RECRUITING Not applicable ClinicalTrials.gov

Sensor Ankle Brace for Special Operations Rehabilitation

Sponsor: Indiana University • ClinicalTrials.gov ID: NCT07776223

Registry updated: 2026-10-14

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Description

The primary purpose of this study overall is to validate a modified version of a commercially available ankle brace. Inertial measurement unit sensors will be incorporated into an existing ankle brace ("sXAB") by TayCo Brace, Inc. In two consecutive studies, gait metrics data collected from the sensor enabled ankle brace will be compared to data collected by the 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. In the Phase 2 protocol, the sXAB will be validated on healthy subjects wearing combat boots performing walking, running, jumping, and stair climbing activities. These movements were selected because they simulate key movements performed during operational activities. 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).

Interventions

Sensor-enabled Athletic X Ankle Brace (sXAB) (Device)
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.

Eligibility criteria

Inclusion Criteria: * Healthy adults: ages 18 - 40 years * considered "healthy to exercise" as determined by the physical activity readiness questionnaire (PAR-Q) * 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 cm are expected to fit in the boots provided). Exclusion Criteria: * Smoking tobacco on a regular basis * Previous lower back or lower limb surgery (including the joints of the pelvis and lower limbs) * Musculoskeletal injury sustained within the 12-weeks prior to enrollment . A musculoskeletal injury is defined as musculoskeletal pain causing a reduction or stoppage of normal physical activity for at least 3 days within a 7-day period, and have not returned to their normal physical activity and exercise without pain for at least the last 6-weeks. * Pregnant (women only) * Current or history of an unresolved musculoskeletal, neurological, cardiovascular, pulmonary/respiratory, metabolic, renal condition, disease, or problem. * Torn anterior or posterior cruciate ligament (ACL or PCL). * Any other disease or problems that may affect movement or the ability to exercise even at a low intensity. * Identification of Functional Ankle Instability (IDFAI) score of \<11. * unable to comfortably perform the drop landing condition. * Feet are too large or too small to fit comfortably in the combat boots provided.

Conditions

Gait Balance Biomechanical Data Postural Control Locomotion

Locations

Indiana University, School of Public Health - Bloomington — Bloomington, Indiana, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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