Normal Upper ExtremityNCT03195751
Wearable Technology in Shoulder Range of Motion
An observational study of Normal Upper Extremity, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The scope of the research is to determine if a motion-based software development kit may substitute for a manual goniometer. If so, this opens up the possibility of remote telemonitoring of upper extremities patients. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Upper Extremity
- What is being tested?
- Software development kit measurements and Manual Goniometer Measurements
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2017to 23 Sep 2017
- Phase
- Observational
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy individuals between 18 and 40 years of age with no prior shoulder pain, no prior shoulder surgeries, and no limitations in shoulder range of motion will be included.
Who may be able to join
- No prior shoulder pain
- No prior shoulder surgeries
- No limitations in shoulder range of motion
Who cannot join
- Prior shoulder surgeries
- Past or present shoulder pain
- Any limitations in shoulder range of motion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wearable Technology in Shoulder Range of Motion: Validation of a Motion-Based Software Development Kit
The scope of the research is to determine if a motion-based software development kit may substitute for a manual goniometer. If so, this opens up the possibility of remote telemonitoring of upper extremities patients.
Read the detailed description
The Capture mobile application or "app" (FocusMotion, Santa Monica, California) was custom designed and securely installed on a single (CCF) smartphone used by the Lead Co-Investigator, Dr. Ramkumar, and serves as a private user interface for the proprietary software development kit (SDK). The Capture app uses a Bluetooth connection to pair with the Pebble Time Round smartwatch to allow for remote timekeeping of the smartphone while in use by the participant. The smartwatch was loaned by FocusMotion to the investigators for the purpose of the study.
This proprietary SDK (FocusMotion) processes user motions recorded by the hardware (accelerometer, gyroscope, magnometer). As data is collected, the software development kit (SDK) classifies the motion as repetitive or non-repetitive, and repetitive motions are further analyzed. As the user completes a workout or movement, the SDK tracks the number of repetitions performed, technique, and rest time. The SDK can provide real-time feedback to the user regarding their form by comparing the movement to a template of an ideal motion for that particular action. The SDK is compatible with any operating system, phone, or wearable device, providing seamless integration with pre-existing technologies.
Measurements from the SDK will be compared to those taken with a manual goniometer for four shoulder maneuvers (abduction, forward flexion, internal rotation, external rotation). Each of the 10 subjects will perform 5 trials of each maneuver for consistency and reproducibility.
Participants without shoulder pain, with full shoulder range of motion and without prior shoulder surgery will be recruited. No other exclusion criteria will be instituted. Individuals will be recruited from CCF undergraduate and graduate medical education programs.
Statistical analysis will be employed to assess the shoulder motion arcs measured from both the SDK and the manual goniometer. Univariate analyses (chi-square for categorical and t-test for continuous variables) will be performed to compare the angle measurements from each patient and angle measurement. Power analysis indicated a 94% chance of detecting a large effect size and a 60% chance of detecting a medium effect size between the two groups at the 5% confidence level. For 1 sample t-tests, power analysis indicated that there was a 92% chance of detecting a medium effect size significant at the 5% confidence level. All data analysis will be performed using Microsoft. Excel analytics software version 14.5.4 A p-value cutoff of <0.05 was used to determine statistical significance.
All adverse events will be reported to the Institutional Review Board.
- Conditions
- Normal Upper Extremity
- Being tested
- Software development kit measurements, Manual Goniometer Measurements
- Keywords
- telemonitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Software development kit measurementsDevice
Also called SDK
This proprietary SDK (FocusMotion) processes user motions recorded by the hardware (accelerometer, gyroscope, magnometer). As data is collected, the software development kit (SDK) classifies the motion as repetitive or non-repetitive, and repetitive motions are further analyzed. As the user completes a movement, the SDK tracks the number of repetitions performed, technique, and rest time. The SDK can provide real-time feedback to the user regarding their form by comparing the movement to a template of an ideal motion for that particular action. The SDK is compatible with any operating system, phone, or wearable device, providing seamless integration with pre-existing technologies.
Manual Goniometer MeasurementsDevice
Also called Goniometer
A manual goniometer was used to measure the range of motion of the shoulder.
| Study group | Role | What they receive |
|---|---|---|
| Manual Goniometer measurements | Measurements of shoulder range of motion using manual goniometer Receives: Device: Manual Goniometer Measurements | |
| Software development kit measurements | Measurements of shoulder range of motion using a proprietary SDK Receives: Device: Software development kit measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in range of motion measurements between goniometer and software development kit measurement
The outcome measure difference will be in degrees.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start13 Sep 2017
- Primary completion23 Sep 2017
- Study completion23 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Upper ExtremityStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph P Iannotti, MD PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195751
- Sponsor's protocol ID
- 17-800
- Status last verified
- Oct 2017
- First submitted
- 20 Jun 2017
- Last updated
- 6 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Technology in Shoulder Range of Motion: Validation of a Motion-Based Software Development Kit
- ClinicalTrials.gov ID
- NCT03195751
- Acronym / sponsor ID
- 17-800
- Conditions
- Normal Upper Extremity
- Keywords
- telemonitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 23 Sep 2017 (actual)
- Study completion
- 23 Sep 2017 (actual)
- First posted
- 22 Jun 2017 (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 scope of the research is to determine if a motion-based software development kit may substitute for a manual goniometer. If so, this opens up the possibility of remote telemonitoring of upper extremities patients.
Detailed description
The Capture mobile application or "app" (FocusMotion, Santa Monica, California) was custom designed and securely installed on a single (CCF) smartphone used by the Lead Co-Investigator, Dr. Ramkumar, and serves as a private user interface for the proprietary software development kit (SDK). The Capture app uses a Bluetooth connection to pair with the Pebble Time Round smartwatch to allow for remote timekeeping of the smartphone while in use by the participant. The smartwatch was loaned by FocusMotion to the investigators for the purpose of the study.
This proprietary SDK (FocusMotion) processes user motions recorded by the hardware (accelerometer, gyroscope, magnometer). As data is collected, the software development kit (SDK) classifies the motion as repetitive or non-repetitive, and repetitive motions are further analyzed. As the user completes a workout or movement, the SDK tracks the number of repetitions performed, technique, and rest time. The SDK can provide real-time feedback to the user regarding their form by comparing the movement to a template of an ideal motion for that particular action. The SDK is compatible with any operating system, phone, or wearable device, providing seamless integration with pre-existing technologies.
Measurements from the SDK will be compared to those taken with a manual goniometer for four shoulder maneuvers (abduction, forward flexion, internal rotation, external rotation). Each of the 10 subjects will perform 5 trials of each maneuver for consistency and reproducibility.
Participants without shoulder pain, with full shoulder range of motion and without prior shoulder surgery will be recruited. No other exclusion criteria will be instituted. Individuals will be recruited from CCF undergraduate and graduate medical education programs.
Statistical analysis will be employed to assess the shoulder motion arcs measured from both the SDK and the manual goniometer. Univariate analyses (chi-square for categorical and t-test for continuous variables) will be performed to compare the angle measurements from each patient and angle measurement. Power analysis indicated a 94% chance of detecting a large effect size and a 60% chance of detecting a medium effect size between the two groups at the 5% confidence level. For 1 sample t-tests, power analysis indicated that there was a 92% chance of detecting a medium effect size significant at the 5% confidence level. All data analysis will be performed using Microsoft. Excel analytics software version 14.5.4 A p-value cutoff of <0.05 was used to determine statistical significance.
All adverse events will be reported to the Institutional Review Board.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Goniometer measurements | – | Device: Manual Goniometer MeasurementsMeasurements of shoulder range of motion using manual goniometer |
| Software development kit measurements | – | Device: Software development kit measurementsMeasurements of shoulder range of motion using a proprietary SDK |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy individuals between 18 and 40 years of age with no prior shoulder pain, no prior shoulder surgeries, and no limitations in shoulder range of motion will be included.
Key inclusion criteria (3 listed)
- No prior shoulder pain
- No prior shoulder surgeries
- No limitations in shoulder range of motion
Key exclusion criteria (3 listed)
- Prior shoulder surgeries
- Past or present shoulder pain
- Any limitations in shoulder range of motion
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 |
|---|---|---|
| Software development kit measurementsAlso: SDKThis proprietary SDK (FocusMotion) processes user motions recorded by the hardware (accelerometer, gyroscope, magnometer). As data is collected, the software development kit (SDK) classifies the motion as repetitive or non-repetitive, and repetitive motions are further analyzed. As the user completes a movement, the SDK tracks the number of repetitions performed, technique, and rest time. The SDK can provide real-time feedback to the user regarding their form by comparing the movement to a template of an ideal motion for that particular action. The SDK is compatible with any operating system, phone, or wearable device, providing seamless integration with pre-existing technologies. | Device | Software development kit measurements |
| Manual Goniometer MeasurementsAlso: GoniometerA manual goniometer was used to measure the range of motion of the shoulder. | Device | Manual Goniometer measurements |
Primary outcome
Difference in range of motion measurements between goniometer and software development kit measurement
Time frame: 24 hours
The outcome measure difference will be in degrees.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
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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.
Joseph P Iannotti, MD PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Upper Extremity, run by The Cleveland Clinic at 1 site in United States.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in range of motion measurements between goniometer and software development kit measurement (time frame: 24 hours). 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 6 Oct 2017.