Interface Pressures, Safety, Adherence, and Tactile Outcomes of Different Pressure Garments After Stroke
1 other identifier
interventional
33
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2026
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 20, 2026
CompletedFirst Submitted
Initial submission to the registry
July 21, 2026
CompletedFirst Posted
Study publicly available on registry
July 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
July 24, 2026
July 1, 2026
7 months
July 21, 2026
July 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Interface pressure measured using PicoPress® Compression System
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.
Baseline, Week-1, Week-2, Week-3, and Week-4
Secondary Outcomes (3)
Shape/Texture Identification (STI) test
Baseline, Week-2, and Week-4
Daily Self-Report and Adverse Events of Special Interest (AESI) Logbook
Completed by participants or caregiver daily, reviewed weekly by researcher
Modified Ashworth Score (MAS)
Baseline, Week-1, Week-2, Week-3, and Week-4
Other Outcomes (2)
Montreal Cognitive Assessment (MoCA) - Bahasa Malaysia version
Prior to participant enrolment
Modified Ashworth Score (MAS)
Prior to participant enrolment
Study Arms (3)
Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment
ACTIVE COMPARATORA customized single-layered finger-to-above-elbow (long glove) pressure garment with 10% circumferential reduction.
Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment
EXPERIMENTALA customized finger-to-above-elbow (long glove) pressure garment with 10% of circumferential reduction. The design is similar to S-10 except it has an extra layer of fabric on the dorsal aspect that provides more compression.
Single-Layered 15% Circumferential Reduction (S-15) Pressure Garment
ACTIVE COMPARATORA customized single-layered finger-to-above-elbow (long glove) pressure garment with 15% circumferential reduction.
Interventions
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.
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 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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2026
First Posted
July 24, 2026
Study Start
July 20, 2026
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
July 24, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share