Sensor Ankle Brace for Special Operations Rehabilitation - Phase 2

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorIndiana University

About this trial

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).

Eligibility criteria

Qualifiers

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).

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Sensor-enabled Athletic X Ankle Brace (sXAB)

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Indiana University

Lead sponsor

TAYCO BRACE, INC

Collaborator

United States Air Force

Collaborator