CVA (Cerebrovascular Accident)NCT07725744
Interface Pressures, Safety, Adherence, and Tactile Outcomes of Different Pressure Garments After Stroke
A study testing Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment, Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment and Single-Layered 15% Circumferential Reduction (S-15) Pressure Garment in people with CVA (Cerebrovascular Accident) and Stroke, run by National University of Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- CVA (Cerebrovascular Accident), Stroke
- What is being tested?
- Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment, Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment and Single-Layered 15% Circumferential Reduction (S-15) Pressure Garment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official 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
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:
- Wear S-10, S-15, or DD-10 for at least 12 hours daily for four weeks
- Measure interface pressure at baseline and weekly
- Assess tactile gnosis at baseline, Week 2, and Week 4
- Record adherence and adverse events using a self-report logbook
- Conditions
- CVA (Cerebrovascular Accident), Stroke
- Being tested
- Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment, Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment, Single-Layered 15% Circumferential Reduction (S-15) Pressure Garment
- Keywords
- interface pressure, pressure garment, pressure changes, tactile gnosis, adherence, safety, Stroke Rehabilitation, Occupational Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Layered 10% Circumferential Reduction (S-10) Pressure GarmentOther
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 GarmentOther
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 GarmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment | Active comparator | A customized single-layered finger-to-above-elbow (long glove) pressure garment with 10% circumferential reduction. Receives: Other: Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment |
| Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment | Experimental | 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. Receives: Other: Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment |
| Single-Layered 15% Circumferential Reduction (S-15) Pressure Garment | Active comparator | A customized single-layered finger-to-above-elbow (long glove) pressure garment with 15% circumferential reduction. Receives: Other: Single-Layered 15% Circumferential Reduction (S-15) Pressure Garment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week-1, Week-2, Week-3, and Week-4
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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.
Measured: Baseline, Week-1, Week-2, Week-3, and Week-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CVA (Cerebrovascular Accident)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- SOCSO Rehabilitation Center, Malaysia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725744
- Sponsor's protocol ID
- JEP-2025-586
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07725744
- Acronym / sponsor ID
- JEP-2025-586
- Conditions
- CVA (Cerebrovascular Accident), Stroke
- Keywords
- interface pressure, pressure garment, pressure changes, tactile gnosis, adherence, safety, Stroke Rehabilitation, Occupational Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- SOCSO Rehabilitation Center, Malaysia
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Wear S-10, S-15, or DD-10 for at least 12 hours daily for four weeks
- Measure interface pressure at baseline and weekly
- Assess tactile gnosis at baseline, Week 2, and Week 4
- Record adherence and adverse events using a self-report logbook
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment | Active comparator | Other: Single-Layered 10% Circumferential Reduction (S-10) Pressure GarmentA 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 | Experimental | Other: Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure GarmentA 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 comparator | Other: Single-Layered 15% Circumferential Reduction (S-15) Pressure GarmentA customized single-layered finger-to-above-elbow (long glove) pressure garment with 15% circumferential reduction. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-Layered 10% Circumferential Reduction (S-10) Pressure GarmentEach 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. | Other | Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment |
| Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure GarmentEach 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. | Other | Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment |
| Single-Layered 15% Circumferential Reduction (S-15) Pressure GarmentEach 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. | Other | Single-Layered 15% Circumferential Reduction (S-15) Pressure Garment |
Primary outcome
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.
3 secondary outcomes
Shape/Texture Identification (STI) test
Time frame: Baseline, Week-2, and Week-4
Daily Self-Report and Adverse Events of Special Interest (AESI) Logbook
Time frame: Completed by participants or caregiver daily, reviewed weekly by researcher
Modified Ashworth Score (MAS)
Time frame: Baseline, Week-1, Week-2, Week-3, and Week-4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment, Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment and Single-Layered 15% Circumferential Reduction (S-15) Pressure Garment in people with CVA (Cerebrovascular Accident) and Stroke, run by National University of Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interface pressure measured using PicoPress® Compression System (time frame: Baseline, Week-1, Week-2, Week-3, and Week-4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.