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Outcome Measures

Primary Outcomes (2)

Validation of kinematic data collected by the sensor-enabled ankle brace (sXAB)
This outcome evaluates whether kinematic data collected using the sensor-enabled ankle brace (sXAB) are sufficiently accurate and reliable compared to gold-standard laboratory systems (motion capture and force plates). Agreement between sXAB and laboratory reference systems will be assessed using measures of validity and reliability for ankle kinematic variables, including sagittal plane joint angles and range of motion. Data are collected during brace conditions across multiple movement tasks.
At study visit(s), completed up to 1 week after enrollment.
Validation of spatiotemporal parameters collected by the sensor-enabled ankle brace (sXAB)
This outcome evaluates whether spatiotemporal parameters collected using the sensor-enabled ankle brace (sXAB) are sufficiently accurate and reliable compared to gold-standard laboratory systems (motion capture and force plates). Agreement between sXAB and laboratory reference systems will be assessed using measures of validity and reliability for stance time, stride length, gait speed. Data are collected during brace conditions across multiple movement tasks.

Study Arms (1)

Single Group: Brace and No-Brace Conditions

EXPERIMENTAL

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.

Device: Sensor-enabled Athletic X Ankle Brace (sXAB)

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.

Single Group: Brace and No-Brace Conditions

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Related Publications (3)

Rhon DI, Greenlee TA, Cook CE, Westrick RB, Umlauf JA, Fraser JJ. Fractures and Chronic Recurrence are Commonly Associated with Ankle Sprains: a 5-year Population-level Cohort of Patients Seen in the U.S. Military Health System. Int J Sports Phys Ther. 2021 Oct 1;16(5):1313-1322. doi: 10.26603/001c.27912. eCollection 2021.

PMID: 34631252BACKGROUND

Gurchiek RD, Choquette RH, Beynnon BD, Slauterbeck JR, Tourville TW, Toth MJ, McGinnis RS. Open-Source Remote Gait Analysis: A Post-Surgery Patient Monitoring Application. Sci Rep. 2019 Nov 29;9(1):17966. doi: 10.1038/s41598-019-54399-1.

PMID: 31784691BACKGROUND

Study Design

Study Type

interventional

Phase

not applicable

Allocation

Masking

NONE

Purpose

OTHER

Intervention Model

SINGLE GROUP

Model Details: This is a randomized, open-label, single-group interventional study evaluating the measurement feasibility of the TayCo Brace, Inc. sensor-enabled Athletic X ankle brace (sXAB). 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 so, we will compare gait and balance metrics derived from the sXAB to those from gold-standard motion capture and research-grade inertial measurement units (IMUs). Protocol/cohort 2 includes a balance test, stair ascent, stair descent, drop landing, walking, and running, all performed under brace and no-brace conditions. The order of bracing conditions will be randomized for each participant, as will the order of tasks and speeds within each condition. The study is not blinded.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Associate Professor of Kinesiology

Sensor Ankle Brace for Special Operations Rehabilitation

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Single Group: Brace and No-Brace Conditions

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Secondary Outcomes (5)

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Single Group: Brace and No-Brace Conditions

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Secondary Outcomes (5)

You may not qualify if:

Data Sharing

Source record

Locations