NCT02167399

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 19, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

Same day

First QC Date

June 10, 2014

Last Update Submit

December 22, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Agreement in Dynamic lower extremity valgus angles during drop jump

    Baseline

Other Outcomes (1)

  • Agreement in Dynamic lower extremity valgus angles during single leg landing drop jump

    Baseline

Study Arms (2)

smart phone inclinometer

For the smart phone analysis we will be using the tilt meter application which is a digital inclinometer application available on the I phone. The phone will be placed in the vertical position utilizing the bubble level feature of the application. The application will be set to display measurements to the closest tenth of the degree, set to log measurements every 0.2 seconds. The subject will stand with knee extended to 0 degrees and quadriceps muscle activated and upper extremity support on opposite side of stance limb. The phone will be placed in the vertical position on the anterior portion of the middle third of the subject's thigh attached using double sided adhesive tape. Being placed as close as possible to level when attached to the anterior thigh with subject in single limb stance with a reading of less than 1 deg as minimum for correct set-up prior to testing. Immediately prior to testing recording will be initiated logging measurements for later assessment.

2-D video analysis

two dimensional video analysis by first placing markers on the subject at the midpoint of the femoral condyles, midpoint of the ankle malleoli, and the proximal thigh along a line from the anterior superior iliac spine (ASIS) to the knee marker. Testing will take place in front of a digital video camera with tape on the floor to give a reference point for the subject being tested. Participants will be tested twice on day 1 and then again 5-9 days later. Subjects will be allowed 2-3 practice trials prior to each test in order to allow the subject to feel comfortable with each test. Following the practice trials the subject will perform 3 trials of each test on bilateral lower extremities. This set up was consistent with the set up by Munro et al.

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

physical therapy clinic

You may qualify if:

  • Willingness to participate
  • ability to perform a single leg squat, drop jump, and single leg drop without pain

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital Sports and Ortho PT Westerville

Westerville, Ohio, 43082, United States

Location

Related Publications (2)

  • 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.

    PMID: 23328403BACKGROUND
  • 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. doi: 10.1123/jsr.21.1.7. Epub 2011 Nov 15.

    PMID: 22104115BACKGROUND

MeSH Terms

Conditions

Leg Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Mitchell C Selhorst, DPT

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 10, 2014

First Posted

June 19, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2014

Study Completion

September 1, 2014

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations