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Wearable Technology in Shoulder Range of Motion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 20, 2017
First Posted Date June 22, 2017
Last Update Posted Date October 6, 2017
Actual Study Start Date September 13, 2017
Actual Primary Completion Date September 23, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 22, 2017)
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.
Original Primary Outcome Measures
 (submitted: June 20, 2017)
Difference in range of motion measurements between goniometer and software development kit measurement [ Time Frame: 24 hours ]
Change History Complete list of historical versions of study NCT03195751 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Wearable Technology in Shoulder Range of Motion
Official Title Wearable Technology in Shoulder Range of Motion: Validation of a Motion-Based Software Development Kit
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Normal Upper Extremity
Intervention
  • 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
  • Device: Manual Goniometer Measurements
    A manual goniometer was used to measure the range of motion of the shoulder.
    Other Name: Goniometer
Study Groups/Cohorts
  • Manual Goniometer measurements
    Measurements of shoulder range of motion using manual goniometer
    Intervention: Device: Manual Goniometer Measurements
  • Software development kit measurements
    Measurements of shoulder range of motion using a proprietary SDK
    Intervention: Device: Software development kit measurements
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 20, 2017)
10
Original Estimated Enrollment Same as current
Actual Study Completion Date September 23, 2017
Actual Primary Completion Date September 23, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03195751
Other Study ID Numbers 17-800
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party The Cleveland Clinic
Study Sponsor The Cleveland Clinic
Collaborators Not Provided
Investigators
Principal Investigator: Joseph P Iannotti, MD PhD The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date October 2017