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Diastasis RectiNCT07017309

Telerehabilitation for Diastasis Recti

An observational study of Diastasis Recti and Telerehabilitation, run by University of Patras at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a pilot study exploring how a 12-week telerehabilitation program can help new mothers manage diastasis recti abdominis (DRA)-a common trunk dysfunction which causes abdominal muscle separation after childbirth. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
What is being tested?
Telerehabilitation Protocol for Diastasis Recti
How many people
13 participants
Where
1 siteGreece
Study dates
15 Mar 2024to 20 May 2025
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
  • No healthy volunteers
  • Adult

Study population: Participants from the wider Achaia region in Greece are invited to join the study through informational leaflets and posters placed in key locations such as the University Campus and the University General Hospital of Patras, as well as through social media channels. Additionally, details about the study are shared by local professional associations and healthcare providers-including obstetricians, midwives, and surgeons.

Who may be able to join

  • female volunteers aged 18 - 50
  • with established DRA (IRD ≥ 2.8 cm) according to Mota et al., (2018) criteria
  • at least 6 months postpartum
  • able to voluntarily contract the transversus abdominis and pelvic floor muscles - comfortable with digital technology and having access to a smartphone, tablet, or computer with a camera and internet connection

Who cannot join

  • recent abdominal surgery (excluding cesarean section)
  • having given birth less than 6 months prior to participation
  • serious musculoskeletal disorders limiting exercise participation
  • neurological conditions limiting exercise participation
  • chronic respiratory disease limiting exercise participation
  • connective tissue disorders that could affect the structure of the linea alba
  • body mass index (BMI) ≥ 30 kg/m²

Trial locations and contacts

1 site in 1 country.

Greece1 site
  • Laboratory of Clinical Rehabilitation and Research (CPRlab), University of Patras

    Pátrai

Other trials in Greece

About this study

Official title: Feasibility and Preliminary Efficacy of a Telerehabilitation Protocol for Diastasis Recti Abdominis: A Pilot Study

This is a pilot study exploring how a 12-week telerehabilitation program can help new mothers manage diastasis recti abdominis (DRA)-a common trunk dysfunction which causes abdominal muscle separation after childbirth. Instead of needing to attend in-person sessions, participants are encouraged to join guided exercise sessions online, with real-time supervision from a physiotherapist. The study aims to assess participant satisfaction with the remote program using a standardized questionnaire. It also evaluates potential changes in abdominal muscle separation (diastasis) through ultrasound, improvements in trunk muscle endurance using functional tests, and changes in body image perception using a body image questionnaire.

Read the detailed description

This pilot study investigates the feasibility, patient satisfaction, and preliminary clinical effects of a 12-week telerehabilitation program targeting postpartum women diagnosed with diastasis recti abdominis (DRA). The intervention is delivered remotely and combines synchronous (real-time, supervised by physiotherapists) and asynchronous (video-recorded) therapeutic exercise sessions. Participants are required to attend two synchronous sessions per week via teleconference, which allows for real-time supervision and interaction with a specialized physiotherapist. They are also encouraged to attend one additional session per week independently using pre-recorded content. The exercise protocol includes progressive-load training focusing on inner core activation (i.e. transversus abdominis, pelvic floor muscles), outer core strengthening, and functional retraining.

Assessments are conducted at baseline, week 4, week 8, and post-intervention (week 12). Ultrasound imaging is used to measure inter-recti distance (IRD) at standard anatomical locations (2 cm above, 5 cm above, and 2 cm below the umbilicus) at baseline and post-intervention. Trunk muscle endurance is assessed through established functional tests, including curl-up manoeuvre, plank variations and McGill's trunk flexor endurance test at baseline, week 4, week 8, and post-intervention (week 12). Body image is evaluated using a validated Greek version of the Body Image States Scale (BISS_Greek) both at baseline and at the end of the intervention. Patient satisfaction is measured via the Greek version of the Telehealth Usability Questionnaire (TUQ_Greek), also accompanied by a custom-designed satisfaction question. Adherence is tracked using exercise diaries.

The study complies with ethical standards in accordance with the Declaration of Helsinki and has been approved by the Research Ethics Committee (R.E.C.) of the University of Patras (Internal Code: 16331/29-01-2024). All participants receive comprehensive written information about the study and data protection procedures and provide informed consent prior to participation. Patient data are anonymized and stored securely on a coded cloud-based platform accessible only to authorized research team members. Any adverse events are managed appropriately, documented in detail, and medical consultation is available during assessment and rehabilitation hours.

Missing, inconsistent, or uninterpretable data are addressed through imputation methods. A comprehensive data dictionary has been developed to ensure consistency in variable definitions, coding, and expected ranges. The accuracy and completeness of data entries is ensured by the research team through internal data validation and comparison with source data.

Participants are recruited through multiple channels, including posters and leaflets distributed at the University of Patras, the University General Hospital of Patras, and throughout the wider Achaia region. Recruitment is also supported by professional networks such as the Panhellenic Medical Association, the Panhellenic Physiotherapists' Association, and individual healthcare professionals (e.g., gynecologists, urologists, obstetricians, surgeons), public engagement events are organized across the Achaia region, and study information are promoted via the university website (Department of Physiotherapy), social media, and professional conferences.

