A patient-centered 'test-drive' strategy for ankle-foot orthosis prescription: Protocol for a randomized participant-blinded trial.

BACKGROUND: Ankle-foot orthoses (AFOs) are commonly used to overcome mobility limitations related to lower limb musculoskeletal injury. Despite a multitude of AFOs to choose from, there is scant evidence to guide AFO prescription and limited opportunities for AFO users to provide experiential input during the process. To address these limitations in the current prescription process, this study evaluates a novel, user-centered and personalized 'test-drive' strategy using a robotic exoskeleton ('AFO emulator') to emulate commercial AFO mechanical properties (i.e., stiffness). The study will determine if brief, in-lab trials (with emulated or actual AFOs) can predict longer term preference, satisfaction, and mobility outcomes after community trials (with the actual AFOs). Secondarily, it will compare the in-lab experience of walking between actual vs. emulated AFOs. METHODS AND ANALYSIS: In this participant-blinded, randomized crossover study we will recruit up to fifty-eight individuals with lower limb musculoskeletal injuries who currently use an AFO. Participants will walk on a treadmill with three actual AFOs and corresponding emulated AFOs for the "in-lab" assessments. For the community trial assessment, participants will wear each of the actual AFOs for a two-week period during activities of daily living. Performance-based and user-reported measures of preference and mobility will be compared between short- and long-term trials (i.e., in-lab vs. two-week community trials), and between in-lab trials (emulated vs. actual AFOs). TRIAL REGISTRATION: The study was prospectively registered at www.clininicaltrials.gov (Clinical Trials Study ID: NCT06113159). Date: November 1st 2023. https://classic.clinicaltrials.gov/ct2/show/NCT06113159.

Mechanical loading of bone-anchored implants during functional performance tests in service members with transfemoral limb loss.

Introduction: For individuals with limb loss, bone-anchored implants create a direct structural and functional connection to a terminal prosthesis. Here, we characterized the mechanical loads distal to the abutment during several functional performance tests in Service members with transfemoral (TF) limb loss, to expand on prior work evaluating more steady-state ambulation on level ground or slopes/stairs. Methods: Two males with unilateral TF limb loss and two males with bilateral TF limb loss participated after two-stage osseointegration (24 and 12 months, respectively). Tri-directional forces and moments were wirelessly recorded through a sensor, fit distal to the abutment, during six functional tests: Timed Up and Go (TUG), Four Square Step Test (FSST), Six Minute Walk Test (6MWT), Edgren Side-Step Test (SST), T-Test (TTEST), and Illinois Agility Test (IAT). Additionally, participants performed a straight-line gait evaluation on a 15 m level walkway at a self-selected speed (0.93-1.24 m/s). Peak values for each component of force and moment were extracted from all six functional tests; percent differences compared each peak with respect to the corresponding mean peak in straight-line walking. Results: Peak mechanical loads were largest during non-steady state components of the functional tests (e.g., side-stepping during SST or TTEST, standing up from the ground during IAT). Relative to walking, peak forces during functional tests were larger by up to 143% (anterior-posterior), 181% (medial-lateral), and 110% (axial); peak moments were larger by up to 108% (flexion-extension), 50% (ab/adduction), and 211% (internal/external rotation). Conclusions: A more comprehensive understanding of the mechanical loads applied to bone-anchored implants during a variety of activities is critical to maximize implant survivability and long-term outcomes, particularly for Service members who are generally young at time of injury and return to active lifestyles.

Peak tibial axial acceleration during walking is related to intact-side lower limb pain in persons with unilateral transtibial amputation.

BACKGROUND: Persons who undergo unilateral transtibial amputation are at an increased risk of secondary musculoskeletal joint pain and degeneration, which has been linked to excessive loading rates of the intact-side limb. Tibial axial acceleration, a feasible measure of loading rates with wearable sensors, would be clinically useful to relate to joint pain in persons with unilateral transtibial amputation. RESEARCH QUESTION: What is the relationship between peak tibial axial accelerations and intact-side joint pain in persons with unilateral transtibial amputation during walking? METHODS: Persons with unilateral transtibial amputation (n = 51) were separated into two groups based on the presence of intact-side limb pain (with pain: n = 16; without pain: n = 35). Tibial axial accelerations were measured with bilateral shank-mounted IMUs while participants completed three 10-meter walk tests. Peak tibial axial accelerations for each limb and between-limb symmetry were compared between groups using analysis of co-variance; significance was set at 0.05. RESULTS: Between persons with vs. without intact-side limb pain, peak tibial axial accelerations were smaller on the prosthetic side (0.64 vs. 0.81 g; p = 0.04), similar on the intact side (0.82 vs. 0.79 g; p = 0.53), and more asymmetrical between sides (intact > prosthetic) (0.81 vs. 1.03 g; p = 0.01). SIGNIFICANCE: Symmetry in peak tibial axial acceleration can assist with identifying preferential limb loading during walking and, with future research, could serve as a useful clinical target for intact-side limb unloading strategies to help mitigate secondary musculoskeletal pain in persons with unilateral transtibial amputation.

