Feasibility and Preliminary Efficacy of a Telerehabilitation Protocol for Diastasis Recti Abdominis: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Telehealth Usability Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Telehealth Usability Questionnaire
时间窗: Assessed at 12 weeks (end of intervention)
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.
Satisfaction Assessment
时间窗: Assessed at 12 weeks (end of intervention)
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.
次要结局
- McGill's Trunk Flexor Endurance Test(Measured at baseline, week 4, week 8, and at 12 weeks)
- Body Image Assessment (BISS)(Measured at baseline, and at 12 weeks (end of intervention))
- Adherence(Assessed at 12 weeks (end of intervention))
- 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)
研究者
Anastasia Skoura
PhD candidate
University of Patras
