A Participatory Model for Cocreating Accessible Rehabilitation Technology for Stroke Survivors: User-Centered Design Approach.

Background: Globally, 1 in 3 people live with health conditions that could be improved with rehabilitation. Ideally, this is provided by trained professionals delivering evidence-based dose, intensity, and content of rehabilitation for optimal recovery. The widely acknowledged inability of global health care providers to deliver recommended levels of rehabilitation creates an opportunity for technological innovation. Design processes that lack close consideration of users' needs and budgets, however, mean that many rehabilitation technologies are neither useful nor used. To address this problem, our multidisciplinary research group have established a cocreation center for rehabilitation technology that places the end user at the center of the innovation process. Objective: This study aims to present the participatory cocreation model that has been developed from our center and illustrate the approach with 2 cases studies. Methods: The model is built around user participation in an intensive rehabilitation program (2-hour sessions, 2-5 times per week, and 8-week duration), supervised by qualified therapists but delivered exclusively through commercial and prototype technology. This provides participants (chronic stroke survivors with movement and/or speech disability) with a rich experience of rehabilitation technology, enabling them to provide truly informed feedback, as well as creating an observatory for the research team. This process is supported by short-term focus groups for specific product development and a longer-term advisory group to consider broader issues of adoption and translation into everyday health care. Results: Our model has been active for 3 years with 92 (92%) out of 100 participants completing the program. Five new technologies have evolved from the process with further ideas logged for future development. In addition, it has led to a set of cocreated protocols for technology-enriched rehabilitation, including recruitment, outcome measures, and intervention structure, which has allowed us to replicate this approach in an acute hospital ward. Conclusions: Suboptimal rehabilitation limits recovery from health conditions. Technology offers the potential support to increase access to recommended levels of rehabilitation but needs to be designed to suit end users and not just their impairment. Our cocreation model, built around participation in an intensive, technology-based program, has produced new accessible technology and demonstrated the feasibility of our overall approach to providing the rehabilitation that people need, for as long as needed.

An Intensive Exercise Program Using a Technology-Enriched Rehabilitation Gym for the Recovery of Function in People With Chronic Stroke: Usability Study.

BACKGROUND: Rehabilitation improves poststroke recovery with greater effect for many when applied intensively within enriched environments. The failure of health care providers to achieve minimum recommendations for rehabilitation motivated the development of a technology-enriched rehabilitation gym (TERG) that enables individuals under supervision to perform high-intensity self-managed exercises safely in an enriched environment. OBJECTIVE: This study aimed to assess the feasibility of the TERG approach and gather preliminary evidence of its effect for future research. METHODS: This feasibility study recruited people well enough to exercise but living with motor impairment following a stroke at least 12 months previously. Following assessment, an 8-week exercise program using a TERG (eg, virtual reality treadmills, power-assisted equipment, balance trainers, and upper limb training systems) was structured in partnership with participants. The feasibility was assessed through recruitment, retention, and adherence rates along with participant interviews. Effect sizes were calculated from the mean change in standard outcome measures. RESULTS: In total, 70 individuals registered interest, the first 50 were invited for assessment, 39 attended, and 31 were eligible and consented. Following a pilot study (n=5), 26 individuals (mean age 60.4, SD 13.3 years; mean 39.0, SD 29.2 months post stroke; n=17 males; n=10 with aphasia) were recruited to a feasibility study, which 25 individuals completed. Participants attended an average of 18.7 (SD 6.2) sessions with an 82% attendance rate. Reasons for nonattendance related to personal life, illness, weather, care, and transport. In total, 19 adverse events were reported: muscle or joint pain, fatigue, dizziness, and viral illness, all resolved within a week. Participants found the TERG program to be a positive experience with the equipment highly usable albeit with some need for individual tailoring to accommodate body shape and impairment. The inclusion of performance feedback and gamification was well received. Mean improvements in outcome measures were recorded across all domains with low to medium effect sizes. CONCLUSIONS: This study assessed the feasibility of a holistic technology-based solution to the gap between stroke rehabilitation recommendations and provision. The results clearly demonstrate a rehabilitation program delivered through a TERG is feasible in terms of recruitment, retention, adherence, and user acceptability and may lead to considerable improvement in function, even in a chronic stroke population. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-doi.org/10.3389/fresc.2021.820929.

No advantage with navigated versus conventional mechanically aligned total knee arthroplasty-10 year results of a randomised controlled trial.

PURPOSE: Computer-assisted surgery (CAS) total knee arthroplasty (TKA) remains a controversial area of surgical practice. The aim of this study is to report the ten-year revision rates and patient-reported outcome measures (PROMS) of a single-blinded, prospective, randomised controlled trial comparing electromagnetically (EM) navigated and conventional TKA. METHODS: 199 patients were randomised to receive either EM navigated or conventional TKA where the aim of implantation was neutral mechanical alignment in all cases. Ten-year revision rates were collated and compared between the two intervention groups. Longitudinal PROMS data was collected prospectively at various time points up to 10 years post-operatively. RESULTS: Over the ten-year period, there were 23 deaths (22.8%) in the EM navigation cohort and 30 deaths (30.6%) in the conventional cohort. At 10 years post-operatively, there was no statistically significant difference in all cause revision between the EM navigation and conventional cohort (4.0 vs 6.1%, p = 0.429). When analysing causes of revision that might be influenced by utilising EM navigation, there was no statistically significant difference in revisions (3.0% EM navigated vs 4.1% conventional group, p = 0.591). Patients that received navigated TKAs had improved Oxford Knee Society, American Knee Society Score and range of motion at 3 months following surgery compared to conventional TKA (p = 0.002, p = 0.032, and p = 0.05, respectively). However, from 1 to 10 years post-operatively, both interventions had equivalent outcomes. CONCLUSION: There is no difference in revision rates or clinical outcomes comparing EM navigated versus conventional TKA at ten-year follow-up. The expected mortality rate makes it unlikely that a difference in revision rates will reach statistical significance in the future. In the setting of an experienced knee arthroplasty surgeon, it is difficult to justify the additional costs of CAS in TKA surgery. LEVEL OF EVIDENCE: I.

Are there functional biomechanical differences in robotic arm-assisted bi-unicompartmental knee arthroplasty compared with conventional total knee arthroplasty? A prospective, randomized controlled trial.

AIMS: The aim of this study was to compare any differences in the primary outcome (biphasic flexion knee moment during gait) of robotic arm-assisted bi-unicompartmental knee arthroplasty (bi-UKA) with conventional mechanically aligned total knee arthroplasty (TKA) at one year post-surgery. METHODS: A total of 76 patients (34 bi-UKA and 42 TKA patients) were analyzed in a prospective, single-centre, randomized controlled trial. Flat ground shod gait analysis was performed preoperatively and one year postoperatively. Knee flexion moment was calculated from motion capture markers and force plates. The same setup determined proprioception outcomes during a joint position sense test and one-leg standing. Surgery allocation, surgeon, and secondary outcomes were analyzed for prediction of the primary outcome from a binary regression model. RESULTS: Both interventions were shown to be effective treatment options, with no significant differences shown between interventions for the primary outcome of this study (18/35 (51.4%) biphasic TKA patients vs 20/31 (64.5%) biphasic bi-UKA patients; p = 0.558). All outcomes were compared to an age-matched, healthy cohort that outperformed both groups, indicating residual deficits exists following surgery. Logistic regression analysis of primary outcome with secondary outcomes indicated that the most significant predictor of postoperative biphasic knee moments was preoperative knee moment profile and trochlear degradation (Outerbridge) (R2 = 0.381; p = 0.002, p = 0.046). A separate regression of alignment against primary outcome indicated significant bi-UKA femoral and tibial axial alignment (R2 = 0.352; p = 0.029), and TKA femoral sagittal alignment (R2 = 0.252; p = 0.016). The bi-UKA group showed a significant increased ability in the proprioceptive joint position test, but no difference was found in more dynamic testing of proprioception. CONCLUSION: Robotic arm-assisted bi-UKA demonstrated equivalence to TKA in achieving a biphasic gait pattern after surgery for osteoarthritis of the knee. Both treatments are successful at improving gait, but both leave the patients with a functional limitation that is not present in healthy age-matched controls. Cite this article: Bone Joint J 2022;103-B(4):433-443.

The use of Bayesian methodology in the development and validation of a tiered assessment approach towards prediction of rat acute oral toxicity.

There exists consensus that the traditional means by which safety of chemicals is assessed-namely through reliance upon apical outcomes obtained following in vivo testing-is increasingly unfit for purpose. Whilst efforts in development of suitable alternatives continue, few have achieved levels of robustness required for regulatory acceptance. An array of "new approach methodologies" (NAM) for determining toxic effect, spanning in vitro and in silico spheres, have by now emerged. It has been suggested, intuitively, that combining data obtained from across these sources might serve to enhance overall confidence in derived judgment. This concept may be formalised in the "tiered assessment" approach, whereby evidence gathered through a sequential NAM testing strategy is exploited so to infer the properties of a compound of interest. Our intention has been to provide an illustration of how such a scheme might be developed and applied within a practical setting-adopting for this purpose the endpoint of rat acute oral lethality. Bayesian statistical inference is drawn upon to enable quantification of degree of confidence that a substance might ultimately belong to one of five LD50-associated toxicity categories. Informing this is evidence acquired both from existing in silico and in vitro resources, alongside a purposely-constructed random forest model and structural alert set. Results indicate that the combination of in silico methodologies provides moderately conservative estimations of hazard, conducive for application in safety assessment, and for which levels of certainty are defined. Accordingly, scope for potential extension of approach to further toxicological endpoints is demonstrated.

Developmental differences in the prospective organisation of goal-directed movement between children with autism and typically developing children: A smart tablet serious game study.

Movement is prospective. It structures self-generated engagement with objects and social partners and is fundamental to children's learning and development. In autistic children, previous reports of differences in movement kinematics compared to neurotypical peers suggest that its prospective organisation might be disrupted. Here, we employed a smart tablet serious game paradigm to assess differences in the feedforward and feedback mechanisms of prospective action organisation, between autistic and neurotypical preschool children. We analysed 3926 goal-directed finger movements made during smart-tablet ecological gameplay, from 28 children with Childhood Autism (ICD-10; ASD) and 43 neurotypical children (TD), aged 3-6 years old. Using linear and generalised linear mixed-effect models, we found the ASD group executed movements with longer movement time (MT) and time to peak velocity (TTPV), lower peak velocity (PV), with PV less likely to occur in the first movement unit (MU) and with a greater number of movement units after peak velocity (MU-APV). Interestingly, compared to the TD group, the ASD group showed smaller increases in PV, TTPV and MT with an increase in age (ASD × age interaction), together with a smaller reduction in MU-APV and an increase in MU-APV at shorter target distances (ASD × Dist interaction). Our results are the first to highlight different developmental trends in anticipatory feedforward and compensatory feedback mechanisms of control, contributing to differences in movement kinematics observed between autistic and neurotypical children. These findings point to differences in integration of prospective perceptuomotor information, with implications for embodied cognition and learning from self-generated action in autism.

Retrospective analysis of Schlafen11 (SLFN11) to predict the outcomes to therapies affecting the DNA damage response.

BACKGROUND: The absence of the putative DNA/RNA helicase Schlafen11 (SLFN11) is thought to cause resistance to DNA-damaging agents (DDAs) and PARP inhibitors. METHODS: We developed and validated a clinically applicable SLFN11 immunohistochemistry assay and retrospectively correlated SLFN11 tumour levels to patient outcome to the standard of care therapies and olaparib maintenance. RESULTS: High SLFN11 associated with improved prognosis to the first-line treatment with DDAs platinum-plus-etoposide in SCLC patients, but was not strongly linked to paclitaxel-platinum response in ovarian cancer patients. Multivariate analysis of patients with relapsed platinum-sensitive ovarian cancer from the randomised, placebo-controlled Phase II olaparib maintenance Study19 showed SLFN11 tumour levels associated with sensitivity to olaparib. Study19 patients with high SLFN11 had a lower progression-free survival (PFS) hazard ratio compared to patients with low SLFN11, although both groups had the benefit of olaparib over placebo. Whilst caveated by small sample size, this trend was maintained for PFS, but not overall survival, when adjusting for BRCA status across the olaparib and placebo treatment groups, a key driver of PARP inhibitor sensitivity. CONCLUSION: We provide clinical evidence supporting the role of SLFN11 as a DDA therapy selection biomarker in SCLC and highlight the need for further clinical investigation into SLFN11 as a PARP inhibitor predictive biomarker.

Early outcomes after robotic arm-assisted bi-unicompartmental knee arthroplasty compared with total knee arthroplasty: a prospective, randomized controlled trial.

AIMS: The aim of this study was to compare the clinical outcomes of robotic arm-assisted bi-unicompartmental knee arthroplasty (bi-UKA) with conventional mechanically aligned total knee arthroplasty (TKA) during the first six weeks and at one year postoperatively. METHODS: A per protocol analysis of 76 patients, 43 of whom underwent TKA and 34 of whom underwent bi-UKA, was performed from a prospective, single-centre, randomized controlled trial. Diaries kept by the patients recorded pain, function, and the use of analgesics daily throughout the first week and weekly between the second and sixth weeks. Patient-reported outcome measures (PROMs) were compared preoperatively, and at three months and one year postoperatively. Data were also compared longitudinally and a subgroup analysis was conducted, stratified by preoperative PROM status. RESULTS: Both operations were shown to offer comparable outcomes, with no significant differences between the groups across all timepoints and outcome measures. Both groups also had similarly low rates of complications. Subgroup analysis for preoperative psychological state, activity levels, and BMI showed no difference in outcomes between the two groups. CONCLUSION: Robotic arm-assisted, cruciate-sparing bi-UKA offered similar early clinical outcomes and rates of complications to a mechanically aligned TKA, both in the immediate postoperative period and up to one year following surgery. Further work is required to identify which patients with osteoarthritis of the knee will derive benefit from a cruciate-sparing bi-UKA. Cite this article: Bone Joint J 2021;103-B(10):1561-1570.

Olaparib plus bevacizumab as maintenance therapy in patients with newly diagnosed, advanced ovarian cancer: Japan subset from the PAOLA-1/ENGOT-ov25 trial.

OBJECTIVE: The addition of maintenance olaparib to bevacizumab demonstrated a significant progression-free survival (PFS) benefit in patients with newly diagnosed, advanced ovarian cancer in the PAOLA-1/ENGOT-ov25 trial (NCT02477644). We evaluated maintenance olaparib plus bevacizumab in the Japan subset of PAOLA-1. METHODS: PAOLA-1 was a randomized, double-blind, phase III trial. Patients received maintenance olaparib tablets 300 mg twice daily or placebo twice daily for up to 24 months, plus bevacizumab 15 mg/kg every 3 weeks for up to 15 months in total. This prespecified subgroup analysis evaluated investigator-assessed PFS (primary endpoint). RESULTS: Of 24 randomized Japanese patients, 15 were assigned to olaparib and 9 to placebo. After a median follow-up for PFS of 27.7 months for olaparib plus bevacizumab and 24.0 months for placebo plus bevacizumab, median PFS was 27.4 versus 19.4 months, respectively (hazard ratio [HR]=0.34; 95% confidence interval [CI]=0.11-1.00). In patients with tumors positive for homologous recombination deficiency, the HR for PFS was 0.57 (95% CI=0.16-2.09). Adverse events in the Japan subset were generally consistent with those of the PAOLA-1 overall population and with the established safety and tolerability profiles of olaparib and bevacizumab. CONCLUSION: Results in the Japan subset of PAOLA-1 support the overall conclusion of the PAOLA-1 trial demonstrating that the addition of maintenance olaparib to bevacizumab provides a PFS benefit in patients with newly diagnosed, advanced ovarian cancer. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02477644.

Resistance exercise training at different loads in frail and healthy older adults: A randomised feasibility trial.

OBJECTIVES: This trial aimed to determine the feasibility of recruitment, retention, adherence, and safety of a resistance training (RT) intervention to skeletal muscle failure in both frail and non-frail older adults. DESIGN: An 8-week randomised feasibility trial. SETTING AND PARTICIPANTS: Older adults, with and without frailty, recruited from both clinics and community. METHODS: Recruitment was based on the number of participants enrolled from those provided with a Patient Information Sheet (PIS). Retention was based on the number of participants who completed the trial. Adherence was based on the number of RT sessions attended out of 16. Outcomes included frailty (Fried criteria), muscle strength (maximal voluntary contraction), functional abilities (Short Physical Performance battery), quality of life (EQ-5D-5L), activities of daily living (LIADL) and safety (diary). RESULTS: Recruitment target (n = 60) was achieved within 15 months, 58 were randomised to high (n = 30) or low repetition-load (n = 28) groups. Mean age of participants was 72 years (range 65-93). Adherence and retention rate for the RT intervention was ≥70%. There was one serious adverse experience due to the RT intervention. There were no differences (P > 0.05) in effects of RT on outcome variables between low and high repetition-load groups. CONCLUSIONS AND IMPLICATIONS: Recruitment of frail people was challenging. Older adults performing supervised RT to skeletal muscle failure was feasible and safe, with appropriate caution, and the repetition-load did not appear to influence its efficacy. Future research into the effectiveness of this simplified model of RT is warranted.

Electromagnetic Navigated Versus Conventional Total Knee Arthroplasty-A Five-Year Follow-Up of a Single-Blind Randomized Control Trial.

BACKGROUND: The objective of this study is to provide the 5-year follow-up results of a randomized study comparing conventional versus electromagnetic computer navigated total knee arthroplasty. METHODS: Analysis of 127 patients (66 navigated and 61 conventional surgeries) was performed from a prospective, single-blinded, randomized controlled trial. Patient-reported outcome measures were collected at 5 years after surgery and compared with previously published 1-year clinical outcomes. Five-year surgical revision rates were collated and compared between intervention groups. RESULTS: Overall, there have been continued improvements in the clinical scores of patients in both groups when compared with clinical data at 1 year; however, at 5 years, there is no statistical difference in any of the patient-reported outcome measures between conventional and navigated surgery. Interestingly, improved implant survivorship was observed in the navigated (0% revision rate) compared with the conventional group (4.9% all-cause revision rate). CONCLUSION: Electromagnetic computer navigated technology produces similar clinical outcomes compared with traditional surgery. Further work is required to monitor implant survivorship, and clinical outcomes with long-term follow-up, to determine the cost effectiveness of this technology.

Robotic arm-assisted versus conventional medial unicompartmental knee arthroplasty: five-year clinical outcomes of a randomized controlled trial.

AIMS: Unicompartmental knee arthroplasty (UKA) is a bone-preserving treatment option for osteoarthritis localized to a single compartment in the knee. The success of the procedure is sensitive to patient selection and alignment errors. Robotic arm-assisted UKA provides technological assistance to intraoperative bony resection accuracy, which is thought to improve ligament balancing. This paper presents the five-year outcomes of a comparison between manual and robotically assisted UKAs. METHODS: The trial design was a prospective, randomized, parallel, single-centre study comparing surgical alignment in patients undergoing UKA for the treatment of medial compartment osteoarthritis (ISRCTN77119437). Participants underwent surgery using either robotic arm-assisted surgery or conventional manual instrumentation. The primary outcome measure (surgical accuracy) has previously been reported, and, along with secondary outcomes, were collected at one-, two-, and five-year timepoints. Analysis of five-year results and longitudinal analysis for all timepoints was performed to compare the two groups. RESULTS: Overall, 104 (80%) patients of the original 130 who received surgery were available at five years (55 robotic, 49 manual). Both procedures reported successful results over all outcomes. At five years, there were no statistical differences between the groups in any of the patient reported or clinical outcomes. There was a lower reintervention rate in the robotic arm-assisted group with 0% requiring further surgery compared with six (9%) of the manual group requiring additional surgical intervention (p < 0.001). CONCLUSION: This study has shown excellent clinical outcomes in both groups with no statistical or clinical differences in the patient-reported outcome measures. The notable difference was the lower reintervention rate at five years for roboticarm-assisted UKA when compared with a manual approach. Cite this article: Bone Joint J 2021;103-B(6):1088-1095.

A Co-creation Centre for Accessible Rehabilitation Technology.

Background: The prevalence of disabling conditions is increasing globally. Rehabilitation improves function and quality of life across many conditions, particularly when applied intensively. The limited workforce, however, cannot deliver evidence-based intensive rehabilitation. By providing individuals with the tools for self- rehabilitation, technology helps bridge the gap between evidence and practise. Few people, however, can access rehabilitation technology. Barriers such as cost, training, education, portability and poor design stand in the way of equitable access. Our group of engineers and researchers have established a centre dedicated to developing accessible technology through close, frequent engagement with users and industry. Methods: The centre employs a co-creation model, coupling engineering and science with user experience and industrial partnerships to develop accessible technology and associated processes. Due to the complexity and size of the challenge the initial focus is stroke. Recruited through a medical charity, participants, with a wide range of disabilities, use prototype and commercial technology during an 8-week rehabilitation programme with supervision from health professionals. The centre includes de-weighting systems, neurostimulation, virtual reality, treadmills, bespoke rehab games, communication apps, powered exercise equipment and gamified resistance equipment. Standard outcome measures (International Classification of Functioning, Disability and Health) are recorded before, during, immediately after, and 3 months after the intervention and used in combination with an interview to design the initial rehabilitation programme, which is reviewed fortnightly. Qualitative methods (surveys and interviews) are used to capture personal experiences of the programme and individual technology and an advisory group of stroke survivors help interpret outcomes to feed into the technology design process. Ethical approval has been granted for a pilot cohort study with stroke survivors, which is currently underway (01/09/2021-31/12/2021) investigating acceptability and feasibility, due to report findings in 2022. Discussion: Through partnerships, research collaborations and a co-creation model a new centre dedicated to the development of accessible rehabilitation technology has been launched and currently undergoing acceptability and feasibility testing with stroke survivors. The centre, through its close engagement with users and industry, has the potential to transform the way rehabilitation technology is developed and help revolutionise the way rehabilitation is delivered.

Robotic arm-assisted bi-unicompartmental knee arthroplasty maintains natural knee joint anatomy compared with total knee arthroplasty: a prospective randomized controlled trial.

AIMS: The aim of this study was to compare robotic arm-assisted bi-unicompartmental knee arthroplasty (bi-UKA) with conventional mechanically aligned total knee arthroplasty (TKA) in order to determine the changes in the anatomy of the knee and alignment of the lower limb following surgery. METHODS: An analysis of 38 patients who underwent TKA and 32 who underwent bi-UKA was performed as a secondary study from a prospective, single-centre, randomized controlled trial. CT imaging was used to measure coronal, sagittal, and axial alignment of the knee preoperatively and at three months postoperatively to determine changes in anatomy that had occurred as a result of the surgery. The hip-knee-ankle angle (HKAA) was also measured to identify any differences between the two groups. RESULTS: The pre- to postoperative changes in joint anatomy were significantly less in patients undergoing bi-UKA in all three planes in both the femur and tibia, except for femoral sagittal component orientation in which there was no difference. Overall, for the six parameters of alignment (three femoral and three tibial), 47% of bi-UKAs and 24% TKAs had a change of < 2° (p = 0.045). The change in HKAA towards neutral in varus and valgus knees was significantly less in patients undergoing bi-UKA compared with those undergoing TKA (p < 0.001). Alignment was neutral in those undergoing TKA (mean 179.5° (SD 3.2°)) while those undergoing bi-UKA had mild residual varus or valgus alignment (mean 177.8° (SD 3.4°)) (p < 0.001). CONCLUSION: Robotic-assisted, cruciate-sparing bi-UKA maintains the natural anatomy of the knee in the coronal, sagittal, and axial planes better, and may therefore preserve normal joint kinematics, compared with a mechanically aligned TKA. This includes preservation of coronal joint line obliquity. HKAA alignment was corrected towards neutral significantly less in patients undergoing bi-UKA, which may represent restoration of the pre-disease constitutional alignment (p < 0.001). Cite this article: Bone Joint J 2020;102-B(11):1511-1518.

A Comparison of the Conventional PiG Marker Method Versus a Cluster-Based Model when recording Gait Kinematics in Trans-Tibial Prosthesis Users and the Implications for Future IMU Gait Analysis.

Validation testing is a necessary step for inertial measurement unit (IMU) motion analysis for research and clinical use. Optical tracking systems utilize marker models which must be precise in measurement and mitigate skin artifacts. Prosthesis wearers present challenges to optical tracking marker model choice. Seven participants were recruited and underwent simultaneous motion capture from two marker sets; Plug in Gait (PiG) and the Strathclyde Cluster Model (SCM). Variability of joint kinematics within and between subjects was evaluated. Variability was higher for PiG than SCM for all parameters. The within-subjects variability as reported by the average standard deviation (SD), was below 5.6° for all rotations of the hip on the prosthesis side for all participants for both methods, with an average of 2.1° for PiG and 2.5° for SCM. Statistically significant differences in joint parameters caused by a change in the protocol were evident in the sagittal plane (p < 0.05) on the amputated side. Trans-tibial gait analysis was best achieved by use of the SCM. The SCM protocol appeared to provide kinematic measurements with a smaller variability than that of the PiG. Validation studies for prosthesis wearer populations must reconsider the marker protocol for gold standard comparisons with IMUs.

Advanced functional biomechanical analysis of medial rotation knee arthroplasty.

BACKGROUND: The Medacta GMK-Sphere total knee arthroplasty (TKA) is designed to mimic the movements and stabilimidty of a natural knee for optimal post-operative function and mobility. This study aimed to quantify the early functional outcome of patients with this implant. METHODS: Patients due to undergo TKA to treat end-stage osteoarthritis were recruited into this study. Functional tests of knee range of motion (ROM), strength, and gait kinematics were carried out pre-operatively and one year post-operatively at routine clinics. Motion capture technology and a force transducer were used to collect all data. Normality tests were completed on all data sets to confirm normal distribution of the data, then paired t-tests were used to statistically compare the results. The level of significance was set as α = 0.05. RESULTS: Sixty-three patients underwent pre-operative assessments; of which 30 returned one year post-operatively and consented to have follow-up testing. The operative knee was found to have poorer function than the contralateral knee pre-operatively (p < 0.05). Post-operatively, knee ROM significantly improved on the operative side to a mean of 116.1 ± 19.0. Gait kinematics also improved, especially in the frontal plane, but some abnormal traits remained in the sagittal plane. Knee strength decreased post-operatively. CONCLUSIONS: The Medacta GMK-Sphere TKA improves knee range of motion sufficiently within the first postoperative year to allow patients to carry out most activities of daily living (>110° knee flexion), but continued poor knee strength may limit their abilities to complete tasks which are more biomechanically demanding than walking.

Identification of neuromuscular targets for restoration of walking ability after stroke: Precursor to precision rehabilitation.

OBJECTIVES: Restoration of walking is a priority for stroke survivors and key target for physical therapies. Upright pedalling (UP) can provide functional walking-like activity using a variety of muscle synergies; it is unclear which synergies might be most useful for recovery of walking. Objectives here were as follows: to examine whether neuromuscular measures derived during UP might identify targets for walking rehabilitation after stroke and to determine test-retest repeatability and concurrent validity of the measures. DESIGN: This was a prospective correlational study. SETTING: The study was carried out in a movement science laboratory. PARTICIPANTS: The participants were 18 adults with stroke (StrS) and 10 healthy older adults (HOA). INTERVENTION/MEASUREMENT: StrS and HOA took part in two identical measurement sessions. During UP, surface electromyography and kinematic data were recorded and then processed to derive three measures: reciprocal activity of quadriceps and hamstrings; percentage muscle activity "on" according to crank angle; and smoothness of movement. RESULTS: HOA and StrS demonstrated differences in reciprocal muscle activity (p = .044) and quadriceps activity according to crank angle (p = .034) but pedalled similarly smoothly (p = .367). For muscle activation according to crank angle in StrS, intraclass correlation coefficients (95% confidence interval) showing acceptable repeatability were 0.46 [0.32, 0.58] affected quadriceps; 0.43 [0.28, 0.56] affected hamstrings; and 0.67 [0.56, 0.75] unaffected quadriceps. CONCLUSION: Muscle activation according to crank angle is a promising measure of lower limb impairment during functional activity after stroke; subsequent investigation should determine magnitude of variance between testing sessions. Reciprocal activity of quadriceps and hamstrings muscles and quadriceps activity according to crank angle are both potential targets for physical therapies to improve motor recovery. Further investigations are warranted.

Phase 3 diagnostic evaluation of a smart tablet serious game to identify autism in 760 children 3-5 years old in Sweden and the United Kingdom.

INTRODUCTION: Recent evidence suggests an underlying movement disruption may be a core component of autism spectrum disorder (ASD) and a new, accessible early biomarker. Mobile smart technologies such as iPads contain inertial movement and touch screen sensors capable of recording subsecond movement patterns during gameplay. A previous pilot study employed machine learning analysis of motor patterns recorded from children 3-5 years old. It identified those with ASD from age-matched and gender-matched controls with 93% accuracy, presenting an attractive assessment method suitable for use in the home, clinic or classroom. METHODS AND ANALYSIS: This is a phase III prospective, diagnostic classification study designed according to the Standards for Reporting Diagnostic Accuracy Studies guidelines. Three cohorts are investigated: children typically developing (TD); children with a clinical diagnosis of ASD and children with a diagnosis of another neurodevelopmental disorder (OND) that is not ASD. The study will be completed in Glasgow, UK and Gothenburg, Sweden. The recruitment target is 760 children (280 TD, 280 ASD and 200 OND). Children play two games on the iPad then a third party data acquisition and analysis algorithm (Play.Care, Harimata) will classify the data as positively or negatively associated with ASD. The results are blind until data collection is complete, when the algorithm's classification will be compared against medical diagnosis. Furthermore, parents of participants in the ASD and OND groups will complete three questionnaires: Strengths and Difficulties Questionnaire; Early Symptomatic Syndromes Eliciting Neurodevelopmental Clinical Examinations Questionnaire and the Adaptive Behavioural Assessment System-3 or Vineland Adaptive Behavior Scales-II. The primary outcome measure is sensitivity and specificity of Play.Care to differentiate ASD children from TD children. Secondary outcomes measures include the accuracy of Play.Care to differentiate ASD children from OND children. ETHICS AND DISSEMINATION: This study was approved by the West of Scotland Research Ethics Service Committee 3 and the University of Strathclyde Ethics Committee. Results will be disseminated in peer-reviewed publications and at international scientific conferences. TRIAL REGISTRATION NUMBER: NCT03438994; Pre-results.

