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临床试验/NCT02192125
NCT02192125已完成早期 1 期

Phase 1 REWIRE - Rehabilitative Wayout In Responsive Home Environments, A Pilot Trial

University of Zurich2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
17
试验地点
2
主要终点
Proof of concept

研究概览

简要总结

The study examines the possible application of the rehabilitation platform REWIRE.

详细描述

The REWIRE rehabilitation platform consists of three hierarchical components: the "Patient Station" (PS), which is installed in the home environment of the patient; the "Hospital Station" (HS), which allows an exchange of information with more horsepower and is served by the therapists in the hospital; and the "Networking Station" (NS), which allows a combination of a plurality of HS.

The PS consists of a standard laptop with a specifically created for the rehabilitation REWIRE platform and pre-installed software (Università degli Studi di Milano, Italy, Applied Intelligent Systems Laboratory Department of Computer Science). In the context of a training system connected to the computer, the software enables the collection of data, which are recorded as part of the training. In this study only exercises for balance ability are part of the training program. The training system consists of a so-called Tymoplate® (Tyromotion, Austria), a medical device class 1 with CE certification and approval by the FDA for use in neurorehabilitation after stroke. The Tymoplate® is connected to the computer and allows by means of a base plate with integrated pressure sensors and custom-developed training software, various postural biofeedback exercises. In combination with 3D cameras (Kinect®, PrimeSense, CA, USA), the patient sees him-/herself or an avatar in real time on a screen which moves in the virtual training environment. By various, attractive and entertaining designed training games as well as provided audio-visual feedback and balanced score system, patients should be maximum motivated to exercise.

The HS enables the interaction between patient and therapist and essentially consists of a MySQL database with web-based interface. The data collected on each PS can be retrieved from the HS and can be used by therapists in order to set up the training program on the PS to control and to adjust the difficulty level of the exercises to the individual performance of each patient.

The NS also consists of a database. It links collected training data and the associated epidemiological data of different HS at the regional level (potentially also between different health institutions) to identify on the application of statistical algorithms general models for the description of relaxation processes in rehabilitation medicine.

In this simple way a frequent and intensive training is without direct therapeutic help in the home setting at low cost possible. By attractive and entertaining designed training games as well as interaction and feedback by the therapist, patients are motivated to train each day with the system and to continually improve in the games. The supervision of the training by the therapist with the rehabilitation platform REWIRE additionally serves to recognize improvements of the individual performance or problems and to adapt the difficulty level of the exercises.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Age ≥ 18 years
  • First-time ischemic stroke
  • Moderate, residual motor deficits of the lower extremity (FAC> 3, 6-min walk ≥ 200 m; Berg Balance Scale 21-52)
  • Ability and willing to participate in the study
  • signed consent form

排除标准

  • Other neurological disorders (eg Parkinson's disease, dementia, multiple sclerosis, peripheral nerve damage, etc.)
  • Moderate to severe aphasia
  • moderate to severe unilateral neglect
  • Severe dementia, MMSE ≤ 20 points
  • Severe depression or psychiatric disorders
  • Other serious diseases, such as severe kidney or liver dysfunction, or serious dysfunction of the cardiovascular system
  • Relevant loss of vision that can not be compensated by aids, eg Hemianopia, visual acuity ≤ 20%
  • Severe pain,> 6 points on the visual analog scale
  • Pregnancy

结局指标

主要结局

Proof of concept

时间窗: week 12

Technical and practical implementation of the rehabilitation platform REWIRE will be evaluated, by a questionnaire.

次要结局

  • Quality of life(week 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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