Contracture of Elbow JointNCT02985788
Self Digital Photography for Assessing Elbow Range of Motion
An observational study of Contracture of Elbow Joint, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contracture of Elbow Joint
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 15 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who have an elbow contracture in the sagittal plane
Who may be able to join
- Elbow contracture in the sagittal place
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Contracture of Elbow Joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital photo-based elbow range of motion measurement compared to traditional goniometry
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
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startSep 2016
- Primary completion15 Nov 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contracture of Elbow JointStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shawn W. O'Driscoll, Mayo Clinic
- Investigators
- Shawn O'Driscoll, PhD MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985788
- Sponsor's protocol ID
- 13-003378
- Status last verified
- Dec 2018
- First submitted
- 8 Nov 2016
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Self Digital Photography for Assessing Elbow Range of Motion
- ClinicalTrials.gov ID
- NCT02985788
- Acronym / sponsor ID
- 13-003378
- Conditions
- Contracture of Elbow Joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who have an elbow contracture in the sagittal plane
Key inclusion criteria (1 listed)
- Elbow contracture in the sagittal place
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawn O'Driscoll, PhD MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contracture of Elbow Joint, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital photo-based elbow range of motion measurement compared to traditional goniometry (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018.