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临床试验/NCT04833088
NCT04833088已完成不适用

Exploratory Study About the Implementation of Technology in the Rehabilitation

Vrije Universiteit Brussel1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2021年6月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
Overview of needs and requirements for the development of the three predefined user scenarios

研究概览

简要总结

This qualitative study aims to identify the needs and recommendations of both patients and healthcare professionals in terms of rehabilitation technology, more specific three pre-defined user scenarios. These scenario were developed based on brainstorm sessions with healthcare professionals from the rehabilitation ward of UZ Brussel and AZ Sint-Maria Halle. The purpose of this study is to create an overview of recommendations that will be used to develop the smart devices in a later stage of the SAIRE project.

详细描述

STUDY DESIGN Based on the aforementioned user scenarios, an explorative qualitive study will be conducted investigating the recommendations and requirements of both patients and healthcare professionals in the development of the smart devices. Focus groups will be organized at UZ Brussel and AZ Sint Maria Halle to collect data from the participants. These discussions will be organized until data saturation is reached. Based on expectations, the investigators estimate on average 3 focus groups for every user scenario will be needed. The recommendations proposed in these focus group discussions will be analyzed and tested in the lab to determine what smart devices are eligible for rehabilitation. The data will also be used to develop AI algorithms that will be implemented in the smart devices.

USER SCENARIOS The first scenario focuses on the registration and triggering of movement of the upper limb in patients with spatial neglect. The aim is to develop a low-budget smart device that stimulates and analyzes movement of the affected side and gives feedback when needed.

The second user scenario aims to combine different smart devices and AI algorithms to create a mobile device that can be placed on a walking aid. This smart device will give feedback in terms of stride length and cadence through visual and auditive cues. A combination of sensor analysis and computer vision will monitor the gait pattern of the patient and correct where needed. These sensors will also incorporate a fall detection system that sends out a signal when a fall is detected.

The third and final scenario describes a smart intravenous (IV) pole that monitors the location of the patient relative to the IV pole and automatically follows the patient during walking. This device consists of a tracker and an accelerometer placed on the patient, and a motorized IV pole that follows the patient and avoid obstacles through computer vision. Additionally, a fall detection system will be integrated to monitor falls.

PROCEDURE Firstly, with regard to the Sars-COV-2 pandemic, all obligated prevention measure will be followed when conducting the focus group discussion. All participants and researchers will wear face masks, maintain distance (1.5 meters) and frequently disinfect hands using alcohol-based hand sanitizer. Additionally, an adequate ventilation of the room will be maintained. If necessary, the focus group discussions will be organized online, using Microsoft Teams (Microsoft, USA).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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
是

入选标准

  • •user scenario 1:
  • •adult (≥ 18 years)
  • •diagnosed with stroke (as defined by the World Health Organization) and suffering from spatial neglect
  • •able to verbally answer questions
  • •ability to give informed consent

排除标准

  • •user scenario 1:
  • •severe cognitive disability (based on assessment of the healthcare professionals)
  • •Inclusion criteria scenario 2:
  • •adult (≥ 18 years)
  • •suffering from gait problems (e.g. frail elderly, Parkinson Disease, recovering from COVID-19)
  • •able to verbally answer questions
  • •ability to give informed consent
  • •Exclusion Criteria user scenario 2:
  • •severe cognitive disability (based on assessment of the healthcare professionals)
  • •Inclusion criteria scenario 3:
  • •adult (≥ 18 years)
  • •requires intensive use of an IV-stand during hospitalisation
  • •able to verbally answer questions
  • •ability to give informed consent
  • •Exclusion Criteria user scenario 3:
  • •severe cognitive disability (based on assessment of the healthcare professionals)

研究组 & 干预措施

Healthcare professionals

Other

干预措施: Focus group discussions (Other)

Patients who suffer from spatial neglect

Other

干预措施: Focus group discussions (Other)

Patients who have walking difficulties

Other

干预措施: Focus group discussions (Other)

Patients who require long term use of an IV-stand

Other

干预措施: Focus group discussions (Other)

结局指标

主要结局

Overview of needs and requirements for the development of the three predefined user scenarios

时间窗: through study completion, an average of 1 year

Recurring themes in the transcribed data of the focus groups will be identified and checked for relevance in terms of the research question (e.g. key functionalities of the device, aesthetic requirements, ...). These relevant themes will then be combined to create an overview for every user scenario individually.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruben Debeuf

The Principal Investigator

Vrije Universiteit Brussel

研究点 (1)

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