- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05111483
Effects of Tupler's Technique on Postpartum Diastasis Recti and Strength Recovery of Abdominal Muscles
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Lahore General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged between 20-40 years
- Both Primiparous and Multiparous women
- Diastasis recti more than 2.5cm within 6 weeks or more postpartum
Exclusion Criteria:
- Neurological signs, specific spinal pathology (e.g. disc lesions, malignancy, or inflammatory disease) or any other major medical pathology.
- Any complication during pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Tupler's technique
The subjects with DRA will receive Tupler's technique treatment plan for 18 weeks in which four steps will be followed.
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The subjects with DRA will receive Tupler's technique treatment plan for 18 weeks in which four steps will be followed.
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Experimental: conventional therapy
The subjects with DRA will receive conventional physical therapy treatment for 16 weeks in which researcher will follow these steps:
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The subjects with DRA will receive conventional physical therapy treatment for 16 weeks in which researcher will follow these steps:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
strength of muscle
Time Frame: 6 months
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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.
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6 months
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Inter-recti distance
Time Frame: 6 months
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through vernier caliper distance will be measured the distance between 2 arms can be checked.
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6 months
|
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Patient Specific Functional Scale
Time Frame: 6 months
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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" |
6 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Thabet 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.
- Fernandes 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/21/0509
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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