Multimodal Pelvic Floor Rehabilitation in Chronic Stroke Survivors: Long-Term Efficacy, Optimal Protocols, and Adjunctive Therapies for Comprehensive Pelvic Floor Dysfunction - A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Modified Oxford scale to determine pelvic floor muscle strength
研究概览
简要总结
Evaluate long-term efficacy of multimodal PFMT in chronic stroke survivors with PFD.
详细描述
Stroke is a leading cause of disability, with pelvic floor dysfunction (PFD) affecting 25-79% of survivors, including urinary incontinence, fecal incontinence/constipation, and sexual dysfunction. Evidence gaps include long-term efficacy (>12 months), optimal PFMT protocols, adjunctive therapies (biofeedback, NMES), bowel/sexual domains, partner impacts, QoL correlations, and prognostic factors. This trial addresses these via a large-scale, multicenter RCT.
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 (Participant)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 45-85; first-ever stroke ≥12 months prior
- •Sexual dysfunction per FSFI/IIEF)
- •Able to follow two-stage commands.
排除标准
- •Pre-stroke PFD
- •Indwelling catheter
- •MoCA <18
研究组 & 干预措施
Prospective, assessor-blinded, four-arm parallel-group RCT with 1:1:1:1 allocation.
Prospective, assessor-blinded, four-arm parallel-group RCT with 1:1:1:1 allocation. Duration: 16 weeks supervised
+ 36 weeks home maintenance (total 12 months follow-up). Setting: Eight rehabilitation centers in Pakistan (e.g., Swat Psychiatric Care & Rehabilitation Center, Al-Makki Rehabilitation Center, etc.).
干预措施: Core PFMT: 8-12 contractions (6-10s hold), 3 sets/day, progressed over 16 weeks. • Group A (Standard PFMT): 3 supervised/week (weeks 1-8), 1/week (9-16) + home. • Group B (Intensified PFMT): 5/week (Other)
Group A (Standard PFMT)
3 supervised/week (weeks 1-8), 1/week (9-16) + home.
干预措施: Core PFMT: 8-12 contractions (6-10s hold), 3 sets/day, progressed over 16 weeks. • Group A (Standard PFMT): 3 supervised/week (weeks 1-8), 1/week (9-16) + home. • Group B (Intensified PFMT): 5/week (Other)
Group B (Intensified PFMT)
5/week (1-8), 3/week (9-16) + home.
干预措施: Core PFMT: 8-12 contractions (6-10s hold), 3 sets/day, progressed over 16 weeks. • Group A (Standard PFMT): 3 supervised/week (weeks 1-8), 1/week (9-16) + home. • Group B (Intensified PFMT): 5/week (Other)
Group C (PFMT + Biofeedback)
Standard + vaginal/anal biofeedback (MAPLe®/Peritron™).
干预措施: Core PFMT: 8-12 contractions (6-10s hold), 3 sets/day, progressed over 16 weeks. • Group A (Standard PFMT): 3 supervised/week (weeks 1-8), 1/week (9-16) + home. • Group B (Intensified PFMT): 5/week (Other)
Group C (PFMT + Biofeedback)
Standard + vaginal/anal biofeedback (MAPLe®/Peritron™).
干预措施: Core PFMT: 8-12 contractions (6-10s hold), 3 sets/day, progressed over 16 weeks. (Other)
结局指标
主要结局
Modified Oxford scale to determine pelvic floor muscle strength
时间窗: Baseline, 8 weeks, 16 weeks, 6 months, 12 months.
Primary outcome measure
次要结局
- Female Sexual Function Index to assess sexual dysfunction in women(Baseline, 8 weeks, 16 weeks, 6 months, 12 months.)
研究者
Muslim khan
Assistant Professor
Iqra National University