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临床试验/NCT05846776
NCT05846776已完成不适用

Preact to Lower the Risk of Falling by Customized Rehabilitation Across Europe: the PRECISE Study In Italy

Istituto Nazionale di Ricovero e Cura per Anziani2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2022年10月26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
43
试验地点
2
主要终点
Change in Usability

研究概览

简要总结

The PRECISE study is a 12-week pilot intervention study to evaluate the usability of the new DigiPrehab technology application in elderly subjects. The DigiPrehab system will enable the early identification of seniors with significant risk factors for falling and will propose an individualized physical training plan at home.

详细描述

The PRECISE project takes the positive results achieved with the DigiRehab application (https://digirehab.dk/en) in home rehabilitation and takes a further step in this direction by combining the personalized training delivered through the application with an artificial intelligence-based predictive model (Artificial intelligence - Decision Support Systems platform, AI-DSS platform) for fall risk assessment in the elderly. In particular, 20 senior participants will test the DSS beta prototype. This new system, called DigiPrehab, will enable early identification of the elderly with significant risk factors for falling and propose an individualized physical training plan to attend to the identified critical areas.

The PRECISE study will be a 12-week pilot intervention study to evaluate the usability of the new DigiPrehab technology application in elderly subjects. The DigiPrehab system will enable the early identification of seniors with significant risk factors for falling and will propose an individualized physical training plan at home.

研究设计

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

入排标准

年龄范围
65 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Independent ambulation
  • Fall risk assessed by Tinetti test
  • Mini Mental State Examination ≥ 24
  • Residents at home
  • Familiarity with web applications
  • Ability and willingness to sign informed consent

排除标准

  • Unstable clinical condition by judgment of the physician
  • Severe visual and/or hearing impairment
  • Severe impairment (Activities of Daily Living) in medical record
  • Absence of primary caregiver

结局指标

主要结局

Change in Usability

时间窗: baseline and 12 weeks later

This outcome will be measured through the System Usability Scale (SUS). It consists of a 10-item questionnaire with five response options for respondents from 'Strongly agree' to 'Strongly disagree'.

次要结局

  • Cognitive impairment(baseline and 12 weeks later)
  • Time Up and Go test (TUG)(baseline and 12 weeks later)
  • Physical performance(baseline and 12 weeks later)
  • Falling risk(baseline and 12 weeks later)
  • Health Questionnaire (EQ-5D-5L)(baseline and 12 weeks later)

研究者

发起方
Istituto Nazionale di Ricovero e Cura per Anziani
申办方类型
Other
责任方
Sponsor

研究点 (2)

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