Clinical trial NCT02043639: ClinicCompanion. Compared to the Use of a Goniometer
Official title: A Study of Effectiveness of clinicCompanion. Compared to the Use of a Goniometer for Range of Motion Measurement.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Shoulder Impingement Syndrome
Keywords: rotation
shoulder
joint
ROM
abduction,
internal rotation,
external rotation,
flexion
normal
joint movement
physical examination
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Medical Companion LLC
First posted: 2014-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Control cost and enhance accuracy of measurement
timeFrame: The goal is to recruit 75 subjects in 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Aurora St Lukes Medical Center
state: Wisconsin
Study officials:
affiliation: Wake Forest University Health Sciences
name: Maharaj m Singh, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Navjot m Kohli, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1016/s1836-9553(10)70049-7.
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. doi: 10.1016/s0894-1130(99)80045-3.
citation: Riddle 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.
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citation: 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.