Sensor-enabled ankle brace for special-operations rehabilitation
Sensor Ankle Brace for Special Operations Rehabilitation
This project will test whether an ankle brace with built-in motion sensors can accurately measure gait and balance in healthy adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Bloomington, Indiana) |
| Trial ID | NCT07085416 on ClinicalTrials.gov |
What this trial studies
Investigators will test a prototype ankle brace (sXAB) that incorporates commercially available inertial measurement unit (IMU) sensors and compare its gait metrics against laboratory gold-standard motion-analysis equipment. Validation occurs in a lab on healthy adults aged 18–40 using two protocols: walking in standard sneakers and, secondarily, performing walking, running, jumping, and stair climbing while wearing combat boots. Participants are screened with the PAR-Q and complete in-person enrollment and sensor testing at Indiana University Bloomington. The primary aim is technical and measurement feasibility rather than health or treatment outcomes.
Who should consider this trial
Good fit: Healthy adults aged 18–40 who are cleared as "healthy to exercise" by the PAR-Q (and for the combat-boot protocol, those with moderate/high activity levels who fit the lab-supplied boots) are ideal candidates.
Not a fit: People who smoke regularly, have had lower back or lower-limb surgery, sustained a musculoskeletal injury within the past 12 weeks, are not cleared to exercise, are older than 40, or cannot fit the provided boots are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the device could enable accurate, portable monitoring of gait and balance to support rehabilitation and return-to-duty decisions.
How similar studies have performed: Inertial measurement units and wearable IMU systems have been validated in prior gait research, but embedding them into an ankle brace for operational movements is a newer application with limited prior validation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bloomington, Indiana
- Indiana University, School of Public Health - Bloomington — Bloomington, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Allison H Gruber, PhD — Indiana University
- Study coordinator: Allison H Gruber, PhD
- Email: ahgruber@iu.edu
- Phone: 8128562447
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.