Upstate Active Clinical Trials

Study Title:

Effect of Posterior Tibial Tendon Dysfunction Specific Braces on Foot Kinematics and outcomes in Patients with Stage II Posterior Tibial Tendon Dysfunction

What is the purpose of the study? (in Layman's terms, please describe the study)

The purpose of this research study is to examine changes in foot movement that result from using different braces for Posterior Tibial Tendon Dysfunction (PTTD). Three of the braces are custom made (Arizona Brace) while one is an off-the-shelf brace (AirLift PTTD). All braces are standard ankle support braces that are currently available to the general public and are commonly used for flatfeet. Finally, outcomes such as pain and strength will be assessed after wearing the braces for 12 weeks.

Upstate Institutional Review Board (IRB) Number:

230516

Study Phase:

N/A

Patient Age Group:

Adults

Principal Investigator:

Christopher G Neville, PT, PhD

What is involved if I participate?

• How long is the study?
  4 months
• Is transportation provided or reimbursed?
  No
• Is parking provided or reimbursed?
  Yes
• What tests and procedures are involved?
  If you agree to participate in the study, you will be asked to attend two testing sessions at the Institute for Human Performance located on the Upstate campus at 505 Irving Avenue, Syracuse, NY 13210. The first testing session will take about 2 hours while the second testing session will be about 1 hour. During the testing session you will undergo a standard clinical examination. This will include an assessment of your strength by asking you to place your foot in different positions against resistance as well as inspection of your feet to determine the location of the bones. Ultrasound images of your ankle may be taken to examine the posterior tibial tendon. This is non-invasive, safe, and uses no radiation. You will complete questionnaires about your foot pain and ability to perform daily tasks. Then markers will be placed on the skin of one foot and leg and you will put on a brace. You will wear a pair of normal walking shoes that have been modified with holes on top so we can see the markers.You will then be asked to walk down a 10 meter walkway between 15 and 30 times wearing each brace to be tested during the session. The movement of the markers placed on your foot and leg are tracked using cameras to measure your foot movements. You will not feel anything from this monitoring other than the presence of the taped markers on your foot. You will then be randomly assigned 1 of the braces tested to take home and wear for the next 12 weeks. You will be given a pair of shoes to wear with the brace during the 12 week period. You will be asked to keep a log of how often you wear the brace. After 12 weeks you will return to the Motion Analysis Lab to repeat the strength tests and fill out the questionnaires again. Digital photos and digital videos will be taken of your foot and leg. As part of this study, we are asking your permission to review x-rays that were previously performed as part of your standard care.

Where will the study take place?

Institute for Human Performance

ClinicalTrials.Gov ID:

NCT01749657

For more information about this trial go to ClinicalTrials.Gov

Who can I contact for more information?

Name: Christopher G Neville, PT, PhD
Phone: 315-464-6888
Email: nevillec@upstate.edu

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