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Background: Many individuals with neurodegenerative (NDD) and immune-mediated inflammatory disorders (IMID) experience debilitating fatigue. Currently, assessments of fatigue rely on patient reported outcomes (PROs), which are subjective and prone to recall biases. Wearable devices, however, provide objective and reliable estimates of gait, an essential component of health, and may present objective evidence of fatigue. This study explored the relationships between gait characteristics derived from an inertial measurement unit (IMU) and patient-reported fatigue in the IDEA-FAST feasibility study., Methods: Participants with IMIDs and NDDs (Parkinson's disease (PD), Huntington's disease (HD), rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), primary Sjogren's syndrome (PSS), and inflammatory bowel disease (IBD)) wore a lower-back IMU continuously for up to 10 days at home. Concurrently, participants completed PROs (physical fatigue (PF) and mental fatigue (MF)) up to four times a day. Macro (volume, variability, pattern, and acceleration vector magnitude) and micro (pace, rhythm, variability, asymmetry, and postural control) gait characteristics were extracted from the accelerometer data. The associations of these measures with the PROs were evaluated using a generalised linear mixed-effects model (GLMM) and binary classification with machine learning., Results: Data were recorded from 72 participants: PD = 13, HD = 9, RA = 12, SLE = 9, PSS = 14, IBD = 15. For the GLMM, the variability of the non-walking bouts length (in seconds) with PF returned the highest conditional R2, 0.165, and with MF the highest marginal R2, 0.0018. For the machine learning classifiers, the highest accuracy of the current analysis was returned by the micro gait characteristics with an intrasubject cross validation method and MF as 56.90% (precision = 43.9%, recall = 51.4%). Overall, the acceleration vector magnitude, bout length variation, postural control, and gait rhythm were the most interesting characteristics for future analysis., Conclusions: Counterintuitively, the outcomes indicate that there is a weak relationship between typical gait measures and abnormal fatigue. However, factors such as the COVID-19 pandemic may have impacted gait behaviours. Therefore, further investigations with a larger cohort are required to fully understand the relationship between gait and abnormal fatigue., (© 2024. The Author(s).)

Background: Although digital mobility outcomes (DMOs) can be readily calculated from real-world data collected with wearable devices and ad-hoc algorithms, technical validation is still required. The aim of this paper is to comparatively assess and validate DMOs estimated using real-world gait data from six different cohorts, focusing on gait sequence detection, foot initial contact detection (ICD), cadence (CAD) and stride length (SL) estimates., Methods: Twenty healthy older adults, 20 people with Parkinson's disease, 20 with multiple sclerosis, 19 with proximal femoral fracture, 17 with chronic obstructive pulmonary disease and 12 with congestive heart failure were monitored for 2.5 h in the real-world, using a single wearable device worn on the lower back. A reference system combining inertial modules with distance sensors and pressure insoles was used for comparison of DMOs from the single wearable device. We assessed and validated three algorithms for gait sequence detection, four for ICD, three for CAD and four for SL by concurrently comparing their performances (e.g., accuracy, specificity, sensitivity, absolute and relative errors). Additionally, the effects of walking bout (WB) speed and duration on algorithm performance were investigated., Results: We identified two cohort-specific top performing algorithms for gait sequence detection and CAD, and a single best for ICD and SL. Best gait sequence detection algorithms showed good performances (sensitivity > 0.73, positive predictive values > 0.75, specificity > 0.95, accuracy > 0.94). ICD and CAD algorithms presented excellent results, with sensitivity > 0.79, positive predictive values > 0.89 and relative errors < 11% for ICD and < 8.5% for CAD. The best identified SL algorithm showed lower performances than other DMOs (absolute error < 0.21 m). Lower performances across all DMOs were found for the cohort with most severe gait impairments (proximal femoral fracture). Algorithms' performances were lower for short walking bouts; slower gait speeds (< 0.5 m/s) resulted in reduced performance of the CAD and SL algorithms., Conclusions: Overall, the identified algorithms enabled a robust estimation of key DMOs. Our findings showed that the choice of algorithm for estimation of gait sequence detection and CAD should be cohort-specific (e.g., slow walkers and with gait impairments). Short walking bout length and slow walking speed worsened algorithms' performances. Trial registration ISRCTN - 12246987., (© 2023. The Author(s).)

