Sensor Ankle Brace for Special Operations Rehabilitation
Indiana University
Summary
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 sensor-enabled ankle brace will measure gait metrics with a high degree of accuracy (within 5%) when compared against the gold-standard lab equipment (i.e., motion capture and research-grade inertial measurement units).
Description
This study is funded by a grant from the United States Air Force awarded to TayCo Brace, Inc. The required research partner, Indiana University (Principal Investigator Allison Gruber, PhD), holds the subaward. All human subjects activities are taking place at the Indiana University Bloomington (IUB) campus. Potential participants for study protocols 1 and 2 will be recruited from the community and the IUB campus. Paper flyers will be posted on campus and the surrounding commercial areas. Electronic flyers will be posted in the IUB classifies, on the iConnect website, and on social media. Poten…
Eligibility
- Age range
- 18–40 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria for both cohorts: * Healthy adults: ages 18 - 40 years * considered "healthy to exercise" as determined by the physical activity readiness questionnaire (PAR-Q) Additional Inclusion Criteria specific to cohort 2 only: * Classified as "moderate" or "high" activity level as defined by the scoring criteria of the International Physical Activity Questionnaire - Short Form (IPAQ) * Comfortably fit into combat boots provided by the laboratory (Men's sizes 8, 9, 10, 11, 12 and Women's sizes 6, 7, 8, 9, 10 will be purchased, and so participants with foot lengths of 22.54-29.27.8…
Interventions
- DeviceSensor-enabled Athletic X Ankle Brace (sXAB)
The intervention is a sensor-enabled version of the TayCo Brace, Inc. Athletic X Ankle Brace (sXAB), which integrates commercially available inertial measurement units (IMUs) into the structure of the brace. The brace is worn on the ankle of the dominant limb during functional movement tasks to evaluate its ability to produce valid gait and balance metrics compared to laboratory-grade measurement systems.
Location
- Indiana University, School of Public Health - BloomingtonBloomington, Indiana