Effects of Tupler's Technique on Postpartum Diastasis Recti and Strength Recovery of Abdominal Muscles

• ClinicalTrials.gov Identifier: NCT05111483
• Recruitment Status: Completed
• First Posted: November 8, 2021
• Last Update Posted: December 8, 2022
• Sponsor: Riphah International University
• Information provided by (Responsible Party): Riphah International University

Tracking Information

• First Submitted Date: October 27, 2021
• First Posted Date: November 8, 2021
• Last Update Posted Date: December 8, 2022
• Actual Study Start Date: August 30, 2021
• Actual Primary Completion Date: July 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 14, 2022)

• 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"

Original Primary Outcome Measures (submitted: October 27, 2021)

• 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.
• Function [ 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

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Tupler's Technique on Postpartum Diastasis Recti and Strength Recovery of Abdominal Muscles
• Official Title: Effects of Tupler's Technique on Postpartum Diastasis Recti and Strength Recovery of Abdominal Muscles

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Diastasis Recti

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.

  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: conventional therapy

  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

Study Arms

• 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.

  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
  Intervention: Other: Tupler technique
• Experimental: conventional therapy

  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
  Intervention: Other: conventional therapy

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 27, 2021): 34
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 31, 2022
• Actual Primary Completion Date: July 31, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: condition happens only in females.

• Ages: 20 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Pakistan

Administrative Information

• NCT Number: NCT05111483
• Other Study ID Numbers: REC/RCR&AHS/21/0509
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Riphah International University
• Original Responsible Party: Rabiya Noor, Riphah International University, Associate Professor
• Current Study Sponsor: Riphah International University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Rabiya Noor, PhD; Riphah International University

• PRS Account: Riphah International University
• Verification Date: December 2022