Diastasis RectiNCT04181554
Postural Stability, Pelvic Floor Dysfunction, Respiratory Muscle Strength in Post-partum Women With Diastasis Recti
An observational study of Diastasis Recti and Post-partum, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diastasis Recti, Post-partum, Postural Stability
- What is being tested?
- Measurement of postural stability
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Oct 2019to 22 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The post-partum women with diastasis recti abdominis will be enrolled to the study.
Who may be able to join
- Post- partum women (min 8 weeks - max 5 years)
Who cannot join
- Having a neurological, orthopedical or any other condition which affect postural stability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diastasis Recti, Post-partum, Postural Stability
- Being tested
- Measurement of postural stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of postural stabilityOther
The postural stability will assess by using Biodex balance system.
| Study group | Role | What they receive |
|---|---|---|
| DRAM group | The post-partum women with DRAM Receives: Other: Measurement of postural stability |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 5 minutes
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.
Measured: 6 minutes
Secondary outcomes (3)
Respiratory muscle strength
Inspiratory and expiratory muscle strength has been assessed by maximal inspiratory and expiratory mouth pressures.
Measured: 5 minutes
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.
Measured: 3 minutes
Pelvic floor dysfunction
Pelvic floor dysfunction will be assessed using "Pelvic Floor Distress Inventory". Lower scores show better pelvic floor functions.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start8 Oct 2019
- Primary completion20 Aug 2020
- Study completion22 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastasis RectiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Denizoğlu Külli, Bezmialem Vakif University
- Investigators
- Hilal Denizoglu Kulli, PhD, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181554
- Sponsor's protocol ID
- hdenizkulli3
- Status last verified
- Mar 2021
- First submitted
- 26 Nov 2019
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diastasis Recti on Postural Stability, Pelvic Floor Dysfunction and Respiratory Muscle Strength in Post-partum Women
- ClinicalTrials.gov ID
- NCT04181554
- Acronym / sponsor ID
- hdenizkulli3
- Conditions
- Diastasis Recti, Post-partum, Postural Stability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 22 Jan 2021 (actual)
- First posted
- 29 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DRAM group | – | Other: Measurement of postural stabilityThe post-partum women with DRAM |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The post-partum women with diastasis recti abdominis will be enrolled to the study.
Key inclusion criteria (1 listed)
- Post- partum women (min 8 weeks - max 5 years)
Key exclusion criteria (1 listed)
- Having a neurological, orthopedical or any other condition which affect postural stability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of postural stabilityThe postural stability will assess by using Biodex balance system. | Other | DRAM group |
Primary outcome
Limits of stability test score
Time frame: 5 minutes
'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)
Sensory integration test score
Time frame: 6 minutes
'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.
3 secondary outcomes
Respiratory muscle strength
Time frame: 5 minutes
Abdominal Muscle Endurance
Time frame: 3 minutes
Pelvic floor dysfunction
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilal Denizoglu Kulli, PhD principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diastasis Recti and Post-partum, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limits of stability test score (time frame: 5 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.