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Mobile Application Utilization for Measurement of Scapular Position (MnMotion)

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ClinicalTrials.gov Identifier: NCT02773654
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:

The purpose of this study is to determine the ability of a mobile clinical application to reliably and accurately track scapular motion in people with asymptomatic and symptomatic shoulders. The ability to accurately and reliably measure shoulder position clinically is an important first step in choosing the best treatment techniques to treat shoulder movement dysfunction. Therefore, the primary objectives of the study are:

  1. To determine the inter- and intra-rater reliability of shoulder joint position measurements in symptomatic and asymptomatic subjects, by using a mobile application, with and without use of a handle for a smartphone
  2. To determine the validity of the shoulder joint position measurements measurements as described above.

Condition or disease Intervention/treatment
Shoulder Pain Other: Healthy Volunteers Other: Symptomatic Volunteers

Detailed Description:

Subjects will be asked to provide demographic and background information such as age, height, history of pain or injury, and descriptions of their physical activity levels. Subjects will receive a clinical screening exam by a licensed physical therapist to determine the type of movement abnormalities present, the severity of their symptoms and to screen for inclusion and exclusion criteria.

To collect scapular position measurement reliability data, subjects will stand through out data collection. Measurements of the scapula will be taken with the mobile application for the arm at rest and in two elevated position. Subjects will wear an off-the-shelf elbow brace when asked to hold their arm in the two elevated positions. These elevated positions will be maintained by having subjects maintain contact of their forearm against a guide. For intra-rater reliability, position measurements will be repeated twice for each of three planes of elevation. Additionally, for inter-rater reliability each measurement will be repeated once by two other examiners. This process will repeated twice when using the application with and without the handle.

For the validation portion of the study, a subgroup of subjects will have the same position measurements performed by a single examiner with additional motion sensors taped to the skin of their scapula and breast bone and a sensor attached to an arm brace strapped to their arm.

In total, the subject will be asked to raise and hold their arm for approximately 5 sec, 36 times during the testing within ranges of motion typically performed during daily activities.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: 1) Mobile Application Utilization for Measurement of Scapular Position 2) 3D Shoulder Motion Measurement Device (The MnMotion System)
Study Start Date : June 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : January 2019

Group/Cohort Intervention/treatment
Healthy Volunteers
Asymptomatic subjects: subjects without complaints or history of shoulder pain or obvious movement abnormalities.
Other: Healthy Volunteers
Scapula static position of subjects with and without shoulder symptoms will be recorded utilizing a mobile phone application placed on their scapula by either the examiner's hands or with a handle, held by the examiner.

Symptomatic Volunteers
Symptomatic subjects: subjects with shoulder pain who have active range of motion beyond 120° of elevation.
Other: Symptomatic Volunteers
Scapula static position of subjects with and without shoulder symptoms will be recorded utilizing a mobile phone application placed on their scapula by either the examiner's hands or with a handle, held by the examiner.




Primary Outcome Measures :
  1. Scapular Position as assessed in degrees of joint angle by the mobile application [ Time Frame: baseline ]
    Scapular position is measured in degrees of joint angle collected by the mobile application software collecting this information from the mobile device's measurement sensors.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  1. Asymptomatic subjects: subjects without complaints or history of shoulder pain or obvious movement abnormalities.
  2. Symptomatic subjects: subjects with shoulder pain who have active range of motion beyond 120° of elevation.
Criteria

Inclusion Criteria:

  1. Asymptomatic subjects: subjects without complaints or history of shoulder pain or obvious movement abnormalities.
  2. Symptomatic subjects: subjects with shoulder pain who have active range of motion beyond 120° of elevation.

Exclusion Criteria:

  1. Symptomatic and asymptomatic subjects: history of trauma including fractures, dislocations, previous shoulder surgeries within the past 6 weeks. Humeral elevation less than 120 degrees, shoulder symptomology that is judged by the examiner to be of cervical origin.
  2. Asymptomatic subjects: Complaints of shoulder pain, positive results on joint tests commonly associated with shoulder impingement, presence of shoulder joint movement abnormalities as determined by a physical therapist, including thoracic scoliosis.

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): NCT02773654


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Paula Ludewig, PhD, PT University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02773654    
Other Study ID Numbers: 1604M86268
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Minnesota:
shoulder
motion
measurement
healthy shoulder
shoulder motion
Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations