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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04181554
Other study ID # hdenizkulli3
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 8, 2019
Est. completion date January 22, 2021

Study information

Verified date March 2021
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date January 22, 2021
Est. primary completion date August 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design


Intervention

Other:
Measurement of postural stability
The postural stability will assess by using Biodex balance system.

Locations

Country Name City State
Turkey Bezmialem Vakif University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Limits of stability test score '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) 5 minutes
Primary Sensory integration test score '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. 6 minutes
Secondary Respiratory muscle strength Inspiratory and expiratory muscle strength has been assessed by maximal inspiratory and expiratory mouth pressures. 5 minutes
Secondary Abdominal Muscle Endurance Volunteers will be asked to perform curl up position as long as possible. The duration time will be measured until a maximum 180 seconds. 3 minutes
Secondary Pelvic floor dysfunction Pelvic floor dysfunction will be assessed using "Pelvic Floor Distress Inventory". Lower scores show better pelvic floor functions. 5 minutes
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