Interface Pressures, Safety, Adherence, and Tactile Outcomes of Different Pressure Garments After Stroke
21. Juli 2026 aktualisiert von: 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
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Studientyp
Interventionell
Einschreibung (Geschätzt)
33
Phase
- Unzutreffend
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: 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.
|
|
Experimental: 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.
|
|
Aktiver Komparator: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Interface pressure measured using PicoPress® Compression System
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Shape/Texture Identification (STI) test
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Montreal Cognitive Assessment (MoCA) - Bahasa Malaysia version
Zeitfenster: 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)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
20. Juli 2026
Primärer Abschluss (Geschätzt)
31. Januar 2027
Studienabschluss (Geschätzt)
31. März 2027
Studienanmeldedaten
Zuerst eingereicht
21. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
21. Juli 2026
Zuerst gepostet (Tatsächlich)
24. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
24. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
21. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- JEP-2025-586
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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