Background: Parkinson's disease (PD) is the fastest growing neurological condition worldwide. Recent theories suggest that symptoms of PD may arise due to spread of Lewy-body pathology where the process begins in the gut and propagate transynaptically via the vagus nerve to the central nervous system. In PD, gait impairments are common motor manifestations that are progressive and can appear early in the disease course. As therapies to mitigate gait impairments are limited, novel interventions targeting these and their consequences, i.e., reducing the risk of falls, are urgently needed. Non-invasive vagus nerve stimulation (nVNS) is a neuromodulation technique targeting the vagus nerve. We recently showed in a small pilot trial that a single dose of nVNS improved (decreased) discrete gait variability characteristics in those receiving active stimulation relative to those receiving sham stimulation. Further multi-dose, multi-session studies are needed to assess the safety and tolerability of the stimulation and if improvement in gait is sustained over time., Design: This will be an investigator-initiated, single-site, proof-of-concept, double-blind sham-controlled randomised pilot trial in 40 people with PD. Participants will be randomly assigned on a 1:1 ratio to receive either active or sham transcutaneous cervical VNS. All participants will undergo comprehensive cognitive, autonomic and gait assessments during three sessions over 24 weeks, in addition to remote monitoring of ambulatory activity and falls, and exploratory analyses of cholinergic peripheral plasma markers. The primary outcome measure is the safety and tolerability of multi-dose nVNS in PD. Secondary outcomes include improvements in gait, cognition and autonomic function that will be summarised using descriptive statistics., Discussion: This study will report on the proportion of eligible and enrolled patients, rates of eligibility and reasons for ineligibility. Adverse events will be recorded informing on the safety and device tolerability in PD. This study will additionally provide us with information for sample size calculations for future studies and evidence whether improvement in gait control is enhanced when nVNS is delivered repeatedly and sustained over time., Trial Registration: This trial is prospectively registered at www.isrctn.com/ISRCTN19394828 . Registered August 23, 2021., (© 2023. The Author(s).)

Background: Measuring mobility in daily life entails dealing with confounding factors arising from multiple sources, including pathological characteristics, patient specific walking strategies, environment/context, and purpose of the task. The primary aim of this study is to propose and validate a protocol for simulating real-world gait accounting for all these factors within a single set of observations, while ensuring minimisation of participant burden and safety., Methods: The protocol included eight motor tasks at varying speed, incline/steps, surface, path shape, cognitive demand, and included postures that may abruptly alter the participants' strategy of walking. It was deployed in a convenience sample of 108 participants recruited from six cohorts that included older healthy adults (HA) and participants with potentially altered mobility due to Parkinson's disease (PD), multiple sclerosis (MS), proximal femoral fracture (PFF), chronic obstructive pulmonary disease (COPD) or congestive heart failure (CHF). A novelty introduced in the protocol was the tiered approach to increase difficulty both within the same task (e.g., by allowing use of aids or armrests) and across tasks., Results: The protocol proved to be safe and feasible (all participants could complete it and no adverse events were recorded) and the addition of the more complex tasks allowed a much greater spread in walking speeds to be achieved compared to standard straight walking trials. Furthermore, it allowed a representation of a variety of daily life relevant mobility aspects and can therefore be used for the validation of monitoring devices used in real life., Conclusions: The protocol allowed for measuring gait in a variety of pathological conditions suggests that it can also be used to detect changes in gait due to, for example, the onset or progression of a disease, or due to therapy., Trial Registration: ISRCTN-12246987., (© 2022. Crown.)

Background: Gait impairment limiting mobility and restricting activities is common after stroke. Auditory rhythmical cueing (ARC) uses a metronome beat delivered during exercise to train stepping and early work reports gait improvements. This study aimed to establish the feasibility of a full scale multicentre randomised controlled trial to evaluate an ARC gait and balance training programme for use by stroke survivors in the home and outdoors., Methods: A parallel-group observer-blind pilot randomised controlled trial was conducted. Adults within 2 years of stroke with a gait-related mobility impairment were recruited from four NHS stroke services and randomised to an ARC gait and balance training programme (intervention) or the training programme without ARC (control). Both programmes consisted of 3x30 min sessions per week for 6 weeks undertaken at home/nearby outdoor community. One session per week was supervised and the remainder self-managed. Gait and balance performance assessments were undertaken at baseline, 6 and 10 weeks. Key trial outcomes included recruitment and retention rates, programme adherence, assessment data completeness and safety., Results: Between November 2018 and February 2020, 59 participants were randomised (intervention n=30, control n=29), mean recruitment rate 4/month. At baseline, 6 weeks and 10 weeks, research assessments were conducted for 59/59 (100%), 47/59 (80%) and 42/59 (71%) participants, respectively. Missing assessments were largely due to discontinuation of data collection from mid-March 2020 because of the UK COVID-19 pandemic lockdown. The proportion of participants with complete data for each individual performance assessment ranged from 100% at baseline to 68% at 10 weeks. In the intervention group, 433/540 (80%) total programme exercise sessions were undertaken, in the control group, 390/522 (75%). Falls were reported by five participants in the intervention group, six in the control group. Three serious adverse events occurred, all unrelated to the study., Conclusion: We believe that a definitive multicentre RCT to evaluate the ARC gait and balance training programme is feasible. Recruitment, programme adherence and safety were all acceptable. Although we consider that the retention rate and assessment data completeness were not sufficient for a future trial, this was largely due to the UK COVID-19 pandemic lockdown., Trial Registration: ISRCTN, ISRCTN10874601 , Registered on 05/03/2018., (© 2022. The Author(s).)