Comparing spinal loads in individuals with unilateral transtibial amputation with and without chronic low back pain: An EMG-informed approach.

Chronic low back pain (cLBP) is highly prevalent after lower limb amputation (LLA), likely due in part to biomechanical factors. Here, three-dimensional full-body kinematics and kinetics during level-ground walking, at a self-selected and three controlled speeds (1.0, 1.3, and 1.6 m/s), were collected from twenty-one persons with unilateral transtibial LLA, with (n = 9) and without cLBP (n = 12). Peak compressive, mediolateral, and anteroposterior L5-S1 spinal loads were estimated from a full-body, transtibial amputation-specific OpenSim model and compared between groups. Predicted lumbar joint torques from muscle activations were compared to inverse dynamics and predicted and measured electromyographic muscle activations were compared for model evaluation and verification. There were no group differences in compressive or anterior shear forces (p > 0.466). During intact stance, peak ipsilateral loads increased with speed to a greater extent in the cLBP group vs. no cLBP group (p=0.023), while during prosthetic stance, peak contralateral loads were larger in the no cLBP group (p=0.047) and increased to a greater extent with walking speed compared to the cLBP group (p=0.008). During intact stance, intact side external obliques had higher activations in the no cLBP group (p=0.039), and internal obliques had higher activations in the cLBP group at faster walking speeds compared to the no cLBP group. Predicted muscle activations demonstrated similar activation patterns to electromyographic-measured activations (r = 0.56-0.96), and error between inverse dynamics and simulated spinal moments was low (0.08 Nm RMS error). Persons with transtibial LLA and cLBP may adopt movement strategies during walking to reduce mediolateral shear forces at the L5-S1 joint, particularly as walking speed increases. However, future work is needed to understand the time course from pain onset to chronification and the cumulative influence of increased spinal loads over time.

Trunk postural control during unstable sitting among individuals with and without low back pain: A systematic review with an individual participant data meta-analysis.

INTRODUCTION: Sitting on an unstable surface is a common paradigm to investigate trunk postural control among individuals with low back pain (LBP), by minimizing the influence lower extremities on balance control. Outcomes of many small studies are inconsistent (e.g., some find differences between groups while others do not), potentially due to confounding factors such as age, sex, body mass index [BMI], or clinical presentations. We conducted a systematic review with an individual participant data (IPD) meta-analysis to investigate whether trunk postural control differs between those with and without LBP, and whether the difference between groups is impacted by vision and potential confounding factors. METHODS: We completed this review according to PRISMA-IPD guidelines. The literature was screened (up to 7th September 2023) from five electronic databases: MEDLINE, CINAHL, Embase, Scopus, and Web of Science Core Collection. Outcome measures were extracted that describe unstable seat movements, specifically centre of pressure or seat angle. Our main analyses included: 1) a two-stage IPD meta-analysis to assess the difference between groups and their interaction with age, sex, BMI, and vision on trunk postural control; 2) and a two-stage IPD meta-regression to determine the effects of LBP clinical features (pain intensity, disability, pain catastrophizing, and fear-avoidance beliefs) on trunk postural control. RESULTS: Forty studies (1,821 participants) were included for the descriptive analysis and 24 studies (1,050 participants) were included for the IPD analysis. IPD meta-analyses revealed three main findings: (a) trunk postural control was worse (higher root mean square displacement [RMSdispl], range, and long-term diffusion; lower mean power frequency) among individuals with than without LBP; (b) trunk postural control deteriorated more (higher RMSdispl, short- and long-term diffusion) among individuals with than without LBP when vision was removed; and (c) older age and higher BMI had greater adverse impacts on trunk postural control (higher short-term diffusion; longer time and distance coordinates of the critical point) among individuals with than without LBP. IPD meta-regressions indicated no associations between the limited LBP clinical features that could be considered and trunk postural control. CONCLUSION: Trunk postural control appears to be inferior among individuals with LBP, which was indicated by increased seat movements and some evidence of trunk stiffening. These findings are likely explained by delayed or less accurate corrective responses. SYSTEMATIC REVIEW REGISTRATION: This review has been registered in PROSPERO (registration number: CRD42021124658).

Effects of a Powered Ankle-Foot Prosthesis and Physical Therapy on Function for Individuals With Transfemoral Limb Loss: Rationale, Design, and Protocol for a Multisite Clinical Trial.

BACKGROUND: Powered ankle-foot prosthetic devices can generate net positive mechanical work during gait, which mimics the physiological ankle. However, gait deviations can persist in individuals with transfemoral limb loss because of habit or lack of rehabilitation. Prosthetic research efforts favor the design or evaluation of prosthetic componentry and rarely incorporate any type of rehabilitation, despite evidence suggesting that it is critical for minimizing gait imbalances. Given the accelerated rate of innovation in prosthetics, there is a fundamental knowledge gap concerning how individuals with transfemoral limb loss should learn to correctly use powered ankle-foot devices for maximum functional benefit. Because of the recent advances in prosthetic technology, there is also a critical unmet need to develop guidelines for the prescription of advanced prosthetic devices that incorporate both physical and psychological components to identify appropriate candidates for advanced technology. OBJECTIVE: The primary goal of this investigation is to examine the roles of advanced prosthetic technology and a device-specific rehabilitative intervention on gait biomechanics, functional efficacy, and pain in individuals with transfemoral limb loss. The secondary goal is to develop preliminary rehabilitation guidelines for advanced lower limb prosthetic devices to minimize gait imbalances and maximize function and to establish preliminary guidelines for powered ankle-foot prosthetic prescription. METHODS: This prospective, multisite study will enroll 30 individuals with unilateral transfemoral limb loss. At baseline, participants will undergo a full gait analysis and assessment of function, neurocognition, cognitive load, subjective preferences, and pain using their current passive prosthesis. The participants will then be fitted with a powered ankle-foot device and randomized into 2 equal groups: a powered device with a device-specific rehabilitation intervention (group A) or a powered device with the current standard of practice (group B). Group A will undergo 4 weeks of device-specific rehabilitation. Group B will receive the current standard of practice, which includes basic device education but no further device-specific rehabilitation. Data collection procedures will then be repeated after 4 weeks and 8 weeks of powered ankle use. RESULTS: This study was funded in September 2017. Enrollment began in September 2018. Data collection will conclude by March 2024. The initial dissemination of results is expected in August 2024. CONCLUSIONS: The projected trends indicate that the number of individuals with limb loss will dramatically increase in the United States. The absence of effective, evidence-based interventions may make individuals with transfemoral limb loss more susceptible to increased secondary physical conditions and degenerative changes. With this expected growth, considerable resources will be required for prosthetic and rehabilitation services. Identifying potential mechanisms for correcting gait asymmetries, either through advanced prosthetic technology or rehabilitative interventions, can provide a benchmark for understanding the optimal treatment strategies for individuals with transfemoral limb loss. TRIAL REGISTRATION: ClinicalTrials.gov NCT03625921; https://clinicaltrials.gov/study/NCT03625921. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53412.

The Influence of Active, Passive, and Manual Therapy Interventions for Low Back Pain on Opioid Prescription and Health Care Utilization.

OBJECTIVE: The aim of this study was to explore associations between the utilization of active, passive, and manual therapy interventions for low back pain (LBP) with 1-year escalation-of-care events, including opioid prescriptions, spinal injections, specialty care visits, and hospitalizations. METHODS: This was a retrospective cohort study of 4827 patients identified via the Military Health System Data Repository who received physical therapist care for LBP in 4 outpatient clinics between January 1, 2015 and January 1, 2018. One-year escalation-of-care events were evaluated based on type of physical therapist interventions (ie, active, passive, or manual therapy) received using adjusted odds ratios. RESULTS: Most patients (89.9%) received active interventions. Patients with 10% higher proportion of visits that included at least 1 passive intervention had a 3% to 6% higher likelihood of 1-year escalation-of-care events. Similarly, with 10% higher proportion of passive to active interventions used during the course of care, there was a 5% to 11% higher likelihood of 1-year escalation-of-care events. When compared to patients who received active interventions only, the likelihood of incurring 1-year escalation-of-care events was 50% to 220% higher for those who received mechanical traction and 2 or more different passive interventions, but lower by 50% for patients who received manual therapy. CONCLUSION: Greater use of passive interventions for LBP was associated with elevated odds of 1-year escalation-of-care events. In addition, the use of specific passive interventions such as mechanical traction in conjunction with active interventions resulted in suboptimal escalation-of-care events, while the use of manual therapy was associated with more favorable downstream health care outcomes. IMPACT: Physical therapists should be judicious in the use of passive interventions for the management of LBP as they are associated with greater likelihood of receiving opioid prescriptions, spinal injections, and specialty care visits.

