CVA (Cerebrovascular Accident), Stroke
Conditions
Keywords
interface pressure, pressure garment, pressure changes, tactile gnosis, adherence, safety, Stroke Rehabilitation, Occupational Therapy
Brief 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
Interventions
OTHERSingle-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.
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.
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.
Sponsors
National University of Malaysia
SOCSO Rehabilitation Center, Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interface pressure measured using PicoPress® Compression System | Baseline, Week-1, Week-2, Week-3, and Week-4 | The change in interface pressure over time and the group-by-time difference in pressure trajectories among the three pressure garment groups. PicoPress® Compression System is a portable pneumatic measuring system designed to measure interface pressure exerted by pressure garment, medical compression bandage or other compression therapeutic materials. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shape/Texture Identification (STI) test | Baseline, Week-2, and Week-4 | A standardized, performance-based test in which participants identify shapes and textures using active touch. It consists of two subsets (i.e., identification of three shapes and identification of three textures) and three difficulty levels (i.e., shape sizes of 15, 8, and 5mm, and distances between dots of 15, 8, 4mm). Each subset is scored from 0 to 3 (one point per size), producing a total score that ranges from 0 to 6. A score of 6 points is interpreted as normal tactile gnosis. |
| Daily Self-Report and Adverse Events of Special Interest (AESI) Logbook | Completed by participants or caregiver daily, reviewed weekly by researcher | The self-developed logbook is a self-report records that will be used to record the adherence metrics (e.g., daily wear duration, number of days worn per week, reason of non-adherence) and the incidence of adverse events (e.g., incidence, severity, action taken). |
| Modified Ashworth Score (MAS) | Baseline, Week-1, Week-2, Week-3, and Week-4 | To differentiate between mechanical garment decay and physiological fluctuations in limb volume, muscle tone (spasticity) will be monitored as a potential confounding variable. |
Outcome results
None listed