Mobile Application Utilization for Measurement of Scapular Position (MnMotion)

1) Mobile Application Utilization for Measurement of Scapular Position 2) 3D Shoulder Motion Measurement Device (The MnMotion System)

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scapular Position as assessed in degrees of joint angle by the mobile application	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.	baseline

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Paula Ludewig, PhD, PT, University of Minnesota

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: May 13, 2016
• First Posted (Estimate): May 16, 2016

Study Record Updates

• Last Update Posted (Actual): March 21, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: shoulder; measurement; motion; healthy shoulder; shoulder motion
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: 1604M86268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED