Digitisation of the Timed Up and Go Test for the General Public

Not Applicable

• Conditions: Mobility Limitation
• Interventions: Device: Medopad

• Registration Number: NCT04229108
• Lead Sponsor: Andrew Gvozdanovic

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.

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-10
• Last Update Submitted: 2020-01-10
• Study First Posted: 2020-01-18
• Last Update Posted: 2020-01-18
• Study Start: 2020-01-27
• Primary Completion: 2020-02-06
• Study Completion: 2020-02-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Healthy volunteer	Medopad	Will record traditional timed up and go followed by two digitised versions

Primary Outcome Measures

Name	Time	Method
Time difference between traditional and digitised timed up and go test	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.

Secondary Outcome Measures

Name	Time	Method
Accelerometer data produced during the performance of all timed up and go tests.	1-2 month	Accelerometer data using a second mobile device in the patient's right pocket. Data will be measured in metres per second\^2 in the x, y, and z axis of the phone.
Gyroscope data produced during the performance of all timed up and go tests.	1-2 months	Collect gyroscope data using a second mobile device in the patient's right pocket. This will measure angular velocity in degrees per second or revolutions per second.