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.

Implementation of relative phase analysis to evaluate continuous interlimb coordination and stability in individuals with lower limb loss: Design and protocol for a retrospective analysis.

INTRODUCTION: The number of people with lower limb loss continues to grow, though most research to date has been non-committal and lacks the appropriate clinical guidance required for proper prosthetic prescription. Previous literature using traditional spatiotemporal and biomechanical measures has not accurately identified differences in gait patterns when using different prosthetic devices. Therefore, a knowledge gap remains. To aid in determining the impact of different devices on gait in individuals with lower limb loss, a more sensitive quantitative measure should be used to supplement traditional biomechanical analyses. Continuous measures of coordination and stability, evaluated using relative phase analysis, has been shown to detect changes in gait patterns when traditional variables cannot. However, these measures have yet to be fully assessed in this population. This investigation will fill the knowledge gap by using relative phase analysis to provide a comprehensive description of kinematic behaviour by evaluating continuous interlimb coordination and stability for individuals with lower limb loss. METHODS AND ANALYSIS: Biomechanical analysis of individuals with lower limb loss during walking activities will be evaluated using relative phase analysis to identify the continuous interlimb coordination and stability relationships between the upper and lower extremities of these individuals. Three-dimensional motion capture will enable kinematic properties of movement to be captured and analysed. Non-traditional measures of analysis will be used. ETHICS AND DISSEMINATION: This study was approved by the Veterans Affairs New York Harbor Healthcare System Institutional Review Board (IRBNet #1573135, MIRB #1775). Findings will be disseminated through peer-reviewed publications, academic conference presentations, invited workshops, webinars and seminars.

Women with limb loss: rationale, design and protocol for a national, exploratory needs assessment to evaluate the unique physical and psychosocial needs of women with limb loss.

INTRODUCTION: There is a growing population of women with limb loss, yet limited research is available to provide evidentiary support for clinical decision-making in this demographic. As such, there is a critical gap in knowledge of evidence-based healthcare practices aimed to maximise the physical and psychosocial needs of women with limb loss. The objective of this study is to develop a comprehensive, survey-based needs assessment to determine the unique impact of limb loss on women, including physical and psychosocial needs. METHODS AND ANALYSIS: A bank of existing limb loss-specific and non-limb loss-specific surveys were arranged around domains of general health, quality of life, prosthetic use and needs, psychosocial health and behaviours and body image. These surveys were supplemented with written items to ensure coverage of relevant domains. Written items were iteratively refined with a multidisciplinary expert panel. The interpretability of items and relevance to limb loss were then internally tested on a small group of rehabilitation, engineering and research professionals. A diverse sample of 12 individuals with various levels of limb loss piloted the instrument and participated in cognitive interviews. Items from existing surveys were evaluated for relevance and inclusion in the survey, but not solicited for content feedback. Pilot testing resulted in the removal of 13 items from an existing survey due to redundancy. Additionally, 13 written items were deleted, 42 written items were revised and 17 written items were added. The survey-based needs assessment has been crafted to comprehensively assess the wide spectrum of issues facing women with limb loss. The final version of the survey-based needs assessment included 15 subsections. ETHICS AND DISSEMINATION: This study was approved by the Veterans Affairs Central Institutional Review Board. The results will be disseminated through national and international conferences, as well as through manuscripts in leading peer-reviewed journals. TRIAL REGISTRATION NUMBER: No healthcare intervention on human participants was conducted.

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.

Evaluation of Weight Shift and X-Factor During Golf Swing of Veterans With Lower Limb Loss.

OBJECTIVE: The purpose of this study was to assess the weight shift and X-Factor values of golfers with lower limb loss. DESIGN: Veterans with above or below knee limb loss participated in a 3-day adaptive golf event hosted by the Department of Veterans Affairs. Professional golf instructors educated participants on proper golf swing mechanics, after which kinematic analysis of trunk rotation and kinetic analysis of weight transfer between the legs during the golf swing were evaluated using three-dimensional motion capture and force platforms. RESULTS: Golfers with a trail leg amputation, regardless of level of limb loss, demonstrated superior weight shift, whereas golfers with lead limb amputation showed greater X-Factor values (all P < 0.05). Golfers with below knee limb loss demonstrated better weight shift strategies compared to those with above knee limb loss, regardless of which leg was amputated (i.e., lead or trail limb, all P < 0.05). CONCLUSIONS: Sports rehabilitation programs should focus on increased weight bearing on the prosthetic limb to achieve appropriate weight shift and increased flexibility to increase X-Factor values. Participation in such programs can offer both physical and psychosocial benefits and may be a valid tool to increase the overall quality of life of veterans with lower limb loss.

Acute influence of an adaptive sporting event on quality of life in veterans with disabilities.

Veterans with disabilities can experience poor quality of life following military service due to the associated negative physical and psychological ramifications. However, participation in physical activities has shown to induce both physical and mental benefits and improve the quality of life of this population. Adaptive sports, an innovative approach to address the unique physical and psychosocial needs of veterans with disabilities, are becoming more widely used as a rehabilitation tool to improve the quality of life for these veterans. This study aimed to determine the acute influence of participation in a single-day, veteran-based, adaptive kayaking and sailing event on the perceived overall health, quality of life, and quality of social life of veterans with varying disabilities. It was hypothesized that all three categories and the sum score of quality of life would reflect a positive acute response after participation in the community-based physical activity event. Veterans responded to three quality of life-related questions using a 5-point Likert scale before and directly after participating in the event. Findings indicated that an adaptive sporting event can have an acute positive influence on the quality of life of veteran participants, with improvements observed in all three categories of perceived quality of life. Therefore, it is advantageous for the whole-health rehabilitation of veterans with disabilities for the Department of Veterans Affairs to continue to provide opportunities for veterans to participate in non-traditional, community-based activities.

