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Not yet recruiting NCT07725744

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

No phase Interventional CVA (Cerebrovascular Accident) Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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.
Who it may be relevant to
Registry conditions: CVA (Cerebrovascular Accident), Stroke. Basic parameters: 21 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

Interventions

  • 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 w
  • 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 evenin
  • 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 w

Primary outcome measures

  • Interface pressure measured using PicoPress® Compression System [Time frame: Baseline, Week-1, Week-2, Week-3, and Week-4]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07725744 · JEP-2025-586

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