Sensor Ankle Brace for Special Operations Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorIndiana University
About this trial
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
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Sensor-enabled Athletic X Ankle Brace (sXAB)
DeviceThe intervention is a sensor-enabled version of the TayCo Brace, Inc. Athletic X Ankle Brace (sXAB), which integrates commercially available inertial measurement units (IMUs) into the structure of the brace. The brace is worn on the ankle of the dominant limb during functional movement tasks to evaluate its ability to produce valid gait and balance metrics compared to laboratory-grade measurement systems.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Single Group: Brace and No-Brace ConditionsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of collecting valid kinematic data with the sensor-enabled ankle brace (sXAB).
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), thereby supporting feasibility of using the sXAB for measuring these variables. Agreement will be assessed using equivalence testing across variables (e.g., joint angles, range of motion), which will be aggregated into a single equivalence score for kinematics by taking the average and standard deviation across variables. Data are collected during brace and no-brace conditions across multiple movement tasks. Feasibility is supported if equivalence criteria are met for all core variables.
Time frame
At study visit(s), completed up to 1 week after enrollment.2
Feasibility of collecting valid spatiotemporal parameters with the sensor-enabled ankle brace (sXAB).
This outcome evaluates whether spatiotemporal parameters 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), thereby supporting feasibility of using the sXAB for measuring these variables. Agreement will be assessed using equivalence testing across variables (e.g., stance time, stride length, gait speed), which will be aggregated into a single equivalence score for spatiotemporal parameters by taking the average and standard deviation across variables. Data are collected during brace and no-brace conditions across multiple movement tasks. Feasibility is supported if equivalence criteria are met for all core variables.
Time frame
At study visit(s), completed up to 1 week after enrollment.3
Feasibility of collecting valid postural balance data with the sensor-enabled ankle brace (sXAB).
This outcome evaluates whether postural balance 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), thereby supporting feasibility of using the sXAB for measuring these variables. Agreement will be assessed using equivalence testing across variables (e.g., sway amplitude and velocity), which will be aggregated into a single equivalence score for postural balance by taking the average and standard deviation across variables. Data are collected during brace and no-brace conditions across multiple movement tasks. Feasibility is supported if equivalence criteria are met for all core variables.
Time frame
At study visit(s), completed up to 1 week after enrollment.Secondary outcomes
1
Feasibility of collecting valid kinetic data with the sensor-enabled ankle brace (sXAB).
This outcome evaluates whether kinetic 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), thereby supporting feasibility of using the sXAB for measuring these variables. Agreement will be assessed using equivalence testing across variables (e.g., peak vertical ground reaction force, total vertical impulse), which will be aggregated into a single equivalence score for kinetics by taking the average and standard deviation across variables. Data are collected during brace and no-brace conditions across multiple movement tasks. Feasibility is supported if equivalence criteria are met for all core variables.
Time frame
At study visit(s), completed up to 1 week after enrollment.2
Feasibility of collecting valid wear time with the sensor-enabled ankle brace (sXAB).
This outcome evaluates whether wear time 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), thereby supporting feasibility of using the sXAB for measuring these variables. Agreement will be assessed using equivalence testing across variables (e.g., time on and off, total daily wear duration), which will be aggregated into a single equivalence score for wear time by taking the average and standard deviation across variables. Data are collected during brace and no-brace conditions across multiple movement tasks. Feasibility is supported if equivalence criteria are met for all core variables.
Time frame
At study visit(s), completed up to 1 week after enrollment.3
Feasibility of valid activity recognition with the sensor-enabled ankle brace (sXAB).
This outcome evaluates whether activity recognition assessed from data collected by 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), thereby supporting feasibility of using the sXAB for measuring these variables. Agreement will be assessed using equivalence testing across variables (e.g., start, stop, and total time walking and running), which will be aggregated into a single equivalence score for activity recognition by taking the average and standard deviation across variables. Data are collected during brace and no-brace conditions across multiple movement tasks. Feasibility is supported if equivalence criteria are met for all core variables.
Time frame
At study visit(s), completed up to 1 week after enrollment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov