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Clinical Applicability of Robot-assisted Gait Training System in Acute Stroke Patients

2016年7月26日 更新者:China Medical University Hospital
Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted gait training system for acute stroke survivors. It is anticipated that robot-assisted gait rehabilitation will achieve significantly better gait and quality of life outcomes than the standing table rehabilitation.

研究概览

详细说明

Stroke is not only the second leading cause of mortality in Taiwan, it is also the primary cause of long-term physical and psychological disabilities in our society. Array of reasons have been suggested to be an obstacle for stroke patients to receive adequate physical rehabilitation, including the lack of physical capacity, severe neurological deficits or the loss of strength. Given the critical importance of high-intensity and high-repetitiveness of early rehabilitation for stroke patients in achieving sustainable long term outcomes, robot-assisted gait rehabilitation devices have gained great interest in the last decade and is slowly becoming part of the clinical rehabilitation program for stroke patients. However, despite the growing interest and the significant resources invested for the development of robot-assisted rehabilitation devices, there still lacks empirical evidence of its clinical applicability for stroke patients. Moreover, available evidence to date have mostly focused on sub-acute and chronic stroke patients and investigation in acute stroke population, especially in those with complete incapacitation for ambulation, is sparse. It is therefore the aim of the proposed project to fulfil this significant gap in our clinical knowledge by comparatively investigate the clinical applicability of a recently developed HIWIN Robotic Gait Training System (MRG-P100) against the traditional rehabilitation program with an emphasis on the determination of psychological and functional capacity recovery status in acute stroke survivors.

研究类型

介入性

注册 (预期的)

60

阶段

  • 不适用

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

      • Taichung、台湾、408
        • 招聘中
        • China Medical University Hospital
        • 接触:
        • 首席研究员:
          • Li-Wei Chou, MD, PhD, MSc
        • 副研究员:
          • Nai-Hsin Meng, MD
        • 副研究员:
          • Andy Chien, PhD

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

20年 至 80年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Between the age of 20-80 years;
  • Diagnosis of first, single unilateral cortical-subcortical acute stroke verified by brain imaging;
  • Paresis of a lower limb;
  • Ability to walk for only a few meters either with or without aid.

Exclusion Criteria:

  • Deemed by a physician to be medically unstable;
  • Other prior musculoskeletal conditions that affected gait capacity;
  • Co-existence of other neurological diseases;
  • Cognitive impairments that would impact on the safe participation in the study (MMSE<23)

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

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Static Standing Table Training
Patients in this group will receive standard hospital based rehabilitation as well as static standing table training
As part of the standard hospital rehabilitation, static standing table allows patient to be in a fully supported standing position
实验性的:Robotic Gait Training
Patients in this group will receive standard hospital based rehabilitation as well as robot-assisted gait rehabilitation training
HIWIN Robotic Gait Training System is an automatic training system that combines weight-bearing standing, repetitive stepping and gait training

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
Berg Balance Scale
大体时间:15-20 minutes
The Berg Balance Scale (or BBS) is a widely used clinical test of a person's static and dynamic balance abilities and is generally considered to be the gold standard for clinical practice
15-20 minutes

次要结果测量

结果测量
措施说明
大体时间
Pittsburgh Sleep Quality Index
大体时间:10-15 minutes
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders
10-15 minutes
EuroQol five dimensions questionnaire (EQ-5D)
大体时间:10-15 minutes
EuroQol five dimensions questionnaire (EQ-5D) is a standardized instrument for measuring generic health status.
10-15 minutes
Resting muscle tone
大体时间:10 minutes
A device developed by Myoton Technology (Myoton AS, Estonia) will be used to determine the resting muscle tone (oscillation frequency [Hz]) of the tibialis anterior muscle, gastrocnemius muscle, rectus femoris muscle and biceps femoris muscle.
10 minutes
Resting muscle elasticity
大体时间:10 minutes
A device developed by Myoton Technology (Myoton AS, Estonia) will be used to determine the resting muscle elasticity (Oscillation stiffness [N/m]) of the tibialis anterior muscle, gastrocnemius muscle, rectus femoris muscle and biceps femoris muscle.
10 minutes
Six minute walk test
大体时间:6 minutes
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
6 minutes
Beck's depression Inventory
大体时间:7-10 minutes
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
7-10 minutes

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

2016年5月1日

初级完成 (预期的)

2017年4月1日

研究完成 (预期的)

2017年12月1日

研究注册日期

首次提交

2016年4月21日

首先提交符合 QC 标准的

2016年4月26日

首次发布 (估计)

2016年4月28日

研究记录更新

最后更新发布 (估计)

2016年7月27日

上次提交的符合 QC 标准的更新

2016年7月26日

最后验证

2016年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

Individual participant data will remain confidential and accessible to only the approved researchers

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.

Static Standing Table的临床试验

3
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