- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02985788
Self Digital Photography for Assessing Elbow Range of Motion
December 11, 2018 updated by: Shawn W. O'Driscoll, Mayo Clinic
Validation of Self Digital Photography for Assessing Elbow Range of Motion
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.
Study Overview
Status
Completed
Conditions
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
Study Type
Observational
Enrollment (Actual)
50
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
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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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
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients who have an elbow contracture in the sagittal plane
Description
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
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
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Digital photo-based elbow range of motion measurement compared to traditional goniometry
Time Frame: up to 2 months
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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
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up to 2 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shawn O'Driscoll, PhD MD, Mayo Clinic
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
September 1, 2016
Primary Completion (Actual)
November 15, 2018
Study Completion (Actual)
November 15, 2018
Study Registration Dates
First Submitted
November 8, 2016
First Submitted That Met QC Criteria
December 5, 2016
First Posted (Estimate)
December 7, 2016
Study Record Updates
Last Update Posted (Actual)
December 13, 2018
Last Update Submitted That Met QC Criteria
December 11, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-003378
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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