Shoulder Impingement SyndromeNCT02043639
ClinicCompanion. Compared to the Use of a Goniometer
An observational study of Shoulder Impingement Syndrome, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
In this study, the goal is to find out if the clinicCompanion™ is effective in measuring range of motion when compared to the goniometer. Currently, the goniometer is an approved device to measure range of motion by the FDA, but the clinicCompanion™ is not. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Impingement Syndrome
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Feb 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: New or established clinic patients from Aurora St. Luke's Medical Center. The subjects will be recruited from the principal investigator's medical practice. Any patient may be included in the study, regardless of his/her diagnosis and must be 18 years of age and older.
Who may be able to join
- new or established clinic patients from PI's medical practice at Aurora St. Luke's Medical Center
- 18 years of age and older
Who cannot join
- no use of limbs
- amputees
Trial locations and contacts
1 site in 1 country.
United States1 site
Aurora St Lukes Medical Center
Milwaukee, Wisconsin, 53215
About this study
Official title: A Study of Effectiveness of clinicCompanion. Compared to the Use of a Goniometer for Range of Motion Measurement.
In this study, the goal is to find out if the clinicCompanion™ is effective in measuring range of motion when compared to the goniometer. Currently, the goniometer is an approved device to measure range of motion by the FDA, but the clinicCompanion™ is not.
Read the detailed description
The study procedure will test the range of motion of the subjects shoulders two different ways: using a goniometer and using the clinicCompanion™. Both tools are designed to measure the degree of movement subjects are able to do. Researchers will take 12 measurements on each arm for each device, for a total of 24 measurements per device. That is a total of 48 measurements for both devices.
- Conditions
- Shoulder Impingement Syndrome
- Keywords
- rotation, shoulder, joint, ROM, abduction,, internal rotation,, external rotation,, flexion, normal, joint movement, physical examination
- Medical subject headings
- Shoulder Impingement Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Control cost and enhance accuracy of measurement
By freeing the doctor from data collection, he or she will be able to spend more time with patient discussing medical conditions and providing pertinent information
Measured: The goal is to recruit 75 subjects in 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startAug 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: Change in technology
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Shoulder Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Companion LLC
- Responsible party
- Sponsor
- Investigators
- Maharaj m Singh, PHD, Principal investigator, Wake Forest University Health SciencesNavjot m Kohli, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043639
- Sponsor's protocol ID
- 13-40 ClinicCompanion.
- Status last verified
- Apr 2016
- First submitted
- 14 Jan 2014
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mullaney MJ, McHugh MP, Johnson CP, Tyler TF. Reliability of shoulder range of motion comparing a goniometer to a digital level. Physiother Theory Pract. 2010 Jul;26(5):327-33. doi: 10.3109/09593980903094230.
PubMed 20557263van de Pol RJ, van Trijffel E, Lucas C. Inter-rater reliability for measurement of passive physiological range of motion of upper extremity joints is better if instruments are used: a systematic review. J Physiother. 2010;56(1):7-17. doi: 10.1016/s1836-9553(10)70049-7.
PubMed 20500132MacDermid JC, Chesworth BM, Patterson S, Roth JH. Intratester and intertester reliability of goniometric measurement of passive lateral shoulder rotation. J Hand Ther. 1999 Jul-Sep;12(3):187-92. doi: 10.1016/s0894-1130(99)80045-3.
PubMed 10459526Riddle DL, Rothstein JM, Lamb RL. Goniometric reliability in a clinical setting. Shoulder measurements. Phys Ther. 1987 May;67(5):668-73. doi: 10.1093/ptj/67.5.668.
PubMed 3575423Khoshelham K, Elberink SO. Accuracy and resolution of Kinect depth data for indoor mapping applications. Sensors (Basel). 2012;12(2):1437-54. doi: 10.3390/s120201437. Epub 2012 Feb 1.
PubMed 22438718Dutta T. Evaluation of the Kinect sensor for 3-D kinematic measurement in the workplace. Appl Ergon. 2012 Jul;43(4):645-9. doi: 10.1016/j.apergo.2011.09.011. Epub 2011 Oct 20.
