跳至主要内容
临床试验/NCT02079779
NCT02079779已完成不适用

Study of the Effectiveness of an Interactive Robot for the Rehabilitation of the Upper Limb in Acute Stroke Patients by Evaluating the 3 Fields of the ICF: a Prospective, Randomized, Controlled, Simple Blind Study

Cliniques universitaires Saint-Luc- Université Catholique de Louvain6 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2015年1月9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
45
试验地点
6
主要终点
Kinematic

研究概览

简要总结

Stroke is the principal cause of permanent disability within the investigators population. This incapacity justifies an intensive and prolonged multidisciplinary rehabilitation, which can be optimized by robotics.

The investigators team has developed a robot designed to rehabilitate the upper limb. This robot allows the patient to perform active, passive, or assisted exercises. The system is also able to assess movement quality and to provide a feedback to the patient and the therapist via a graphical interface. This therapy is designed to improve functional recovery of patients, and then their quality of life.

Few quality studies have evaluated the efficacy of robotic assisted therapy in patients at the acute stage of rehabilitation (< 3 months post stroke) when most improvements are observed.

Thus, the aim of this study was to objectify the effectiveness of robotic-assisted rehabilitation in the acute stage after stroke by evaluating the 3 fields of the ICF (International Classification of Functioning, Disability and Health) and performing a prospective multicenter randomized controlled single blind trial. In this study, 60 stroke patients will be recruited and randomized into two groups. All patients will receive a similar classical rehabilitation as a basis. Patients of the control and experimental groups will receive a supplement of classical rehabilitation and robotic-assisted therapy, respectively.

详细描述

INTRODUCTION

The cerebral vascular accident affects two people per thousand each year (Duncan et al. 2005). This injury is the leading cause of permanent disability in our population. The brain damage is expressed by different neurological impairments and functional disabilities. These disabilities justify intensive and sustained multidisciplinary rehabilitation to reduce neurological impairments, to improve the activities and participation of patients, and, ultimately, their quality of life (Duncan et al., 2005).

Recently appeared in rehabilitation to stimulate maximum brain plasticity robotic devices meet the actual recommendations existing in stroke's rehabilitation (Langhorne et al., 2011). Indeed, the robots allow the execution of a large number of movements whose quality is controlled. A visual interface gives the patient a feedback of its movements, and offers exercises oriented functional tasks that have meaning for him and the possibly dive into a virtual reality. All these elements justify the clinical development of robots to assist the therapists (Pignolo et al. 2009).

The therapeutic efficacy of these robots for the rehabilitation of the upper limb was evaluated especially in chronic stroke patients (> 6 months after stroke) (Mehrholz et al., 2012). Unfortunately, few quality studies was conducted in these patients at the acute stage of rehabilitation, during which the potential of brain plasticity is the most important and the largest functional progress are observed (Stinear et al. 2012). In addition, few studies have evaluated the effect of these therapies robotic on the three fields of the ICF (Mehrholz et al., 2012). Many studies focus on impairments (e.g. muscle strength) without assessing the functional ability of the patient in activities of daily living.

OBJECTIVES

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
Single (Outcomes Assessor)

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

入选标准

  • first stroke
  • acute stroke (less than 1 month)
  • unilateral localisation of the stroke
  • moderate to severe upper limb impairments (7<Fugl Meyer score<50/66)

排除标准

  • brainstem or cerebellum stroke
  • an unstable clinical condition contraindicating the upper limb rehabilitation treatments
  • cognitive disorders preventing the understanding of the instructions
  • other neurological or orthopedic pathology affecting the upper limb

结局指标

主要结局

Kinematic

时间窗: Change from Baseline in Kinematic at an expected average of 2 months (after the treamtment) and 6 months post stroke

次要结局

  • Abilhand(Change from Baseline in activity of daily living at an expected average of 2 months (after the treamtment) and 6 months post stroke)
  • Stroke Impairment Assessment Set (sensitive and Pain items)(Change from Baseline in sensitivity and pain at an expected average of 2 months (after the treamtment) and 6 months post stroke)
  • Stroke Impact Scale (Participation item)(Change from Baseline in participation in social activities at an expected average of 2 months (after the treamtment) and 6 months post stroke)
  • Box and Block test(Change from Baseline in manual ability at an expected average of 2 months (after the treamtment) and 6 months post stroke)
  • Fugl-Meyer upper limb assessment(Change from Baseline in upper limb motor control at an expected average of 2 months (after the treamtment) and 6 months post stroke)
  • Strenght test of the Medical Research council(Change from Baseline in upper limb strenght at an expected average of 2 months (after the treamtment) and 6 months post stroke)
  • Wolf Motor Function Test(Change from Baseline in activity of daily living at an expected average of 2 months (after the treamtment) and 6 months post stroke)
  • Ashworth test(Change from Baseline in upper limb spasticity at an expected average of 2 months (after the treamtment) and 6 months post stroke)
  • Bell's test(Change from Baseline in Hemineglect at an expected average of 2 months (after the treamtment) and 6 months post stroke)
  • Activlim(Change from Baseline in activity of daily living at an expected average of 2 months (after the treamtment) and 6 months post stroke)

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Sponsor

研究点 (6)

Loading locations...

相似试验

Efficacy Study of an Interactive Robot for the... | 临床试验