Shoulder PainMnMotionNCT02773654
Mobile Application Utilization for Measurement of Scapular Position
An observational study of Shoulder Pain, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Healthy Volunteers and Symptomatic Volunteers
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: 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:
- 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
- To determine the validity of the shoulder joint position measurements measurements as described above.
Read the 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.
- Conditions
- Shoulder Pain
- Being tested
- Healthy Volunteers, Symptomatic Volunteers
- Keywords
- shoulder, motion, measurement, healthy shoulder, shoulder motion
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy VolunteersOther
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 VolunteersOther
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 group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Asymptomatic subjects: subjects without complaints or history of shoulder pain or obvious movement abnormalities. Receives: Other: Healthy Volunteers | |
| Symptomatic Volunteers | Symptomatic subjects: subjects with shoulder pain who have active range of motion beyond 120° of elevation. Receives: Other: Symptomatic Volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula Ludewig, PhD, PT, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773654
- Sponsor's protocol ID
- 1604M86268
- Acronym
- MnMotion
- Status last verified
- Mar 2019
- First submitted
- 10 May 2016
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1) Mobile Application Utilization for Measurement of Scapular Position 2) 3D Shoulder Motion Measurement Device (The MnMotion System)
- ClinicalTrials.gov ID
- NCT02773654
- Acronym / sponsor ID
- MnMotion / 1604M86268
- Conditions
- Shoulder Pain
- Keywords
- shoulder, motion, measurement, healthy shoulder, shoulder motion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Other: Healthy VolunteersAsymptomatic subjects: subjects without complaints or history of shoulder pain or obvious movement abnormalities. |
| Symptomatic Volunteers | – | Other: Symptomatic VolunteersSymptomatic subjects: subjects with shoulder pain who have active range of motion beyond 120° of elevation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy VolunteersScapula 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 | Healthy Volunteers |
| Symptomatic VolunteersScapula 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 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Ludewig, PhD, PT principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scapular Position as assessed in degrees of joint angle by the mobile application (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.