跳至主要内容
临床试验/NCT04229108
NCT04229108Unknown不适用

A Feasibility Study Into a Self-recorded, Digital, Timed Up and Go Test Using the Medopad Platform for the General Public

Andrew Gvozdanovic0 个研究点目标入组 20 人开始时间: 2020年1月27日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
主要终点
Time difference between traditional and digitised timed up and go test

研究概览

简要总结

The question this feasibility study aims to answer is whether or not participants are able to accurately and reliably perform and self record the timed up and go test in a non-clinical environment using the Medopad application. This forms part of a larger question of whether or not a more frequently performed TUG test, could act as a physical activity marker.

详细描述

This is a single centre study which will take place in a mock clinical and non-clinical environment. The site-specific requirements including a clear space in which the participant can walk for 3m, and a firm chair with sturdy arms. The individuals performing the clinically led test must have experience in performing clinical examinations and be able to explain the steps involved in the Timed Up and Go in a clear and cohesive manner as judged by the study operators.

Participants will initially be asked to perform a clinician led 'Timed Up and Go' (TUG), this result will be recorded including:

  1. Number of attempts
  2. Use of arm rests to aid
  3. Whether mobility aid is used

Each participant will be given a rest period of at least 10 minutes. Participants will be asked to download the Medopad application onto their own mobile device. Once onboarded, they will be shown how to use the TUG module and then asked to complete a non-clinician led TUG, this result will be digitally stored on the application. Participants will be instructed to carry out the TUG in the following manner: sit in an upright chair with arm rests, with no extra cushions or pillows on the seat. They will be advised to ideally use a firm chair of height ~46cm with arm rests. Whilst at home, they will be asked to place the 3m ruler down in front of the chair they plan to use, open up the application and enter the TUG module. At this point, they will be prompted to take a picture of their chair, they will then need to sit down and rest for 5 minutes and re-read through the TUG module information. After 5 minutes they will need to press the 'Go' button on the application and perform the test, pressing the 'Stop' button on completion.

Following this initial test, participants will then be asked to repeat this TUG in a week's time. They will be provided with a standardised 3 metre measuring device to ensure correct distance at home. After completion of the final TUG test, they will be asked to complete a short feedback questionnaire regarding their experience.

研究设计

研究类型
Interventional
干预模型
Sequential
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Aged 18 or over
  • English speaking
  • Able to follow instructions and commands
  • Assistance of 0 (but can use mobility aids)
  • Low falls risk (no falls within the past year)
  • Able and willing to perform at least 2 consecutive timed up and go tasks in a clinical setting, with at least a further repeat of the TUG task independently at home
  • Ownership of an iOS or Android capable smartphone which can run the Medopad app

排除标准

  • Cognitive disorders/impairment (MMSE ≤ 24) unless test to be performed by carer who feels this is appropriate
  • Severe visual impairment (interfering with their ability to use the application)
  • Physical impairment preventing safe use of the TUG test in the home environment
  • Those without the appropriate facilities to perform the TUG at home (i.e no appropriate chair meeting minimum criteria)
  • Unable to physically use the Medopad application
  • Pregnancy
  • Inability to consent to study

结局指标

主要结局

Time difference between traditional and digitised timed up and go test

时间窗: 1-2 month

The primary outcome measure will be to record the time taken to complete the traditional timed up and go test versus the time taken when the test is performed by non-clinicians in a non-clinical setting using the Medopad application TUG module. Time will be measured in minutes and seconds.

次要结局

  • Accelerometer data produced during the performance of all timed up and go tests.(1-2 month)
  • Gyroscope data produced during the performance of all timed up and go tests.(1-2 months)

研究者

发起方
Andrew Gvozdanovic
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Andrew Gvozdanovic

Clinical Manager

Medopad

相似试验