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Wearable Technology in Shoulder Range of Motion

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ClinicalTrials.gov Identifier: NCT03195751
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Brief 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.

Condition or disease Intervention/treatment
Normal Upper Extremity Device: Software development kit measurements Device: Manual Goniometer Measurements

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.


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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Wearable Technology in Shoulder Range of Motion: Validation of a Motion-Based Software Development Kit
Actual Study Start Date : September 13, 2017
Actual Primary Completion Date : September 23, 2017
Actual Study Completion Date : September 23, 2017

Group/Cohort Intervention/treatment
Manual Goniometer measurements
Measurements of shoulder range of motion using manual goniometer
Device: Manual Goniometer Measurements
A manual goniometer was used to measure the range of motion of the shoulder.
Other Name: Goniometer

Software development kit measurements
Measurements of shoulder range of motion using a proprietary SDK
Device: Software development kit measurements
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.
Other Name: SDK




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • No prior shoulder pain
  • No prior shoulder surgeries
  • No limitations in shoulder range of motion

Exclusion Criteria:

  • Prior shoulder surgeries
  • Past or present shoulder pain
  • Any limitations in shoulder range of motion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195751


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Joseph P Iannotti, MD PhD The Cleveland Clinic

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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03195751     History of Changes
Other Study ID Numbers: 17-800
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Cleveland Clinic:
telemonitoring