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.

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.

Demographic and Functional Characteristics of National Veterans Wheelchair Games Participants: A Cross-sectional Study.

INTRODUCTION: Although many studies report the impact of adaptive sports and recreation on quality of life for people with disabilities across several age groups, few have focused on the Veteran population. The purpose of this study was to establish a baseline of common characteristics of the Veteran population that participated in the National Veterans Wheelchair Games (NVWG) in 2017 and 2018, including their perception on how their participation is associated with function and social factors. MATERIALS AND METHODS: A cross-sectional study was implemented as part of a quality assurance collaboration between the University of Pittsburgh and the Veterans Administration National Veterans Sports Programs and Special Events. Demographic and quality-of-life data were collected through the Functional Mobility Assessment (FMA) and associated Uniform Dataset as well as the Sports Participation Outcome Research Tool and Comprehensive Uniform Survey (SPORTACUS). This report provides and discusses the descriptive analyses that were performed on the data and establishes a framework to assess the impact of sports and exercise for Veterans with disabilities. RESULTS: A sample of 426 Veterans, 87% who were male and an average population age of 56 years old, reported high FMA scores on each of 10 items (daily routine, comfort, health, operate, reach, transfer, personal care, indoor mobility, outdoor mobility, and transportation) along with SPORTACUS scores scoring above 5, based on a 1-6 scoring scale (1 being "completely disagree" and 6 being "completely agree"), on each domain indicating sports participation is associated with their ability to function and participate in the community. CONCLUSION: Based on these results, it can be concluded for this military Veteran population that participation in a large, organized adaptive sports programs such as the NVWG has a positive association with daily function, quality of life, community participation, and use of higher quality assistive technology.

A Review of Unique Considerations for Female Veterans With Amputation.

This article explores unique considerations that face both women living with limb loss and their health care providers. This demographic of patient has a higher rate of artificial limb rejection, thus challenging providers to address needs for cosmesis and function that varies from those of male counterparts. Health care providers for women with amputations, such as the Veterans Affairs, must evolve health care delivery, research practices, and work jointly with industry in order to meet the needs of this population.

Outcomes Associated With the Intrepid Dynamic Exoskeletal Orthosis (IDEO): A Systematic Review of the Literature.

High-energy lower extremity trauma is a consequence of modern war and it is unclear if limb amputation or limb salvage enables greater recovery. To improve function in the injured extremity, a passive dynamic ankle-foot orthosis, the Intrepid Dynamic Exoskeletal Orthosis (IDEO), was introduced with specialized return to run (RTR) therapy program. Recent research suggests, these interventions may improve function and return to duty rates. This systematic literature review sought to rate available evidence and formulate empirical evidence statements (EESs), regarding outcomes associated with IDEO utilization. PubMed, CINAHL, and Google Scholar were systematically searched for pertinent articles. Articles were screened and rated. EESs were formulated based upon data and conclusions from included studies. Twelve studies were identified and rated. Subjects (n = 487, 6 females, mean age 29.4 year) were studied following limb trauma and salvage. All included studies had high external validity, whereas internal validity was mixed because of reporting issues. Moderate evidence supported development of four EESs regarding IDEO use with specialized therapy. Following high-energy lower extremity trauma and limb salvage, use of IDEO with RTR therapy can enable return to duty, return to recreation and physical activity, and decrease pain in some high-functioning patients. In higher functioning patients following limb salvage or trauma, IDEO use improved agility, power and speed, compared with no-brace or conventional bracing alternatives.