NCT07017309

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

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

March 15, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

May 23, 2025

Last Update Submit

June 11, 2025

Conditions

Keywords

Diastasis recti abdominispostpartum rehabilitationtelerehabilitationcore stabilizationPelvic Floor ExercisesWomen's Health Physiotherapy

Outcome Measures

Primary Outcomes (2)

  • 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.

    Assessed at 12 weeks (end of intervention)

  • 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.

    Assessed at 12 weeks (end of intervention)

Secondary Outcomes (8)

  • Inter-recti distance (IRD)

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

  • Trunk flexion endurance

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

  • Front plank endurance

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

  • Right side plank endurance

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

  • Left side plank endurance

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

  • +3 more secondary outcomes

Study Arms (1)

Intervention group

Behavioral: Telerehabilitation Protocol for Diastasis Recti

Interventions

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.

Intervention group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Pátrai, Greece

Location

MeSH Terms

Conditions

Diastasis Recti And Weakness Of The Linea Alba

Study Officials

  • Evdokia Billis, PhD

    University of Patras

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

May 23, 2025

First Posted

June 12, 2025

Study Start

March 15, 2024

Primary Completion

May 20, 2025

Study Completion

May 20, 2025

Last Updated

June 12, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations