Multimodal Pelvic Floor Rehabilitation in Chronic Stroke... | NCT07420569 | Trialant

Multimodal Pelvic Floor Rehabilitation in Chronic Stroke... | NCT07420569 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prospective, assessor-blinded, four-arm parallel-group RCT with 1:1:1:1 allocation.	Active Comparator	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.).	Other: 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
Group A (Standard PFMT)	Active Comparator	3 supervised/week (weeks 1-8), 1/week (9-16) + home.	Other: 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
Group B (Intensified PFMT)	Active Comparator	5/week (1-8), 3/week (9-16) + home.	Other: 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
Group C (PFMT + Biofeedback)	Active Comparator	Standard + vaginal/anal biofeedback (MAPLe®/Peritron™).	Other: 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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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	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.).

Outcomes Module

Secondary Outcomes

Measure	Description	Time Frame
Female Sexual Function Index to assess sexual dysfunction in women	standardized tools to aid data collection	Baseline, 8 weeks, 16 weeks, 6 months, 12 months.

Document Section

Large Document Module