Sensor Ankle Brace for Special Operations Rehabilitation
Purpose
The primary purpose of this study overall is to validate a modified version of a commercially available ankle brace. Inertial measurement unit sensors will be 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 2 protocol, the sXAB will be validated on healthy subjects wearing combat boots performing walking, running, jumping, and stair climbing activities. These movements were selected because they simulate key movements performed during operational activities. 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
- Gait
- Balance
- Biomechanical Data
- Postural Control
- Locomotion
Eligibility
- Eligible Ages
- Between 18 Years and 40 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Healthy adults: ages 18 - 40 years - considered "healthy to exercise" as determined by the physical activity readiness questionnaire (PAR-Q) - 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
- 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. - 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- This is a randomized, open-label, single-group interventional study evaluating the measurement feasibility of the TayCo Brace, Inc. sensor-enabled Athletic X ankle brace (sXAB). 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 so, we will compare gait and balance metrics derived from the sXAB to those from gold-standard motion capture and research-grade inertial measurement units (IMUs). Protocol/cohort 2 includes a balance test, stair ascent, stair descent, drop landing, walking, and running, all performed under brace and no-brace conditions. The order of bracing conditions will be randomized for each participant, as will the order of tasks and speeds within each condition. The study is not blinded.
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Single Group: Brace and No-Brace Conditions |
This study includes a single group of participants (collected across two cohorts) who complete movement tasks under two within-subject conditions: (1) wearing a sensor-enabled ankle brace ("brace" condition), and (2) without the brace ("no-brace" condition). Each participant serves as their own control. The brace condition order is randomized, and all participants experience both conditions. |
|
Recruiting Locations
Bloomington, Indiana 47405
More Details
- Status
- Recruiting
- Sponsor
- Indiana University
Detailed Description
All human subjects activities are taking place at the Indiana University Bloomington (IUB) campus. Potential participants for the Phase 2 study protocol will be recruited from the community and the IUB campus. Potential participants will either contact the research team to complete the initial screening or respond to the flyer via a QR code that takes them directly to the online version of the screening form. The screening form asks yes/no questions from the Physical Activity Readiness Questionnaire (PARQ+) and additional questions about the individuals health history, musculoskeletal injury history, and current physical activity levels. After initial screening to determine eligibility, provisionally eligible participants will come to the laboratory on the IUB campus to complete enrollment and study procedures. At the first in-person visit, participants will read the informed consent document and, after all questions have been answered, sign the informed consent document if they agree to participate in the study. Next, participants will complete a health history questionnaire which repeats the PARQ+ questions and additional health history questions presented in the initial screening to confirm eligibility. Foot length measurements and additional surveys (i.e., the Identification of Functional Ankle Instability (IDFAI) and International Physical Activity Questionnaire - Short Form (IPAQ)) will be administered. If eligibility is confirmed, participants will be enrolled and complete the study procedures. After eligibility is confirmed, participants will also complete the past-year physical activity questionnaire (PYPAQ) and a running history questionnaire. Following the surveys, height and weight will be measured then the dominant limb test and the preferred speed test will be performed. The dominant limb test determines whether the right or left lower limb is the dominant limb by observing which limb participants use to kick a ball. The preferred speed test involves the participant walking or running at or near their reported preferred speed (or 2.9 mph for walking and 4.5 mph for running if preferred speed is unknown). The speed will be blinded to the participant. The researcher will increase or decrease the speed in 0.5-1.0 mph increments until the participant identifies the same speed as their preferred speed three times. Next, the participant will be prepared for data collection. Participants will be asked to change into form fitting clothing (provided by the laboratory, if needed) and combat boots provided by the laboratory (Phase 2). Reflective markers and the lab's research-grade inertial measurement units (IMUs) will be placed on anatomical landmarks of both feet, lower-legs, thighs, and pelvis, and the sensor-enabled ankle brace ("sXAB") will be secured on the dominant limb, if the first randomized condition is the brace condition. Participants will warm-up by walking on a treadmill before completing each of the brace conditions (brace and no-brace) to acclimate wearing the brace and/or the reflective markers and lab IMUs. Participants will then be asked to complete the movement tests specific to each protocol (Phase 2: standing balance, stairs, drop landing, walking at preferred speed, and running at preferred speed) while wearing the sXAB and without wearing the brace ("no brace" condition) as three-dimensional motion capture data, force plate data, IMU data, and data from the sXAB (if worn) are recorded. The order of the bracing conditions will be presented in a random order. The brace will be worn on the dominant limb. Within each brace condition, the standing balance test will be performed first then the remaining movements will be presented in a random order. After the first brace condition is complete, the participant will be prepared to complete the second brace condition then repeat the warm-up, standing balance test, and the movement tests. Participants may complete Phase 2 activities in either one or two study visits, depending on participant preference.