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临床试验/NCT02755415
NCT02755415Unknown不适用

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

China Medical University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Berg Balance Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

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

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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)

结局指标

主要结局

Berg Balance Scale

时间窗: 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

次要结局

  • EuroQol five dimensions questionnaire (EQ-5D)(10-15 minutes)
  • Pittsburgh Sleep Quality Index(10-15 minutes)
  • Resting muscle tone(10 minutes)
  • Resting muscle elasticity(10 minutes)
  • Six minute walk test(6 minutes)
  • Beck's depression Inventory(7-10 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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