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临床试验/NCT03616314
NCT03616314已完成不适用

Effects of Early Stepping Verticalization With or Without FES Compared to Conventional Physiotherapy on the Occurrence of Critical Illness Polyneuropathy in Patients Affected by Acquired Brain Injury: a Retrospective Study

Ospedale Generale Di Zona Moriggia-Pelascini1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
39
试验地点
1
主要终点
CIP occurrence

研究概览

简要总结

Background: Intensive Care Unit (ICU) survivors often develop an acquired weakness due to a Critical Illness Polyneuropathy (CIP). Early mobilization in ICU, by reducing the bed rest and decreasing the oxidative stress, was shown to represent a valid preventive option.

Purpose: To evaluate whether ICU sessions of stepping verticalization associated with Functional Electrical Stimulation (FES) of the lower limbs are able to reduce the occurrence of CIP in Acquired Brain Injured (ABI) patients.

Methods: all the ABI patients admitted in our Neurorehabilitation Unit from our ICU were retrospectively evaluated. Patients affected by previous peripheral neuropathy, diabetes, cancer, alcoholism, viral hepatitis, AIDS and autoimmune diseases were excluded. They were divided into 3 groups according to the rehabilitation strategy received in ICU: group 1 received conventional physiotherapy + stepping verticalization sessions with Erigo® (Hocoma, Switzerland); group 2 received conventional physiotherapy + stepping verticalization sessions with FES using ErigoPro®; group 3 received only conventional physiotherapy. As for internal protocol, all patients started rehabilitation in the first week from the ABI and performed 60 minutes/day of rehabilitation, 5 days/week. Primary outcome was the evidence of CIP at Neurorehabilitation admission (=ICU discharge), according to neurophysiological criteria. Secondary outcomes were the strength impairment at Neurorehabilitation discharge, measured by the total Motricity Index score and the Functional Ambulation Classification (FAC) score, assessing quality of gait.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • arriving directly from our acute care facility
  • hospitalized in ICU due to an acute brain injury

排除标准

  • previous peripheral neuropathies
  • alcoholism
  • viral hepatitis
  • autoimmune diseases
  • absence of clinical or neurophysiological informations at data collection

结局指标

主要结局

CIP occurrence

时间窗: at enrollment

Presence of critical illness polyneuropathy at the end of ICU stay

次要结局

  • motricity index(at enrollment)
  • Functional Ambulation Classification (FAC)(at enrollment)

研究者

发起方
Ospedale Generale Di Zona Moriggia-Pelascini
申办方类型
Other
责任方
Sponsor

研究点 (1)

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