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Completed
NCT07085416
Sensor Ankle Brace for Special Operations Rehabilitation - Phase 1
Conditions: Gait, Balance, Biomechanical Data, Postural Control, Locomotion
Sex: All
Ages: 18 Years – 40 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 20
Sponsor: Indiana University
Location: Indiana University, School of Public Health - Bloomington Bloomington Indiana
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. 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).
Eligibility Criteria
Inclusion Criteria:
* Healthy adults: ages 18 - 40 years
* considered "healthy to exercise" as determined by the physical activity readiness questionnaire (PAR-Q)
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07085416). StuddyBuddy aggregates publicly available trial information.