An interventional study of Sensor-enabled Athletic X Ankle Brace (sXAB) in Gait, Balance and Biomechanical Data, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Indiana University · Not applicable, Interventional, and Other
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).
All human subjects activities are taking place at the Indiana University Bloomington (IUB) campus. Potential participants for the Phase 1 study protocol will be recruited from the community and the IUB campus. Potential participants will either contact the research team to complete the initial screening or respond to the flyer via a QR code that takes them directly to the online version of the screening form. The screening form asks yes/no questions from the Physical Activity Readiness Questionnaire (PARQ+) and additional questions about the individuals health history, musculoskeletal injury history, and current physical activity levels. After initial screening to determine eligibility, provisionally eligible participants will come to the laboratory on the IUB campus to complete enrollment and study procedures.
At the in-person visit, participants will read the informed consent document and, after all questions have been answered, sign the informed consent document if they agree to participate in the study. Next, participants will complete a health history questionnaire which repeats the PARQ+ questions and additional health history questions presented in the initial screening to confirm eligibility. After eligibility is confirmed, foot length measurements and additional surveys will be completed [i.e., the Identification of Functional Ankle Instability (IDFAI), the International Physical Activity Questionnaire - Short Form (IPAQ), and the past-year physical activity questionnaire (PYPAQ)].
Following the surveys, height and weight will be measured then the dominant limb test and the preferred speed test will be performed. The dominant limb test determines whether the right or left lower limb is the dominant limb by observing which limb participants use to kick a ball. The preferred speed test involves the participant walking or running at or near their reported preferred speed (or 2.9 mph for walking and 4.5 mph for running if preferred speed is unknown). The speed will be blinded to the participant. The researcher will increase or decrease the speed in 0.5-1.0 mph increments until the participant identifies the same speed as their preferred speed three times.
Next, the participant will be prepared for data collection. Participants will be asked to change into form fitting clothing (provided by the laboratory, if needed) and the shoes they prefer to wear during exercise or physical activity. Reflective markers and the lab's research-grade inertial measurement units (IMUs) will be placed on anatomical landmarks of both feet, lower-legs, thighs, and pelvis, and the sensor-enabled ankle brace ("sXAB") will be secured on the dominant limb, if the first randomized condition is the brace condition. Participants will warm-up by walking on a treadmill before completing each of the brace conditions (brace and no-brace) to acclimate wearing the brace and/or the reflective markers and lab IMUs. Participants will then be asked to complete the movement tests specific to each protocol (Phase 1: standing balance, walking at preferred speed, walking at a standardized speed of 2.9 mph) while wearing the sXAB and without wearing the brace ("no brace" condition) as three-dimensional motion capture data, force plate data, IMU data, and data from the sXAB (if worn) are recorded. The order of the bracing conditions will be presented in a random order. The brace will be worn on the dominant limb. Within each brace condition, the standing balance test will be performed first then the remaining movements will be presented in a random order. After the first brace condition is complete, the participant will be prepared to complete the second brace condition then repeat the warm-up, standing balance test, and the movement tests.
Participants are expected to complete Phase 1 activities during a single study visit.
Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
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Exclusion Criteria:
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)
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.
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, force plates, and research-grade IMUs). Agreement will be assessed using validation testing across variables (e.g., sagittal plane ankle joint angles, range of motion), which will be aggregated into a single validation score for kinematics by taking the average and standard deviation across variables. Data are collected during brace and no-brace conditions across multiple movement tasks. Validation is supported if validation criteria are met for all core variables.
Time frame: At study visit(s), completed up to 1 week after enrollment
Validation of spatiotemporal data 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, force plates, and research-grade IMUs). Agreement will be assessed using validation testing across variables (e.g., stance time, stride length, gait speed), which will be aggregated into a single validation score for spatiotemporal parameters by taking the average and standard deviation across variables. Data are collected during brace and no-brace conditions across multiple movement tasks. Validation is supported if validation criteria are met for all core variables.
Time frame: At study visit(s), completed up to 1 week after enrollment
Validation of kinetic data collected by the sensor-enabled ankle brace (sXAB)
This outcome evaluates whether kinetic data collected using the sensor-enabled ankle brace (sXAB) are sufficiently accurate and reliable compared to gold-standard laboratory systems (motion capture, force plates, and research-grade IMUs). Agreement will be assessed using validation testing across variables (e.g., peak vertical ground reaction force, total vertical impulse), which will be aggregated into a single validation score for kinetics by taking the average and standard deviation across variables. Data are collected during brace and no-brace conditions across multiple movement tasks. Validation is supported if validation criteria are met for all core variables.
Time frame: At study visit(s), completed up to 1 week after enrollment
Validation of balance data collected by the sensor-enabled ankle brace (sXAB)
This outcome evaluates whether postural balance data collected using the sensor-enabled ankle brace (sXAB) are sufficiently accurate and reliable compared to gold-standard laboratory systems (motion capture, force plates, and research-grade IMUs). Agreement will be assessed using validation testing across variables (e.g., sway amplitude and velocity), which will be aggregated into a single validation score for postural balance by taking the average and standard deviation across variables. Data are collected during brace and no-brace conditions across multiple movement tasks. Validation is supported if validation criteria are met for all core variables.
Time frame: At study visit(s), completed up to 1 week after enrollment
Equivalence 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 equivalent to data collected using gold-standard laboratory systems (motion capture, force plates, and research-grade IMUs). Agreement will be assessed using equivalence testing across variables (e.g., peak vertical ground reaction force, total vertical impulse), which will be aggregated into a single equivalence score for kinetics by taking the average and standard deviation across variables. Data are collected during brace and no-brace conditions across multiple movement tasks. Equivalence is supported if equivalence criteria are met for all core variables.
Time frame: At study visit(s), completed up to 1 week after enrollment
Equivalence of spatiotemporal data collected by the sensor-enabled ankle brace (sXAB)
This outcome evaluates whether spatiotemporal parameters collected using the sensor-enabled ankle brace (sXAB) are equivalent to data collected using gold-standard laboratory systems (motion capture, force plates, and research-grade IMUs). Agreement will be assessed using equivalence testing across variables (e.g., stance time, stride length, gait speed), which will be aggregated into a single equivalence score for spatiotemporal parameters by taking the average and standard deviation across variables. Data are collected during brace and no-brace conditions across multiple movement tasks. Equivalence is supported if equivalence criteria are met for all core variables.
Time frame: At study visit(s), completed up to 1 week after enrollment
Plan to share: Yes — The principal investigator will share data summaries and statistical outcomes with TayCo Brace, Inc. to inform improvements to the sXAB device between protocol phases and guide future development. Only de-identified, processed data will be shared. Shared data may include participant demographics (e.g., age, sex, height), survey responses, and data from motion capture, force plates, IMUs, and the sXAB. The U.S. Department of Defense personnel responsible for human subject protections may request access to de-identified research records, which will be provided in their preferred format and method. Data collected in this study may also be used for future research and scholarly publications. All shared or reused data will be de-identified.
Supporting information: Study protocol, Sap, Csr, Analytic code
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