Exploring relationships among multi-disciplinary assessments for knee joint health in service members with traumatic unilateral lower limb loss: a two-year longitudinal investigation.

Motivated by the complex and multifactorial etiologies of osteoarthritis, here we use a comprehensive approach evaluating knee joint health after unilateral lower limb loss. Thirty-eight male Service members with traumatic, unilateral lower limb loss (mean age = 38 yr) participated in a prospective, two-year longitudinal study comprehensively evaluating contralateral knee joint health (i.e., clinical imaging, gait biomechanics, physiological biomarkers, and patient-reported outcomes); seventeen subsequently returned for a two-year follow-up visit. For this subset with baseline and follow-up data, outcomes were compared between timepoints, and associations evaluated between values at baseline with two-year changes in tri-compartmental joint space. Upon follow-up, knee joint health worsened, particularly among seven Service members who presented at baseline with no joint degeneration (KL = 0) but returned with evidence of degeneration (KL ≥ 1). Joint space narrowing was associated with greater patellar tilt (r[12] = 0.71, p = 0.01), external knee adduction moment (r[13] = 0.64, p = 0.02), knee adduction moment impulse (r[13] = 0.61, p = 0.03), and CTX-1 concentration (r[11] = 0.83, p = 0.001), as well as lesser KOOSSport and VR-36General Health (r[16] = - 0.69, p = 0.01 and r[16] = - 0.69, p = 0.01, respectively). This longitudinal, multi-disciplinary investigation highlights the importance of a comprehensive approach to evaluate the fast-progressing onset of knee osteoarthritis, particularly among relatively young Service members with lower limb loss.

Post-Traumatic Osteoarthritis, Psychological Health, and Quality of Life After Lower Limb Injury in U.S. Service Members.

INTRODUCTION: The aims of this project were to assess (1) the prevalence and timing of post-traumatic osteoarthritis (PTOA) after a traumatic lower limb injury, (2) the risk of PTOA based on injury type, and (3) the association of PTOA with psychological health and quality of life (QoL). MATERIALS AND METHODS: The Wounded Warrior Recovery Project (WWRP) database and the Expeditionary Medical Encounters Dataset were queried to identify service members injured during deployment. The Military Health System Data Repository was utilized to extract medical record data to identify individuals with PTOA. Data on PTSD, depression symptoms, and QoL were extracted from the WWRP. RESULTS: Of the 2,061 WWRP participants with lower limb injuries, 124 (6%) were diagnosed with PTOA, with first PTOA diagnosis occurring 3.8 ± 3.1 years after injury. Of the injury categories identified, only fractures were associated with high odds of lower limb PTOA (adjusted odds ratio [OR] = 3.92, 95% confidence interval [CI]: 2.38, 6.44). Individuals with PTOA diagnoses reported lower QoL scores relative to those without PTOA (F(1,2057) = 14.21, B = -0.05, P < .05). Additionally, rates of PTSD and depression symptoms were high but not different between those with or without PTOA. CONCLUSIONS: Despite a low prevalence of lower limb PTOA in our study, fractures increased the risk of PTOA after deployment-related injuries. Additionally, those with PTOA reported lower QoL scores relative to those without PTOA. The findings of this study highlight the personalized needs of patients with trauma beyond just the repair of the immediate injury.

Characterization of initial ankle-foot prosthesis prescription patterns in U.S. Service members following unilateral transtibial amputation.

Introduction: The purpose of this study was to explore relationships between patient-specific characteristics and initial ankle-foot prosthesis prescription patterns among U.S. Service members with unilateral transtibial limb loss. Methods: A retrospective review of health records identified 174 individuals with unilateral transtibial limb loss who received care at Walter Reed National Military Medical Center between 2001 and 2019. We examined patient-specific factors such as demographics, participant duty status at injury and amputation, amputation etiology, and timing between injury, amputation, and initial prescription. The type of first prescribed ankle-foot prosthesis was categorized as energy storing and return - nonarticulating, energy storing and return - articulating, or computer controlled. Results: Sex, amputation etiology, time from injury to initial prescription, and time from amputation to initial prescription differed by type of initial ankle-foot prosthesis prescription. Service members with shorter intervals between injury-initial prescription and amputation-initial prescription, and those injured by combat blast, were more likely to receive a non-articulating device. Incorporating sex, time from injury-initial prescription, time from amputation-initial prescription, and amputation etiology as predictors of prosthesis type, we were able to correctly classify 72% of all first prostheses prescribed. Discussion: Patient-specific characteristics such as sex, the time between injury-initial prescription, time from amputation-initial prescription and amputation etiology are essential characteristics that influence initial ankle-foot prosthesis prescription patterns in U.S. Service members.

