Interface Pressures, Safety, Adherence, and Tactile Outcomes of Different Pressure Garments After Stroke

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

Conditions

• CVA (Cerebrovascular Accident)
• Stroke

Interventions

OTHER

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.

OTHER

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.

OTHER

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.

Sponsors & Collaborators

• SOCSO Rehabilitation Center, Malaysia

  collaborator UNKNOWN

• National University of Malaysia

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-20

Primary Completion

2027-01-31

Completion

2027-03-31