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Creation and Validation of a Questionnaire Evaluating Diastasis Recti (QUEDIA)

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ClinicalTrials.gov Identifier: NCT04158180
Recruitment Status : Not yet recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Collaborator:
University Hospital, Caen
Information provided by (Responsible Party):
University of Valencia

Brief Summary:

Introduction Abdominal diastasis is defined as the presence of divergence between the rectus abdominis muscles along the linea alba. Some authors describe a prevalence of 40% in women up to one year postpartum. Some studies suggest that the presence of abdominal diastasis can be related to the appearance of low back, pelvic and abdominal pain and even urinary incontinence. These factors can significantly affect the quality of life of women with diastasis both socially, sexual and personal level. According to several studies, this pathology is related to higher rates of depression and an alteration in the self-perception of body image that makes these women to look to specialized medical care.

At present, the quantitative evaluation of abdominal diastasis is performed purely anatomically. This evaluation consists in measuring the separation between the two rectus abdominis. Currently there is no consensus as to the protocol that should be used for this measurement.

So far, no instrument is able to quantitatively measure the consequences of abdominal diastasis. These consequences should include relevant parameters such as quality of life, perception of body image and secondary functional limitations.

The objective of this study is the creation and validation of a specific questionnaire to evaluate the signs and symptoms of diastasis of the rectus abdominis.

Material and methods A) Creation of the questionnaire

  1. Literature review
  2. Online survey
  3. Expert panel
  4. Pilot questionnaire test

B) Validation of the questionnaire The psychometric properties of the questionnaire will be evaluated in a sample of patients with abdominal diastasis. The sample will be composed of a group of women who present a separation of the rectus abdominis that come to the consultation of a specialized professional


Condition or disease Intervention/treatment
Diastasis Recti and Weakness of the Linea Alba Diastasis Recti Diagnostic Test: Questionnaire

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 125 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Creation and Validation of a Questionnaire on Diastasis Recti Signs and Symptoms
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : October 1, 2020

Intervention Details:
  • Diagnostic Test: Questionnaire
    A battery of questionnaires will be propose to the participants


Primary Outcome Measures :
  1. Inter recti distance [ Time Frame: 1 week ]
    Caliper


Secondary Outcome Measures :
  1. Quality of life (QOL) [ Time Frame: 1 week ]
    Questionnaire

  2. Body image [ Time Frame: 1 week ]
    Questionnaire

  3. Disability [ Time Frame: 1 week ]
    Questionnaire

  4. Abdominal pain [ Time Frame: 1 week ]
    Questionnaire



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Adult women with diastasis recti attending to a physiotherapist or midwive center will be propose to participate in the study. A signed informed consent will be necessary to participate in this research.
Criteria

Inclusion Criteria:

  • subjects with diastasis recti,
  • adult,
  • women.

Exclusion Criteria:

  • cognitive disabilities that can difficult a good understanding of the questionnaire,
  • lack of knowledge of Spanish language.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158180


Contacts
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Contact: Montserrat Rejano Campo, MSc 0033627083914 montserejano@hotmail.com

Sponsors and Collaborators
University of Valencia
University Hospital, Caen

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Responsible Party: University of Valencia
ClinicalTrials.gov Identifier: NCT04158180     History of Changes
Other Study ID Numbers: QUEDIA
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diastasis, Muscle
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries