The investigation is an early feasibility study in up to 5 subjects, in which the primary objective is to capture preliminary safety and effectiveness information on the Magnetic Bead Tracking system.
This is an early feasibility study designed to provide preliminary evidence for the safety and effectiveness of the Magnetic Bead Tracking System for the control of a one degree-of-freedom (DoF) ankle-foot prosthesis at the transtibial amputation level on up to N=5 study subjects. Each subject will serve as their own control in a repeated measures ('within subjects') design. During experimentation, each subject will have prosthetic gait performance measured while using the Magnetic Bead Tracking System compared to an intrinsic robotic controller. The Magnetic Bead Tracking System consists of pairs of magnetic beads, and a set of magnetic field sensors that are intended to measure and track the length of muscles and the speed at which they move in real-time. The system uses multiple pairs of implanted magnetic beads to track tissue strains via an array of externally worn magnetic field sensors, which senses the relative locations of the implanted magnetic beads. When implanted in muscle in the residual limb of an amputee, the muscle length signal is used as an indicator of human intent and is conveyed to a robotic prosthesis, providing heightened, natural, reflexive control of prosthetic limbs in subjects with transtibial amputation. Specifically, in the proposed study, the system will be used with a computer controlled, powered ankle prosthesis to provide sensory position, speed, and force data to increase the accuracy of neuromuscular control models and allow for intuitive, simultaneous position and torque control of the prosthesis. Safety of the Magnetic Bead Tracking System will be evaluated throughout the study by assessing the adverse event type, incidence, timing, severity, treatment, outcome, and relationship to the device. Adverse events with clinical signs or symptoms will be collected when volunteered by subjects and/or observed by Investigators. Serious Adverse Events will be reported on a per event and per subject basis up to 6 months. At each study visit, the subject will be asked to report any issues, and will have a comprehensive examination of the affected limb performed by study physicians and/or trained staff. Due to the small number of subjects, this study will be treated as a case study. For each case, information, such as demographic and subject information, adherence to the study protocol, safety, and performance data will be collected and described. At the end of the study, each case will be evaluated, and a determination will be made, as to whether (1) any unanticipated adverse device effects and/or revisions/removals of the device occurred, and (2) the study objective was met for that particular case. For each case, variables will be summarized qualitatively by visit and (where applicable) by difference from pre-op assessment and post-op assessments. This assessment will be performed separately for each case. In addition, a quantitative measurement of preferred walking speed will serve as a primary variable for the evaluation of system performance in AIM 1, and the time to traverse an obstacle course will serve as a primary variable for AIM 2.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
The Magnetic Beads will be implanted in a subject during either an already required revision of an existing unilateral or bilateral transtibial amputation or during the performance of a unilateral or bilateral transtibial amputation.
Brigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGWalking Speed
The preferred and fastest walking speeds across level-ground and uneven walking surfaces will be measured as the primary study variables for AIM 1. To make these measurements, the time duration will be measured for each study subject to walk at steady state speed overground across 10m walkways at their preferred and fastest walking speeds. Subjects will receive standardized instructions encouraging them to either walk at their comfortable walking speed, or at their maximum walking speed, across each level-ground andan uneven 10m walkway. The investigators expect that the preferred and maximum speeds will be higher when employing the magnetomicrometry (MM) prosthetic controller compared to the commercial intrinsic controller, in support of the H1 hypothesis.
Time frame: One timepoint, between days 150-180.
Obstacle course speed
The time to traverse an obstacle course will be evaluated to test obstacle avoidance, changes in walking direction, slope/stair variations, and speed transients, testing the ability of each controller to deliver rapid gait maneuvers while subjects walk across the unstructured environment. The investigators expect that the time to complete the obstacle course will be lower when employing the MM controller compared to the commercial intrinsic controller, further supporting the H1 hypothesis.
Time frame: One timepoint, between days 150-180.
Walking Distance
The Six Minute Walk Test (6MWT) across a level-ground surface will be evaluated, or the maximum distance a person can walk in a six-minute period. Using an indoor track, the total distance each subject can walk throughout a six-minute interval will be measured for each controller (magnetomicrometry (MM) vs. Intrinsic). The investigators expect that the 6MWT will be higher when employing the MM prosthetic controller compared to the commercial intrinsic controller, further supporting the H1 hypothesis.
Time frame: One timepoint, between days 150-180.
Gait Symmetry
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Asymmetry between the double-support time preceding intact limb (tdspi) and preceding prosthetic limb (tdsip) transitions will be measured on level ground and slopes (instrumented treadmill), and for stair ascent and descent. The investigators expect that a composite measure of Gait Symmetry will demonstrate the best performance when the powered ankle-foot prosthesis is controlled using the MM controller, further supporting the H1 hypothesis.
Time frame: One timepoint, between days 150-180.
Biologic Realism
Prosthetic and unaffected leg ankle net-work, wA , will be measured as defined in \[2\] on level ground and slopes (instrumented treadmill), and for stair ascent and descent. The investigators expect that the net-work measures when employing the MM controller will more closely match that of the contralateral intact ankle than compared to the commercial intrinsic controller, further confirming the H1 hypothesis.
Time frame: One timepoint, between days 150-180.
Musculoskeletal Stress
Bilateral knee moments will be measured as defined in on level ground and slopes (instrumented treadmill). The investigators expect the contralateral knee adduction moment measure of musculoskeletal stress to be lowered when employing the MM controller as compared with the intrinsic controller, further supporting the H1 hypothesis.
Time frame: One timepoint, between days 150-180.
Stability (1)
Posturographic parameters will be derived from pelvic center of mass (COM) position collected as subjects stand on a one axis (anteroposterior) balance board. The investigators expect that stability metrics will show the best performance when the powered ankle-foot prosthesis is controlled using the MM interface as compared with the intrinsic controller, further supporting the H1 hypothesis.
Time frame: One timepoint, between days 150-180.
Relative pain levels
The relative pain levels experienced by the user at the unaffected knee and lower back will be assessed using a Visual Analogue Scale (VAS, 0 to 10). The investigators expect a lower pain score when the powered ankle-foot prosthesis is configured for the MM controller as compared with the intrinsic controller, further supporting the H1 hypothesis.
Time frame: One timepoint, between days 150-180.
General Mobility
Patient-reported mobility will be assessed as measured by the Prosthetic Limb Users Survey of Mobility (PLUS-M). The investigators expect a score of greater than or equal to 5 when using the MM controller, indicating a significant improvement in mobility compared to the commercial intrinsic controller.
Time frame: One timepoint, between days 150-180.
Embodiment
Patient-reported embodiment will be assessed as measures by the Prosthesis Embodiment Scale for Lower Limb Amputees (PEmbS-LLA). PEmbS-LLA is a 10-item, patient-reported questionnaire (using a 7-point Likert scale) designed to measure how well a lower limb amputee integrates their prosthesis into their body representation and sense of self.The investigators expect a higher level of embodiment when using the MM controller compared to the commercial intrinsic controller.
Time frame: One timepoint, between days 150-180.
Stability (2)
Equilibrium scores, limits of stability, symmetry, and latency and amplitude of response to perturbation will be assessed from Computerized Dynamic Posturography (CDP). The investigators expect that stability metrics will show the best performance when the powered ankle-foot prosthesis is controlled using the MM interface as compared with the intrinsic controller, further supporting the H1 hypothesis.
Time frame: One timepoint, between days 150-180.