Sensor Ankle Brace for Special Operations Rehabilitation

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 1, 2026 → Dec 31, 2026
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Record History

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  1. Minor Primary and study completion pushed from Sep 1, 2026 to Dec 31, 2026
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 4 of 5 entries
    • Publications: details revised at 3 of 3 entries
  2. Minor Secondary endpoints: details revised at 4 of 5 entries
    • Study title shortened, about 3 words
    v2
  3. Minor Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07776223
Lead Sponsor Indiana University
Collaborators: TAYCO BRACE, INC, United States Air Force
Conditions
(from sponsor)
Gait, Balance, Biomechanical Data, Postural Control, Locomotion
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov