跳至主要内容
临床试验/NCT02770300
NCT02770300终止不适用

Effect of an Automatic Personalized Robot-assisted Rehabilitation on Cortical Organization and Clinical Recovery After Stroke

Wearable Robotics srl.2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2016年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
28
试验地点
2
主要终点
Efficacy evaluated through Fugl-Meyer

研究概览

简要总结

The primary goal of this project is to test the safeness and clinical effectiveness of a novel exoskeleton for the upper limb (Arm Light Exoskeleton Rehab Station, ALEx RS) developed at Wearable Robotics srl, for the force assistance of stroke patients during robotic-rehabilitation.

The secondary study aim is to design and test an automatic personalized robot-based upper limb motor rehabilitation protocol targeting the specific kinematic performance of each patient.

Finally, the study also aims to define the "neuro-biomechanical state" of the patient and its evolution during the therapy by studying cortical signals and muscular synergies. This information will be used to improve the personalization of the robotic treatment by targeting not only the motor performance but also the cerebral and muscular activity of the patient.

The study is longitudinally designed in order to test the safeness and clinical effectiveness of ALEx RS over time, and to monitor the clinical effectiveness of the automatic personalized robotic therapy from the beginning until the end of the treatment. Moreover, in order to estimate the long-term clinical effectiveness of the treatment, the assessment methods proposed in the clinical trial will be repeated one month after the end of the treatment.

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
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • stroke patients
  • right and left hand dominant
  • cerebral lesion onset between 2-8 weeks
  • able to participate in a session of about 30-60 minutes
  • right-hemiplegic with at least 10° of motion in the treated joints (shoulder and elbow)
  • age: more than 18 years old

排除标准

  • subjects with an active implantable device or wearing an active device (e.g., pacemakers, metallic objects in the brain, infusion pumps, etc.)
  • persistent delirium or disturbed vigilance
  • moderate or severe language comprehension deficits
  • skull breach
  • new stroke lesions during rehabilitation
  • patients incapable of discernment
  • subjects with reduced mobility due to previous injuries or abnormalities unrelated with the cerebral accident

结局指标

主要结局

Efficacy evaluated through Fugl-Meyer

时间窗: 2 years

Safety evaluated through the number of adverse events

时间窗: 2 years

次要结局

  • Efficacy of personalized therapy evaluated through Fugl-Meyer(2 years)

研究者

发起方
Wearable Robotics srl.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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