Sensor Ankle Brace for Special Operations Rehabilitation

NCT07085416 | Recruiting FDA Device

• 2 other identifiers: 22304FWR20240183X
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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 this, the investigators will evaluate the performance of commercially available inertial measurement unit sensors incorporated into an existing ankle brace ("sXAB") by TayCo Brace, Inc. We will compare the gait metrics calculated from the sensors incorporated into the brace with 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. The sensors in the ankle brace will be validated in the lab, first on healthy subjects walking in standard tennis shoes/sneakers (protocol 1), and secondarily in the lab on healthy subjects wearing combat boots performing walking, running, jumping, and stair climbing (protocol 2). These movements were selected because they simulate key movements performed during operational activities. Protocol 1 will take place first, then aspects of the sXAB will be evaluated and implemented, then protocol 2 will take place. Participants completing protocol 1 are eligible to complete protocol 2. The study includes two cohorts of participants completing different functional tasks. 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

Keywords

adult; gait; gait analysis; humans; ankle brace; motion capture; sensor validation; wearable electronic devices; wearable sensors; inertial measurement unit; IMU; locomotion; running; walking; landing; stair ascent; stair descent

Outcome Measures

Primary Outcomes (3)

• Feasibility of collecting valid kinematic data with 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), thereby supporting feasibility of using the sXAB for measuring these variables. Agreement will be assessed using equivalence testing across variables (e.g., joint angles, range of motion), which will be aggregated into a single equivalence 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. Feasibility is supported if equivalence criteria are met for all core variables.

  At study visit(s), completed up to 1 week after enrollment.

• Feasibility of collecting valid spatiotemporal parameters with 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), thereby supporting feasibility of using the sXAB for measuring these variables. 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. Feasibility is supported if equivalence criteria are met for all core variables.

  At study visit(s), completed up to 1 week after enrollment.

• Feasibility of collecting valid postural balance data with 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), thereby supporting feasibility of using the sXAB for measuring these variables. Agreement will be assessed using equivalence testing across variables (e.g., sway amplitude and velocity), which will be aggregated into a single equivalence 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. Feasibility is supported if equivalence criteria are met for all core variables.

  At study visit(s), completed up to 1 week after enrollment.

Secondary Outcomes (3)

• Feasibility of collecting valid kinetic data with the sensor-enabled ankle brace (sXAB).

  At study visit(s), completed up to 1 week after enrollment.

• Feasibility of collecting valid wear time with the sensor-enabled ankle brace (sXAB).

  At study visit(s), completed up to 1 week after enrollment.

• Feasibility of valid activity recognition with the sensor-enabled ankle brace (sXAB).

  At study visit(s), completed up to 1 week after enrollment.

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults: ages 18 - 40 years
• considered "healthy to exercise" as determined by the physical activity readiness questionnaire (PAR-Q)
• Classified as "moderate" or "high" activity level as defined by the scoring criteria of the International Physical Activity Questionnaire - Short Form (IPAQ)
• Comfortably fit into combat boots provided by the laboratory (Men's sizes 8, 9, 10, 11, 12 and Women's sizes 6, 7, 8, 9, 10 will be purchased, and so participants with foot lengths of 22.54-29.27.8 cm are expected to fit in the boots provided).

You may not qualify if:

• Smoking tobacco on a regular basis
• Previous lower back or lower limb surgery (including the joints of the pelvis and lower limbs)
• Musculoskeletal injury sustained within the 12-weeks prior to enrollment . A musculoskeletal injury is defined as musculoskeletal pain causing a reduction or stoppage of normal physical activity for at least 3 days within a 7-day period, and have not returned to their normal physical activity and exercise without pain for at least the last 6-weeks.
• Pregnant (women only)
• Current or history of an unresolved musculoskeletal, neurological, cardiovascular, pulmonary/respiratory, metabolic, renal condition, disease, or problem.
• Torn anterior or posterior cruciate ligament (ACL or PCL).
• Any other disease or problems that may affect movement or the ability to exercise even at a low intensity.
• Identification of Functional Ankle Instability (IDFAI) score of \<11.
• unable to comfortably perform the drop landing condition.
• Feet are too large or too small to fit comfortably in the combat boots provided.

Sponsors & Collaborators

• Indiana University: lead
• TAYCO BRACE, INC: collaborator
• United States Air Force: collaborator

Study Sites (1)

Indiana University, School of Public Health - Bloomington

Bloomington, Indiana, 47405, United States

RECRUITING

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: 34631252 BACKGROUND

• 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: 31784691 BACKGROUND

• Hafer JF, Provenzano SG, Kern KL, Agresta CE, Grant JA, Zernicke RF. Measuring markers of aging and knee osteoarthritis gait using inertial measurement units. J Biomech. 2020 Jan 23;99:109567. doi: 10.1016/j.jbiomech.2019.109567. Epub 2019 Dec 27.

  PMID: 31916999 BACKGROUND

Study Officials

• Allison H Gruber, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison H Gruber, PhD

CONTACT

8128562447; ahgruber@iu.edu

Adriana M Alamilla, MS

CONTACT

708-745-8368; admiltko@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Kinesiology

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). Participants may complete one or both protocols. Protocol/cohort 1 includes a balance test and walking at two speeds with and without the sXAB. 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.

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 25, 2025
• Study Start: October 16, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 18, 2026
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: De-identified data will be provided to TayCo Brace, Inc. after completion of each protocol phase (i.e., following Protocol 1 and again after Protocol 2). TayCo Brace, Inc. may retain these data indefinitely for product development purposes. No individual participant data will be publicly posted or shared beyond the research sponsor and authorized personnel.
• Access Criteria: Access to individual participant data is limited to authorized personnel at TayCo Brace, Inc. and U.S. Department of Defense research oversight officials. No public access to individual-level data is planned. All data shared will be de-identified and used solely for device development or regulatory oversight purposes. Access to de-identified data for additional research may be considered upon request, subject to institutional approval and data use agreements.

Locations

US (1)