a2018.0016.
PubMed 29512814Thabet AA, Alshehri MA. Efficacy of deep core stability exercise program in postpartum women with diastasis recti abdominis: a randomised controlled trial. J Musculoskelet Neuronal Interact. 2019 Mar 1;19(1):62-68.
PubMed 30839304Fernandes da Mota PG, Pascoal AG, Carita AI, Bo K. Prevalence and risk factors of diastasis recti abdominis from late pregnancy to 6 months postpartum, and relationship with lumbo-pelvic pain. Man Ther. 2015 Feb;20(1):200-5. doi: 10.1016/j.math.2014.09.002. Epub 2014 Sep 19.
PubMed 25282439
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tupler's Technique on Postpartum Diastasis Recti and Strength Recovery of Abdominal Muscles
- ClinicalTrials.gov ID
- NCT05111483
- Acronym / sponsor ID
- REC/RCR&AHS/21/0509
- Conditions
- Diastasis Recti
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 8 Nov 2021 (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 is the separation of the muscles along the midline of the abdomen, typically as seen in women after pregnancy. Separation is mostly larger than 2cm width at above, below or level of umbilicus. With this muscular pathology women do not feel any pain symptom just perceiving symptoms of physical discomfort, abdomen muscle weakness and its bulging. Excess weight of mother or baby and multiple birth pregnancy is the common risk factor for the DRA. Various tools will be used for the diagnosis of DRA such as vernier caliper by using centimeter ruler, diagnostic ultrasonography that give the exact measurement, pressure biofeedback unit which is used to assess the strength of weak muscles, and patient specific functional scale that used to determine the functional limitation and its improvement.
To treat the DRA conservatively, Tupler's technique and conventional physical therapy will be directed. Electrical muscular stimulations will also be given as a baseline before applying both treatments. In Tupler's technique, diastasis rehab splint and Tupler's exercises will be used whereas in conservative physical therapy, scarf tie around abdomen while performing exercises, Respiratory rehabilitation manoeuvre and abdominal muscle exercises will be used. The aim of the study is to find the the effects of Tupler's technique and conventional physical therapy treatment for abdominal muscle strength regaining and in reducing the diastasis recti among females with diastasis recti after their postpartum period. It is a Randomized clinical trial and convenient random sampling is to be used with an inclusion criterion of patients having age between 20-40 years, Both primiparous and multiparous women and Diastasis recti more than 2.5cm within 6 weeks or more postpartum. Patients will be randomly allocated into two groups, Group A will receive Tupler's technique and Group B will receive conventional physical therapy intervention. Total duration of study will be six months. Assessment will be done before and after the treatment. Pressure biofeedback unit, vernier caliper, ultrasound and patient specific functional scale are to be used to measure the outcomes. Data will be assessed by using parametric/non parametric test after completion of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tupler's technique | Experimental | Other: Tupler techniqueThe subjects with DRA will receive Tupler's technique treatment plan for 18 weeks in which four steps will be followed. 1. Repositioning with diastasis rehab splint : 2. Protect the connective tissue 3. Tupler's technique exercises (elevators, contractions, standing pelvic tilt, head lifts, leg slides, low back stretch) with 10 repetitions for each exercise. 4. Diastasis safe exercises program to maintain the gains |
| conventional therapy | Experimental | Other: conventional therapyThe subjects with DRA will receive conventional physical therapy treatment for 16 weeks in which researcher will follow these steps: 1. Tie a scarf around abdomen while performing exercises 2. Exercise program for diastasis recti abdominal muscles; sit ups, reverse sit ups, reverse trunk twist and U-seat exercises. (10 repetitions for each exercise) 3. Respiratory rehabilitation manoeuvre |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged between 20-40 years
- Both Primiparous and Multiparous women
- Diastasis recti more than 2.5cm within 6 weeks or more postpartum
Key exclusion criteria (2 listed)
- Neurological signs, specific spinal pathology (e.g. disc lesions, malignancy, or inflammatory disease) or any other major medical pathology.
- Any complication during pregnancy
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 |
|---|---|---|
| Tupler techniqueThe subjects with DRA will receive Tupler's technique treatment plan for 18 weeks in which four steps will be followed. 1. Repositioning with diastasis rehab splint : 2. Protect the connective tissue 3. Tupler's technique exercises (elevators, contractions, standing pelvic tilt, head lifts, leg slides, low back stretch) with 10 repetitions for each exercise. 4. Diastasis safe exercises program to maintain the gains | Other | Tupler's technique |
| conventional therapyThe subjects with DRA will receive conventional physical therapy treatment for 16 weeks in which researcher will follow these steps: 1. Tie a scarf around abdomen while performing exercises 2. Exercise program for diastasis recti abdominal muscles; sit ups, reverse sit ups, reverse trunk twist and U-seat exercises. (10 repetitions for each exercise) 3. Respiratory rehabilitation manoeuvre | Other | conventional therapy |
Primary outcome
strength of muscle
Time frame: 6 months
Pressure biofeedback is a tool designed to facilitate muscle re-education by detecting movement of the lumbar spine associated with a deep abdominal contraction in relation to an air-filled reservoir. gauge is attached increase in pressure tell more strength.
Inter-recti distance
Time frame: 6 months
through vernier caliper distance will be measured the distance between 2 arms can be checked.
Patient Specific Functional Scale
Time frame: 6 months
Patient Specific Functional Scale was developed by Stratford et al 1995 as a self-report outcome measure of function that could be used in patients with varying levels of independence. Scale is from 0 - 10. In Which "0" represents "unable to perform" and "10" represents "able to perform at prior level"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Background: PubMed 29512814Michalska A, Rokita W, Wolder D, Pogorzelska J, Kaczmarczyk K. Diastasis recti abdominis - a review of treatment methods. Ginekol Pol. 2018;89(2):97-101. doi: 10.5603/GP.a2018.0016.
- Background: PubMed 30839304Thabet AA, Alshehri MA. Efficacy of deep core stability exercise program in postpartum women with diastasis recti abdominis: a randomised controlled trial. J Musculoskelet Neuronal Interact. 2019 Mar 1;19(1):62-68.
- Background: PubMed 25282439Fernandes da Mota PG, Pascoal AG, Carita AI, Bo K. Prevalence and risk factors of diastasis recti abdominis from late pregnancy to 6 months postpartum, and relationship with lumbo-pelvic pain. Man Ther. 2015 Feb;20(1):200-5. doi: 10.1016/j.math.2014.09.002. Epub 2014 Sep 19.
- Individual participant dataSharing planned: No
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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.
Rabiya Noor, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tupler technique and conventional therapy in people with Diastasis Recti, run by Riphah International University 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 8 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
strength of muscle (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05111483, which also lists 3 linked publications.
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 8 Dec 2022.