Condition: Gait · Balance · Biomechanical Data · Sponsor: Indiana University
The primary purpose of this study is to conduct a clinical trial to test a prototype device for feasibility and not health outcomes. To do this, the investigators will evaluate the performance of commercially available inertial measurement unit sensors incorporated into an existing ankle brace ("sXAB") by TayCo Brace, Inc. We will compare the gait metrics calculated from the sensors incorporated into the brace with gold-standard equipment that is used in research and clinical settings to determine whether the sXAB performs adequately in terms of measurement or technical feasibility prior to further clinical evaluation. The sensors in the ankle brace will be validated in the lab, first on healthy subjects walking in standard tennis shoes/sneakers (protocol 1), and secondarily in the lab on healthy subjects wearing combat boots performing walking, running, jumping, and stair climbing (protocol 2). These movements were selected because they simulate key movements performed during operational activities. Protocol 1 will take place first, then aspects of the sXAB will be evaluated and implemented, then protocol 2 will take place. Participants completing protocol 1 are eligible to complete protocol 2. The study includes two cohorts of participants completing different functional tasks. All participants experience both conditions: with an ankle brace and without an ankle brace. Comparisons are made within-subject between brace and no-brace conditions. It is hypothesized that the sen…
This description comes directly from the study's public registry record.
Allison H Gruber, PhD · 8128562447 · ahgruber@iu.edu
Adriana M Alamilla, MS · 708-745-8368 · admiltko@iu.edu
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| Indiana University, School of Public Health - Bloomington | Bloomington, Indiana, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07085416