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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
Andrew Gvozdanovic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mobility Limitation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 7, 2020
    Last Updated
    January 10, 2020
    Sponsor
    Andrew Gvozdanovic
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    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

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