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NCT07085416 · ClinicalTrials.gov registry record · NA
Sensor Ankle Brace for Special Operations Rehabilitation
A NA study of Balance and Gait, sponsored by Indiana University.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT07085416: Recruiting NA study of Balance and Gait, sponsored by Indiana University.
NCT07085416 is a NA study of Balance and Gait that is actively recruiting participants, run by Indiana University. The registered enrollment target is 60 participants, below the 107-participant average among 7 other Balance trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07085416, a NA study of Balance and Gait, is actively recruiting participants, sponsored by Indiana University.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
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).
Primary Outcome
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 variabl
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 |
What NCT07085416 shows while recruiting
NCT07085416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 107-participant average among 7 other Balance trials with a reported enrollment target (44% lower).
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.
NCT07085416 reports a single indexed study location in Indiana.
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.
What interventions are being tested in trial NCT07085416?
The interventions under investigation include: Sensor-enabled Athletic X Ankle Brace (sXAB) (DEVICE).
Who is sponsoring clinical trial NCT07085416?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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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