Mobility LimitationNCT04229108
Digitisation of the Timed Up and Go Test for the General Public
A study testing Medopad in people with Mobility Limitation, run by Andrew Gvozdanovic.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mobility Limitation
- What is being tested?
- Medopad
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 27 Jan 2020to 6 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Feasibility Study Into a Self-recorded, Digital, Timed Up and Go Test Using the Medopad Platform for the General Public
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.
Read the 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.
- Conditions
- Mobility Limitation
- Being tested
- Medopad
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedopadDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer | Other | Will record traditional timed up and go followed by two digitised versions Receives: Device: Medopad |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-2 month
Secondary outcomes (2)
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.
Measured: 1-2 month
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.
Measured: 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start27 Jan 2020 (estimated)
- Primary completion6 Feb 2020 (estimated)
- Study completion6 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobility LimitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Intervention model
- Sequential
- Model description
- Medopad application
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrew Gvozdanovic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Andrew Gvozdanovic, Medopad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229108
- Sponsor's protocol ID
- MEDOPAD007
- Status last verified
- Jan 2020
- First submitted
- 7 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Into a Self-recorded, Digital, Timed Up and Go Test Using the Medopad Platform for the General Public
- ClinicalTrials.gov ID
- NCT04229108
- Acronym / sponsor ID
- MEDOPAD007
- Conditions
- Mobility Limitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Andrew GvozdanovicIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2020 (estimated)
- Primary completion
- 6 Feb 2020 (estimated)
- Study completion
- 6 Feb 2020 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Medopad application
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer | Other | Device: MedopadWill record traditional timed up and go followed by two digitised versions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MedopadTimed 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 | Device | Healthy volunteer |
Primary outcome
Time difference between traditional and digitised timed up and go test
Time frame: 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.
2 secondary outcomes
Accelerometer data produced during the performance of all timed up and go tests.
Time frame: 1-2 month
Gyroscope data produced during the performance of all timed up and go tests.
Time frame: 1-2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Medopad in people with Mobility Limitation, run by Andrew Gvozdanovic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Gvozdanovic (+44(0)7828007886, andrew.gvozdanovic@medopad.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time difference between traditional and digitised timed up and go test (time frame: 1-2 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.