Clinical trial NCT04229108: Digitisation of the Timed Up and Go Test for the General Public
Official title: A Feasibility Study Into a Self-recorded, Digital, Timed Up and Go Test Using the Medopad Platform for the General Public
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mobility Limitation
Lead sponsor: Medopad
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Intervention model description: Medopad application
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

At each test performance, the participant will be asked to place a second mobile device with the Medopad application loaded. The motion capture module of this device's application with be initiated as the start of the test and record accelerometer and gyroscope data during the test's performance. It will then be stopped.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Time difference between traditional and digitised timed up and go test
timeFrame: 1-2 month
Secondary outcomes:
measure: Accelerometer data produced during the performance of all timed up and go tests.
timeFrame: 1-2 month
measure: Gyroscope data produced during the performance of all timed up and go tests.
timeFrame: 1-2 months
Other outcomes:
measure: Qualitative research questionnaire into patient satisfaction with the study and timed up and go module
timeFrame: 1-2 month
Locations:
Study officials:
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