Sensor Ankle Brace for Special Operations Rehabilitation

Part of paid clinical trials in Bloomington, Indiana.

Sponsor
Indiana University
Study ID
NCT07085416
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 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).

Key Dates

Start date
Oct 16, 2025
Status verified
Oct 2025
Primary completion
Mar 31, 2026
Completion
Jun 18, 2026

Study Design

Enrollment
60 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

Feasibility of collecting valid kinematic data with 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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