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Идёт набор NCT06587308

Effects of Different Pressure Garments on Upper Extremity Sensorimotor Functions and Quality of Life After Stroke

Без фазы С лечением Cerebral Vascular Accident (CVA)/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: Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment, Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment, Single-Layered No Circumferential Reduction (S-0) Pressure Garment.
Кому может быть актуально
Состояния в реестре: Cerebral Vascular Accident (CVA)/Stroke. Базовые параметры: 18 лет — 80 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
Китай
Следующий шаг
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Официальное название

Effects of Pressure Garments of Varying Designs on Upper Extremity Sensorimotor Functions and Quality of Life After Stroke: A Multicenter, Double-Blind, Prospective Randomized Controlled Trial

Обзор

The study aims to compare the effects of dorsal-double-layered 10% circumferential reduction (DD-10), single-layered 10% circumferential reduction (S-10), and single-layered no circumferential reduction (S-0) pressure garments on sensorimotor functions, including motor control, dexterity, muscle tone, pain, self-perceived upper extremity function, and quality of life among stroke patients during the 8 weeks of application (Time 1: Baseline, Time 2: Week 4, Time 3: Week 8).

Вмешательства

  • Другое Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment
    During Phase IA, i.e., the first four weeks between Time 1 (Baseline) and Time 2 (Week 4), when participants are hospitalized in the rehabilitation department of the hospital. participants will need to wear the DD-10 pressure garment for 3 hours in the morning, 3 hours in the afternoon, and 8 hours at night daily. Additionally, all participants will need to attend an occupational therapy session for 30 minutes, 5 days a week. During Phase IB, i.e., the second four weeks between Time 2 (Week 4),
  • Другое Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment
    During Phase IA, i.e., the first four weeks between Time 1 (Baseline) and Time 2 (Week 4), when participants are hospitalized in the rehabilitation department of the hospital. participants will need to wear the S-10 pressure garment for 3 hours in the morning, 3 hours in the afternoon, and 8 hours at night daily. Additionally, all participants will need to attend an occupational therapy session for 30 minutes, 5 days a week. During Phase IB, i.e., the second four weeks between Time 2 (Week 4), a
  • Другое Single-Layered No Circumferential Reduction (S-0) Pressure Garment
    During Phase IA, i.e., the first four weeks between Time 1 (Baseline) and Time 2 (Week 4), when participants are hospitalized in the rehabilitation department of the hospital. participants will need to wear the S-0 pressure garment for 3 hours in the morning, 3 hours in the afternoon, and 8 hours at night daily. Additionally, all participants will need to attend an occupational therapy session for 30 minutes, 5 days a week. During Phase IB, i.e., the second four weeks between Time 2 (Week 4), an

Первичные конечные точки

  • Fugl-Meyer Assessment (FMA) [Срок оценки: Baseline, Week 4. Week 8]
Вторичные конечные точки (5)
  • Modified Ashworth Scale (MAS) [Срок оценки: Baseline, Week 4. Week 8]
  • Visual Analogue Scale (VAS) [Срок оценки: Baseline, Week 4. Week 8]
  • Box and Block Test (BBT) [Срок оценки: Baseline, Week 4. Week 8]
  • Disabilities of Arm, Shoulder and Hand (DASH) Outcome Measure [Срок оценки: Baseline, Week 4. Week 8]
  • 36-Item Short Form Health Survey (SF-36) [Срок оценки: Baseline, Week 4. Week 8]

Критерии участия

Критерии включения

  • Between 18 and 80 years of age
  • Within 1-12 months of ischemic or hemorrhagic stroke
  • First onset resulting in hemiparesis of a limb with Burnnstrom stage of 3, 4 or 5
  • Modified Ashworth Scale with scores of less than or equal 2 for elbow, wrist, and hand muscle tone in the affected upper extremity
  • Able to understand instruction

Критерии исключения

  • Serious cardiovascular or respiratory diseases
  • Skin lesions, infections or other skin problems
  • Serious circulatory problems such as deep vein thrombosis
  • Allergies or significant discomfort to pressure garment materials
  • Upper extremity fractures or severe joint problems
  • Severe cognitive impairment with Saint Louis University Mental Status (SLUMs) scores equal to or less than 27 (above high school level of education)/25 (below high school level of education)

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Китай · 3 центра
  • The Affiliated Hospital of Shandong Second Medical University — Weifang
  • Weifang Hospital of Traditional Chinese Medicine — Weifang
  • Weifang Municipal Peoples Hospital — Weifang

Публикации

  • Xu Z, Chai SC, Chu SY, Li K. Effects of pressure garments of varying designs on upper extremity sensorimotor functions and quality of life after stroke: Study protocol for a multicenter, double-blind, prospective randomized controlled trial. PLoS One. 2025 Jun 23;20(6):e0326680. doi: 10.1371/journal.pone.0326680. eCollection 2025. PMID 40549786

Идентификаторы

NCT: NCT06587308 · JEP-2024-582

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