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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02985788
Other study ID # 13-003378
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2016
Est. completion date November 15, 2018

Study information

Verified date December 2018
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date November 15, 2018
Est. primary completion date November 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 up to 2 months
See also
  Status Clinical Trial Phase
Completed NCT03179098 - Immediate Effects of Superficial Heat Associated With Elongation in the Posttraumatic Elbow Contracture N/A