Interface Pressures, Safety, Adherence, and Tactile Outcomes of Different Pressure Garments After Stroke
21 juillet 2026 mis à jour par: National University of Malaysia
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
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
33
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
|
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.
|
|
Expérimental: 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.
|
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.
|
|
Comparateur actif: 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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Interface pressure measured using PicoPress® Compression System
Délai: 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.
|
Baseline, Week-1, Week-2, Week-3, and Week-4
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Shape/Texture Identification (STI) test
Délai: 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.
|
Baseline, Week-2, and Week-4
|
|
Daily Self-Report and Adverse Events of Special Interest (AESI) Logbook
Délai: 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).
|
Completed by participants or caregiver daily, reviewed weekly by researcher
|
|
Modified Ashworth Score (MAS)
Délai: 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.
|
Baseline, Week-1, Week-2, Week-3, and Week-4
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Montreal Cognitive Assessment (MoCA) - Bahasa Malaysia version
Délai: 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.
|
Prior to participant enrolment
|
|
Modified Ashworth Score (MAS)
Délai: 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.
|
Prior to participant enrolment
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
20 juillet 2026
Achèvement primaire (Estimé)
31 janvier 2027
Achèvement de l'étude (Estimé)
31 mars 2027
Dates d'inscription aux études
Première soumission
21 juillet 2026
Première soumission répondant aux critères de contrôle qualité
21 juillet 2026
Première publication (Réel)
24 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
24 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- JEP-2025-586
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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