Mobile Application Utilization for Measurement of Scapular Position (MnMotion)

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

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.

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota

Investigators

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

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT02773654
• Other Study ID Numbers: 1604M86268
• First Posted: May 16, 2016
• 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:

Shoulder Pain; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations