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Идёт набор NCT06700694

Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units

Без фазы С лечением Intensive Care Unit Acquired Weakness

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: Technology-assisted, family-engaged in-bed activities, Protocol-oriented early mobilization program.
Кому может быть актуально
Состояния в реестре: Intensive Care Unit Acquired Weakness. Базовые параметры: от 18 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
Тайвань
Следующий шаг
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Официальное название

The Effect of Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units: A Randomized Controlled Trial

Обзор

This single-blind, three-group parallel randomized controlled trial will involve 138 patients with critical illness, randomly assigned at a 1:1:1 ratio to the technology-assisted early mobilization group (46 patients), the systematic early mobilization group (46 patients), or the control group (46 patients). The technology-assisted early mobilization group will receive interventions within 72 hours of ventilator use. The interventions include protocol-oriented early mobilization program carried out by physiotherapist and researcher and technology-assisted in-bed activities primarily assisted by family members. The systematic early mobilization group will receive only the similar protocol-oriented early mobilization program within 72 hours of ventilator use. The control group will receive routine rehabilitation as usual. The primary outcomes include occurrence of intensive care unit-acquired weakness (ICUAW). Secondary outcomes include muscle strength, delirium, sleep status, clinical outcomes, activities of daily living, and quality of life. Measurements will be assessed on the day of enrollment, during the ICU stay, on the day of ICU discharge (or up to 28 days), on the day of hospital discharge, and six months after hospital discharge.

Вмешательства

  • Другое Technology-assisted, family-engaged in-bed activities
    Technology-assisted, family-engaged in-bed activities include handgrip interactive games, virtual reality butterfly catching, virtual reality magic cube games, and immersive in-bed cycling, performed 20 minutes per session, twice daily, five days a week, primarily assisted by family members.
  • Другое Protocol-oriented early mobilization program
    The protocol-oriented early mobilization program is implemented based on the patient's muscle strength and the Intensive care unit Mobility Scale (IMS), including lying, sitting, standing, stepping, and walking, once daily for 20-60 minutes, five days a week, carried out by physiotherapist and researcher.

Первичные конечные точки

  • Occurrence of intensive care unit-acquired weakness (ICUAW) [Срок оценки: On the day of enrollment and ICU discharge (or up to 28 days after enrollment).]
Вторичные конечные точки (12)
  • Muscle power [Срок оценки: On the day of enrollment and ICU discharge (or up to 28 days after enrollment).]
  • Hand-grip strength [Срок оценки: On the day of enrollment and ICU discharge (or up to 28 days after enrollment).]
  • Delirium [Срок оценки: Through intervention completion, up to 28 days.]
  • Subjective sleep status [Срок оценки: Through intervention completion, up to 28 days.]
  • Objective sleep status [Срок оценки: Through intervention completion, up to 28 days.]
  • Functional Status [Срок оценки: On the day of enrollment and ICU discharge (or up to 28 days after enrollment).]
  • Duration of ventilation use [Срок оценки: On the day of hospital discharge (expected up to 3 month).]
  • Length of stay in the ICU [Срок оценки: On the day of hospital discharge (expected up to 3 month).]
  • Length of stay in the hospital [Срок оценки: On the day of hospital discharge (expected up to 3 month).]
  • Adverse event [Срок оценки: Through intervention completion, up to 28 days.]
  • Activities of daily living (ADL) [Срок оценки: On the day of ICU discharge (up to 28 days after enrollment), hospital discharge (expected up to 3 month), and six-month after hospital discharge.]
  • Sleep quality [Срок оценки: On the day of hospital discharge (expected up to 3 month) and six-month after hospital discharge.]

Критерии участия

Критерии включения

  • Aged ≥ 18 years
  • Being mechanically ventilated ≥ 24 hours
  • Richmond Agitation-Sedation Scale (RASS): 0 to -1
  • No vision, hearing, or body movements restriction
  • With clear consciousness and ability to communicate in Chinese
  • Expected to stay in the ICU > 96 hours.

Критерии исключения

  • Have developed delirium before enrollment (ICDSC > 4)
  • With acute physiology and chronic health evaluation (APACHE II) score > 25 after ICU admission within 24 hours
  • With muscle weakness caused by severe acute brain injury (e.g., traumatic brain injury or stroke), spinal coral injury, other neuromuscular conduction diseases, or long-term bedridden or hemiplegia.

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
Простое слепое
Основная цель
Профилактика

Центры проведения

Тайвань · 1 центр
  • Taipei Medical University Hospital — Taipei

Идентификаторы

NCT: NCT06700694 · N202403085

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