Development and Implementation of a Remote Monitoring and Feedback System for Female Pelvic Floor Rehabilitation Training Based on Artificial Intelligence
9 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
96
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100730
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pelvic Floor Muscle Contractility
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Type I and Type II pelvic floor muscle fiber strength
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
19 de octubre de 2025
Finalización primaria (Actual)
29 de marzo de 2026
Finalización del estudio (Actual)
29 de marzo de 2026
Fechas de registro del estudio
Enviado por primera vez
5 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de julio de 2026
Publicado por primera vez (Actual)
13 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de julio de 2026
Última verificación
1 de octubre de 2023
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- I-24PJ2211
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .