- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04181554
Postural Stability, Pelvic Floor Dysfunction, Respiratory Muscle Strength in Post-partum Women With Diastasis Recti
March 12, 2021 updated by: Hilal Denizoğlu Külli, Bezmialem Vakif University
The Effect of Diastasis Recti on Postural Stability, Pelvic Floor Dysfunction and Respiratory Muscle Strength in Post-partum Women
The aim of this study is to determine the effect of inter-rectus distance on postural stability, pelvic floor dysfunction and respiratory muscle strength in women with diastasis recti abdominis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Diastasis of recti abdominis muscles (DRAM) is defined as a separation of the two rectus abdominis muscles along the linea alba.
Increased volume in the abdominal cavity, hormonal changes during pregnancy, neurodevelopmental differences, or abdominal wall laxity may caused.
It is very common during pregnancy and may continue for eight weeks in postnatal period.
The loss of abdominal wall stability and weakened pelvic floor muscles may occur with DRAM.
The abdominal wall is one of the key point for body posture, trunk and pelvic stability.
However, in our best knowledge, there is no study in the literature that evaluates women with and without DRA in terms of components related to postural control systems.
Study Type
Observational
Enrollment (Actual)
51
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey
- Bezmialem Vakıf University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
The post-partum women with diastasis recti abdominis will be enrolled to the study.
Description
Inclusion Criteria:
- Post- partum women (min 8 weeks - max 5 years)
Exclusion Criteria:
- Having a neurological, orthopedical or any other condition which affect postural stability.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
DRAM group
The post-partum women with DRAM
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The postural stability will assess by using Biodex balance system.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Limits of stability test score
Time Frame: 5 minutes
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'Limits of Stability Test' will be performed using Biodex Balance System®.
Subjects will stand on the platform and try to reach in eight directions spot that shown on the screen.
The test results present scores for all eight directions and an overall score.
Lower scores show worse performance (0= worst performance; 100= perfect performance)
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5 minutes
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Sensory integration test score
Time Frame: 6 minutes
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'Sensory integration test' will be performed using Biodex Balance System®.
Volunteers will stand still on the platform in condition eyes open and closed on the firm and soft (foam) surfaces.
The test scores are sway index for each condition and a composite score.
Lower scores present better postural stability.
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6 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory muscle strength
Time Frame: 5 minutes
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Inspiratory and expiratory muscle strength has been assessed by maximal inspiratory and expiratory mouth pressures.
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5 minutes
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Abdominal Muscle Endurance
Time Frame: 3 minutes
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Volunteers will be asked to perform curl up position as long as possible.
The duration time will be measured until a maximum 180 seconds.
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3 minutes
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Pelvic floor dysfunction
Time Frame: 5 minutes
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Pelvic floor dysfunction will be assessed using "Pelvic Floor Distress Inventory".
Lower scores show better pelvic floor functions.
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5 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hilal Denizoglu Kulli, PhD, Bezmialem Vakif University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 8, 2019
Primary Completion (Actual)
August 20, 2020
Study Completion (Actual)
January 22, 2021
Study Registration Dates
First Submitted
November 26, 2019
First Submitted That Met QC Criteria
November 26, 2019
First Posted (Actual)
November 29, 2019
Study Record Updates
Last Update Posted (Actual)
March 16, 2021
Last Update Submitted That Met QC Criteria
March 12, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- hdenizkulli3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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