Sensor Ankle Brace for Gait
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Enrollment and Initial Assessment
Participants complete informed consent, health history questionnaire, and initial assessments including foot length measurements and surveys.
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.
Follow-up
Participants are monitored for data accuracy and reliability post data collection.
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
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
TAYCO BRACE, INC
Collaborator
United States Air Force
Collaborator
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