Wearable Technology in Shoulder Range of Motion
Condition: Normal Upper Extremity
Study type: Observational

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.
    

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.
    

Intervention name(s): Software development kit measurements; Manual Goniometer Measurements
Intervention type(s): Device; Device
Intervention description(s): 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.; A manual goniometer was used to measure the range of motion of the shoulder.
Other intervention name(s): SDK; Goniometer
Observational model: Cohort
Time perspective: Prospective
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.
      
Keywords: telemonitoring