Clinical trial NCT07017309: Telerehabilitation for Diastasis Recti
Official title: Feasibility and Preliminary Efficacy of a Telerehabilitation Protocol for Diastasis Recti Abdominis: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diastasis Recti
Telerehabilitation
Diastasis Recti Abdominis (DRA)
Diastasis Recti And Weakness Of The Linea Alba
Keywords: Diastasis recti abdominis
postpartum rehabilitation
telerehabilitation
core stabilization
Pelvic Floor Exercises
Women&#39;s Health Physiotherapy
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Telehealth Usability Questionnaire
timeFrame: Assessed at 12 weeks (end of intervention)
measure: Satisfaction Assessment
timeFrame: Assessed at 12 weeks (end of intervention)
Secondary outcomes:
measure: Inter-recti distance (IRD)
timeFrame: Measured at baseline, and at 12 weeks (end of intervention)
measure: Trunk flexion endurance
timeFrame: Measured at baseline, week 4, week 8, and at 12 weeks
measure: Front plank endurance
timeFrame: Measured at baseline, week 4, week 8, and at 12 weeks
measure: Right side plank endurance
timeFrame: Measured at baseline, week 4, week 8, and at 12 weeks
measure: Left side plank endurance
timeFrame: Measured at baseline, week 4, week 8, and at 12 weeks
measure: McGill's Trunk Flexor Endurance Test
timeFrame: Measured at baseline, week 4, week 8, and at 12 weeks
measure: Body Image Assessment (BISS)
timeFrame: Measured at baseline, and at 12 weeks (end of intervention)
measure: Adherence
timeFrame: Assessed at 12 weeks (end of intervention)
Other outcomes:
Locations:
city: Patras
country: Greece
facility: Laboratory of Clinical Rehabilitation and Research (CPRlab), University of Patras
Study officials:
affiliation: University of Patras
name: Evdokia Billis, PhD
role: STUDY_DIRECTOR
References: