Development and Implementation of a Remote Monitoring and Feedback System for Female Pelvic Floor Rehabilitation Training Based on Artificial Intelligence
9. juli 2026 oppdatert av: Peking Union Medical College Hospital
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.
Studieoversikt
Status
Fullført
Studietype
Intervensjonell
Registrering (Faktiske)
96
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100730
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: App-Based Remote Pelvic Floor Rehabilitation
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.
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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.
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Ingen inngripen: Routine Home-Based Pelvic Floor Rehabilitation
The routine home-based rehabilitation nursing model implemented at our hospital's Pelvic Floor Center was adopted, encompassing health education, nurse-patient communication, screening appointment scheduling, and follow-up monitoring.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pelvic Floor Muscle Contractility
Tidsramme: Baseline, 6 weeks post-intervention, and 12 weeks post-intervention
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Pelvic floor muscle strength
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Baseline, 6 weeks post-intervention, and 12 weeks post-intervention
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Type I and Type II pelvic floor muscle fiber strength
Tidsramme: Baseline, 6 weeks post-intervention, and 12 weeks post-intervention
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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.
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Baseline, 6 weeks post-intervention, and 12 weeks post-intervention
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Pelvic Floor Distress Inventory (PFDI-20) score
Tidsramme: Baseline, 6 weeks post-intervention, and 12 weeks post-intervention
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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.
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Baseline, 6 weeks post-intervention, and 12 weeks post-intervention
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Quality of life score
Tidsramme: Baseline, 6 weeks post-intervention, and 12 weeks post-intervention
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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.
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Baseline, 6 weeks post-intervention, and 12 weeks post-intervention
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Adherence to pelvic floor muscle training
Tidsramme: Baseline, 6 weeks post-intervention, and 12 weeks post-intervention
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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
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Baseline, 6 weeks post-intervention, and 12 weeks post-intervention
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Samarbeidspartnere og etterforskere
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Studierekorddatoer
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Studer hoveddatoer
Studiestart (Faktiske)
19. oktober 2025
Primær fullføring (Faktiske)
29. mars 2026
Studiet fullført (Faktiske)
29. mars 2026
Datoer for studieregistrering
Først innsendt
5. juli 2026
Først innsendt som oppfylte QC-kriteriene
9. juli 2026
Først lagt ut (Faktiske)
13. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. juli 2026
Sist bekreftet
1. oktober 2023
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- I-24PJ2211
Plan for individuelle deltakerdata (IPD)
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