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

21 de julio de 2026 actualizado por: 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:

  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

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

33

Fase

  • No aplica

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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.
Comparador activo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Interface pressure measured using PicoPress® Compression System
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Shape/Texture Identification (STI) test
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Montreal Cognitive Assessment (MoCA) - Bahasa Malaysia version
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

20 de julio de 2026

Finalización primaria (Estimado)

31 de enero de 2027

Finalización del estudio (Estimado)

31 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

21 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de julio de 2026

Publicado por primera vez (Actual)

24 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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