NCT07085416 Sensor Ankle Brace for Special Operations Rehabilitation
| NCT ID | NCT07085416 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Gait |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-10-16 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-10-16 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
Inclusion Criteria for both cohorts: * Healthy adults: ages 18 - 40 years * considered "healthy to exercise" as determined by the physical activity readiness questionnaire (PAR-Q) Additional Inclusion Criteria specific to cohort 2 only: * 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). Exclusion Criteria for both cohorts: * 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. Additional Exclusion Criteria specific to cohort 2 only: * 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.
Contact & Investigator
Allison H Gruber, PhD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT07085416 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Gait. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07085416 currently recruiting?
Yes, NCT07085416 is actively recruiting participants. Contact the research team at ahgruber@iu.edu for enrollment information.
Where is the NCT07085416 trial being conducted?
This trial is being conducted at Bloomington, United States.
Who is sponsoring the NCT07085416 clinical trial?
NCT07085416 is sponsored by Indiana University. The principal investigator is Allison H Gruber, PhD at Indiana University. The trial plans to enroll 60 participants.