跳至主要内容
临床试验/NCT06173635
NCT06173635已完成不适用

A Laboratory Trial to Explore the Benefits of the New Maxi Move 5 (MM5) Technology

Arjo AB1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2023年12月20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
Arjo AB
入组人数
21
试验地点
1
主要终点
1. Time to complete each transfer will be recorded

研究概览

简要总结

This trial aims to evaluate the added improvements from a caregiver and patient benefit perspective.

The trial should identify the forces involved for the caregiver when manoeuvring the lift.

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
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For expert patient:
  • ≥18 years
  • Healthy male or female
  • 80-100 kg
  • 24 healthy volunteers (caregivers) will be recruited. They will require a strong working knowledge of passive floor lifts and patient positioning with the use of loop and clip slings.

排除标准

  • 未提供

结局指标

主要结局

1. Time to complete each transfer will be recorded

时间窗: up to 24 months

Time to complete each activity and each task within the activity will be measured in seconds.

5 Subjective responses from the expert patient being transferred will be recorded

时间窗: up to 24 months

This will be collected by the use of questionnaires

2. A detailed hierarchical task analysis (HTA) of each activity will be completed using the video recordings and experimenter field notes for each transfer to asses the number of correct placements for each device.

时间窗: up to 24 months

Correct placement will be visually controlled with the use of markers on the subject and the final positioning device (e.g chair, toilet or bed) for each transfer. This will be reported as distance from the ideal position.

3. Physical load for movement of the hoist throughout the activities for each device will be measured.

时间窗: up to 24 months

Force required to complete the range of patient and hoist positioning tasks, forward, backwards, rotation movement, patient positioning etc. These forces will be used with the HTA data to calculate the amount of physical force delivered by the participants with each device and each transfer. The forces used will be presented in newton.

4 Collect subjective data from the caregivers that describe, comfort, ease of use, effort and willingness to adopt in practice, etc

时间窗: up to 24 months

This will be collected by the use of questionnaires

次要结局

未报告次要终点

研究者

发起方
Arjo AB
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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