NCT06530589

Brief Summary

Diastasis Rectus Abdominis is the condition in which two abdominal muscles rectus abdominis separated and cause widening and thinning of Linea alba. The Tupler's Technique is Evidence Based intervention for the management of Diastasis Rectus Abdominis. The purpose of this study is to see the Effectiveness of Tupler's Technique on the Management of Diastasis Rectus Abdomins in Post-Partum Females.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

July 28, 2024

Last Update Submit

February 20, 2025

Conditions

Keywords

Diastasis Rectus AbdominisPost-Partum PeriodTupler's TechniqueAbdominal Strength

Outcome Measures

Primary Outcomes (4)

  • Digital nylon caliper to measure inter-recti Distance

    Digital nylon caliper is the valid and reliable instrument to measure the inter-recti distance and inter-recti distance will be measured at three levels. at the level of umbilicus, 4.5cm above umbilicus and 4.5cm below umbilicus.

    Before intervention, after 3 weeks and after 6 weeks.

  • Oswestry low bac pain disability Questionnaire

    This is a valid tool to assess back pain and this questionnaire has 10 sections and we grade level of disability according to grading criteria. 0-4shows no disability, 5-14 shows mild disability, and 15-24 shows moderate disability, and 25-34 shows severe disability and grade 35-50 means completely disabled.

    Before intervention, after 3 weeks and after 6 weeks.

  • Numeric Pain rating scale

    By using this scale we will measure the intensity of back pain. i scores pain from 0-10. 0 means no pain, 5 means moderate pain and 10 means severe pain.

    Before intervention, after 3 weeks and after 6 weeks.

  • Maternal post-partum quality of life instrument (MPQOL-I)

    This questionnaire has 5 domains. psychological, reltion with family and friends, relation with spouse, socioeconomic and health related domain and we can assess every domain of female life.

    Before intervention, after 3 weeks and after 6 weeks.

Study Arms (2)

Interventional Group

EXPERIMENTAL

Tupler's Technique will be applied to this group. This technique includes Tupler's technique exercises and patients will also wears diastasis rehab splints. Patients will perform seated isometric exercises (elevator and contracting exercises) after wearing diastasis rehab splint. Repetitions of exercises will be 100 and whole intervention will be provided for 6 weeks.

Other: Tupler's Technique

Control Group

ACTIVE COMPARATOR

Traditional treatment protocol will be applied to this group that includes traditional exercises for diastasis rectus abdominis and this protocol will be followed 3 times per week for 6 weeks.

Other: Traditional Exercises

Interventions

Patient will wear diastasis rehab splint and will follow Tupler's techniqe protocol for 6 weeks. In the first 2 weeks both elevator and contracting exercises will be performed and after 2 weeks in the 3rd week only contracting exercises will be perform and for these exercises we divide abdomen into 6 floors and will patient have to contract her tummy towards the 3rd to 5th floor in first week, towards the 4th to 5th floor in 2nd week and from 5th to 6th floor in the 3rd week. in the wek 4 to week 6 head lifts will also be started along with contracting exercises from 5th to 6th floor.

Interventional Group

The traditional treatment includes traditional abdominal exercises that patient will be perform for 6 weeks and three times per week with 15 repetitions of each exercise. These exercises includes posterior pelvic tilt' static abdominal contractions', reverse sit up exercise, kegals, russian twist , trunk twist and reverse trunk twist.

Control Group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Primiparous and multiparous females (Vaginal delivery).
  • Greater than and equal to 12 weeks post-partum
  • Age limit will be18-30 years
  • BMI under or equa to 29kg/m2
  • Visiting with the complain of low back pain
  • Diastasis of rectus abdominis at the level of umbilicus with mild, moderate and severe condition.

You may not qualify if:

  • Other musculoskeletal disease (disc prolapse and disc bulge)
  • Trauma of bowel and bladder
  • Heart and respiratory conditions including sneezing and excessive coughing
  • Any pelvic floor, abdominal and spinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Allied Hospital Faisalabad

Faisalābad, Punjab Province, 38000, Pakistan

Location

Madinah Teaching Hospital Faisalabad

Faisalābad, Punjab Province, 38000, Pakistan

Location

Study Officials

  • Huma Riaz, PhD

    Riphah International University, Islamabad, Pakistan

    STUDY CHAIR
  • Aqsa Shahid, MSPT*

    Riphah International University, Islamabad, Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There will be comparison between two groups, experimental and control
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2024

First Posted

July 31, 2024

Study Start

August 1, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 21, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations