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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorNational University of Malaysia

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

33 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

National University of Malaysia

Lead sponsor

SOCSO Rehabilitation Center, Malaysia

Collaborator