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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02167399
Other study ID # IRB14-00222
Secondary ID
Status Completed
Phase N/A
First received June 10, 2014
Last updated December 22, 2014
Start date June 2014
Est. completion date September 2014

Study information

Verified date December 2014
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Evidence supports the use of two dimensional video analysis to assess the presence of dynamic knee valgus during generally used screening tasks, however there is limited evidence to support the use of the various smart phone applications as a time and money saving option for clinic use . Subjects that present to the clinic and display dynamic valgus at the knee during the lateral step down test will be given the option to participate in the study. If they consent to the study they will be evaluated with 2-Dimensional video analysis to determine the amount of valgus present at the knee during the lateral step down test. The subject will also have the smart phone attached to their lower leg and the amount of valgus will be concurrently measured by the selected application. The primary objective of this study is to determine the validity of an application on the smart phone to provide an objective measure of dynamic knee valgus. The secondary objective of this study is to determine the possibility of the use of the application as a source of feedback during neuromuscular re-education training in order to decrease or eliminate a subject's dynamic valgus collapse and subsequently decreased their risk for future injury.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date September 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 13 Years and older
Eligibility Inclusion Criteria:

- Willingness to participate

- ability to perform a single leg squat, drop jump, and single leg drop without pain

Exclusion Criteria:

- lower extremity injury within 6 months prior to testing

- history of lower extremity surgery

- lower extremity weight bearing restrictions

- inability to follow directions

- neoprene/latex allergy

- Adhesive allergy

- Current neurological or developmental condition

- inability to attend follow-up session

- actively receiving Physical Therapy intervention for varus/valgus impairment

- Current pregnancy

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United States Nationwide Children's Hospital Sports and Ortho PT Westerville Westerville Ohio

Sponsors (1)

Lead Sponsor Collaborator
Mitchell Selhorst

Country where clinical trial is conducted

United States, 

References & Publications (2)

Munro A, Herrington L, Carolan M. Reliability of 2-dimensional video assessment of frontal-plane dynamic knee valgus during common athletic screening tasks. J Sport Rehabil. 2012 Feb;21(1):7-11. Epub 2011 Nov 15. — View Citation

Swenson DM, Collins CL, Fields SK, Comstock RD. Epidemiology of U.S. high school sports-related ligamentous ankle injuries, 2005/06-2010/11. Clin J Sport Med. 2013 May;23(3):190-6. doi: 10.1097/JSM.0b013e31827d21fe. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Agreement in Dynamic lower extremity valgus angles during single leg landing drop jump Patient's dynamic lower extremity valgus during a single leg drop jump from a 12 inch step will be measured using both 2-D video analysis and smart phone inclinometer analysis. Measurements of 2-D and smart phone will be taken at the same time. Analysis will be repeated at 2nd visit to assess the reliability of the measurements Baseline No
Primary Agreement in Dynamic lower extremity valgus angles during single leg squat Patient's dynamic lower extremity valgus during single leg squat will be measured using both 2-D video analysis and smart phone inclinometer analysis. Measurements of 2-D and smart phone will be taken at the same time. Analysis will be repeated at 2nd visit to assess the reliability of the measurements Baseline No
Secondary Agreement in Dynamic lower extremity valgus angles during drop jump Patient's dynamic lower extremity valgus during a drop jump from a 12 inch step will be measured using both 2-D video analysis and smart phone inclinometer analysis. Measurements of 2-D and smart phone will be taken at the same time. Analysis will be repeated at 2nd visit to assess the reliability of the measurements Baseline No
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