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NCT07725744
Interface Pressures, Safety, Adherence, and Tactile Outcomes of Different Pressure Garments After Stroke
Conditions: CVA (Cerebrovascular Accident), Stroke
Sex: All
Ages: 21 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 33
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
Eligibility Criteria
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07725744). StuddyBuddy aggregates publicly available trial information.