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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05111483
Other study ID # REC/RCR&AHS/21/0509
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 30, 2021
Est. completion date July 31, 2022

Study information

Verified date December 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date July 31, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Tupler technique
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 therapy
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

Locations

Country Name City State
Pakistan Lahore General Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months
Primary Inter-recti distance through vernier caliper distance will be measured the distance between 2 arms can be checked. 6 months
Primary 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"
6 months
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