Background: Mitochondrial disease is a heterogenous group of rare, complex neurometabolic disorders. Despite their individual rarity, collectively mitochondrial diseases represent the most common cause of inherited metabolic disorders in the UK; they affect 1 in every 4300 individuals, up to 15,000 adults (and a similar number of children) in the UK. Mitochondrial disease manifests multisystem and isolated organ involvement, commonly affecting those tissues with high energy demands, such as skeletal muscle. Myopathy manifesting as fatigue, muscle weakness and exercise intolerance is common and debilitating in patients with mitochondrial disease. Currently, there are no effective licensed treatments and consequently, there is an urgent clinical need to find an effective drug therapy., Aim: To investigate the efficacy of 12-week treatment with acipimox on the adenosine triphosphate (ATP) content of skeletal muscle in patients with mitochondrial disease and myopathy., Methods: AIMM is a single-centre, double blind, placebo-controlled, adaptive designed trial, evaluating the efficacy of 12 weeks' administration of acipimox on skeletal muscle ATP content in patients with mitochondrial myopathy. Eligible patients will receive the trial investigational medicinal product (IMP), either acipimox or matched placebo. Participants will also be prescribed low dose aspirin as a non-investigational medical product (nIMP) in order to protect the blinding of the treatment assignment. Eighty to 120 participants will be recruited as required, with an interim analysis for sample size re-estimation and futility assessment being undertaken once the primary outcome for 50 participants has been obtained. Randomisation will be on a 1:1 basis, stratified by Fatigue Impact Scale (FIS) (dichotomised as < 40, ≥ 40). Participants will take part in the trial for up to 20 weeks, from screening visits through to follow-up at 16 weeks post randomisation. The primary outcome of change in ATP content in skeletal muscle and secondary outcomes relating to quality of life, perceived fatigue, disease burden, limb function, balance and walking, skeletal muscle analysis and symptom-limited cardiopulmonary fitness (optional) will be assessed between baseline and 12 weeks., Discussion: The AIMM trial will investigate the effect of acipimox on modulating muscle ATP content and whether it can be repurposed as a new treatment for mitochondrial disease with myopathy., Trial Registration: EudraCT2018-002721-29 . Registered on 24 December 2018, ISRCTN 12895613. Registered on 03 January 2019, https://www.isrctn.com/search?q=aimm., (© 2022. The Author(s).)

Background: Ensuring that a trial is designed so that its participants reflect those who might benefit from the results, or be spared harms, is key to the potential benefits of the trial reaching all they should. This paper describes the process, facilitated by Trial Forge, that was used between July 2019 and October 2020 to develop the INCLUDE Ethnicity Framework, part of the wider INCLUDE initiative from the National Institute for Health Research to improve inclusion of under-served groups in clinical research studies., Methods: Development of the Framework was done in seven phases: (1) outline, (2) initial draft, (3) stakeholder meeting, (4) modify draft, (5) Stakeholder feedback, (6) applying the Framework and (7) packaging. Phases 2 and 3 were face-to-face meetings. Consultation with stakeholders was iterative, especially phases 4 to 6. Movement to the next phase was done once all or most stakeholders were comfortable with the results of the current phase. When there was a version of the Framework that could be considered final, the Framework was applied to six trials to create a set of examples (phase 6). Finally, the Framework, guidance and examples were packaged ready for dissemination (phase 7)., Results: A total of 40 people from stakeholder groups including patient and public partners, clinicians, funders, academics working with various ethnic groups, trial managers and methodologists contributed to the seven phases of development. The Framework comprises two parts. The first part is a list of four key questions: 1. Who should my trial apply to? 2. Are the groups identified likely to respond in different ways? 3. Will my study intervention make it harder for some groups to engage? 4. Will the way I have designed the study make it harder for some groups to engage? The second part is a set of worksheets to help trial teams address these questions. The Framework can be used for any stage of trial, for a healthcare intervention in any disease area. The Framework was launched on 1st October 2020 and is available open access at the Trial Forge website: https://www.trialforge.org/trial-forge-centre/include/ ., Conclusion: Thinking about the number of people in our trials is not enough: we need to start thinking more carefully about who our participants are.

Background: PDSAFE is an individually-tailored, physiotherapist-delivered, balance, strength and strategy training programme aimed at preventing falls among people with Parkinson's. We evaluated the cost-effectiveness of PDSAFE compared with usual care for people with Parkinson's at higher risk of falling, from a UK National Health Service and Personal Social Service perspective., Methods: Resource use and quality of life data (EQ-5D-3L) were collected from 238 participants randomised to the PDSAFE intervention and 236 participants randomised to control, at baseline, 3 months, 6 months (primary outcome), and 12 months. Adjusted cost and quality-adjusted life-years (QALYs) were estimated using generalised linear models and uncertainty estimated using a non-parametric bootstrap., Results: Over 6 months, the PDSAFE intervention was associated with an incremental cost of £925 (95% CI £428 to £1422) and a very small and statistically insignificant QALY gain of 0.008 (95% CI - 0.006 to 0.021). The resulting incremental cost-effectiveness ratio (ICER) was £120,659 per QALY and the probability of the intervention being cost-effective at a UK threshold of £30,000/QALY was less than 1%. The ICER varied substantially across subgroups although no subgroup had an ICER lower than the £30,000 threshold. The result was sensitive to the time horizon with the ICER reducing to £55,176 per QALY when adopting a 12-month time horizon and assuming a sustained treatment effect on QoL, nevertheless, the intervention was still not cost-effective according to the current UK threshold., Conclusions: Evidence from this trial suggests that the PDSAFE intervention is unlikely to be cost-effective at 6 months. The 12-month analysis suggested that the intervention became closer to being cost-effective if quality of life effects were sustained beyond the intervention period, however this would require confirmation. Further research, including qualitative studies, should be conducted to better understand the treatment effect of physiotherapy and its impact on quality of life in people with Parkinson's given existing mixed evidence on this topic., Trial Registration: ISRCTN48152791. Registered 17 April 2014. http://www.isrctn.com/ISRCTN48152791.

Background: Participants in clinical research studies often do not reflect the populations for which healthcare interventions are needed or will be used. Enhancing representation of under-served groups in clinical research is important to ensure that research findings are widely applicable. We describe a multicomponent workstream project to improve representation of under-served groups in clinical trials., Methods: The project comprised three main strands: (1) a targeted scoping review of literature to identify previous work characterising under-served groups and barriers to inclusion, (2) surveys of professional stakeholders and participant representative groups involved in research delivery to refine these initial findings and identify examples of innovation and good practice and (3) a series of workshops bringing together key stakeholders from funding, design, delivery and participant groups to reach consensus on definitions, barriers and a strategic roadmap for future work. The work was commissioned by the UK National Institute for Health Research Clinical Research Network. Output from these strands was integrated by a steering committee to generate a series of goals, workstream plans and a strategic roadmap for future development work in this area., Results: 'Under-served groups' was identified and agreed by the stakeholder group as the preferred term. Three-quarters of stakeholders felt that a clear definition of under-served groups did not currently exist; definition was challenging and context-specific, but exemplar groups (e.g. those with language barriers or mental illness) were identified as under-served. Barriers to successful inclusion of under-served groups could be clustered into communication between research teams and participant groups; how trials are designed and delivered, differing agendas of research teams and participant groups; and lack of trust in the research process. Four key goals for future work were identified: building long-term relationships with under-served groups, developing training resources to improve design and delivery of trials for under-served groups, developing infrastructure and systems to support this work and working with funders, regulators and other stakeholders to remove barriers to inclusion., Conclusions: The work of the INCLUDE group over the next 12 months will build on these findings by generating resources customised for different under-served groups to improve the representativeness of trial populations.

Background: Mobility problems are present in 70-80% of stroke survivors and can result in impaired gait and reduced physical activity limiting independent living. Auditory rhythmic cueing (ARC) has been used to provide auditory feedback and shows promise in improving a variety of walking parameters following stroke. The aim of this pilot study is to assess the feasibility of conducting a multi-centre, observer blind, randomised controlled trial of auditory rhythmical cueing (ARC) intervention in home and community settings in North East England., Methods: This pilot observer blind randomised controlled feasibility trial aims to recruit 60 participants over 15 months from community stroke services in the North East of England. Participants will be within 24 months of stroke onset causing new problems with mobility. Each participant will be randomised to the study intervention or control group. Intervention treatment participants will undertake 18 auditory rhythmical cueing (ARC) treatment sessions over 6 weeks (3 × 30 min per week, 6 supervised (physiotherapist/research associate)/12 self-managed) in a home/community setting. A metronome will be used to provide ARC during a series of balance and gait exercises, which will be gradually progressed. The control treatment participants will undertake the same duration balance and gait exercise training programme as the intervention group but without the ARC. Feasibility will be determined in terms of recruitment, retention, adverse events, adherence, collection of descriptive clinical and accelerometer motor performance data at baseline, 6 weeks and 10 weeks and description of participant, provider and clinical therapists' experiences. As well as using questionnaires to collate participant views, qualitative interviews will be undertaken to further understand how the intervention is delivered in practice in a community setting and to identify aspects perceived important by participants., Discussion: The ACTIVATE study will address an important gap in the evidence base by reporting whether it is feasible to deliver auditory rhythmical cueing in the home and community to improve gait and balance parameters following stroke. The feasibility of the study protocol will be established and results will inform the design of a future multi-centre randomised controlled trial., Trial Registration: Trial register: ISRCTN, Trial identifier: ISRCTN10874601: Date of registration: 12/03/2018., Competing Interests: Competing interestsThe authors declare that they have no competing interests., (© The Author(s) 2020.)

Background: Falls are two to four times more frequent amongst older adults living in long-term care (LTC) than community-dwelling older adults and have deleterious consequences. It is hypothesised that a progressive exercise program targeting balance and strength will reduce fall rates when compared to a seated exercise program and do so cost effectively., Methods/design: This is a single blind, parallel-group, randomised controlled trial with blinded assessment of outcome and intention-to-treat analysis. LTC residents (age ≥ 65 years) will be recruited from LTC facilities in New Zealand. Participants (n = 528 total, with a 1:1 allocation ratio) will be randomly assigned to either a novel exercise program (Staying UpRight), comprising strength and balance exercises designed specifically for LTC and acceptable to people with dementia (intervention group), or a seated exercise program (control group). The intervention and control group classes will be delivered for 1 h twice weekly over 1 year. The primary outcome is rate of falls (per 1000 person years) within the intervention period. Secondary outcomes will be risk of falling (the proportion of fallers per group), fall rate relative to activity exposure, hospitalisation for fall-related injury, change in gait variability, volume and patterns of ambulatory activity and change in physical performance assessed at baseline and after 6 and 12 months. Cost-effectiveness will be examined using intervention and health service costs. The trial commenced recruitment on 30 November 2018., Discussion: This study evaluates the efficacy and cost-effectiveness of a progressive strength and balance exercise program for aged care residents to reduce falls. The outcomes will aid development of evidenced-based exercise programmes for this vulnerable population., Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618001827224. Registered on 9 November 2018. Universal trial number U1111-1217-7148.

Background: People with dementia (PWD) experience ten times as many incident falls as people without dementia. Little is known about how best to deliver services to people with dementia following a fall. We used an integrated, mixed-methods approach to develop a new intervention which combines theory generated via a realist synthesis and data on current provision and pathways, gathered through a prospective observational study as well as qualitative interviews, focus groups and ethnographic observation. This intervention is to be tested in a feasibility study in the UK National Health Service., Methods: People living with dementia in one of three geographical areas will be eligible for the study if they experience a fall requiring healthcare attention and have an informal carer. Potential participants will be identified by community services (primary care, paramedics, telecare), secondary care (ED, facilitated discharge services, rehabilitation outreach teams) and research case registers. Participants will receive a complex multidisciplinary intervention focused on their goals and interests for up to 12 weeks. The intervention will be delivered by occupational therapists, physiotherapists and rehabilitation support workers. Feasibility outcomes will include recruitment and retention, suitability and acceptability of outcome measures and acceptability, feasibility and fidelity of intervention components. PWD outcome measures will include number of falls, Montreal Cognitive Assessment (MOCA), European Quality of Life Instrument (EQ-5D-5L), Quality of Life-Alzheimer's Disease Scale (QOL-AD), Modified Falls Efficacy Scale (MFES) and Goal Attainment Scaling (GAS). PWD outcome measures completed by an informal carer will include Disability Assessment for Dementia (DAD), EQ-5D-5L Proxy, QoL-AD Proxy and a Health Utilisation Questionnaire (HUQ). The carer outcome measure will be the Zarit Burden Interview (ZBI). An embedded process evaluation will explore barriers and facilitators to recruitment and intervention delivery., Discussion: The study results will inform whether and how a larger multicentre RCT should be undertaken. A full RCT would have the potential to show how outcomes can be improved for people with dementia who have fallen., Ethics and Dissemination: The National Research Ethics Service Committee Newcastle and North Tyneside 2 approved the feasibility study., Trial Registration: International Standard Randomised Controlled Trial Registry. Registration number: ISRCTN41760734. Date of registration: 16/11/2015., Competing Interests: This study has obtained a favourable ethical opinion from the North East, Newcastle and North Tyneside 2 NHS Research Ethics Committee (REC) prior to the start of the trial (reference 17/NE/0297). The CI will notify the REC of all required substantial amendments to the trial and those non-substantial amendments that result in a change to trial documentation (e.g. protocol or patient information sheet).Not applicable.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Background: The use of miniaturized magneto-inertial measurement units (MIMUs) allows for an objective evaluation of gait and a quantitative assessment of clinical outcomes. Spatial and temporal parameters are generally recognized as key metrics for characterizing gait. Although several methods for their estimate have been proposed, a thorough error analysis across different pathologies, multiple clinical centers and on large sample size is still missing. The aim of this study was to apply a previously presented method for the estimate of spatio-temporal parameters, named Trusted Events and Acceleration Direct and Reverse Integration along the direction of Progression (TEADRIP), on a large cohort (236 patients) including Parkinson, mildly cognitively impaired and healthy older adults collected in four clinical centers. Data were collected during straight-line gait, at normal and fast walking speed, by attaching two MIMUs just above the ankles. The parameters stride, step, stance and swing durations, as well as stride length and gait velocity, were estimated for each gait cycle. The TEADRIP performance was validated against data from an instrumented mat., Results: Limits of agreements computed between the TEADRIP estimates and the reference values from the instrumented mat were - 27 to 27 ms for Stride Time, - 68 to 44 ms for Stance Time, - 31 to 31 ms for Step Time and - 67 to 52 mm for Stride Length. For each clinical center, the mean absolute errors averaged across subjects for the estimation of temporal parameters ranged between 1 and 4%, being on average less than 3% (< 30 ms). Stride length mean absolute errors were on average 2% (≈ 25 mm). Error comparisons across centers did not show any significant difference. Significant error differences were found exclusively for stride and step durations between healthy elderly and Parkinsonian subjects, and for the stride length between walking speeds., Conclusions: The TEADRIP method was effectively validated on a large number of healthy and pathological subjects recorded in four different clinical centers. Results showed that the spatio-temporal parameters estimation errors were consistent with those previously found on smaller population samples in a single center. The combination of robustness and range of applicability suggests the use of the TEADRIP as a suitable MIMU-based method for gait spatio-temporal parameter estimate in the routine clinical use. The present paper was awarded the "SIAMOC Best Methodological Paper 2017".

Background: Application of objective measurement of stroke gait with accelerometer-based wearable technology and associated algorithms is increasing, despite reports questioning the accuracy of this technique in quantifying specific stroke-related gait impairments. The aim of this study is to determine the feasibility, validity and reliability of a low-cost open-source system incorporating algorithms and a single tri-axial accelerometer-based wearable to quantify gait characteristics in the laboratory and community post-stroke., Methods: Twenty-five participants with stroke wore the wearable (AX3, Axivity) on the lower back during a laboratory 2 minute continuous walk (preferred pace) on two occasions a week apart and continuously in the community for two consecutive 7 day periods. Video, instrumented walkway (GaitRite) and an OPAL accelerometer-based wearable were used as laboratory references., Results: Feasibility of the proposed system was good. The system was valid for measuring step count (ICC 0.899). Inherent differences in gait quantification between algorithm and GaitRite resulted in difficulties comparing agreement between the different systems. Agreement was moderate-excellent (ICC 0.503-0.936) for mean and variability gait characteristics vs. OPAL. Agreement was moderate-poor between the system and OPAL for asymmetry characteristics. Moderate-excellent reliability (ICC 0.534-0.857) was demonstrated for 11/14 laboratory measured gait characteristics. Community test-retest reliability was good-excellent (ICC 0.867-0.983) for all except one (ICC 0.699) of the 19 gait characteristics., Conclusion: The proposed system is a low-cost, reliable tool for quantifying gait post-stroke with multiple potential applications. Further refinement to optimise gait quantification algorithms for certain gait characteristics including gait asymmetry is required.

Background: Loss of arm function is a common and distressing consequence of stroke. We describe the protocol for a pragmatic, multicentre randomised controlled trial to determine whether robot-assisted training improves upper limb function following stroke., Methods/design: Study design: a pragmatic, three-arm, multicentre randomised controlled trial, economic analysis and process evaluation., Setting: NHS stroke services., Participants: adults with acute or chronic first-ever stroke (1 week to 5 years post stroke) causing moderate to severe upper limb functional limitation. Randomisation groups: 1. Robot-assisted training using the InMotion robotic gym system for 45 min, three times/week for 12 weeks 2. Enhanced upper limb therapy for 45 min, three times/week for 12 weeks 3. Usual NHS care in accordance with local clinical practice Randomisation: individual participant randomisation stratified by centre, time since stroke, and severity of upper limb impairment., Primary Outcome: upper limb function measured by the Action Research Arm Test (ARAT) at 3 months post randomisation., Secondary Outcomes: upper limb impairment (Fugl-Meyer Test), activities of daily living (Barthel ADL Index), quality of life (Stroke Impact Scale, EQ-5D-5L), resource use, cost per quality-adjusted life year and adverse events, at 3 and 6 months. Blinding: outcomes are undertaken by blinded assessors. Economic analysis: micro-costing and economic evaluation of interventions compared to usual NHS care. A within-trial analysis, with an economic model will be used to extrapolate longer-term costs and outcomes. Process evaluation: semi-structured interviews with participants and professionals to seek their views and experiences of the rehabilitation that they have received or provided, and factors affecting the implementation of the trial., Sample Size: allowing for 10% attrition, 720 participants provide 80% power to detect a 15% difference in successful outcome between each of the treatment pairs. Successful outcome definition: baseline ARAT 0-7 must improve by 3 or more points; baseline ARAT 8-13 improve by 4 or more points; baseline ARAT 14-19 improve by 5 or more points; baseline ARAT 20-39 improve by 6 or more points., Discussion: The results from this trial will determine whether robot-assisted training improves upper limb function post stroke., Trial Registration: ISRCTN, identifier: ISRCTN69371850 . Registered 4 October 2013.

Background: Gait is emerging as a powerful diagnostic and prognostic tool, and as a surrogate marker of disease progression for Parkinson's disease (PD). Accelerometer-based body worn monitors (BWMs) facilitate the measurement of gait in clinical environments. Moreover they have the potential to provide a more accurate reflection of gait in the home during habitual behaviours. Emerging research suggests that measurement of gait using BWMs is feasible but this has not been investigated in depth. The aims of this study were to explore (i) the impact of environment and (ii) ambulatory bout (AB) length on gait characteristics for discriminating between people with PD and age-matched controls., Methods: Fourteen clinically relevant gait characteristics organised in five domains (pace, variability, rhythm, asymmetry, postural control) were quantified using laboratory based and free-living data collected over 7 days using a BWM placed on the lower back in 47 PD participants and 50 controls., Results: Free-living data showed that both groups walked with decreased pace and increased variability, rhythm and asymmetry compared to walking in the laboratory setting. Four of the 14 gait characteristics measured in free-living conditions were significantly different between controls and people with PD compared to two measured in the laboratory. Between group differences depended on bout length and were more apparent during longer ABs. ABs ≤ 10s did not discriminate between groups. Medium to long ABs highlighted between-group significant differences for pace, rhythm and asymmetry. Longer ABs should therefore be taken into account when evaluating gait characteristics in free-living conditions., Conclusion: This study provides encouraging results to support the use of a single BWM for free-living gait evaluation in people with PD with potential for research and clinical application.

Background: Falls amongst people with Parkinson's (PwP) result in significant disability and reduced quality of life. There is emerging evidence that exercise-based and physiotherapeutic interventions are of benefit for improving fall risk factors, such as balance. However, the benefit, in terms of preventing falls, is mixed. The development of effective interventions has been identified as the highest research priority for this population. The aim of this trial is to establish the effectiveness and cost-effectiveness of a novel, home-based physiotherapy programme, compared with usual care, on falls amongst PwP., Methods/design: A UK multi-centre, community-based, single blind, randomised controlled trial with twelve month follow-up, and nested economic evaluation and qualitative studies will be undertaken. Six hundred PwP who live in their own home, have had one or more falls in the previous year and an MMSE score of ≥24 will be recruited. Those living in care homes and those needing assistance from another person to walk indoors will not be eligible. The intervention is a physiotherapist delivered, individually tailored and progressive, home-based programme (PDSAFE) comprising task orientated movement strategy training, functional lower limb strengthening and balance training, of six months duration. Unsupervised daily home exercises and strategies will be practised and supported using technology. Control participants will receive usual care. Data collection will include falls, cognitive state, balance and mobility, fear of falling, freezing of gait, mood, quality of life, carer quality of life and resource use. Data will be collected at baseline, three, six and twelve months. Longitudinal semi-structured interviews will be undertaken with forty participants to explore the expectations and experiences of participants. The primary outcome is risk of repeat falling at six months post-randomisation., Discussion: The aims of this trial are to establish the effectiveness and cost-effectiveness of a novel, home-delivered physiotherapy intervention (PDSAFE) compared with usual care on risk of falling for PwP who have a history of falling. PDSAFE is a novel intervention that builds upon the existing literature and targeting known risk factors, being the first study that uses a novel delivery modus (technology) in conjunction with traditional physiotherapeutic approaches., Trial Registration: Current Controlled Trials ISRCTN48152791.

Background: Computer based gaming systems, such as the Microsoft Kinect (Kinect), can facilitate complex task practice, enhance sensory feedback and action observation in novel, relevant and motivating modes of exercise which can be difficult to achieve with standard physiotherapy for people with Parkinson's disease (PD). However, there is a current need for safe, feasible and effective exercise games that are appropriate for PD rehabilitation. The aims of this study were to i) develop a computer game to rehabilitate dynamic postural control for people with PD using the Kinect; and ii) pilot test the game's safety and feasibility in a group of people with PD., Methods: A rehabilitation game aimed at training dynamic postural control was developed through an iterative process with input from a design workshop of people with PD. The game trains dynamic postural control through multi-directional reaching and stepping tasks, with increasing complexity across 12 levels of difficulty. Nine people with PD pilot tested the game for one session. Participant feedback to identify issues relating to safety and feasibility were collected using semi-structured interviews., Results: Participants reported that they felt safe whilst playing the game. In addition, there were no adverse events whilst playing. In general, the participants stated that they enjoyed the game and seven of the nine participants said they could imagine themselves using the game at home, especially if they felt it would improve their balance. The Flow State Scale indicated participants were immersed in the gameplay and enjoyed the experience. However, some participants reported that they found it difficult to discriminate between different types and orientations of visual objects in the game and some also had difficulty with the stepping tasks, especially when performed at the same time as the reaching tasks., Conclusion: Computer-based rehabilitation games using the Kinect are safe and feasible for people with PD although intervention trials are needed to test their safety, feasibility and efficacy in the home.

Background: Retirement from work involves significant lifestyle changes and may represent an opportunity to promote healthier eating patterns in later life. However, the effectiveness of dietary interventions during this period has not been evaluated., Methods: We undertook a systematic review of dietary interventions among adults of retirement transition age (54 to 70 years). Twelve electronic databases were searched for randomized controlled trials evaluating the promotion of a healthy dietary pattern, or its constituent food groups, with three or more months of follow-up and reporting intake of specific food groups. Random-effects models were used to determine the pooled effect sizes. Subgroup analysis and meta-regression were used to assess sources of heterogeneity., Results: Out of 9,048 publications identified, 68 publications reporting 24 studies fulfilled inclusion criteria. Twenty-two studies, characterized by predominantly overweight and obese participants, were included in the meta-analysis. Overall, interventions increased fruit and vegetable (F&V) intake by 87.5 g/day (P <0.00001), with similar results in the short-to-medium (that is, 4 to 12 months; 85.6 g/day) and long-term (that is, 13 to 58 months; 87.0 g/day) and for body mass index (BMI) stratification. Interventions produced slightly higher intakes of fruit (mean 54.0 g/day) than of vegetables (mean 44.6 g/day), and significant increases in fish (7 g/day, P = 0.03) and decreases in meat intake (9 g/day, P <0.00001)., Conclusions: Increases in F&V intakes were positively associated with the number of participant intervention contacts. Dietary interventions delivered during the retirement transition are therefore effective, sustainable in the longer term and likely to be of public health significance.

