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临床试验/NCT04373109
NCT04373109已完成不适用

Stroke Rehabilitation Outcome During COVID-19 Lockdown

Jeremia Held1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年4月16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
36
试验地点
1
主要终点
Motor Activity Log - 14 Item Version

研究概览

简要总结

COVID-19 has a big impact on individuals and society as a whole. Especially persons with (multiple) comorbidities such as stroke are affected. The impact of COVID-19 on stroke rehabilitation delivery and stroke patients' functioning is unclear.

详细描述

With 16'000 patients hospitalized and with new permanent disability in approximately 7'000 individuals every year in Switzerland, stroke has a major impact on quality of life and is an enormous socioeconomic burden. Virtually all patients receive inpatient rehabilitation in the sub-acute phase poststroke. However, also in the later phases poststroke, patients receive rehabilitation interventions in outpatient rehabilitation clinics and private practices, with goal to improve or maintain their functional capacity.

Currently, Switzerland finds itself in an extraordinary situation. The Federal Council has issued a series of measures aimed at the population, organizations and institutions, and the cantons. The aim is to curb the spread of the coronavirus and assure the provision of healthcare. The people are invoked to stay at home and only leave the home if absolutely necessary. If they are over the age of 65 or have an underlying medical condition, the Federal Council strongly recommend that you stay at home under any circumstances unless you have to go to the doctor.

With the recommendation of the Swiss Federal Council almost all stroke patients belong to the group who should stay home. Furthermore, all outpatient rehabilitation clinics have reduced the interventions to a minimum. It is unknown how a sudden stop of rehabilitation influences the stroke patients' functional capacities and their perceived quality of life.

研究设计

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

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

  • Ischemic or haemorrhagic stroke, confirmed by MRI-DWI and/or CT
  • Participating in a stroke research project before the Lockdown (ESTREL - BASEC Nr. 2018-02021/ RE-USE - BASEC-Nr. 2017-01070)
  • Age 18 years or older
  • Verbal and written informed consent of the patient after participants' information

排除标准

  • Severe communication or cognitive deficits, that cause inability to follow the procedures

结局指标

主要结局

Motor Activity Log - 14 Item Version

时间窗: 3 month after start lockdown

Patient-reported upper limb use in daily life

Patient-Reported Outcomes Measurement Information System - 29 Version

时间窗: 3 month after start lockdown

Patient-self-assessment comprising the following categories: 1) physical function, 2) anxiety, 3) depression, 4) fatigue, 5) sleep disturbance, 6) ability to participate in social roles and activities, 7) pain interference and 8) pain intensity

Rehabilitation data

时间窗: 3 month after start lockdown

Nature of rehabilitation therapy, and number and duration of rehabilitation therapy sessions

International Physical Activity Questionnaire

时间窗: 3 month after start lockdown

Patient-reported engagement in physical activity in daily life

次要结局

  • Global Rating of Perceived Changes (physical activity engagement and upper limb use)(4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown)
  • Functional Ambulation Categories(4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown)
  • Action Research Arm Test(4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown)
  • Motor Activity Log - 14 Item Version(4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 6 months after lockdown)
  • Hospital Anxiety and Depression Scale(4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown)
  • Ten-Meter Walk Test(4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown)
  • Fatigue Severity Scale(4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown)
  • Rivermead Mobility Index(4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown)
  • Fugl-Meyer Motor Assessment(4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown)
  • modified Rankin Scale(4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown)
  • Rehabilitation data(4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 6 months after lockdown)
  • Montreal Cognitive Assessment(4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown)
  • Activities-specific Balance Confidence Scale(4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown)
  • National Institutes of Health Stroke Scale(4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown)
  • International Physical Activity Questionnaire(4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 6 months after lockdown)
  • Patient-Reported Outcomes Measurement Information System - 29 Version(4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 6 months after lockdown)

研究者

发起方
Jeremia Held
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jeremia Held

Dr.

University of Zurich

研究点 (1)

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