NCT02773654

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. 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. 2.To determine the validity of the shoulder joint position measurements measurements as described above.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

May 10, 2016

Last Update Submit

March 19, 2019

Conditions

Keywords

shouldermotionmeasurementhealthy shouldershoulder motion

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Healthy Volunteers

Asymptomatic subjects: subjects without complaints or history of shoulder pain or obvious movement abnormalities.

Other: Healthy Volunteers

Symptomatic Volunteers

Symptomatic subjects: subjects with shoulder pain who have active range of motion beyond 120° of elevation.

Other: Symptomatic Volunteers

Interventions

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.

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paula Ludewig, PhD, PT

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 16, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2017

Study Completion

January 1, 2019

Last Updated

March 21, 2019

Record last verified: 2019-03

Locations