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Sunnaas International Network´s Stroke Study (SINs)

2017年4月24日 更新者:Birgitta Langhammer、Sunnaas Rehabilitation Hospital

A Prospective Multicenter Study of Stroke Rehabilitation in Seven Countries: Norway, China, USA, Russia, Israel, Palestine, and Sweden.

A descriptive study of the stroke rehabilitation content in specialized clinics in seven countries: procedures for admission to rehabilitation, services available and provided to patients, as well as duration of the stay and discharge routines. An observational study of changes in regard to the physical function, quality of life and psycho-social factors in stroke patients before and after specialized rehabilitation

研究概览

地位

完全的

条件

详细说明

The descriptive study is two folded:

1) Description of the rehabilitation centers and the content the respective clinic presents as specialized rehabilitation.

A description of the expected change this input will result in in form of patients change in ADL and life satisfaction, with repeated measurements:

2a) reports of change in activities of daily living from baseline, to one fixed time (18-22 days in rehab),at discharge (which will vary),6 and 12 months post discharge (relatively fixed time) .

2b) reports of possible change in life satisfaction at baseline, discharge, 6 and 12 months after discharge.

Since the times for admission is expected to vary, which will be described under 1),we also want to measure if and how this difference might influence results. Therefore a fixed measure is inserted between admission and discharge. we have added a "relatively" fixed date at 6 months post stroke in order to see if change of function from specialized rehabilitation will differ in a longitudinal perspective, and if possible to see if the difference in time to admission (time from debut till admission in specialized rehabilitation)might influence results.

3) description of psycho- social factors at 6 and 12 months post discharge

研究类型

观察性的

注册 (实际的)

230

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Beijing、中国
        • China Research rehabilitation center
    • Sichuan
      • Chengdu、Sichuan、中国
        • Sichuan 81 rehabilitation center
      • Tel Aviv、以色列
        • Sheba Medical Center
      • Petrozavodsk、俄罗斯联邦
        • Petrozavodsk
      • Gaza、巴勒斯坦领土,被占领
        • El Wafa rehabilitation center
    • Palestine
      • Betlehem、Palestine、巴勒斯坦领土,被占领
        • Betlehem arab society rehabilitation
      • Nesoddtangen、挪威
        • Sunnaas rehabilitation hospital
      • Gothenburgh、瑞典
        • Sahlgrenska University Hospital
    • New York
      • New York、New York、美国
        • Rusk Institute

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

stroke patients in need of specialised comprehensive rehabilitation

描述

Inclusion Criteria:

  • primary diagnosis of stroke, in need of specialized comprehensive rehabilitation, voluntary participation

Exclusion Criteria:

  • sub-arachnoid hæmorrhage, tumor or other severe medical condition in combination with stroke that will influence outcomes

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:预期

队列和干预

团体/队列
干预/治疗
stroke patients
specialized rehabilitation in a multidisciplinary team, Sunnaas International Network
Description of specialized rehabilitation and Influence on activities, life satisfaction, psycho social aspects 6 and 12 months post discharge
其他名称:
  • multidisciplinary specialised rehabilitation

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
activities of daily living
大体时间:patients will be followed 6 months from baseline testing
Changes in Activities of daily living are monitored as an indirect evaluation of how the specialized rehabilitation may influence patients' outcomes.
patients will be followed 6 months from baseline testing

次要结果测量

结果测量
措施说明
大体时间
The Life Satisfaction checklist (LiSat-11)
大体时间:patients will be followed 6 months from baseline testing
LiSat-11 consists of patients estimations of satisfaction with life as a whole as well as satisfaction in ten specific domains: vocation, economy, leisure, contacts, sexual life, activities of daily living (ADL), family life, partner relationship, somatic health, psychological health
patients will be followed 6 months from baseline testing

其他结果措施

结果测量
措施说明
大体时间
National Institutes of health stroke scale (NIHSS)
大体时间:patients will be tested baseline and at discharge

NIHSS is a clinical stroke assessment tool to evaluate and document neurological status in acute stroke patients.

The timeframe for discharge will vary with the different clinics since this is one of the differences expected.

Length of stay is one of the outcomes

patients will be tested baseline and at discharge
Modified Rankin Scale
大体时间:patients will be followed 6 months from baseline testing
it is an evaluation of the degree of disability or dependence in the daily activities of people who have suffered a stroke
patients will be followed 6 months from baseline testing
Description of the psycho- social situation
大体时间:6 months after discharge
A semi - structured interview, with focus on the psycho-social situation 6 months after rehabilitation, will be performed. Questions will focus on the work-, financial situation, what sort of follow-up services, recreational- and social activities are available, and what is considered the major change of life after stroke.
6 months after discharge
description of institution
大体时间:baseline
a questionaire where the participants are required to describe the services available, methods used in rehabilitation, intensity of training, procedures for intake and discharge
baseline
registration data
大体时间:baseline
questionnaire regarding demographic data; age, gender, civil status, comorbidity, medication
baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年9月1日

初级完成 (实际的)

2014年12月1日

研究完成 (实际的)

2016年10月1日

研究注册日期

首次提交

2012年11月8日

首先提交符合 QC 标准的

2012年11月23日

首次发布 (估计)

2012年11月26日

研究记录更新

最后更新发布 (实际的)

2017年4月25日

上次提交的符合 QC 标准的更新

2017年4月24日

最后验证

2017年4月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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