跳至主要内容
临床试验/NCT03361696
NCT03361696已完成不适用

Development, Optimization, Efficiency of the Interface System of Communication and Control of the Environment

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Quality of life questionnaire SF36

研究概览

简要总结

The objective of this project is the realization of tests at home and in Hospitals or Functional Rehabilitation for the improvement of the communication with the family and medical entourage, the facility of the emotional expression, the evaluation of the pain, the control of home automation to increase their autonomy, facilitated their reintegration at home. The work is the last step of the research program started in 2009, with the optimization of the installation of the system, the improvement of physical and computer ergonomic aspects and the development of dedicated interfaces according to the type of disability and needs. of each one.

A work upstream of the definition of specifications taking into account the medical constraints was realized and the actions of improvement of the models, the algorithms, the robustness and the effectiveness of the treatment are in progress . The specific adaptation to concrete cases should lead to a system that allows 90% of the population of people with disabilities to exploit the system and significantly improve their level of communication, autonomy and in fact their daily lives.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patients (2-80 years old) with complete or near complete motor disability of both upper limbs or four limbs: Sequelae of trauma or advanced rheumatologic disease (spinal cord injury, upper limb amputation, head trauma, chronic polyarthritis), Diseases Congenital (myopathies, agenesis upper limbs), sequelae of vascular accident (medullary infarction, syringomyelia), neurodegenerative diseases (amyotrophic lateral sclerosis, multiple sclerosis, conduction block neuropathy, etc ..).
  • Patients older than 55 years without disability but with a loss of dependence.
  • Troubles of the communication and loss of autonomy.

排除标准

  • Patient with severe visual contraindications (decreased visual acuity with correction of ± 6/7 dioptres, major oculomotor abnormalities).
  • Patients with significant cognitive impairment to understand simple instructions related to the use of the system

结局指标

主要结局

Quality of life questionnaire SF36

时间窗: change over baseline and end of follow-up at 6 month

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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