NCT07702565

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

1.8 years

First QC Date

July 9, 2026

Last Update Submit

July 9, 2026

Conditions

Keywords

Postpartum ExerciseSensorimotor PhysiotherapyPelvic Floor RehabilitationLumbopelvic Motor ControlPerineal Sensory FunctionBiofeedbackFunctional RecoveryPostpartum Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

  • Change in Pelvic Motor Control Composite Score

    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.

    Baseline, week 6, week 12, and week 24

  • Change in Perineal Sensory Function

    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.

    Baseline, week 6, week 12, and week 24

Secondary Outcomes (8)

  • Change in Pelvic Floor Muscle Strength

    Baseline, week 6, week 12, and week 24

  • Change in Urinary Incontinence Severity

    Baseline, week 6, week 12, and week 24

  • Change in Pelvic Floor Distress

    Baseline, week 6, week 12, and week 24

  • Change in Pelvic Floor Impact on Daily Function

    Baseline, week 6, week 12, and week 24

  • Change in Core Endurance

    Baseline, week 6, week 12, and week 24

  • +3 more secondary outcomes

Study Arms (2)

Exercise-Based Sensorimotor Physiotherapy Program

EXPERIMENTAL

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.

Behavioral: Exercise-Based Sensorimotor Physiotherapy Program

Standard Postpartum Education and Home Advice

OTHER

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.

Other: Standard Postpartum Education and Home Advice

Interventions

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.

Also known as: Sensorimotor Physiotherapy
Exercise-Based Sensorimotor Physiotherapy Program

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.

Also known as: Standard Postpartum Advice
Standard Postpartum Education and Home Advice

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri University

Kayseri, Kayseri, 38130, Turkey (Türkiye)

Location

Study Officials

  • Özge Çopuroğlu

    Kayseri University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors were blinded to group allocation. Participants were instructed not to disclose their assigned group during follow-up assessments. Blinding of participants and the treating physiotherapist was not feasible because of the supervised exercise-based nature of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were stratified by delivery mode, vaginal delivery or cesarean delivery, and then randomly allocated in a 1:1 ratio to either the Sensorimotor Physiotherapy Group or the Control Group. The Sensorimotor Physiotherapy Group received a 12-week supervised exercise-based sensorimotor physiotherapy program, while the Control Group received standard postpartum education and home advice.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

July 9, 2026

First Posted

July 14, 2026

Study Start

March 1, 2024

Primary Completion

December 1, 2025

Study Completion

March 1, 2026

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations