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Self Digital Photography for Assessing Elbow Range of Motion

This study is currently recruiting participants.
Verified December 2016 by Shawn W. O'Driscoll, Mayo Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT02985788
First Posted: December 7, 2016
Last Update Posted: December 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Shawn W. O'Driscoll, Mayo Clinic
  Purpose
Loss of elbow range of motion can significantly affect activities of daily living. Measuring elbow range of motion is critical for tracking post surgical outcomes. This study seeks to validate the ability to validate self photography as a means of followup through long distance correspondence.

Condition
Contracture of Elbow Joint

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Validation of Self Digital Photography for Assessing Elbow Range of Motion

Further study details as provided by Shawn W. O'Driscoll, Mayo Clinic:

Primary Outcome Measures:
  • Digital photo-based elbow range of motion measurement compared to traditional goniometry [ Time Frame: up to 2 months ]
    Patients will follow instructions to take a photograph of themselves capturing elbow range of motion (flexion, extension, supination and pronation). Elbow range of motion will then be measured clinically with a goniometer. Patient's active participation will be 1 day. Range of motion will be measured off of photographs 1 month after capturing pictures and repeated 2 weeks later


Estimated Enrollment: 50
Study Start Date: September 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Video Instructions
Instructions on how to take a flexion/extension picture will be delivered in video format. These instructions will be followed by written instruction on how to take pictures examining pronation/supination.
Written instructions
Instructions on how to take a flexion/extension picture will be delivered in a written, on paper format. These instructions will be followed by written instruction on how to take pictures examining pronation/supination.

Detailed Description:
Loss of elbow range of motion is common after trauma and can significantly affect activities of daily living. Patients across the country travel to tertiary referral centers to have this problem addressed. Followup is critical and can often be difficult given distances between patients home and their healthcare provider. Measuring postoperative outcomes requires accurate and reliable documentation of range of motion. Previously, the investigators have validated digital photography as a means of accurately measuring elbow range of motion. In that study, photographs were taken by a non-professional photographer. With the advance in personal technology, patients now have the ability to take photos themselves. This study seeks to validate self photography, which will ultimately improve patient follow up and improve clinical monitoring
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who have an elbow contracture in the sagittal plane
Criteria

Inclusion Criteria:

  • Elbow contracture in the sagittal place

Exclusion Criteria:

  • Unable to read English
  • Unable to forward flex shoulder to 90 degrees or hold their shoulder at 90 degrees for the duration of the examination
  • Unable to tolerate the exercise due to pain
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02985788


Contacts
Contact: Tammy Olson 507-293-7613 olson.tammy@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tammy Olson    507-293-7613    olson.tammy@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Shawn O'Driscoll, PhD MD Mayo Clinic
  More Information

Responsible Party: Shawn W. O'Driscoll, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02985788     History of Changes
Other Study ID Numbers: 13-003378
First Submitted: November 8, 2016
First Posted: December 7, 2016
Last Update Posted: December 7, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases