GaitNCT07085416
Sensor Ankle Brace for Special Operations Rehabilitation - Phase 1
A study testing Sensor-enabled Athletic X Ankle Brace (sXAB) in people with Gait and Balance, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait, Balance, Biomechanical Data
- What is being tested?
- Sensor-enabled Athletic X Ankle Brace (sXAB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2025to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults: ages 18 - 40 years
- considered "healthy to exercise" as determined by the physical activity readiness questionnaire (PAR-Q)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University, School of Public Health - Bloomington
Bloomington, Indiana, 47405
About this study
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).
Read the detailed description
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.
- Conditions
- Gait, Balance, Biomechanical Data, Postural Control, Locomotion
- Being tested
- Sensor-enabled Athletic X Ankle Brace (sXAB)
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Sensor-enabled Athletic X Ankle Brace (sXAB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At study visit(s), completed up to 1 week after enrollment
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At study visit(s), completed up to 1 week after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start16 Oct 2025
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GaitStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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 1 includes a balance test and walking at two speeds with and without the sXAB. 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- TAYCO BRACE, INC, United States Air Force
- Responsible party
- Principal investigator, Allison Gruber, PhD, Indiana University
- Investigators
- Allison H Gruber, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085416
- Sponsor's protocol ID
- 22304a
- Other IDs
- FWR20240183X
- Status last verified
- Aug 2026
- First submitted
- 26 Jun 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Publications
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.
PubMed 34631252Gurchiek 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.
PubMed 31784691Hafer 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.
PubMed 31916999
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensor Ankle Brace for Special Operations Rehabilitation - Phase 1
- ClinicalTrials.gov ID
- NCT07085416
- Acronym / sponsor ID
- 22304a
- Conditions
- Gait, Balance, Biomechanical Data, Postural Control, Locomotion
- Keywords
- adult, gait, gait analysis, humans, ankle brace, motion capture, sensor validation, wearable electronic devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- TAYCO BRACE, INC, United States Air Force
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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 1 includes a balance test and walking at two speeds with and without the sXAB. 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.
| Arm | Type | Receives |
|---|---|---|
| Single Group: Brace and No-Brace Conditions | Experimental | Device: Sensor-enabled Athletic X Ankle Brace (sXAB)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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adults: ages 18 - 40 years
- considered "healthy to exercise" as determined by the physical activity readiness questionnaire (PAR-Q)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Single Group: Brace and No-Brace Conditions |
Primary outcome
Validation of kinematic data collected by the sensor-enabled ankle brace (sXAB)
Time frame: At study visit(s), completed up to 1 week after enrollment
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.
Validation of spatiotemporal data collected by the sensor-enabled ankle brace (sXAB)
Time frame: At study visit(s), completed up to 1 week after enrollment
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.
4 secondary outcomes
Validation of kinetic data collected by the sensor-enabled ankle brace (sXAB)
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)
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)
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)
Time frame: At study visit(s), completed up to 1 week after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Background: PubMed 34631252Rhon 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.
- Background: PubMed 31784691Gurchiek 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.
- Background: PubMed 31916999Hafer 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison H Gruber, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensor-enabled Athletic X Ankle Brace (sXAB) in people with Gait and Balance, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of kinematic data collected by the sensor-enabled ankle brace (sXAB) (time frame: At study visit(s), completed up to 1 week after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07085416, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.