NCT05111483

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

11 months

First QC Date

October 27, 2021

Last Update Submit

December 7, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • Inter-recti distance

    through vernier caliper distance will be measured the distance between 2 arms can be checked.

    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"

    6 months

Study Arms (2)

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

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

Other: conventional therapy

Interventions

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

Tupler's technique

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

conventional therapy

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailscondition happens only in females.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 20-40 years
  • Both Primiparous and Multiparous women
  • Diastasis recti more than 2.5cm within 6 weeks or more postpartum

You may not qualify if:

  • Neurological signs, specific spinal pathology (e.g. disc lesions, malignancy, or inflammatory disease) or any other major medical pathology.
  • Any complication during pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahore General Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (3)

  • 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.

    PMID: 29512814BACKGROUND
  • 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.

    PMID: 30839304BACKGROUND
  • 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.

    PMID: 25282439BACKGROUND

Study Officials

  • Rabiya Noor, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2021

First Posted

November 8, 2021

Study Start

August 30, 2021

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

December 8, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations