- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07702565
Exercise-Based Sensorimotor Physiotherapy for Postpartum Pelvic Health and Functional Recovery
Effects of a 12-Week Exercise-Based Sensorimotor Physiotherapy Program on Postpartum Pelvic Health and Functional Recovery: A Stratified Randomized Controlled Trial
This study evaluated whether a 12-week exercise-based sensorimotor physiotherapy program could improve pelvic health and functional recovery in postpartum women. Participants were women aged 18-40 years who were between 6 weeks and 6 months after a singleton delivery. They were randomly assigned to either a sensorimotor physiotherapy group or a control group. The physiotherapy group received supervised exercises targeting pelvic floor activation, lumbopelvic motor control, sensory re-education, proprioceptive training, functional stabilization, and biofeedback-assisted training. The control group received standard postpartum education and home advice.
The main outcomes were pelvic motor control and perineal sensory function. Other outcomes included pelvic floor muscle strength, urinary symptoms, pelvic distress, core endurance, postural stability, pain intensity, and health-related quality of life. Outcomes were assessed at baseline, week 6, week 12, and week 24. The study aimed to determine whether structured sensorimotor physiotherapy provides greater benefits than standard postpartum advice and whether recovery patterns differ according to vaginal or cesarean delivery.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
This was a prospective, single-center, assessor-blinded, stratified, parallel-group randomized controlled trial conducted in postpartum women. The study was designed to evaluate the effects of a structured 12-week exercise-based sensorimotor physiotherapy program on postpartum pelvic health, lumbopelvic motor control, sensory function, and functional recovery.
Eligible postpartum women were stratified according to delivery mode, vaginal delivery or cesarean delivery, and then randomly allocated to either the Sensorimotor Physiotherapy Group or the Control Group. The intervention group received supervised individual physiotherapy sessions twice weekly for 12 weeks, together with a structured home exercise program. The intervention included pelvic floor activation, lumbopelvic motor control training, proprioceptive exercises, sensory re-education, functional stabilization, and surface electromyography-assisted biofeedback. The control group received standard postpartum education and general home advice.
Outcome assessments were performed at baseline, week 6, week 12, and week 24 by blinded assessors. The primary focus was to determine whether the sensorimotor physiotherapy program improved pelvic motor control and perineal sensory function compared with standard postpartum advice. Secondary outcomes were used to evaluate broader functional and patient-reported recovery, including pelvic floor strength, urinary symptoms, pelvic distress, core endurance, postural stability, pain intensity, and health-related quality of life. Delivery mode was examined as an exploratory factor that could influence recovery patterns.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Kayseri
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Kayseri, Kayseri, Tyrkiet (Türkiye), 38130
- Kayseri University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Women aged 18-40 years.
- Postpartum women between 6 weeks and 6 months after delivery.
- Singleton delivery.
- Vaginal delivery or cesarean delivery.
- Ability to understand and perform the required assessment procedures.
- Ability to participate in the exercise-based intervention procedures.
- Provision of written informed consent before enrollment.
Exclusion Criteria:
- Third- or fourth-degree perineal tears.
- Pelvic organ prolapse stage II or higher according to the POP-Q classification.
- Active urinary tract infection or genital infection.
- Previous pelvic or abdominal surgery unrelated to cesarean delivery.
- Neurological conditions affecting lumbopelvic motor control.
- Musculoskeletal conditions affecting lumbopelvic motor control.
- Chronic pelvic pain syndromes.
- Psychiatric disorders limiting participation.
- Participation in structured physiotherapy or pelvic rehabilitation within the preceding 6 months.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Exercise-Based Sensorimotor Physiotherapy Program
A 12-week physiotherapist-led exercise-based sensorimotor physiotherapy program delivered individually twice weekly for approximately 45 minutes per session.
The program included pelvic floor activation, diaphragmatic breathing, lumbopelvic motor control training, abdominal-pelvic floor synergy exercises, proprioceptive stimulation, tactile discrimination tasks, sensory re-education, functional stabilization, task-specific training, and surface electromyography-assisted biofeedback.
Participants also completed a structured home exercise program for 15-20 minutes per day, five days per week.
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A 12-week physiotherapist-led exercise-based sensorimotor physiotherapy program delivered individually twice weekly for approximately 45 minutes per session.
The program included pelvic floor activation, diaphragmatic breathing, lumbopelvic motor control training, abdominal-pelvic floor synergy exercises, proprioceptive training, tactile discrimination tasks, sensory re-education, functional stabilization, task-specific training, and surface electromyography-assisted biofeedback.
Participants also completed a structured home exercise program for 15-20 minutes per day, five days per week.
Andre navne:
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Andet: Standard Postpartum Education and Home Advice
A standard postpartum education and home advice program including information on postpartum anatomy, posture correction, bladder care, and general pelvic floor exercises.
Participants received a printed home exercise leaflet and two telephone contacts at weeks 4 and 8 to encourage continuation of general advice.
No supervised physiotherapy, individualized exercise progression, biofeedback, or structured sensorimotor training was provided.
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A standard postpartum education and home advice program including information on postpartum anatomy, posture correction, bladder care, and general pelvic floor exercises.
Participants received a printed home exercise leaflet and two telephone contacts at weeks 4 and 8 to encourage continuation of general advice.
No supervised physiotherapy, individualized exercise progression, biofeedback, or structured sensorimotor training was provided.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Pelvic Motor Control Composite Score
Tidsramme: Baseline, week 6, week 12, and week 24
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Pelvic motor control was assessed using the Pelvic Motor Control Composite Score, an experimental composite index derived from surface electromyography-based parameters including normalized root mean square amplitude, onset latency, relaxation time, and contraction intermittency.
Higher scores indicate better lumbopelvic motor control.
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Baseline, week 6, week 12, and week 24
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Change in Perineal Sensory Function
Tidsramme: Baseline, week 6, week 12, and week 24
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Perineal sensory function was assessed using pressure detection threshold measured with a calibrated handheld algometer and two-point discrimination measured with a precision caliper.
Lower values indicate better sensory responsiveness and tactile discrimination.
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Baseline, week 6, week 12, and week 24
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Pelvic Floor Muscle Strength
Tidsramme: Baseline, week 6, week 12, and week 24
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Pelvic floor muscle strength was assessed using the Modified Oxford Scale and the PERFECT scheme.
Higher scores indicate greater pelvic floor muscle strength and function.
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Baseline, week 6, week 12, and week 24
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Change in Urinary Incontinence Severity
Tidsramme: Baseline, week 6, week 12, and week 24
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Urinary incontinence severity was assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form.
Higher scores indicate greater urinary incontinence severity.
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Baseline, week 6, week 12, and week 24
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Change in Pelvic Floor Distress
Tidsramme: Baseline, week 6, week 12, and week 24
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Pelvic floor-related distress was assessed using the Pelvic Floor Distress Inventory-20.
Higher scores indicate greater pelvic floor symptom-related distress.
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Baseline, week 6, week 12, and week 24
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Change in Pelvic Floor Impact on Daily Function
Tidsramme: Baseline, week 6, week 12, and week 24
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The functional impact of pelvic floor symptoms was assessed using the Pelvic Floor Impact Questionnaire-7.
Higher scores indicate greater negative impact of pelvic floor symptoms on daily activities and quality of life.
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Baseline, week 6, week 12, and week 24
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Change in Core Endurance
Tidsramme: Baseline, week 6, week 12, and week 24
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Core endurance was assessed using prone plank and side plank duration.
Longer duration indicates better core endurance.
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Baseline, week 6, week 12, and week 24
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Change in Postural Stability
Tidsramme: Baseline, week 6, week 12, and week 24
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Postural stability was assessed using center-of-pressure displacement during stabilometry.
Lower center-of-pressure displacement or sway area indicates better postural stability.
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Baseline, week 6, week 12, and week 24
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Change in Pain Intensity
Tidsramme: Baseline, week 6, week 12, and week 24
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Pain intensity was assessed using a 0-10 visual analogue scale.
Higher scores indicate greater pain intensity.
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Baseline, week 6, week 12, and week 24
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Change in Health-Related Quality of Life
Tidsramme: Baseline, week 6, week 12, and week 24
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Health-related quality of life was assessed using the 12-item Short Form Health Survey version 2. Higher scores indicate better perceived health-related quality of life.
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Baseline, week 6, week 12, and week 24
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Özge Çopuroğlu, Kayseri University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- KayseriUniversity111
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