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Sensor Ankle Brace for Special Operations Rehabilitation
NCT07085416 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DEVICE Sensor-enabled Athletic X Ankle Brace (sXAB)
Study Locations (1)
Indiana
- Indiana University, School of Public Health - Bloomington — Bloomington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-10-16 |
| Est. Completion | 2026-06-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07085416
The ClinicalTrials.gov registry entry for NCT07085416 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 1,026 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Balance appearing as the primary indexed condition, and to 1 intervention — of which Sensor-enabled Athletic X Ankle Brace (sXAB) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07085416 reports 1 study location spanning 1 distinct geographic area — top geographies include Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07085416 about?
NCT07085416 is a clinical study titled "Sensor Ankle Brace for Special Operations Rehabilitation". 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 ("sXA...
What is the current status of trial NCT07085416?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-10-16. Estimated completion is 2026-06-18.
What conditions does trial NCT07085416 study?
This clinical trial studies the following conditions: Balance, Gait, Biomechanical Data, Postural Control, Locomotion. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07085416?
The interventions under investigation include: Sensor-enabled Athletic X Ankle Brace (sXAB) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07085416?
This trial is sponsored by Indiana University, which has 1,026 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07085416 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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