ClinicCompanion. Compared to the Use of a Goniometer

October 1, 2024 updated by: Wake Forest University Health Sciences

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora St Lukes Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The goal is to recruit 75 subjects in 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

Medical Companion LLC

Investigators

  • Principal Investigator: Maharaj m Singh, PHD, Wake Forest University Health Sciences
  • Principal Investigator: Navjot m Kohli, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 21, 2014

First Posted (Estimated)

January 23, 2014

Study Record Updates

Last Update Posted (Actual)

October 3, 2024

Last Update Submitted That Met QC Criteria

October 1, 2024

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-40 ClinicCompanion.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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