NCT04229108

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

January 27, 2020

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

10 days

First QC Date

January 7, 2020

Last Update Submit

January 10, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1-2 month

Secondary Outcomes (2)

  • Accelerometer data produced during the performance of all timed up and go tests.

    1-2 month

  • Gyroscope data produced during the performance of all timed up and go tests.

    1-2 months

Other Outcomes (1)

  • Qualitative research questionnaire into patient satisfaction with the study and timed up and go module

    1-2 month

Study Arms (1)

Healthy volunteer

OTHER

Will record traditional timed up and go followed by two digitised versions

Device: Medopad

Interventions

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

Healthy volunteer

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: Medopad application
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Manager

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 18, 2020

Study Start

January 27, 2020

Primary Completion

February 6, 2020

Study Completion

February 6, 2020

Last Updated

January 18, 2020

Record last verified: 2020-01