Canadian Prosthetics Orthotics Journal最新文献

Background: The number of patients receiving orthotics and prosthetic services is increasing globally. A way to investigate patients' insight about services provided to them is to evaluate their satisfaction with the received services. Furthermore, incorporating patients' preferences into practice is an inseparable part of evidence-based practice. Applying such information in practice can contribute to the enhancement of the quality of services, the effectiveness of therapeutic interventions, and finally, the economic growth of service centers.

Objectives: To evaluate patients' satisfaction with the orthotic and prosthetic devices and services provided by the orthotics and prosthetics clinic of Iran University of Medical Sciences.

Methodology: In this study, 173 people referring to the orthotics and prosthetics clinic of Iran University of Medical Sciences were recruited, and their satisfaction level was examined using the Orthotics and Prosthetics Users' Survey questionnaire (OPUS) through a phone interview.

Findings: Concerning the devices, the mean value of total satisfaction score was 74:00±19.80 and the highest score belonged to no wear or rupture of the clothes with their devices (mean value = 4.76±0.84). In terms of services, the mean value of total satisfaction score was 72.12 ± 15.90 with the highest score belonging to the politeness of the clinic staff (mean value = 4.92±0.57). When the time point from receiving service was taken into account, the patients who received the service for less than a year showed higher satisfaction level with the service (p=0.024). Although satisfaction with the device was slightly higher among the participants who used the devices for more than a year, no significant difference was observed between the two groups in terms of device satisfaction.

Conclusions: The overall satisfaction level from the devices and services was relatively high. However, the satisfaction level with the costs and coordination of the staff with the physicians showed a decline.

This Editorial presents an overview of the uptake of clinical outcome measures in the prosthetics and orthotics sector and considers how the use of objective measures contribute to demonstrating value provided. A decade ago, payors began to demand objective data to document costs vs. benefits from prosthetic and orthotic providers. The speed with which the sector responded to help develop measures and to begin to integrate them into practice is remarkable. This suggests an encouraging resilience and ability to adapt on the part of the sector as other trends such as Values-Based Health Care emerge to challenge the sector.

Background: The human hand is critical in assisting with activities of daily living (ADL). Amputation of the hand can affect a person physically, socially and psychologically. Knowledge of outcome measures used to assess upper limb activity of intact and amputee populations may aid in guiding research to develop applicable measurement tools specific to the amputee population. Tools could aid developments in prosthetic design and prescription, which benefit both users and healthcare researchers.

Objectives: This literature review examined outcome measurement tools used with non-amputee and amputee populations to assess hand activity. The objectives were to identify which characteristics of hand activity are captured by currently available measurement tools.

Methodology: Searches were conducted using PubMed, Cochrane and ProQuest for studies investigating hand activity for amputee and non-amputee populations. A total of 15 studies were included. PRISMA guidelines were used to assist with study selection. Data extraction and narrative synthesis were carried out.

Findings: A total of 32 outcome measures were found. Frequently used tools were: Box and Block Test, Swedish Disabilities of the Arm Shoulder and Hand Questionnaire, and range of motion. Studies employed a combination of 2 to 12 tools. Themes extracted were: importance of function and quality of life, the need for realistic tasks, and the need for outcome measures specific of the population.

Conclusion: There is a gap in research surrounding outcome measurement tools used to assess hand activity in the amputee population. A combination of outcome measures are required to obtain insight into the hand activities of intact and amputee populations. Function and quality of life are important aspects to consider when describing hand activity.

Background: The risk of tripping in people with amputation is greater than that of able-bodied individuals due to reduced toe clearance during the swing phase. Appropriate prosthetic suspension may increase toe clearance by providing more secured attachment between the residual limb and prosthetic socket. Research is lacking on the Unity suspension system's effect on swing toe clearance.

Methods: Twelve people with transtibial amputation were fitted with the Unity suspension system. After one month accommodation period, the person walked with active (ON) or inactive vacuum (OFF) in a CAREN-Extended virtual reality system, across multiple simulated real-world scenarios. Prosthetics minimum swing toe clearance, and kinematic data, while the vacuum was ON or OFF, were compared with the intact side and a group of 12 able-bodied individuals.

Results: Minimum swing toe clearance (MSTC) and knee flexion angle were larger on the prosthetic side (active and inactive vacuum) compared to both the intact side and the control group. However, hip flexion angle on the prosthetic side was approximately 17% smaller than the control group. Unlike the control group, MSTC with active and inactive vacuum suspension was not significantly different between level walking and other walking conditions. Finally, among all walking conditions, the lowest swing toe clearance for both control and the amputee groups was recorded when the limb was at the top of a side-slope.

Conclusion: An effective suspension system could improve toe clearance; however, significant differences were not found between active and inactive vacuum conditions. The likelihood of inappropriate foot contact on side-slope ground might be greater than other walking conditions for both able-bodied and amputee groups, possibly leading to stumbling or falling.

Background: Gait symmetry is the degree of equality of biomechanical parameters between limbs within a gait cycle. Human gait is highly symmetrical; however, in the presence of pathology, gait often lacks symmetry. Biofeedback (BFB) systems have demonstrated the potential to reduce gait asymmetry, improve gait function, and benefit overall long-term musculoskeletal health.

Objectives: The aim of this study was to develop a BFB system and evaluate three unique BFB strategies, including bidirectional control - constant vibration (BC), bidirectional control - variable vibration (BV), and unidirectional control - variable vibration (UV) relevant to gait symmetry. The assessed feedback strategies were a combination of vibration frequency/amplitude levels, vibration thresholds, and vibrotactile stimuli from one and two vibrating motors (tactors). Learning effect and short-term retention were also assessed.

Methodology: Testing was performed using a custom BFB system that induces stance time asymmetries to modulate temporal gait symmetry. The BFB system continuously monitors specific gait events (heel-strike and toe-off) and calculates the symmetry ratio, based on the stance time of both limbs to provide real-time biomechanical information via the vibrating motors. Overall walking performance of ten (n=10) able-bodied individuals (age 24.8 ± 4.4 years) was assessed via metrics of symmetry ratio, symmetry ratio error, walking speed, and motor's vibration percentages.

Findings: All participants utilized BFB somatosensory information to modulate their symmetry ratio. UV feedback produced a greater change in symmetry ratio, and it came closer to the targeted symmetry ratio. Learning or short-term retention effects were minimal. Walking speeds were reduced with feedback compared to no feedback; however, UV walking speeds were significantly faster compared to BV and BC.

Conclusion: The outcomes of this study provide new insights into the development and implementation of feedback strategies for gait retraining BFB systems that may ultimately benefit individuals with pathological gait. Future work should assess longer-term use and long-term learning and retention effects of BFB systems in the populations of interest.

Background: A relationship between walking ability and self-efficacy has been demonstrated in various rehabilitation patient populations. In experienced prosthetic ambulators, walking ability is related to self-efficacy of balance, however, this relationship has not been quantified for those with newly acquired lower limb amputations (LLA).

Objectives: To investigate the association between walking performance (objective) and self-reported walking abilities (subjective) on balance self-efficacy in those with LLA.

Methodology: Cross-sectional study of 27 people (17 men; mean age=63.57±9.33) at discharge from inpatient prosthetic rehabilitation for first major unilateral LLA. Individuals completed 6m straight path walking and the L-Test under single- and dual-task conditions. The Prosthesis Evaluation Questionnaire (PEQ) was administered, and the Ambulation subscale provided subjective measures of walking ability. A single PEQ question on satisfaction with walking (16B) was also used as a proxy for subjective walking ability. The Activities-specific Balance Confidence Scale measured balance self-efficacy. Multivariable linear regression was used to evaluate the strength of association between walking ability (objective and subjective) and balance self-efficacy (dependent variable).

Findings: Walking velocity on the 6m straight path under single-task (p=0.011) and dual-task conditions (p=0.039), the single-task L-Test (p=0.035) and self-reported satisfaction with walking (p=0.019) were associated with self-efficacy of balance.

Conclusions: Objective measures of walking ability that were independently associated with balance self-efficacy included straight path walking velocity under single and dual-task conditions and the single-task L-Test. Satisfaction with walking was also associated with balance self-efficacy. This highlights the interplay between physical and psychological factors during rehabilitation. More research in the area of self-efficacy and walking ability is needed to establish self-efficacy as a target during prosthetic rehabilitation for those with LLA.