Continuous inter-limb coordination deficits in children with unilateral spastic cerebral palsy.

BACKGROUND: Continuous inter-limb coordination and the ability to offset perturbations to a movement pattern (i.e., stability) are important factors in efficient motor performance. Patients with movement disorders often show deficits in coordination and stability, although little is known about these features in children with cerebral palsy. The purpose of this study was to identify the continuous inter-limb coordination and stability deficits in children with cerebral palsy and determine if improvement occurs with upper extremity intervention. METHODS: Children with cerebral palsy participated in bimanual or unimanual intensive therapy. Continuous inter-limb coordination between the arms and between the more-affected arm and leg was evaluated using relative phase analysis during four gross motor tasks, including in-place marching and standing with asymmetric and symmetric arm swing. A control group of children with cerebral palsy and a group of typically developing children were also evaluated. FINDINGS: Children with cerebral palsy displayed coordination deficits compared to typically developing children (p<0.01), yet both groups presented similarly poor levels of stability (p=0.39). Compared to standing, adding legs to the task negatively impacted the coordination (p<0.01) and stability (p<0.01) of all children. Both groups improved coordination between the arms post-intervention (p<0.05 for all cases), however neither group improved stability (p>0.05 for all cases). INTERPRETATION: Relative phase analysis successfully provided a sensitive measurement of coordination and stability in pathologic and non-pathologic populations. Findings indicate that all children have difficulty producing consistent movement patterns and suggest that both bimanual and unimanual interventions can improve continuous coordination in children with cerebral palsy.

Modulation of gait inter-limb coordination in children with unilateral spastic cerebral palsy after intensive upper extremity intervention.

Motor function difficulties associated with unilateral spastic cerebral palsy (USCP) impact gait inter-limb coordination between the upper and lower extremities. Two motor learning based, upper extremity treatments, Constraint Induced Movement Therapy (CIMT) and Hand Arm Bimanual Therapy (HABIT), have resulted in improvements in coordination and function between the arms in children with USCP. However, no study has investigated whether coordination between the upper and lower extremities improves after either intervention during a functional task, such as walking. Gait analysis was performed before and after participation in intensive (3 weeks, 90 h total) CIMT and HABIT interventions to determine if intensive upper extremity treatment can improve inter-limb coordination between the upper and lower extremities of children (n = 20, 6-17 years old) with USCP. While upper extremity clinical evaluations indicated hand function improvements, there were no changes in lower extremity parameters for either treatment. However, we found that 10 out of 11 children with a 2:1 arm swing-to-stride ratio at pre-test improved to a 1:1 ratio at post-test. Temporal synchronicity of contralateral limbs, swing displacement of the more affected arm, and arm swing side symmetry unexpectedly decreased. Positive changes in coordination were observed in children who demonstrated poor coordination during walking at pre-test, yet the changes were not robust. Principle component analysis did not indicate changes in limb coupling. While more coordinated, gross-motor training of the upper and lower extremity may reveal greater changes, lower extremity gait patterns were not improved in high functioning children with USCP.

Evaluation of gait-related variables in lean and obese dogs at a trot.

OBJECTIVE: To assess differences in sagittal plane joint kinematics and ground reaction forces between lean and obese adult dogs of similar sizes at 2 trotting velocities. ANIMALS: 16 adult dogs. PROCEDURES: Dogs with body condition score (BCS) of 8 or 9 (obese dogs; n = 8) and dogs with BCS of 4 or 5 (lean dogs; 8) on a 9-point scale were evaluated. Sagittal plane joint kinematic and ground reaction force data were obtained from dogs trotting at 1.8 and 2.5 m/s with a 3-D motion capture system, a force platform, and 12 infrared markers placed on bony landmarks. RESULTS: Mean stride lengths for forelimbs and hind limbs at both velocities were shorter in obese than in lean dogs. Stance phase range of motion (ROM) was greater in obese dogs than in lean dogs for shoulder (28.2° vs 20.6°), elbow (23.6° vs 16.4°), hip (27.2° vs 22.9°), and tarsal (38.9° vs 27.9°) joints at both velocities. Swing phase ROM was greater in obese dogs than in lean dogs for elbow (61.2° vs 53.7°) and hip (34.4° vs 29.8°) joints. Increased velocity was associated with increased stance ROM in elbow joints and increased stance and swing ROM in hip joints of obese dogs. Obese dogs exerted greater peak vertical and horizontal ground reaction forces than did lean dogs. Body mass and peak vertical ground reaction force were significantly correlated. CONCLUSIONS AND CLINICAL RELEVANCE: Greater ROM detected during the stance phase and greater ground reaction forces in the gait of obese dogs, compared with lean dogs, may cause greater compressive forces within joints and could influence the development of osteoarthritis.