Principal components analysis of postural sway in persons with unilateral lower limb amputation: A wearable sensor approach.

Standing sway assessments can detect sensory imbalances which compromise postural control. Persons with lower limb amputation (LLA) often demonstrate impaired postural control, increasing fall risk. Here, principal features of postural sway were identified in persons with unilateral LLA using a single, commercially available wearable sensor. Sixty-one persons with LLA (n = 44 transtibial; n = 17 transfemoral) stood on a firm surface with eyes open/closed while wearing a single accelerometer mounted over the sacrum. Common parameters quantified spatiotemporal and spectral features of sway in anterior-posterior (AP) and mediolateral (ML) directions. Principal component (PC) dimensionality reduction was applied and loadings inspected to identify a reduced, non-redundant set among 14 original variables capturing 90 % variance. Six PCs described ≥ 90 % variance, with the first 3 explaining 75 %. With eyes open and closed, PC1 was loaded by variables characterizing trajectory planar size: area, jerk (i.e., sway smoothness), AP/ML RMS path distance, and AP/ML path range. With eyes open, PC2 was loaded by variables characterizing direction and spectral features: ellipse rotation, AP centroidal frequency, and ML jerk. With eyes closed, PC2 spectral loadings increased: ML centroidal frequency, ML frequency dispersion, and AP centroidal frequency. With eyes open, PC3 was loaded by ellipse rotation, jerk, ML velocity, ML centroidal frequency. With eyes closed, PC3 was loaded by ellipse rotation, ML centroidal frequency, ML frequency dispersion, and AP path velocity, characterizing off-axis error/corrections. RMS of path distance, ellipse rotation, centroidal frequency, frequency dispersion, path velocity, and jerk are a concise parameter set, derived from an accelerometer, to capture principal sway features in persons with LLA during standing balance with visual perturbations.

A mental workload and biomechanical assessment during split-belt locomotor adaptation with and without optic flow.

Adaptive human performance relies on the central nervous system to regulate the engagement of cognitive-motor resources as task demands vary. Despite numerous studies which employed a split-belt induced perturbation to examine biomechanical outcomes during locomotor adaptation, none concurrently examined the cerebral cortical dynamics to assess changes in mental workload. Additionally, while prior work suggests that optic flow provides critical information for walking regulation, a few studies have manipulated visual inputs during adaption to split-belt walking. This study aimed to examine the concurrent modulation of gait and Electroencephalography (EEG) cortical dynamics underlying mental workload during split-belt locomotor adaptation, with and without optic flow. Thirteen uninjured participants with minimal inherent walking asymmetries at baseline underwent adaptation, while temporal-spatial gait and EEG spectral metrics were recorded. The results revealed a reduction in step length and time asymmetry from early to late adaptation, accompanied by an elevated frontal and temporal theta power; the former being well corelated to biomechanical changes. While the absence of optic flow during adaptation did not affect temporal-spatial gait metrics, it led to an increase of theta and low-alpha power. Thus, as individuals adapt their locomotor patterns, the cognitive-motor resources underlying the encoding and consolidation processes of the procedural memory were recruited to acquire a new internal model of the perturbation. Also, when adaption occurs without optic flow, a further reduction of arousal is accompanied with an elevation of attentional engagement due to enhanced neurocognitive resources likely to maintain adaptive walking patterns.

Criteria for Advanced Prosthetic Foot Prescription: Rationale, Design, and Protocol for a Multisite, Randomized Controlled Trial.

BACKGROUND: The prescription of prosthetic ankle-foot devices is often based on the professional judgment of the limb loss care team or limited evidentiary research. Current prosthetic research efforts have focused on the design and development of prosthetic devices rather than on understanding which devices are the most appropriate to prescribe. This investigation will evaluate biomechanical, functional, and subjective outcome measures to help determine the optimal prescription parameters of prosthetic ankle-foot devices. OBJECTIVE: This study aims to develop evidence-based guidelines for limb loss care teams for the appropriate prescription of commercially available prosthetic ankle-foot devices to improve function and satisfaction. METHODS: This investigation will be a multisite, randomized, crossover clinical trial targeting the enrollment of 100 participants. Participants will use 3 different types of prosthetic devices (energy storing and returning, articulating, and powered) in random order. Participants will be fitted and trained with each device and then separately use each device for a 1-week acclimation period. Following each 1-week acclimation period, participants will be evaluated using several functional measures and subjective surveys. A random subset of participants (30/100, 30%) will also undergo full-body gait analysis, following each 1-week acclimation period, to collect biomechanical data during level ground and incline and decline walking. After all individual device evaluations, participants will be given all 3 prostheses concurrently for 4 weeks of home and community use to capture user preference. Activity monitoring and a guided interview will be used to determine overall user preference. RESULTS: The study was funded in August 2017, and data collection began in 2018. Data collection is expected to be completed before July 2023. Initial dissemination of results is expected to occur in the winter of 2023. CONCLUSIONS: By identifying biomechanical, functional, and subjective outcomes that are sensitive to differences in prosthetic ankle-foot devices, a benchmark of evidence can be developed to guide effective prosthetic prescription. TRIAL REGISTRATION: ClinicalTrials.gov NCT03505983; https://clinicaltrials.gov/ct2/show/NCT03505983. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45612.

