Sensor Ankle Brace for Special Operations Rehabilitation

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).

Conditions

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

Interventions

DEVICE

Sensor-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.

Sponsors & Collaborators

• TAYCO BRACE, INC

  collaborator UNKNOWN

• United States Air Force

  collaborator FED

• Indiana University

  lead OTHER

Principal Investigators

• Allison H Gruber, PhD · Indiana University

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-10-16

Primary Completion

2026-03-31

Completion

2026-06-18

FDA Device

Yes

Countries

• United States

Study Locations