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Interface Pressures, Safety, Adherence, and Tactile Outcomes of Different Pressure Garments After Stroke
Sponsor: National University of Malaysia
Summary
This study aims to investigate the interface pressure changes of single-layer with 10% circumferential reduction (S-10), single-layer with 15% circumferential reduction (S-15), and dorsal double-layered with 10% circumferential reduction (DD-10)pressure garments over time, their relationships with adherence and adverse events, and their effects on tactile gnosis. Participants will: 1. Wear S-10, S-15, or DD-10 for at least 12 hours daily for four weeks 2. Measure interface pressure at baseline and weekly 3. Assess tactile gnosis at baseline, Week 2, and Week 4 4. Record adherence and adverse events using a self-report logbook
Official title: Interface Pressures, Safety, Adherence, and Tactile Outcomes of Different Pressure Garments After Stroke: A Prospective, Participant-Blinded, Three-Arm, Parallel-Group Randomized Controlled Trial
Key Details
Gender
All
Age Range
21 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
33
Start Date
2026-07-20
Completion Date
2027-03-31
Last Updated
2026-07-24
Healthy Volunteers
No
Conditions
Interventions
Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment
Each participant will receive a single-layered 10% circumferential reduction (S-10) pressure garment, fabricated based on their circumferential measurement. Participants will receive standardized verbal and written instructions on prescribed wear schedules, donning and doffing techniques, skin inspection, and hygiene. Caregivers will be trained to assist when required. Participants will be asked to wear the pressure garment daily for at least 6 hours in the day and 6 hours in the evening for 4 weeks, and to record daily wear in a provided logbook. All participants will receive usual stroke rehabilitation in addition to the application of the pressure garment.
Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment
Each participant will receive a dorsal doubled-layered 10% circumferential reduction (DD-10) pressure garment, fabricated based on their circumferential measurement. Participants will receive standardized verbal and written instructions on prescribed wear schedules, donning and doffing techniques, skin inspection, and hygiene. Caregivers will be trained to assist when required. Participants will be asked to wear the pressure garment daily for at least 6 hours in the day and 6 hours in the evening for 4 weeks, and to record daily wear in a provided logbook. All participants will receive usual stroke rehabilitation in addition to the application of the pressure garment.
Single-Layered 15% Circumferential Reduction (S-15) Pressure Garment
Each participant will receive a single-layered 15% circumferential reduction (S-15) pressure garment, fabricated based on their circumferential measurement. Participants will receive standardized verbal and written instructions on prescribed wear schedules, donning and doffing techniques, skin inspection, and hygiene. Caregivers will be trained to assist when required. Participants will be asked to wear the pressure garment daily for at least 6 hours in the day and 6 hours in the evening for 4 weeks, and to record daily wear in a provided logbook. All participants will receive usual stroke rehabilitation in addition to the application of the pressure garment.