Health costs and efficiencies of patient-specific and single-use instrumentation in total knee arthroplasty: a randomised controlled trial.

Aim: To investigate whether patient-specific instrumentation (PSI) and single-use instrumentation (SUI) improve operating room efficiency in terms of time and cost to the healthcare provider over conventional/reusable instrumentation (CVR) when performing total knee arthroplasty (TKA). Patients and methods: Patients requiring TKA were randomised into one of four surgical groups: CVR, CVS (conventional/SUI), PSR (PSI/reusable) and PSS (PSI/SUI). All surgical procedures were video recorded to determine specific surgical time intervals. Other variables reported included the number of instrument trays used, missing equipment, direct instrument costs and the weight of the instruments the staff had to handle. Oxford Knee Score (OKS), estimated blood loss and lengths of hospital stay were also recorded as markers of patient experience. Results: PSR was significantly quicker in all the recorded time intervals, used less trays, experienced less missing equipment and resulted in lower blood loss and shorter hospital stays. SUI reported significantly slower operating room times and resulted in higher blood loss, but SUI was 88% lighter and 20% cheaper on average when compared with their reusable counterparts. Despite the economic advantages of PSI and SUI, the patients who reported greatest improvements in OKS were those allocated to the CVR group, but no clinically meaningful difference in OKS was found at any time point. Conclusions: PSI and SUI for TKA have the potential of reducing operating room times over conventional, reusable sets. This reduction will benefit theatre personnel ergonomically, while presenting the healthcare provider with potential cost-saving benefits in terms of reduced sterilisation costs and surgical times.

Treadmill training augmented with real-time visualisation feedback and function electrical stimulation for gait rehabilitation after stroke: a feasibility study.

BACKGROUND: Stroke rehabilitation often uses the motor relearning concept that require patients to perform active practice of skill-specific training and to receive feedback. Treadmill training augmented with real-time visualisation feedback and functional electrical stimulation may have a beneficial synergistic effect on motor recovery. This study aims to determine the feasibility of this kind of enhanced treadmill training for gait rehabilitation among patients after stroke. A system for dynamic visualisation of lower-limb movement based on 3-dimentional motion capture and a computer timed functional electrical stimulation system was developed. Participants received up to 20-min enhanced treadmill training instead of their over-ground gait training once or twice a week for 6 weeks at Coathill hospital, Lanarkshire, United Kingdom. Number of training sessions attended, and training duration were used to assess feasibility. Ankle kinematics in the sagittal plane of walking with and without functional electrical stimulation support of the pre-tibial muscles were also compared and used to confirm the functional electrical stimulation was triggered at the targeted time. RESULTS: Six patients after stroke participated in the study. The majority of participants were male (5/6) with a age range from 30 to 84 years and 4/6 had left hemiplegia. All participants suffered from brain infarction and were at least 3 months after stroke. Number of training sessions attended ranged from 5 to 12. The duration of training sessions ranged from 11 to 20 min. No serious adverse events were reported. The computerised functional electrical stimulation to the pre-tibial muscles was able to reduce plantarflexion angle during the swing phase with statistical significance (p = 0.015 at 80%; p = 0.008 at 90 and 100% of the gait cycle). CONCLUSIONS: It is safe and feasible to use treadmill gait training augmented with real-time visual feedback and computer-controlled functional electrical stimulation with patients after stroke in routine clinical practice. TRIAL REGISTRATION: NCT03348215. Registered 20 November 2017.