Canadian Prosthetics Orthotics Journal最新文献

Background: Interventions which have focused on improving the physical activity of individuals with lower limb amputation can be mostly categorized into behavioural-based and prosthetic-based interventions. The aim of this review was to assess the quality of these interventions, and to identify the key gaps in research in this field.

Methodology: The databases of Scopus, Pubmed, Embase, Medline and Web of Science were searched between September and December of 2019 for articles relating to physical activity, amputees and interventions. Articles were assessed quantitively based on internal validity, external validity and intervention intensity.

Findings: Sixteen articles (5 behavioural, 11 prosthetic) were assessed. Both approaches had comparable methodological quality and mixed efficacy for producing a significant change in physical activity outcomes. Almost all interventions used a simplistic measurement of activity as their outcome.

Conclusions: There is an insufficient amount of studies to assess the overall efficacy of behavioural interventions in regard to how they impact on physical activity behaviour. However, the increase of quality of the methodology in the more recent studies could indicate that future interventions will retain similar levels of quality. Prosthetic interventions have shown no major improvement in efficacy compared to similar reviews and may need to utilise more advanced prosthetic components to attain significant changes in physical activity. Activity outcomes should expand into more complex activity measurements to properly understand the physical activity profile of people with lower limb amputation.

Background: Direct Socket for transfemoral (DS-TF) prosthetic user is a novel method of fabricating a laminated interface on to the residual limb but requires different training, production method and service model than what most prosthetists are familiar with. This method and model may improve patient satisfaction by enabling interface fabrication and delivery in one visit.

Objectives: Document patient satisfaction regarding DS-TF interface versus the prosthetic users' previous socket in terms of interface function and the clinic service model.

Methodology: In this longitudinal study (from July 2018 to April 2020), the DS-TF was implemented in six prosthetic clinics across the United States. Certified prosthetists (CP) and assistants were trained using a standard protocol. 47 prosthetic users participated, both those in need of a new socket and those without need. Two modules from the Orthotics and Prosthetics Users' Survey (OPUS), involving questions related to satisfaction with the Device and Services, was used to evaluate each DS-TF user outcome vs. baseline. The only part of the prosthesis that was replaced was the interface, except in 2 cases.

Findings: Each DS-TF interface was fabricated, fit and delivered in a single clinic visit. At 6-months follow-up, 38 users reported an average of 29.8% increase in satisfaction with their new interface compared with original, and a 14.8% increase in satisfaction with the services they received from the clinic in providing of the new prosthesis vs. their original prosthesis. The main outcome increases were between baseline (initial fitting) and 6-week follow-up and remained consistent after 6 months. This improvement was consistent irrespective if the user needed a new socket for clinical reasons or not.

Conclusions: This study shows that after a standardized training and implementation, the DS-TF fabrication process including a new interface, improves the user's satisfaction with their prosthetic device and services.

Background: A number of individuals with unilateral transfemoral amputation (TFA) run in a prosthesis with an unlocked prosthetic knee, while others choose to run with a locked prosthetic knee to increase stability. Research regarding running with an unlocked knee (UK) versus a locked knee (LK), with respect to energy efficiency, is limited and might be enhanced by characterization of the impact of knee condition on kinematics.

Objectives: To investigate the effect of an UK versus LK on hip kinematics, energy efficiency, and running speed.

Methodology: Five male novice runners with unilateral TFA completed one three-minute self-selected running speed (SSRS) trial and three peak speed trials per knee condition. Hip kinematics, energy efficiency, and running speed were compared between conditions.

Findings: Four of the five subjects exhibited a fast walk, rather than a consistent run. Hip flexion increased for all subjects and hip abduction decreased for four subjects during swing phase for the UK condition. Hip kinematic asymmetry was reduced for the UK condition in the sagittal plane for four individuals; hip kinematic asymmetry was also reduced in the frontal plane for the UK condition for three of these individuals. Mean energy efficiency was better for the UK condition (UK: 0.282 mLO2/kg/m, LK: 0.328 mLO2/kg/m). Peak running speed did not differ significantly between knee conditions (UK: 1.47m/s, LK:1.32m/s).

Conclusions: For novice recreational runners with unilateral transfemoral amputation, the UK condition resulted in improved energy efficiency and enhanced kinematic symmetry, despite comparable peak speed relative to the LK condition. Therefore the UK condition may be advantageous for mid-range distance running.

The Canadian healthcare system serves as an example of equity and federal service to citizens across the world. However, it is not without its challenges. Prosthetic coverage across Canada is highly variable and largely unable to provide equal coverage for Canadian persons living with amputation. Many persons with limb loss are forced to rely upon personal resources, fundraising, or the charity of non-governmental organizations in order to meet this basic healthcare need. This disparity in the Canadian healthcare system is unusual and largely undescribed in the literature. We thus explore the nature of Canadian healthcare prosthetic coverage across Canada, investigating the variability in coverage, presence of prosthetic coverage policies, clarity of policy, eligibility criteria, and interval of prosthetic replacement. Our findings highlight potential areas for improvement within current Canadian healthcare policy.

Background: Lower limb amputees have a high incidence of comorbidities, such as osteoarthritis, which are believed to be caused by kinetic asymmetries. A lack of prosthetic adaptation to different terrains requires kinematic compensations, which may influence these asymmetries.

Method: Six SIGAM grade E-F trans-tibial amputees (one bilateral) wore motion capture markers while standing on force plates, facing down a 5° slope. The participants were tested under three prosthetic conditions; a fixed attachment foot (FIX), a hydraulic ankle (HYD) and a microprocessor foot with a 'standing support' mode (MPF). The resultant ground reaction force (GRF) and support moment for prosthetic and sound limbs were chosen as outcome measures. These were compared between prosthetic conditions and to previously captured able-bodied control data.

Results: The distribution of GRF between sound and prosthetic limbs was not significantly affected by foot type. However, the MPF condition required fewer kinematic compensations, leading to a reduction in sound side support moment of 59% (p=0.001) and prosthetic side support moment of 43% (p=0.02) compared to FIX. For the bilateral participant, only the MPF positioned the GRF vector anterior to the knees, reducing the demand on the residual joints to maintain posture.

Conclusions: For trans-tibial amputees, loading on lower limb joints is affected by prosthetic foot technology, due to the kinematic compensations required for slope adaptation. MPFs with 'standing support' might be considered reasonable and necessary for bilateral amputees, or amputees with stability problems due to the reduced biomechanical compensations evident.

Background: Rapid Prototyping is becoming an accessible manufacturing method but before clinical adoption can occur, the safety of treatments needs to be established. Previous studies have evaluated the static strength of traditional sockets using ultimate strength testing protocols outlined by the International Organization for Standardization (ISO).

Objective: To carry out a pilot test in which 3D printed sockets will be compared to traditionally fabricated sockets, by applying a static ultimate strength test.

Methodology: 36 sockets were made from a mold of a transtibial socket shape,18 for cushion liners with a distal socket attachment block and 18 for locking liners with a distal 4-hole pattern. Of the 18 sockets, 6 were thermoplastic, 6 laminated composites & 6 3D printed Polylactic Acid. Sockets were aligned in standard bench alignment and placed in a testing jig that applied forces simulating individuals of different weight putting force through the socket both early and late in the stance phase. Ultimate strength tests were conducted in these conditions. If a setup passed the ultimate strength test, load was applied until failure.

Findings: All sockets made for cushion liners passed the strength tests, however failure levels and methods varied. For early stance, thermoplastic sockets yielded, laminated sockets cracked posteriorly, and 3D printed socket broke circumferentially. For late stance, 2/3 of the sockets failed at the pylon. Sockets made for locking liners passed the ultimate strength tests early in stance phase, however, none of the sockets passed for forces late in stance phase, all broke around the lock mechanism.

Conclusion: Thermoplastic, laminated and 3D printed sockets made for cushion liners passed the ultimate strength test protocol outlined by the ISO for forces applied statically in gait. This provides initial evidence that 3D printed sockets are statically safe to use on patients and quantifies the static strength of laminated and thermoplastic sockets. However, all set-ups of sockets made for locking liners failed at terminal stance. While further work is needed, this suggests that the distal reinforcement for thermoplastic, laminated and 3D printed sockets with distal cylindrical locks may need to be reconsidered.

Background: Physiological Cost Index (PCI) is a simple method used to estimate energy expenditure during walking. It is based on a ratio between heart rate and self-selected walking speed. Previous studies reported that PCI is reliable in individuals with lower limb amputation but only if there is an important walking impairment. No previous studies have investigated the correlation of PCI with the Energy Cost Walking (ECW) in active individuals with traumatic unilateral trans-tibial amputation, considering that this particular category of amputees has an ECW quite similar to healthy individual without lower limb amputation. Moreover, it is important to determine if PCI is also correlated to ECW in the treadmill test so as to have an alternative to over-ground test.

Objectives: The aim of this study was to evaluate the correlation between PCI and ECW in active individuals with traumatic trans-tibial amputation in different walking conditions. The secondary aim was to evaluate if this correlation permits to determine ECW from PCI values.

Methodology: Ninety traumatic amputees were enrolled. Metabolic data, heart rate and walking speed for the calculation of ECW and for PCI were computed over-ground and on a treadmill with 0% and 12% slopes during a 6-minute walking test.

Findings: There is a significant correlation between ECW and PCI walking over-ground (p=0.003; R²=0.10) and on treadmill with 12% slopes (p=0.001; R²=0.11) but there is only a poor to moderate correlation around the trendline. No significant correlation was found walking on treadmill with 0% slope. The Bland-Altman plot analysis suggests that is not possible to evaluate ECW directly from PCI.

Conclusions: PCI is a reliable alternative measure of energy expenditure during walking in active individuals with trans-tibial amputation when performing over-ground or at high intensity effort on treadmill. PCI is therefore useful only for monitoring a within subject assessment.

Background: Transtibial prosthesis socket trim lines have remained fairly consistent over the past decade, and based on methods such as a supracondylar cuff suspension. However, with vacuum suspension methods, trim lines can change.

Objective: An objective of this technical note was to inform practitioners how to fabricate a socket in a better way. A step-by-step fabrication guide is provided for the prosthetist.

Methods: A unilateral transtibial amputee was selected for this technical note. We provide a detailed description of the different steps of fabrication as well as patient feedback. The fabrication involved fabrication of a vacuum socket using Pre-preg carbon fiber and anti-bacterial Ethylene-Vinyl-Acetate (EVA), as a proximal flexible brim.

Findings: The properties of EVA and Pre-preg carbon fiber allow for fabrication of a transtibial socket with a flexible proximal brim. The new design resulted in greater comfort and increased range of motion in the patient studied. The patient subjectively noted enhanced squatting and cycling capabilities while using the updated socket and flexible proximal brim.

Conclusion: This technical note presented a fabrication guide for a new style of socket and preliminary patient feedback. Clinical studies evaluating functional and biomechanical effects of this new socket design are needed.

Background: Small residual limb-socket displacement is a good indicator of prosthetic suspension system quality. Active vacuum suspension systems can decrease vertical movement inside the socket, compared to non-active suction systems. This study mechanically evaluated limb-socket displacement with the Össur Unity active vacuum system.

Method: Forty-eight conditions were evaluated: four cylindrical and four conical sockets (polypropylene, polyethylene terephthalate glycol-modified (PETG), thermoset resin (acrylic), Thermolyn soft materials); two Iceross Seal-In V liners (standard, high profile); three vacuum conditions (active vacuum, inactive vacuum, no suction with valve open). An Instron 4428 test machine applied 0-100N linear ramped tensile loads to each positive mold, with the socket secured in place, while displacement between the mold and socket was recorded. Following the displacement tests, the load before failure (i.e., 10 mm displacement) was measured.

Results: Average and standard deviations for movement between the mold and sockets were small. The displacement average for all conditions was 0.30±0.16mm for active vacuum, 0.32±0.16mm for inactive vacuum, and 0.39±0.22mm for no suction. Across all trials, active vacuum systems tolerated significantly (p<0.001) more load before failure (812±221N) compared to inactive vacuum (727±213N), and no suction (401±184N). The maximum load before failure (1142±53N) was for the cylindrical polypropylene socket and high-profile liner.

Conclusion: The Unity system successfully controlled pistoning inside the socket for regular activity loads and also controlled the greatest traction loads. While relative movement was smallest for Unity, all conditions (inactive vacuum, no suction) were viable for loads less than 100N. Furthermore, similar results can be achieved when using different socket fabrication materials.

Case description: Good residual limb skin health is vital to successful prosthetic prescription. Unnatural loading profiles and excessive sweating can lead to skin and soft tissue problems. Perforated liners allow the transport of moisture away from the skin and allow negative pressure (a condition that has been shown to aid wound healing) to act directly on the residuum surface.

Aim: Assess the effects of perforated prosthetic liner use, particularly with respect to wound healing.

Method: Three patient histories were retrospectively reviewed following prescription of perforated prosthetic liners due to excessive sweating or prolonged residual limb health concerns. Photographic records from patient files were used to document changes in residual limb condition. Patients also provided subjective feedback regarding their experiences.

Findings: Two cases described active amputees with persistent blistering irritated during exercise. Another case described a patient of low mobility level with a history of residual limb skin infections. All saw their conditions heal and reported a reduction in problematic sweating. Two patients reported cancelling surgical interventions after substantial improvements with the perforated liner.

Discussion: These findings provide evidence that the use of perforated prosthetic liners allow improvements in residual limb health, while still permitting prosthetic use.