Given the exploratory nature of this pilot study, no formal power calculation has been conducted. The sample size is intended to assess feasibility and inform the design of future larger-scale trials. Descriptive statistics will summarise participant characteristics and satisfaction outcomes. Repeated-measures ANOVA or non-parametric equivalents will be used to analyze changes over time in clinical outcomes, depending on data distribution. Statistical significance is set at p<0.05

Being tested
Telerehabilitation Protocol for Diastasis Recti
Keywords
Diastasis recti abdominis, postpartum rehabilitation, telerehabilitation, core stabilization, Pelvic Floor Exercises, Women&#39;s Health Physiotherapy
Medical subject headings
Diastasis Recti And Weakness Of The Linea Alba

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telerehabilitation Protocol for Diastasis RectiBehavioural

    12-week telerehabilitation program combining synchronous (live, supervised by physiotherapists) and asynchronous (video -recorded) therapeutic exercise sessions focused on progressive inner core exercises (i.e. transversus abdominis, pelvic floor muscle retraining), outer core strengthening, and functional retraining.

Study groups in NCT07017309
Study groupRoleWhat they receive
Intervention groupNot described
Receives: Behavioral: Telerehabilitation Protocol for Diastasis Recti

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Telehealth Usability Questionnaire

    Telehealth Usability Questionnaire is a validated tool including 21 items that assess six domains: usefulness, ease of use and learnability, interface quality, interaction quality, reliability, satisfaction and future use. Items are rated on a 7-point Likert scale, from "1: strongly disagree" to "7: strongly agree", and with higher average scores indicating greater usability. Maximum score can be 7, while minimum score can be 1.

    Measured: Assessed at 12 weeks (end of intervention)

  2. Satisfaction Assessment

    A closed-ended question, asking participants to rate their satisfaction with the telerehabilitation program on a 5-point Likert scale, from 1 : "not at all satisfied" to 5 "very satisfied."Higher values on the scale indicate higher satisfaction.

    Measured: Assessed at 12 weeks (end of intervention)

Secondary outcomes (8)
  1. Inter-recti distance (IRD)

    IRD is assessed using a real-time 2D diagnostic ultrasound imaging unit at three locations; at 2 cm and 5 cm above the umbilicus and at 2 cm below the umbilicus, in a supine, relaxed position with knees flexed and during exhalation.

    Measured: Measured at baseline, and at 12 weeks (end of intervention)

  2. Trunk flexion endurance

    Trunk flexion endurance is assessed in a static trunk flexion position on a mat, using a stopwatch and is documented in seconds. Higher values indicate higher endurance.

    Measured: Measured at baseline, week 4, week 8, and at 12 weeks

  3. Front plank endurance

    Front plank endurance is assessed in a front plank position on a mat, using a stopwatch and is documented in seconds. Higher values indicate higher endurance.

    Measured: Measured at baseline, week 4, week 8, and at 12 weeks

  4. Right side plank endurance

    Right side plank endurance is assessed in a right side plank position on a mat, using a stopwatch and is documented in seconds. Higher values indicate higher endurance.

    Measured: Measured at baseline, week 4, week 8, and at 12 weeks

  5. Left side plank endurance

    Left side plank endurance is assessed in a left side plank position on a mat, using a stopwatch and is documented in seconds. Higher values indicate higher endurance.

    Measured: Measured at baseline, week 4, week 8, and at 12 weeks

  6. McGill's Trunk Flexor Endurance Test

    McGill's Trunk Flexor Endurance Test is assessed in an inclined sitting position on a mat, using a stopwatch and is documented in seconds. Higher values indicate higher endurance.

    Measured: Measured at baseline, week 4, week 8, and at 12 weeks

  7. Body Image Assessment (BISS)

    The questionnaire consists of six statements related to how individuals perceive their physical appearance, body size and shape, weight, feelings of physical attractiveness, as well as current feelings about appearance compared to usual perceptions. Responses are rated on a 9-point bipolar Likert scale. A higher total score indicates a higher body image perception.

    Measured: Measured at baseline, and at 12 weeks (end of intervention)

  8. Adherence

    Participant adherence is tracked by recording the number and type (remote supervised, or video-based) of weekly exercise sessions using a custom-made exercise diary. Higher numbers indicate higher adherence. Highest total number of sessions is 36 (up to 24 can be supervised sessions and up to 12 can be video recorded sessions). At least 24 sessions (both supervised and video-recorded) are required for inclusion in the final analysis. Minimum total number of sessions is 24.

    Measured: Assessed at 12 weeks (end of intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2025
  2. Study start15 Mar 2024
  3. Primary completion20 May 2025
  4. Study completion20 May 2025

Resources

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
Cohort
Time perspective
Prospective
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07017309
Sponsor's protocol ID
DRATelerehab-Pilot-16331
Status last verified
Jun 2025
First submitted
23 May 2025
Last updated
12 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diastasis Recti and Telerehabilitation, run by University of Patras at 1 site in Greece.

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 4 inclusion and 7 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 12 Jun 2025. 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 Greece. 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?

Telehealth Usability Questionnaire (time frame: Assessed at 12 weeks (end of intervention)). 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 12 Jun 2025; AzTrials last refreshed its copy on 31 Oct 2026.

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