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Sensor Ankle Brace for Special Operations Rehabilitation - Phase 1

NCT07085416 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-19

No results posted yet for this study

Summary

The primary purpose of this study overall is to validate a modified version of a commercially available ankle brace. Inertial measurement unit sensors 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 1 protocol, the sXAB will be validated in the lab on healthy subjects walking in standard tennis shoes/sneakers. 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
2026-01-15
Completion
2026-01-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07085416 on ClinicalTrials.gov