RecruitingNot ApplicableNCT07085416

Sensor Ankle Brace for Special Operations Rehabilitation

Sponsor

Indiana University

Enrollment

60 participants

Start Date

Oct 16, 2025

Study Type

INTERVENTIONAL

Conditions

Balance Postural Control Gait Biomechanical Data Locomotion

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).

Eligibility

Min Age: 18 YearsMax Age: 40 Years

Inclusion Criteria4

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 Criteria10

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.

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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.