PubMed 22018839
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Effectiveness of clinicCompanion. Compared to the Use of a Goniometer for Range of Motion Measurement.
- ClinicalTrials.gov ID
- NCT02043639
- Acronym / sponsor ID
- 13-40 ClinicCompanion.
- Conditions
- Shoulder Impingement Syndrome
- Keywords
- rotation, shoulder, joint, ROM, abduction,, internal rotation,, external rotation,, flexion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Change in technology
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Medical Companion LLC
- Study start
- Aug 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 23 Jan 2014 (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.
In this study, the goal is to find out if the clinicCompanion™ is effective in measuring range of motion when compared to the goniometer. Currently, the goniometer is an approved device to measure range of motion by the FDA, but the clinicCompanion™ is not.
Detailed description
The study procedure will test the range of motion of the subjects shoulders two different ways: using a goniometer and using the clinicCompanion™. Both tools are designed to measure the degree of movement subjects are able to do. Researchers will take 12 measurements on each arm for each device, for a total of 24 measurements per device. That is a total of 48 measurements for both devices.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- New or established clinic patients from Aurora St. Luke's Medical Center. The subjects will be recruited from the principal investigator's medical practice. Any patient may be included in the study, regardless of his/her diagnosis and must be 18 years of age and older.
Key inclusion criteria (2 listed)
- new or established clinic patients from PI's medical practice at Aurora St. Luke's Medical Center
- 18 years of age and older
Key exclusion criteria (2 listed)
- no use of limbs
- amputees
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Control cost and enhance accuracy of measurement
Time frame: The goal is to recruit 75 subjects in 18 months
By freeing the doctor from data collection, he or she will be able to spend more time with patient discussing medical conditions and providing pertinent information
Results and safety
The study was stopped early (reason given: Change in technology). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Background: PubMed 20557263Mullaney MJ, McHugh MP, Johnson CP, Tyler TF. Reliability of shoulder range of motion comparing a goniometer to a digital level. Physiother Theory Pract. 2010 Jul;26(5):327-33. doi: 10.3109/09593980903094230.
- Background: PubMed 20500132van de Pol RJ, van Trijffel E, Lucas C. Inter-rater reliability for measurement of passive physiological range of motion of upper extremity joints is better if instruments are used: a systematic review. J Physiother. 2010;56(1):7-17. doi: 10.1016/s1836-9553(10)70049-7.
- Background: PubMed 10459526MacDermid JC, Chesworth BM, Patterson S, Roth JH. Intratester and intertester reliability of goniometric measurement of passive lateral shoulder rotation. J Hand Ther. 1999 Jul-Sep;12(3):187-92. doi: 10.1016/s0894-1130(99)80045-3.
- Background: PubMed 3575423Riddle DL, Rothstein JM, Lamb RL. Goniometric reliability in a clinical setting. Shoulder measurements. Phys Ther. 1987 May;67(5):668-73. doi: 10.1093/ptj/67.5.668.
- Background: PubMed 22438718Khoshelham K, Elberink SO. Accuracy and resolution of Kinect depth data for indoor mapping applications. Sensors (Basel). 2012;12(2):1437-54. doi: 10.3390/s120201437. Epub 2012 Feb 1.
- Background: PubMed 22018839Dutta T. Evaluation of the Kinect sensor for 3-D kinematic measurement in the workplace. Appl Ergon. 2012 Jul;43(4):645-9. doi: 10.1016/j.apergo.2011.09.011. Epub 2011 Oct 20.
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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.
Maharaj m Singh, PHD principal investigator
Wake Forest University Health Sciences
Navjot m Kohli, MD principal investigator
Wake Forest University Health Sciences
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 Impingement Syndrome, run by Wake Forest University Health Sciences 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: stopped early, as of the sponsor's last update on 3 Oct 2024. 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 was stopped early (reason given: Change in technology). Results are not available in the source record.
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?
Control cost and enhance accuracy of measurement (time frame: The goal is to recruit 75 subjects in 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02043639, which also lists 6 linked publications.
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 3 Oct 2024.