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NCT Number: NCT07725744

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

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

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Key information

Conditions

CVA (Cerebrovascular Accident) Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment

Other

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.

Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment

Other

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.

Single-Layered 15% Circumferential Reduction (S-15) Pressure Garment

Other

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.

Primary outcomes

  1. Interface pressure measured using PicoPress® Compression System

    Time frame: 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 outcomes

  1. Shape/Texture Identification (STI) test

    Time frame: 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.

  2. Daily Self-Report and Adverse Events of Special Interest (AESI) Logbook

    Time frame: 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).

  3. Modified Ashworth Score (MAS)

    Time frame: 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.

Other outcomes

  1. Montreal Cognitive Assessment (MoCA) - Bahasa Malaysia version

    Time frame: Prior to participant enrolment

    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.

  2. Modified Ashworth Score (MAS)

    Time frame: Prior to participant enrolment

    A method used to assess muscle tone by a scale of 0 to 4, where 0 indicates no spasticity and 4 indicates severe spasticity.

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Collaborators

  • SOCSO Rehabilitation Center, Malaysia

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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