NCT04181554

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 8, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2021

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

11 months

First QC Date

November 26, 2019

Last Update Submit

March 12, 2021

Conditions

Diastasis RectiPost-partumPostural Stability

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Respiratory muscle strength

    5 minutes

  • Abdominal Muscle Endurance

    3 minutes

  • Pelvic floor dysfunction

    5 minutes

Study Arms (1)

DRAM group

The post-partum women with DRAM

Other: Measurement of postural stability

Interventions

Measurement of postural stabilityOTHER

The postural stability will assess by using Biodex balance system.

DRAM group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The post-partum women with diastasis recti abdominis will be enrolled to the study.

You may qualify if:

  • Post- partum women (min 8 weeks - max 5 years)

You may not qualify if:

  • Having a neurological, orthopedical or any other condition which affect postural stability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf University

Istanbul, Turkey (Türkiye)

Location

Study Officials

  • Hilal Denizoglu Kulli, PhD

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Department of Physiotherapy and Rehabilitation

Study Record Dates

First Submitted

November 26, 2019

First Posted

November 29, 2019

Study Start

October 8, 2019

Primary Completion

August 20, 2020

Study Completion

January 22, 2021

Last Updated

March 16, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)