Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
10 participants
OBSERVATIONAL
2017-09-13
2017-09-23
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Manual Goniometer measurements
Measurements of shoulder range of motion using manual goniometer
Manual Goniometer Measurements
A manual goniometer was used to measure the range of motion of the shoulder.
Software development kit measurements
Measurements of shoulder range of motion using a proprietary SDK
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.
Interventions
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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.
Manual Goniometer Measurements
A manual goniometer was used to measure the range of motion of the shoulder.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No prior shoulder surgeries
* No limitations in shoulder range of motion
Exclusion Criteria
* Past or present shoulder pain
* Any limitations in shoulder range of motion
18 Years
40 Years
ALL
Yes
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Principal Investigators
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Joseph P Iannotti, MD PhD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Other Identifiers
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17-800
Identifier Type: -
Identifier Source: org_study_id