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临床试验/NCT04694833
NCT04694833Unknown不适用

Self-assessment and Telerehabilitation Using Virtual Reality Devices and Serious Games to Improve Motor and Cognitive Impairments in Stroke Patients

Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年10月23日最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
2
主要终点
Upper Extremity Fugl-Meyer Assessment

研究概览

简要总结

After a stroke, individuals present with motor and/or cognitive impairments. These impairments limit activity, restrict participation and affect quality of life. Therefore, rehabilitation programs are provided from the earliest days. However, an important proportion of patients do not achieve the recommended amount of rehabilitation therapy (even in institutional systems). In fact, patients do not always have access to healthcare systems. Moreover, hospital resources and healthcare systems are often limited (especially in poor countries) which has led to the development of new cost-effective rehabilitation methods such as self-rehabilitation and tele-rehabilitation.

This study aims :

  1. to develop and validate relevant self-assessments tools in virtual reality
  2. to propose auto-adaptative virtual reality-based therapies based on the link between motor and cognitive functions.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

  • Stroke patients (with hemiparesis or cognitive impairment such as apraxia, aphasia or hemineglect) OR healthy subjects
  • Able to undersand simple instructions

排除标准

  • Other disease that could affect upper limb motor function or cognition

结局指标

主要结局

Upper Extremity Fugl-Meyer Assessment

时间窗: Through study completion, on average 24 weeks

Highly recommended scale that assess upper limb motor function (0% = worse outcome; 100% best outcome).

The Bells Test

时间窗: Through study completion, on average 24 weeks

A cancellation task, permits a quantitative and qualitative evaluation of visual neglect

System Usability Scale

时间窗: Through study completion, on average 24 weeks

Reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree

Box and Block Test

时间窗: Through study completion, on average 24 weeks

A measure of manual dexterity and activity that requires repeatedly moving 1-inch blocks from one side of a box to another in 60 seconds.

Action Research Arm Test

时间窗: Through study completion, on average 24 weeks

A 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning). Items are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally).

次要结局

  • Upper limb 3D position(Through study completion, on average 24 weeks)
  • Upper limb peak velocity(Through study completion, on average 24 weeks)
  • Upper limb smoothness(Through study completion, on average 24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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