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

Interface Pressures, Safety, Adherence, and Tactile Outcomes of Different Pressure Garments After Stroke: A Prospective, Participant-Blinded, Three-Arm, Parallel-Group Randomized Controlled 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

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; CVA (Cerebrovascular Accident)
• Intervention / Treatment: Other: Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment; Other: Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment; Other: Single-Layered 15% Circumferential Reduction (S-15) Pressure Garment

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment; 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; 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.
Experimental: Dorsal-Double-Layered 10% Circumferential Reduction (DD-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; 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.
Active Comparator: Single-Layered 15% Circumferential Reduction (S-15) 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	Baseline, Week-1, Week-2, Week-3, and Week-4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Prior to participant enrolment

Collaborators and Investigators

• Sponsor: National University of Malaysia
• Collaborators: SOCSO Rehabilitation Center, Malaysia

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: safety; adherence; Occupational Therapy; interface pressure; Stroke Rehabilitation; pressure garment; pressure changes; tactile gnosis
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; S 10; EFEMP1 protein, human
• Other Study ID Numbers: JEP-2025-586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No