About this trial
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
Eligibility criteria
Qualifiers
adults aged between 21 years to 60 years old
a history of stroke (no restrictions on the stroke type)
Modified Ashworth Scale of 1, 1+ or 2 when hand performing flexion and extension
no cognitive impairment (Montreal Cognitive Assessment (MoCA ⩾ 21)
Disqualifiers
skin lesions, infections or other skin problems
serious circulatory problems such as deep vein thrombosis
hypersensitive to Lycra materials
behavioural disturbances or motor impairments caused by other orthopaedic or neurological conditions other than stroke
Trial design
Treatments tested in this trial
- Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment
- Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment
- Single-Layered 15% Circumferential Reduction (S-15) Pressure Garment
Treatment groups
Locations
Sponsors and collaborators
National University of Malaysia
Lead sponsor
SOCSO Rehabilitation Center, Malaysia
Collaborator