Interface Pressures, Safety, Adherence, and Tactile Outcomes of Different Pressure Garments After Stroke | NCT07725744

NCT07725744

Overview

NCT ID: NCT07725744
Lead Sponsor: National University of MalaysiaOTHER
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
Brief 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 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)

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 24, 2026Actual
Start Date: Jul 20, 2026Estimated
Primary Completion Date: Jan 31, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 33Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: No data available
Locations: No data available

Similar Studies

Participant Group/Arms

Single-Layered 10% Circumferential Reduction (S-10) Pressure GarmentActive Comparator

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

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

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

Single-Layered 15% Circumferential Reduction (S-15) Pressure GarmentActive Comparator

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