Digitisation of the Timed Up and Go Test for the General Public
Primary Purpose
Mobility Limitation
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Medopad
Sponsored by
About this trial
This is an interventional other trial for Mobility Limitation
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Healthy volunteer
Arm Description
Will record traditional timed up and go followed by two digitised versions
Outcomes
Primary Outcome Measures
Time difference between traditional and digitised timed up and go test
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
Accelerometer data produced during the performance of all timed up and go tests.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04229108
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 27, 2020 (Anticipated)
Primary Completion Date
February 6, 2020 (Anticipated)
Study Completion Date
February 6, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrew Gvozdanovic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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:
Number of attempts
Use of arm rests to aid
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Medopad application
Masking
None (Open Label)
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy volunteer
Arm Type
Other
Arm Description
Will record traditional timed up and go followed by two digitised versions
Intervention Type
Device
Intervention Name(s)
Medopad
Intervention Description
Timed up and go module of Medopad application. About page explains how to perform test and conditions, subsequent page contains timer, once completed test, commence on final page which has a number of short questions to complete
Primary Outcome Measure Information:
Title
Time difference between traditional and digitised timed up and go test
Description
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.
Time Frame
1-2 month
Secondary Outcome Measure Information:
Title
Accelerometer data produced during the performance of all timed up and go tests.
Description
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.
Time Frame
1-2 month
Title
Gyroscope data produced during the performance of all timed up and go tests.
Description
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.
Time Frame
1-2 months
Other Pre-specified Outcome Measures:
Title
Qualitative research questionnaire into patient satisfaction with the study and timed up and go module
Description
A questionnaire will be used to collect quantitative scaled data (1-5, with 1 being a worse outcome i.e least satisfied, least happy and 5 being associated with a better outcome, i.e more satisfied, most happy) surrounding: how satisfied participants were with the study process, how happy participants were with visual appearance of the application, and how happy participants were using the application. The questionnaire will also collect qualitative data on whether participants would be happy to use the digitised form of the TUG in the future (yes or no) and any areas to improve the study or application (free text).
Time Frame
1-2 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Gvozdanovic
Phone
+44(0)7828007886
Email
andrew.gvozdanovic@medopad.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Digitisation of the Timed Up and Go Test for the General Public
We'll reach out to this number within 24 hrs