40 Participants NeededMy employer runs this trial

Sensor Ankle Brace for Gait

AH
AM
Overseen ByAdriana M Alamilla, MS
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Indiana University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

AH

Allison H Gruber, PhD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for healthy adults who can walk, run, jump, and climb stairs while wearing combat boots. Participants should not have any injuries or conditions that affect their movement or balance.

Inclusion Criteria

Comfortably fit into combat boots provided by the laboratory (Men's sizes 8-12, Women's sizes 6-10, foot length 22.5-29.27 cm)
I am a healthy adult between 18 and 40 years old.
I am healthy enough to exercise according to the PAR-Q.
See 1 more

Exclusion Criteria

I am currently pregnant.
I had a muscle or bone injury recently that still limits my normal activities.
I cannot comfortably perform a drop landing.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (virtual or in-person)

Enrollment and Initial Assessment

Participants complete informed consent, health history questionnaire, and initial assessments including foot length measurements and surveys.

1 day
1 visit (in-person)

Data Collection and Movement Tests

Participants perform movement tests with and without the sensor-enabled ankle brace, including standing balance, stairs, drop landing, walking, and running.

1 week
1-2 visits (in-person)

Follow-up

Participants are monitored for data accuracy and reliability post data collection.

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Sensor-enabled Athletic X Ankle Brace (sXAB)

Trial Overview

The study tests a new ankle brace with built-in sensors (sXAB) to see if it accurately measures walking and movement compared to standard lab equipment. Each person tries activities both with and without the brace.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Single Group: Brace and No-Brace ConditionsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

TAYCO BRACE, INC

Collaborator

United States Air Force

Collaborator

Trials
21
Recruited
52,700+