An interventional study of Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment and Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment in CVA (Cerebrovascular Accident) and Stroke, sponsored by National University of Malaysia. Not yet recruiting. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by National University of Malaysia · Not applicable, Interventional, and Treatment
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:
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 33 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →National University of Malaysia is the lead sponsor of 124 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A customized single-layered finger-to-above-elbow (long glove) pressure garment with 10% circumferential reduction.
Other: Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment
A 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.
Other: Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment
A customized single-layered finger-to-above-elbow (long glove) pressure garment with 15% circumferential reduction.
Other: Single-Layered 15% Circumferential Reduction (S-15) 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.
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.
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.
Time frame: Baseline, Week-1, Week-2, Week-3, and Week-4
Shape/Texture Identification (STI) test
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.
Time frame: Baseline, Week-2, and Week-4
Daily Self-Report and Adverse Events of Special Interest (AESI) Logbook
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).
Time frame: Completed by participants or caregiver daily, reviewed weekly by researcher
Modified Ashworth Score (MAS)
To differentiate between mechanical garment decay and physiological fluctuations in limb volume, muscle tone (spasticity) will be monitored as a potential confounding variable.
Time frame: Baseline, Week-1, Week-2, Week-3, and Week-4
Montreal Cognitive Assessment (MoCA) - Bahasa Malaysia version
A widely used screening tool for detecting cognitive impairment, particularly mild cognitive impairment. It is a 10-minute, 30-point assessment that evaluates various cognitive domains, including working memory, delayed recall, visuospatial abilities, executive functions, attention, concentration, language, and orientation to time and place.
Time frame: Prior to participant enrolment
Modified Ashworth Score (MAS)
A method used to assess muscle tone by a scale of 0 to 4, where 0 indicates no spasticity and 4 indicates severe spasticity.
Time frame: Prior to participant enrolment
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Jan 2027, 6 months later.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 6 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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