Pelvic Floor Rehabilitation Training
Conditions
Brief summary
Pelvic Floor Rehabilitation Training Prescription Label: An individualized training prescription generated by aggregating a comprehensive profile of maternal information through AI and applying data deep-mining algorithms, aiming to deliver targeted and precise interventions for mothers at different behavioral stages.PFMT Error-Correction Feedback Program: A program that identifies abnormal pelvic floor muscle contractions in mothers by and analyzing electromyographic (EMG) signals from the abdominal muscles, gluteal muscles, and other muscle groups, and develops an error-correction program with text, visual, and audio prompts. Maternal Mobile APP: A system developed with functions including self-management, health education, nurse-patient communication, and remote monitoring. Preliminary Clinical Application: A randomized controlled trial (RCT) will be conducted in women at 6-8 weeks postpartum using the remote monitoring and feedback system for pelvic floor rehabilitation training. The clinical application effects will be evaluated to achieve full-process assessability, guidance, and supervision of postpartum PFMT, thereby improving maternal participation, compliance, and correctness in PFMT.
Interventions
BEHAVIORALa remote monitoring and feedback system for female pelvic floor rehabilitation training based on artificial intelligence
The researchers assisted the participants in downloading the user-side APP, and provided and instructed them on the use of the home-based pelvic floor rehabilitation device. On the healthcare provider side, remote monitoring of the participants' compliance with pelvic floor muscle training was conducted, and compensatory errors were corrected individually. The training regimen was intelligently adjusted based on real-time data, and the participants completed daily check-ins and questionnaire assessments via the APP.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 18 years; * Women who underwent pelvic floor screening at our hospital's Pelvic Floor Center at 6-8 weeks postpartum; * Have normal cognitive ability and are able to use mobile apps or other means to access information; * Voluntarily participate in the study and sign the informed consent form.
Exclusion criteria
* Women with contraindications to pelvic floor muscle training (e.g., vaginal or rectal bleeding, etc.); * Those with psychiatric disorders that preclude cooperation with this study; * Those who have difficulty adhering to follow-up visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Floor Muscle Contractility | Baseline, 6 weeks post-intervention, and 12 weeks post-intervention | Pelvic floor muscle strength |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type I and Type II pelvic floor muscle fiber strength | Baseline, 6 weeks post-intervention, and 12 weeks post-intervention | Physiological indicators of pelvic floor muscle pressure were assessed using a pelvic floor muscle pressure measurement device. The parameters included: (1) Type I muscle fiber strength and fatigue - representing slow-twitch fibers responsible for sustained resting tone and endurance; (2) Type II muscle fiber strength and fatigue - representing fast-twitch fibers responsible for rapid, forceful contractions; and (3) maximum vaginal contraction pressure - reflecting the overall maximal voluntary contraction capacity of the pelvic floor muscles. |
| Pelvic Floor Distress Inventory (PFDI-20) score | Baseline, 6 weeks post-intervention, and 12 weeks post-intervention | Pelvic floor dysfunction-related symptoms were assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20). The total score ranges from 0 to 300, with higher scores indicating greater symptom distress and more severe pelvic floor dysfunction. |
| Quality of life score | Baseline, 6 weeks post-intervention, and 12 weeks post-intervention | Quality of life was assessed using the Incontinence Impact Questionnaire-7 (IIQ-7). The total score ranges from 0 to 100, with higher scores indicating a greater negative impact of urinary incontinence on daily activities, emotional well-being, and social functioning, reflecting poorer quality of life. |
| Adherence to pelvic floor muscle training | Baseline, 6 weeks post-intervention, and 12 weeks post-intervention | Adherence to pelvic floor muscle training (PFMT) was monitored and recorded through the mobile APP. Adherence was defined as the percentage of prescribed training sessions actually completed over the 12-week intervention period. Participants were conside |
Countries
China
Outcome results
None listed