Overcoming obstacles to prosthetic fittings requires frequent tryouts of sockets and components. Repetitions of interventions are upsetting for users and place substantial economic burden on healthcare systems. Encouraging prosthetic care innovations capable of alleviating clinical and financial shortcomings of socket-based solutions is essential. Nonetheless, evidence of socio-economic benefits of an innovation are required to facilitate access to markets. Unfortunately, complex decisions must be made when allocating resources toward the most relevant health economic evaluation (HEE) at a given stage of development of an innovation. This paper first, aimed to show the importance and challenges of HEEs of intervention facilitating prosthetic fittings. Next, the main trends in HEEs at various phases of product development and clinical acceptance of prosthetic care innovations were outlined. Then, opportunities for a basic framework of a preliminary cost-utility analysis (CUA) during the mid-stage of development of prosthetic care innovations were highlighted. To do this, fundamental and applied health economic literature and prosthetic-specific publications were reviewed to extract and analyse the trends in HEEs of new medical and prosthetic technologies, respectively. The findings show there is consensus around the weaknesses of full CUAs (e.g., lack of timeliness, resource-intensive) and strengths of preliminary CUAs (e.g., identify evidence gaps, educate design of full CUA, fast-track approval). However, several obstacles must be overcome before preliminary CUA of prosthetic care innovations will be routinely carried out. Disparities of methods and constructs of usual preliminary CUA are barriers that could be alleviated by a more standardized framework. The paper concludes by identifying that there are opportunities for the development of a basic framework of preliminary CUA of prosthetic care innovations. Ultimately, the collaborative design of a framework could simplify selection of the methods, standardise outcomes, ease comparisons between innovations and streamline pathways for adoption. This might facilitate access to economical solutions that could improve the life of individuals suffering from limb loss.

Several obstacles must be overcome before preliminary cost-utility analyses (CUA) of prosthetic care innovations can be routinely performed. The basic framework of preliminary CUAs and hands- on recommendations suggested previously might contribute to wider adoption. However, a practical application for an emerging intervention is needed to showcase the capacity of this proposed preliminary CUA framework. This study presented the outcomes of preliminary CUA of the distal weight bearing Keep Walking Implant (KWI), an emerging prosthetic care innovation that may reduce socket fittings for individuals with transfemoral amputation. The preliminary CUAs compared the provision of prosthetic care without (usual intervention) and with the KWI (new intervention) using a 15-step iterative process focused on feasibility, constructs, analysis, and interpretations of outcomes from an Australia government prosthetic care perspective over a six-year time horizon. Baseline and incremental costs were extracted from schedules of allowable expenses. Baseline utilities were extracted from a study and converted into quality-adjusted life-year (QALY). Incremental utilities were calculated based on sensible gains of QALY from baselines. The provision of the prosthetic care with the KWI could generate an indicative incremental cost-utility ratio (ICUR) of -$36,890 per QALY, which was $76,890 per QALY below willingness-to-pay threshold, provided that the KWI reduces costs by $17,910 while increasing utility by 0.485 QALY compared to usual interventions. This preliminary CUA provided administrators of healthcare organizations in Australia and elsewhere with prerequisite evidence justifying further access to market and clinical introduction of the KWI. Altogether, this work suggests that the basic framework of the preliminary CUA of a prosthetic care innovation proposed previously is feasible and informative when a series of assumptions are carefully considered. This study further confirms that preliminary CUAs prosthetic care interventions might be a relevant alternative to full CUA for other medical treatments.

The rapid advancement of prosthetic and orthotic (P&O) technology raises the question how the industry can ensure that patients have access to the benefits and providers get paid properly and fairly by healthcare payers. This is a challenge that not only P&O but all areas of health technology face. In many areas of medicine and health products, such as drugs and medical devices, health-technology assessments (HTA) have become a standard procedure in the coverage and reimbursement process. In most countries, P&O is lagging behind that development, although some countries have already formalized HTA for prosthetic and orthotic products and may even use cost-effectiveness analyses to determine pricing and payment amounts. This article gives an overview on the coverage and reimbursement processes in the United States, Canada, Germany, France, Sweden, the United Kingdom, Poland, Japan, and China. This selection reflects the variety and diversity of coverage and reimbursement processes that the P&O industry faces globally. The paper continues with an overview on the necessary research and investment efforts that manufacturers will have to make in the future, and contemplates the likely consequences for the manufacturer community in the market place. Health economics may help support the transition from price-based to value-based coverage and reimbursement but will come at considerable costs to the industry.

The demand has increased for evidence regarding the effectiveness and value of prosthetic and orthotic rehabilitation interventions. Clinicians and managers are under pressure to provide treatment recommendations and demonstrate effectiveness through outcomes. It is often assumed that rehabilitation interventions, including the provision of custom-made and custom-fit orthotic and prosthetic devices, are beneficial to patients. Assessing the value of orthotic and prosthetic services has become more critical to continue to ensure equitable access to needed services. Health economics and outcomes research methods serve as tools to gauge the value of prosthetic and orthotic rehabilitation interventions. The purpose of this article is to provide an overview of the current need of health economics and outcomes research in orthotics and prosthetics, to introduce common economic methods that assist to generate real-world evidence, and to discusses the potential value of economic methods for clinicians and clinical practice.