ClinicCompanion. Compared to the Use of a Goniometer

Shoulder Impingement Syndrome Clinical Trial

Official title:

A Study of Effectiveness of clinicCompanion. Compared to the Use of a Goniometer for Range of Motion Measurement.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02043639
• Other study ID #: 13-40 ClinicCompanion.
• Status: Terminated
• Phase: N/A
• First received: January 14, 2014
• Last updated: April 13, 2016
• Start date: August 2013
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: Aurora Health Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• new or established clinic patients from PI's medical practice at Aurora St. Luke's Medical Center

• 18 years of age and older

Exclusion Criteria:

• no use of limbs

• amputees

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome

Locations

Country	Name	City	State
United States	Aurora St Lukes Medical Center	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Aurora Health Care	Medical Companion LLC

Country where clinical trial is conducted

United States, 

References & Publications (6)

Dutta 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. — View Citation

Khoshelham 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. — View Citation

MacDermid 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. — View Citation

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. — View Citation

Riddle DL, Rothstein JM, Lamb RL. Goniometric reliability in a clinical setting. Shoulder measurements. Phys Ther. 1987 May;67(5):668-73. — View Citation

van 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The goal is to recruit 75 subjects in 18 months	No