Unlabelled: Evidence for exercise based computer games (exergaming) as a rehabilitation tool for people with Parkinson's disease (PD) is only now emerging and is yet to be synthesised. To this end, we conducted a systematic review of the exergaming literature to establish what is known about the safety, feasibility and effectiveness of exergaming for rehabilitation of motor symptoms experienced by people with PD. Seven electronic databases were searched for key terms surrounding exergaming and PD. Data were extracted by two reviewers independently. From an initial yield of 1217 articles, seven were included in the review. Six studies used commercial games with the Nintendo Wii fit platform. The scientific quality of reporting was generally good, however the overall methodological design of studies was weak, with only one randomised controlled trial being reported., Safety: Participant safety was not measured in any of the studies. Feasibility: People with PD were able to play exergames, improve their performance of gameplay and enjoyed playing. However, one study observed that people with PD had difficulty with fast and complex games. Effectiveness: Six studies showed that exergaming elicited improvements in a range of clinical balance measures or reduction in the severity of motor symptoms. Results from the only randomised controlled trial showed that exergaming was as effective as traditional balance training for people with PD to improve the UPDRS II, standing balance and cognition, with improvements in both groups retained 60 days after the training ended. In conclusion, exergaming is an emerging tool to help rehabilitate motor skills in people with PD. Although we were able to establish that exergaming is feasible in people with PD, more research is needed to establish its safety and clinical effectiveness, particularly in the home. The use of commercial games may be too difficult for some people with PD and exergames tailored specifically to the rehabilitation needs and capabilities of people with PD are required for optimal efficacy, adherence and safety.

Background: Retirement represents a major transitional life stage in middle to older age. Changes in physical activity typically accompany this transition, which has significant consequences for health and well-being. The aim of this systematic review was to evaluate the evidence for the effect of interventions to promote physical activity in adults aged 55 to 70 years, focusing on studies that reported long-term effectiveness. This systematic review adheres to a registered protocol (PROSPERO CRD42011001459)., Methods: Randomized controlled trials of interventions to promote physical activity behavior with a mean/median sample age of 55 to 70 years, published between 2000 and 2010, were identified. Only trials reporting the long-term effect (≥ 12 months) on objective or self-reported physical activity behavior were included. Trials reporting physiological proxy measures of physical activity were excluded. Meta-analyses were conducted when trials provided sufficient data and sensitivity analyses were conducted to identify potential confounding effects of trials of poor methodological quality or with attrition rates ≥ 30%., Results: Of 17,859 publications identified, 32 were included which reported on 21 individual trials. The majority of interventions were multimodal and provided physical activity and lifestyle counselling. Interventions to promote physical activity were effective at 12 months (standardized mean difference (SMD) = 1.08, 95% confidence interval (CI) = 0.16 to 1.99, pedometer step-count, approximating to an increase of 2,197 steps per day; SMD = 0.19, 95% CI = 0.10 to 0.28, self-reported physical activity duration outcome), but not at 24 months based on a small subset of trials. There was no evidence for a relationship between intervention effectiveness and mode of delivery or number of intervention contacts; however, interventions which involved individually tailoring with personalized activity goals or provision of information about local opportunities in the environment may be more effective., Conclusions: Interventions in adults aged 55 to 70 years led to long term improvements in physical activity at 12 months; however, maintenance beyond this is unclear. Identified physical activity improvements are likely to have substantial health benefits in reducing the risk of age-related illnesses. These findings have important implications for community-based public health interventions in and around the retirement transition.

Background: Recent work has demonstrated that fall risk can be attributed to cognitive as well as motor deficits. Indeed, everyday walking in complex environments utilizes executive function, dual tasking, planning and scanning, all while walking forward. Pilot studies suggest that a multi-modal intervention that combines treadmill training to target motor function and a virtual reality obstacle course to address the cognitive components of fall risk may be used to successfully address the motor-cognitive interactions that are fundamental for fall risk reduction. The proposed randomized controlled trial will evaluate the effects of treadmill training augmented with virtual reality on fall risk., Methods/design: Three hundred older adults with a history of falls will be recruited to participate in this study. This will include older adults (n=100), patients with mild cognitive impairment (n=100), and patients with Parkinson's disease (n=100). These three sub-groups will be recruited in order to evaluate the effects of the intervention in people with a range of motor and cognitive deficits. Subjects will be randomly assigned to the intervention group (treadmill training with virtual reality) or to the active-control group (treadmill training without virtual reality). Each person will participate in a training program set in an outpatient setting 3 times per week for 6 weeks. Assessments will take place before, after, and 1 month and 6 months after the completion of the training. A falls calendar will be kept by each participant for 6 months after completing the training to assess fall incidence (i.e., the number of falls, multiple falls and falls rate). In addition, we will measure gait under usual and dual task conditions, balance, community mobility, health related quality of life, user satisfaction and cognitive function., Discussion: This randomized controlled trial will demonstrate the extent to which an intervention that combines treadmill training augmented by virtual reality reduces fall risk, improves mobility and enhances cognitive function in a diverse group of older adults. In addition, the comparison to an active control group that undergoes treadmill training without virtual reality will provide evidence as to the added value of addressing motor cognitive interactions as an integrated unit., Trial Registration: (NIH)-NCT01732653.