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临床试验/NCT04402736
NCT04402736已完成不适用

Feasibility and Effectiveness of a Modified Barthel Index-based Rehabilitation Nursing Program for Acute Ischemic Stroke

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2018年1月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
104
试验地点
1
主要终点
Change from baseline the Modified Barthel Index (MBI) on day 7

研究概览

简要总结

In the clinical setting, it is difficult to obtain effective rehabilitation during the acute phase, the reasons may include insufficient awareness of early rehabilitation due mainly to a limitation in number and variety of rehabilitation professionals in Low- and middle-income countries. It is necessary to shift tasks to other healthcare providers who are trained to provide rehabilitation like nurses. The purpose of this study is to examine the feasibility and effectiveness of a modified Barthel Index based rehabilitation nursing program on acute stroke inpatients.

详细描述

Ischemic stroke is the main cause of disability in the world. More than 70% of stroke patients show various degrees of neural function impairment. Early rehabilitation in acute phase is beneficial for improving patient's activity of daily livings and motor function. However, it is difficult to obtain effective rehabilitation during the acute phase of stroke because of the insufficiency of professional rehabilitation therapists in stroke wards in China. The investigators assume that implementing program based on modified Barthel Index can realize nursing-directed motor rehabilitation during acute phase of ischemic stroke. The present study is to conduct quasi-experimental research to confirm the feasibility and effectiveness of nursing-directed precision rehabilitation in acute stroke patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •diagnosed with ischemic stroke and met the diagnostic criteria of the World Health Organization;
  • •initial stroke within seven days, with limb dysfunction;
  • •NIHSS scale consciousness scores of 0 or 1;
  • •provided informed consent form.

排除标准

  • •incomplete clinical data;
  • •having a physical disability or other diseases that affect the limb function;
  • •having cognitive impairment or other diseases that interfere with participation;
  • •having serious cardiopulmonary dysfunction or another disease that requires absolute bed rest;
  • •having progressive stroke or having severe complications that patients drop the study before completion.

研究组 & 干预措施

Modified Barthel Index-based rehabilitation nursing program

Experimental

Patients received the Modified Barthel Index based rehabilitation nursing from qualified nurses.

干预措施: The modified Barthel Index-based rehabilitation nursing program (Behavioral)

Usual care

Other

Patients received the usual care.

干预措施: Usual care (Behavioral)

结局指标

主要结局

Change from baseline the Modified Barthel Index (MBI) on day 7

时间窗: Day 0 and day 7

The MBI score ranges from 0 to 100, the higher scores mean a better outcome.

Change from baseline the motor assessment scale (MAS) on day 7

时间窗: Day 0 and day 7

The MAS scale excluding general tonus, may be summed to provide an overall score out of a possible 48 points and the higher scores mean a better outcome.

Change from baseline the National Institute of Health Stroke Scale (NIHSS) on day 7

时间窗: Day 0 and day 7

The NIHSS scale ranges from 0 to 42, and the higher scores mean a worse outcome.

次要结局

  • The completion rate(Day 7)
  • The adverse events rate(Day 7)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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