Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mobile Application Utilization for Measurement of Scapular Position (MnMotion)

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

Tracking Information
First Submitted Date May 10, 2016
First Posted Date May 16, 2016
Last Update Posted Date March 21, 2019
Study Start Date June 2016
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 13, 2016)
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.
Original Primary Outcome Measures Same as current
Change History
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 Mobile Application Utilization for Measurement of Scapular Position
Official Title 1) Mobile Application Utilization for Measurement of Scapular Position 2) 3D Shoulder Motion Measurement Device (The MnMotion System)
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Shoulder Pain
Intervention
  • 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.
  • 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.
Study Groups/Cohorts
  • Healthy Volunteers
    Asymptomatic subjects: subjects without complaints or history of shoulder pain or obvious movement abnormalities.
    Intervention: Other: Healthy Volunteers
  • Symptomatic Volunteers
    Symptomatic subjects: subjects with shoulder pain who have active range of motion beyond 120° of elevation.
    Intervention: Other: Symptomatic Volunteers
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
Estimated Enrollment
 (submitted: May 13, 2016)
50
Original Estimated Enrollment Same as current
Actual Study Completion Date January 2019
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older 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 NCT02773654
Other Study ID Numbers 1604M86268
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University of Minnesota
Study Sponsor University of Minnesota
Collaborators Not Provided
Investigators
Principal Investigator: Paula Ludewig, PhD, PT University of Minnesota
PRS Account University of Minnesota
Verification Date March 2019