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Набор скоро начнётся NCT07725744

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

Без фазы С лечением CVA (Cerebrovascular Accident) Stroke

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 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.
Кому может быть актуально
Состояния в реестре: CVA (Cerebrovascular Accident), Stroke. Базовые параметры: 21 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Interface Pressures, Safety, Adherence, and Tactile Outcomes of Different Pressure Garments After Stroke: A Prospective, Participant-Blinded, Three-Arm, Parallel-Group Randomized Controlled Trial

Обзор

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

Вмешательства

  • Другое 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
  • Другое 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
  • Другое 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

Первичные конечные точки

  • Interface pressure measured using PicoPress® Compression System [Срок оценки: Baseline, Week-1, Week-2, Week-3, and Week-4]
Вторичные конечные точки (3)
  • Shape/Texture Identification (STI) test [Срок оценки: Baseline, Week-2, and Week-4]
  • Daily Self-Report and Adverse Events of Special Interest (AESI) Logbook [Срок оценки: Completed by participants or caregiver daily, reviewed weekly by researcher]
  • Modified Ashworth Score (MAS) [Срок оценки: Baseline, Week-1, Week-2, Week-3, and Week-4]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07725744 · JEP-2025-586

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