Investigating post-mild traumatic brain injury neuromuscular function and musculoskeletal injury risk: A protocol for a prospective, observational, case-controlled study in service members and active individuals.

INTRODUCTION: Musculoskeletal injury (MSKI) risk is increased following mild traumatic brain injury (mTBI). Increased MSKI risk is present up to 2 years following post-mTBI return-to-duty/activity relative to both non-mTBI peers and to their pre-mTBI selves across a range of populations, including military service members, and professional, college and high school athletes. Despite the well documented increased post-mTBI MSKI risk, the underlying neuromuscular mechanisms contributing to this increased risk have yet to be definitively determined. A number of potential mechanisms have been suggested (eg, aberrant kinematics, dynamic balance impairments, lower voluntary muscle activation), but none have been confirmed with a comprehensive, prospective study. This study aims to: (1) elucidate the neuromuscular control mechanisms following mTBI that contribute to increased MSKI risk, and (2) prospectively track patient outcomes (up to 12 months; MSKI occurrences and patient-reported outcomes (PRO)). METHODS AND ANALYSIS: This is a multicentre prospective, case-matched control observational study to identify deficiencies in neuromuscular function following mTBI that may contribute to increased MSKI risk. Participants (aim to recruit 148, complete data collection on 124) will be classified into two cohorts; mTBI and control. All participants will undergo longitudinal (initial, 6 weeks post-initial, 12 weeks post-initial) comprehensive three-dimensional biomechanical (jump-landing; single leg hop; cut; gait), neuromuscular (interpolated twitch technique, muscular ramp contraction) and sensory (joint repositioning; light touch sensation) assessments to elucidate the underlying neuromuscular control mechanisms post-mTBI that may contribute to increased MSKI. Occurrences of MSKI and PROs (National Institutes of Health Patient-Reported Outcome Measurement Information System: Physical Function, Pain Interference, Depression, Anxiety; Brief Resilience Scale; Tampa Scale of Kinesiophobia), will be tracked monthly (up to 1 year) via electronic data capture platforms. ETHICS AND DISSEMINATION: The study received approval from the Walter Reed National Military Medical Center Institutional Review Board. Results will be made available to the associated funding agency and other researchers via conference proceedings and journal articles. TRIAL REGISTRATION NUMBER: NCT05122728.

Hooks Versus Pedicle Screws at the Upper Instrumented Level: An In Vitro Biomechanical Comparison.

STUDY DESIGN: Controlled laboratory study. OBJECTIVE: The aim was to compare motions at the upper instrumented vertebra (UIV) and supra-adjacent level (UIV+1) between two fixation techniques in thoracic posterior spinal fusion constructs. We hypothesized there would be greater motion at UIV+1 after cyclic loading across all constructs and bilateral pedicle screws (BPSs) with posterior ligamentous compromise would demonstrate the greatest UIV+1 range of motion. SUMMARY OF BACKGROUND DATA: Proximal junctional kyphosis is a well-recognized complication following long thoracolumbar posterior spinal fusion, however, its mechanism is poorly understood. MATERIALS AND METHODS: Twenty-seven thoracic functional spine units were randomly divided into three UIV fixation groups (n=9): (1) BPS, (2) bilateral transverse process hooks (TPHs), and (3) BPS with compromise of the posterior elements between UIV and UIV+1 (BPS-C). Specimens were tested on a servohydraulic materials testing system in native state, following instrumentation, and after cyclic loading. functional spine units were loaded in flexion-extension (FE), lateral bending, and axial rotation. RESULTS: After cyclic testing, the TPH group had a mean 29.4% increase in FE range of motion at UIV+1 versus 76.6% in the BPS group ( P <0.05). The BPS-C group showed an increased FE of 49.9% and 62.19% with sectioning of the facet joints and interspinous ligament respectively prior to cyclic testing. CONCLUSION: BPSs at the UIV led to greater motion at UIV+1 compared to bilateral TPH after cyclic loading. This is likely due to the increased rigidity of BPS compared to TPH leading to a "softer" transition between the TPH construct and native anatomy at the supra-adjacent level. Facet capsule compromise led to a 49.9% increase in UIV+1 motion, underscoring the importance of preserving the posterior ligamentous complex. Clinical studies that account for fusion rates are warranted to determine if constructs with a "soft transition" result in less proximal junctional kyphosis in vivo .

Fall Prevention Training for Service Members With an Amputation or Limb Salvage Following Lower Extremity Trauma.

INTRODUCTION: Recent military conflicts have resulted in a significant number of lower extremity injuries to U.S. service members that result in amputation or limb preservation (LP) procedures. Service members receiving these procedures report a high prevalence and deleterious consequences of falls. Very little research exists to improve balance and reduce falls, especially among young active populations such as service members with LP or limb loss. To address this research gap, we evaluated the success of a fall prevention training program for service members with lower extremity trauma by (1) measuring fall rates, (2) quantifying improvements in trunk control, and (3) determining skill retention at 3 and 6 months after training. MATERIALS AND METHODS: Forty-five participants (40 males, mean [±SD] age, 34 ± 8 years) with lower extremity trauma (20 with unilateral transtibial amputation, 6 with unilateral transfemoral amputation, 5 with bilateral transtibial amputation, and 14 with unilateral LP procedures) were enrolled. A microprocessor-controlled treadmill was used to produce task-specific postural perturbations which simulated a trip. The training was conducted over a 2-week period and consisted of six 30-minute sessions. The task difficulty was increased as the participant's ability progressed. The effectiveness of the training program was assessed by collecting data before training (baseline; repeated twice), immediately after training (0 month), and at 3 and 6 months post-training. Training effectiveness was quantified by participant-reported falls in the free-living environment before and after training. Perturbation-induced recovery step trunk flexion angle and velocity was also collected. RESULTS: Participants reported reduced falls and improved balance confidence in the free-living environment following the training. Repeated testing before training revealed that there were no pre-training differences in trunk control. The training program improved trunk control following training, and these skills were retained at 3 and 6 months after training. CONCLUSION: This study showed that task-specific fall prevention training reduced falls across a cohort of service members with diverse types of amputations and LP procedures following lower extremity trauma. Importantly, the clinical outcome of this effort (i.e., reduced falls and improved balance confidence) can lead to increased participation in occupational, recreational, and social activities and thus improved quality of life.

Relationship between phantom limb pain, function, and psychosocial health in individuals with lower-limb loss.

INTRODUCTION: The adverse influence of chronic pain on function and psychological health in the general population is well understood. However, the relationship between phantom limb pain (PLP) after limb loss with function and psychological health is less clear. The study purpose was to assess the influences of PLP presence and intensity on function and psychosocial health in individuals with lower-limb loss (LLL). METHODS: One hundred two individuals with major LLL completed a study-specific questionnaire on the presence and intensity of their PLP. The Patient-Reported Outcomes Measurement Information System -29 questionnaire was also administered. RESULTS: Of 102 participants, 64% reported PLP, with a mean intensity of 4.8 ± 2.3 out of 10. Individuals with vs. without PLP demonstrated significantly greater sleep disturbances ( p = 0.03), whereas the differences in function, fatigue, pain interference, depressive symptoms, anxiety, or ability to participate in social roles and activities were not statistically different between groups ( p > 0.05). Of note, mean scores for many of the Patient-Reported Outcomes Measurement Information System-29 short forms among the current sample were similar to the mean of the general population, minimizing the potential clinical impact of PLP on these domains. CONCLUSIONS: Our findings indicate a lack of meaningful associations between PLP presence or intensity with function, and psychosocial health among individuals with LLL. These findings conflict with previous research suggesting an adverse relationship between PLP, function, and psychosocial health after limb loss.

Lumbar Degenerative Disease and Muscle Morphology Before and After Lower Limb Loss in Four Military Patients.

INTRODUCTION: Low back pain (LBP) is highly prevalent after lower limb amputation (LLA). Reports describing longitudinal changes in spine health before and after amputation are rare. This study describes lumbar spine pathology, muscle morphology, and the continuum of care for LBP before and after LLA. MATERIALS AND METHODS: We queried electronic medical records of patients who sought care for LBP before and after unilateral LLA between January 2002 and April 2020 and who had documented lumbar imaging pre- and post-LLA. Patient demographics, muscle morphology, spinal pathology, premorbid and comorbid conditions, self-reported pain, and treatment interventions were assessed. RESULTS: Four patients with LBP and imaging before and after LLA were identified. Intervertebral disc degeneration progressed after amputation in three patients, whereas facet arthrosis progressed in both female patients. The fat content of lumbar musculature generally increased after amputation. Conservative management of LBP before and after amputation was standard, with progression to steroidal injections. CONCLUSIONS: Lumbar spine health may degrade after amputation. Here, lumbar muscle size did not change after LLA, yet the fat content increased in combination with increases in facet and intervertebral disc degeneration.

Functional Performance Outcomes of a Powered Knee-Ankle Prosthesis in Service Members With Unilateral Transfemoral Limb Loss.

INTRODUCTION: Clinical knowledge surrounding functional outcomes of a powered knee-ankle (PKA) device is limited, particularly among younger and active populations with limb loss. Here, three service members (SM) with unilateral transfemoral limb loss received an optimally tuned PKA prosthesis and device-specific training. MATERIALS AND METHODS: Once proficiency with the PKA device was demonstrated on benchmark activities, and outcomes with the PKA and standard-of-care (SoC) prostheses were obtained via a modified graded treadmill test, 6-minute walk test, and overground gait assessment. RESULTS: All SM demonstrated proficiency with the PKA prosthesis within the minimum three training sessions. With the PKA versus SoC prosthesis, cost of transport during the modified graded treadmill test was 4.0% ± 5.2% lower at slower speeds (i.e., 0.6-1.2 m/s), but 7.0% ± 5.1% greater at the faster walking speeds (i.e., ≥1.4 m/s). For the 6-minute walk test, SM walked 83.9 ± 13.2 m shorter with the PKA versus SoC prosthesis. From the overground gait assessment, SM walked with 20.6% ± 10.5% greater trunk lateral flexion and 31.8% ± 12.8% greater trunk axial rotation ranges of motion, with the PKA versus SoC prosthesis. CONCLUSIONS: Compared to prior work with the PKA in a civilian cohort, although SM demonstrated faster device proficiency (3 versus 12 sessions), SM walked with greater compensatory motions compared to their SoC prostheses (contrary to the civilian cohort). As such, it is important to understand patient-specific factors among various populations with limb loss for optimizing device-specific training and setting functional goals for occupational and/or community reintegration, as well as reducing the risk for secondary complications over the long term.

Pre-neuromusculoskeletal injury Risk factor Evaluation and Post-neuromusculoskeletal injury Assessment for Return-to-duty/activity Enhancement (PREPARE) in military service members: a prospective, observational study protocol.

BACKGROUND: Non-battle related musculoskeletal injuries (MSKI) are one of the primary medical issues diminishing Service member medical readiness. The MSKI problem is challenging because it is difficult to assess all of the factors that increase MSKI risk and influence post-MSKI outcomes. Currently, there are no high-throughput, clinically-feasible, and comprehensive assessments to generate patient-centric data for informing pre- and post-MSKI risk assessment and mitigation strategies. The objective of the "Pre-neuromusculoskeletal injury Risk factor Evaluation and Post-neuromusculoskeletal injury Assessment for Return-to-duty/activity Enhancement (PREPARE)" study is to develop a comprehensive suite of clinical assessments to identify the patient-specific factors contributing to MSKI risks and undesired post-MSKI outcomes. METHODS: This is a phased approach, multi-center prospective, observational study (ClinicalTrials.gov number: NCT05111925) to identify physical and psychosocial factors contributing to greater MSKI risk and undesired post-MSKI outcomes, and to identify and validate a minimal set of assessments to personalize risk mitigation and rehabilitation strategies. In Phase I, one cohort (n = 560) will identify the physical and psychosocial factors contributing to greater MSKI risks (single assessment), while a second cohort (n = 780) will identify the post-MSKI physical and psychosocial factors contributing to undesired post-MSKI outcomes (serial assessments at enrollment, 4 weeks post-enrollment, 12 weeks post-enrollment). All participants will complete comprehensive movement assessments captured via a semi-automated markerless motion capture system and instrumented walkway, joint range of motion assessments, psychosocial measures, and self-reported physical fitness performance and MSKI history. We will follow participants for 6 months. We will identify the minimum set of clinical assessments that provide requisite data to personalize MSKI risk mitigation and rehabilitation strategies, and in Phase II validate our optimized assessments in new cohorts. DISCUSSION: The results of this investigation will provide clinically relevant data to efficiently inform MSKI risk mitigation and rehabilitation programs, thereby helping to advance medical care and retain Service members on active duty status. TRIAL REGISTRATION: PREPARE was prospectively registered on ClinicalTrials.gov (NCT05111925) on 5 NOV 2021, prior to study commencement.