Sensor Ankle Brace for Special Operations Rehabilitation - Phase 2

Part of paid clinical trials in Bloomington, Indiana.

Sponsor
Indiana University
Study ID
NCT07776223
Status
Recruiting
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Conditions

  • Balance
  • Biomechanical Data
  • Gait
  • Locomotion
  • Postural Control

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

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.

Study Details

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).

Key Dates

First listed
Aug 20, 2026
Start date
May 5, 2026
Status verified
Aug 2026
Primary completion
Sep 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Single Group: Brace and No-Brace Conditions
    This study includes a single group of participants (collected across two cohorts) who complete movement tasks under two within-subject conditions: (1) wearing a sensor-enabled ankle brace ("brace" condition), and (2) without the brace ("no-brace" condition). Each participant serves as their own control. The brace condition order is randomized, and all participants experience both conditions.

Primary Outcome Measure

Validation of kinematic data collected by the sensor-enabled ankle brace (sXAB) [ Time Frame: At study visit(s), completed up to 1 week after enrollment. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University, School of Public Health - BloomingtonBloomingtonIndiana47405
Allison H Gruber, PhD
[email protected]
8128562447
Adriana M Alamilla, MS
[email protected]
708-745-8368
Allison H Gruber, PhD (PRINCIPAL_INVESTIGATOR)

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Indiana University, School of Public Health - Bloomington· Bloomington, IN

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