- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04051489
A Novel Smartphone Application for "Smart" Knee Osteoarthritis Trials
Test-retest Reliability and Validity of and a Novel Smartphone Application to Objectively Measure Physical Function in Individuals With Knee Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
São Paulo
-
São Carlos, São Paulo, Brazil, 13565905
- Federal University of São Carlos
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or female subjects at least 50 years old with symptomatic knee osteoarthritis
- English Speaker
- Be able to walk 20 meters without an assistive device, such as a cane, walker or crutches.
- Have an iPhone 6 or higher with internet connection. * Confirmation of knee osteoarthritis will be based on American College of Rheumatology (ACR) classification criteria:
Exclusion Criteria:
- Prior surgery on either knee within 6 months of enrollment
- Received corticosteroid injection in the knee within 3 months of enrollment
- Evidence or history of any other inflammatory arthritis (rheumatoid arthritis, gout, psoriatic arthritis).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Mobile App
Individuals with symptomatic knee osteoarthritis
|
Beta Testing 1: The Beta test 1 will be performed with participants inside the Research Center. The purpose of this phase is to increase usability, acceptability and reliability of the mHealth App in participants with knee osteoarthritis (KOA). Beta Testing 2: The Beta test 2 will be performed with patients outside the Research Center, at their houses. The purpose is to focus on the mHealth App remote usability, acceptability, and data collection. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Get up and Go - TEST RETEST (clinical setting)
Time Frame: Day 1
|
In the clinical setting, the clinician asks the patient to stand up from a chair, walk 3 meters, turn around, return and sit back in the chair.
The time on the test is used as a predictor of functional independence: below 20 seconds is considered normal and over 30 seconds as potentially indicative of increased risk for falls and functional dependence.
For the automated test, the patient will wear a chest strap fixing the mobile phone over the sternum.
On a sitting position, the patient will open the mHealth App and through the use of audible feedback, will receive the same test instructions as in the clinic.
With the use of algorithms, the mHealth App will pre-determine and tell the patient how many steps to take to achieve the distance of 3 meters.
After the test is completed, the data will be automatically sent to the cloud system.
|
Day 1
|
The Get up and Go - TEST RETEST (clinical setting)
Time Frame: 7 days after day 1
|
In the clinical setting, the clinician asks the patient to stand up from a chair, walk 3 meters, turn around, return and sit back in the chair.
The time on the test is used as a predictor of functional independence: below 20 seconds is considered normal and over 30 seconds as potentially indicative of increased risk for falls and functional dependence.
For the automated test, the patient will wear a chest strap fixing the mobile phone over the sternum.
On a sitting position, the patient will open the mHealth App and through the use of audible feedback, will receive the same test instructions as in the clinic.
With the use of algorithms, the mHealth App will pre-determine and tell the patient how many steps to take to achieve the distance of 3 meters.
After the test is completed, the data will be automatically sent to the cloud system.
|
7 days after day 1
|
The Get up and Go - DIURNAL CHANGE (home setting)
Time Frame: Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
|
At home, for the automated test, the patient will wear a chest strap fixing the mobile phone over the sternum.
On a sitting position, the patient will open the mHealth App and through the use of audible feedback, will receive the same test instructions as in the clinic.
With the use of algorithms, the mHealth App will pre-determine and tell the patient how many steps to take to achieve the distance of 3 meters.
After the test is completed, the data will be automatically sent to the cloud system.
|
Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
|
The 30 Seconds Sit to Stand - TEST RETEST (clinical setting)
Time Frame: Day 1
|
In the clinical setting, the clinician asks the patient to sit in the middle of the chair, with the back straight, feet apart resting on the floor and in line with the shoulders.
The patient has to rise from a sitting to a standing position as many times as possible in 30 seconds.
With the results of this test, it is possible to evaluate a wide variety of skill levels, with scores ranging from 0 (for those unable to complete one repetition) to more than 20 repetitions (for the most physically fit individuals).
For the automated test, the patient will wear a chest strap fixing the mobile phone over the sternum.
On a sitting position, the patient will open the mHealth App and through the use of audible feedback, will receive the same test instructions as in the clinic.
With the use of algorithms, the mHealth App will automatically count the total sit to stand repetitions within a 30 seconds period.
After the test is completed, the data will be automatically sent to the cloud system.
|
Day 1
|
The 30 Seconds Sit to Stand - TEST RETEST (clinical setting)
Time Frame: 7 days after day 1
|
In the clinical setting, the clinician asks the patient to sit in the middle of the chair, with the back straight, feet apart resting on the floor and in line with the shoulders.
The patient has to rise from a sitting to a standing position as many times as possible in 30 seconds.
With the results of this test, it is possible to evaluate a wide variety of skill levels, with scores ranging from 0 (for those unable to complete one repetition) to more than 20 repetitions (for the most physically fit individuals).
For the automated test, the patient will wear a chest strap fixing the mobile phone over the sternum.
On a sitting position, the patient will open the mHealth App and through the use of audible feedback, will receive the same test instructions as in the clinic.
With the use of algorithms, the mHealth App will automatically count the total sit to stand repetitions within a 30 seconds period.
After the test is completed, the data will be automatically sent to the cloud system.
|
7 days after day 1
|
The 30 Seconds Sit to Stand - DIURNAL CHANGE (home setting)
Time Frame: Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
|
At home, for the automated test, the patient will wear a chest strap fixing the mobile phone over the sternum.
On a sitting position, the patient will open the mHealth App and through the use of audible feedback, will receive the same test instructions as in the clinic.
With the use of algorithms, the mHealth App will automatically count the total sit to stand repetitions within a 30 seconds period.
After the test is completed, the data will be automatically sent to the cloud system.
|
Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
|
The 20-meter Walk - TEST RETEST (clinical setting)
Time Frame: Day 1
|
This test assesses gait speed and changes in patient's physical function over time.
The clinician asks the patient to walk at a comfortable pace in a 20-meter unobstructed course and measures the time to perform the test.
For the automated test, the patient will wear a chest strap fixing the mobile phone over the sternum.
On a standing position, the patient will open the mHealth App and through the use of audible feedback, will receive the same test instructions as in the clinic.
With the use of algorithms, the mHealth App will automatically determine when the 20-meter distance is reached and will say to the patient to gradually stop, measuring the total time to complete the test.
After the test is completed, the data will be automatically sent to the cloud system.
|
Day 1
|
The 20-meter Walk - TEST RETEST (clinical setting)
Time Frame: 7 days after day 1
|
This test assesses gait speed and changes in patient's physical function over time.
The clinician asks the patient to walk at a comfortable pace in a 20-meter unobstructed course and measures the time to perform the test.
For the automated test, the patient will wear a chest strap fixing the mobile phone over the sternum.
On a standing position, the patient will open the mHealth App and through the use of audible feedback, will receive the same test instructions as in the clinic.
With the use of algorithms, the mHealth App will automatically determine when the 20-meter distance is reached and will say to the patient to gradually stop, measuring the total time to complete the test.
After the test is completed, the data will be automatically sent to the cloud system.
|
7 days after day 1
|
The 20-meter Walk - DIURNAL CHANGE (home setting)
Time Frame: Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
|
At home, for the automated test, the patient will wear a chest strap fixing the mobile phone over the sternum.
On a standing position, the patient will open the mHealth App and through the use of audible feedback, will receive the same test instructions as in the clinic.
With the use of algorithms, the mHealth App will automatically determine when the 20-meter distance is reached and will say to the patient to gradually stop, measuring the total time to complete the test.
After the test is completed, the data will be automatically sent to the cloud system.
|
Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
|
Numeric Rating Scale - TEST RETEST (clinical setting)
Time Frame: Day 1
|
A Numeric Rating Scale (NRS) will be applied to measure both knee pain. NRS is a well recognized tool to measure the intensity of pain that visually represents the intensity of pain that the individual believes to present. The scale will be displayed on the app and will have a range of 0 to 10, with 0 being the complete absence of pain and 10, the maximum intensity of pain reported by the individual. A Numeric Rating Scale (NRS) will be applied to measure both knee pain. NRS is a well recognized tool to measure the intensity of pain that visually represents the intensity of pain that the individual believes to present. The scale will be displayed on the app and will have a range of 0 to 10, with 0 being the complete absence of pain and 10, the maximum intensity of pain reported by the individual. |
Day 1
|
Numeric Rating Scale - TEST RETEST (clinical setting)
Time Frame: 7 days after day 1
|
A Numeric Rating Scale (NRS) will be applied to measure both knee pain. NRS is a well recognized tool to measure the intensity of pain that visually represents the intensity of pain that the individual believes to present. The scale will be displayed on the app and will have a range of 0 to 10, with 0 being the complete absence of pain and 10, the maximum intensity of pain reported by the individual. A Numeric Rating Scale (NRS) will be applied to measure both knee pain. NRS is a well recognized tool to measure the intensity of pain that visually represents the intensity of pain that the individual believes to present. The scale will be displayed on the app and will have a range of 0 to 10, with 0 being the complete absence of pain and 10, the maximum intensity of pain reported by the individual. |
7 days after day 1
|
Numeric Rating Scale - DIURNAL CHANGE (home setting)
Time Frame: Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
|
At home, a Numeric Rating Scale (NRS) will be applied to measure both knee pain.
NRS is a well recognized tool to measure the intensity of pain that visually represents the intensity of pain that the individual believes to present.
The scale will be displayed on the app and will have a range of 0 to 10, with 0 being the complete absence of pain and 10, the maximum intensity of pain reported by the individual.A Numeric Rating Scale (NRS) will be applied to measure both knee pain.
NRS is a well recognized tool to measure the intensity of pain that visually represents the intensity of pain that the individual believes to present.
The scale will be displayed on the app and will have a range of 0 to 10, with 0 being the complete absence of pain and 10, the maximum intensity of pain reported by the individual.
|
Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Lucas O Dantas, PT, Universidade Federal de Sao Carlos
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB #: 13237
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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