Effects of a 12-Week Exercise-Based Sensorimotor Physiotherapy Program on Postpartum Pelvic Health and Functional Recovery: A Stratified Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change in Pelvic Motor Control Composite Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Exercise-Based Sensorimotor Physiotherapy Program (Behavioral)
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.
干预措施: Standard Postpartum Education and Home Advice (Other)
结局指标
主要结局
Change in Pelvic Motor Control Composite Score
时间窗: Baseline, week 6, week 12, and week 24
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.
Change in Perineal Sensory Function
时间窗: Baseline, week 6, week 12, and week 24
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.
次要结局
- Change in Pelvic Floor Muscle Strength(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)
- Change in Postural Stability(Baseline, week 6, week 12, and week 24)
- Change in Pain Intensity(Baseline, week 6, week 12, and week 24)
- Change in Health-Related Quality of Life(Baseline, week 6, week 12, and week 24)
- Change in Pelvic Floor Distress(Baseline, week 6, week 12, and week 24)
- Change in Urinary Incontinence Severity(Baseline, week 6, week 12, and week 24)
研究者
Özge BAYKAN ÇOPUROĞLU
Asst. Prof.
Kayseri University