Multicentre pilot randomised control trial of a self-directed exergaming intervention for poststroke upper limb rehabilitation: research protocol.

INTRODUCTION: Technology-facilitated, self-directed upper limb (UL) rehabilitation, as an adjunct to conventional care, could enhance poststroke UL recovery compared with conventional care alone, without imposing additional resource burden. The proposed pilot randomised controlled trial (RCT) aims to assess whether stroke survivors will engage in self-directed UL training, explore factors associated with intervention adherence and evaluate the study design for an RCT testing the efficacy of a self-directed exer-gaming intervention for UL recovery after stroke. METHODS AND ANALYSIS: This is a multicentre, internal pilot RCT; parallel design, with nested qualitative methods. The sample will consist of stroke survivors with UL paresis, presenting within the previous 30 days. Participants randomised to the intervention group will be trained to use an exergaming device and will be supported to adopt this as part of their self-directed rehabilitation (ie, without formal support/supervision) for a 3-month period. The primary outcome will be the Fugl Meyer Upper Extremity Assessment (FM-UE) at 6 months poststroke. Secondary outcomes are the Action Research Arm Test (ARAT), the Barthel Index and the Modified Rankin Scale. Assessment time points will be prior to randomisation (0-1 month poststroke), 3 months and 6 months poststroke. A power calculation to inform sample size required for a definitive RCT will be conducted using FM-UE data from the sample across 0-6 months time points. Semistructured qualitative interviews will examine factors associated with intervention adoption. Reflexive thematic analysis will be used to code qualitative interview data and generate key themes associated with intervention adoption. ETHICS AND DISSEMINATION: The study protocol (V.1.9) was granted ethical approval by the Health Research Authority, Health and Care Research Wales, and the London- Harrow Research Ethics Committee (ref. 21/LO/0054) on 19 May 2021. Trial results will be submitted for publication in peer-reviewed journals, presented at national and international stroke meetings and conferences and disseminated among stakeholder communities. TRIAL REGISTRATION NUMBER: NCT04475692.

Understanding implementation of a complex intervention in a stroke rehabilitation research trial: A qualitative evaluation using Normalisation Process Theory.

BACKGROUND: The Implicit Learning in Stroke study was a pilot cluster randomised controlled trial, investigating the use of different motor learning strategies in acute stroke rehabilitation. Participating Stroke Units (n = 8) were from the South East/West regions of the UK, with the experimental intervention (implicit learning) being delivered by clinical teams. It required therapists to change how they gave instructions and feedback to patients during rehabilitation. This paper reports the processes underpinning implementation of the implicit learning intervention. The evaluation aimed to i) understand how therapists made sense of, engaged with and interpreted the effects of the intervention; ii) compare this to the experience reported by patients; iii) extrapolate learning of broader relevance to the design and conduct of research involving complex interventions in stroke rehabilitation. METHODS: Qualitative evaluation, with data collected through focus groups with clinical staff (n = 20) and semi structured interviews with people with stroke (n = 19). Mixed inductive and theory driven analysis, underpinned by Normalisation Process Theory. RESULTS: How therapists made sense of and experienced the intervention impacted how it was implemented. The intervention was delivered by individual therapists, and was influenced by their individual values, beliefs and concerns. However, how teams worked together to build a shared (team) understanding, also played a key role. Teams with a more "flexible" interpretation, reported the view that the intervention could have benefits in a wide range of scenarios. Those with a more fixed, "rule based" interpretation, found it harder to implement, and perceived the benefits to be more limited. Therapists' concerns that the intervention may impair therapeutic relationships and patient learning were not reflected in how patients experienced it. CONCLUSIONS: Changing practice, whether in a research study or in the "real world", is complex. Understanding the process of implementation is crucial to effective research delivery. Implementation frameworks facilitate understanding, and subsequently the systematic and iterative development of strategies for this to be addressed. How teams (rather than individuals) work together is central to how complex interventions are understood and implemented. It is possible that new complex interventions work best in contexts where there are 'flexible' cultures. Researchers should consider, and potentially measure this, before they can effectively implement and evaluate an intervention. TRIAL REGISTRATION: Clinical Trials - NCT03792126.

Examining Usability, Acceptability, and Adoption of a Self-Directed, Technology-Based Intervention for Upper Limb Rehabilitation After Stroke: Cohort Study.

BACKGROUND: Upper limb (UL) recovery after stroke is strongly dependent upon rehabilitation dose. Rehabilitation technologies present pragmatic solutions to dose enhancement, complementing therapeutic activity within conventional rehabilitation, connecting clinicians with patients remotely, and empowering patients to drive their own recovery. To date, rehabilitation technologies have been poorly adopted. Understanding the barriers to adoption may shape strategies to enhance technology use and therefore increase rehabilitation dose, thus optimizing recovery potential. OBJECTIVE: We examined the usability, acceptability, and adoption of a self-directed, exercise-gaming technology within a heterogeneous stroke survivor cohort and investigated how stroke survivor characteristics, technology usability, and attitudes toward technology influenced adoption. METHODS: A feasibility study of a novel exercise-gaming technology for self-directed UL rehabilitation in early subacute stroke survivors (N=30) was conducted in an inpatient, acute hospital setting. Demographic and clinical characteristics were recorded; participants' performance in using the system (usability) was assessed using a 4-point performance rating scale (adapted from the Barthel index), and adherence with the system was electronically logged throughout the trial. The technology acceptance model was used to formulate a survey examining the acceptability of the system. Spearman rank correlations were used to examine associations between participant characteristics, user performance (usability), end-point technology acceptance, and intervention adherence (adoption). RESULTS: The technology was usable for 87% (n=26) of participants, and the overall technology acceptance rating was 68% (95% CI 56%-79%). Participants trained with the device for a median of 26 (IQR 16-31) minutes daily over an enrollment period of 8 (IQR 5-14) days. Technology adoption positively correlated with user performance (usability) (ρ=0.55; 95% CI 0.23-0.75; P=.007) and acceptability as well as domains of perceived usefulness (ρ=0.42; 95% CI 0.09-0.68; P=.03) and perceived ease of use (ρ=0.46; 95% CI 0.10-0.74; P=.02). Technology acceptance decreased with increased global stroke severity (ρ=-0.56; 95% CI -0.79 to -0.22; P=.007). CONCLUSIONS: This technology was usable and acceptable for the majority of the cohort, who achieved an intervention dose with technology-facilitated, self-directed UL training that exceeded conventional care norms. Technology usability and acceptability were determinants of adoption and appear to be mediated by stroke severity. The results demonstrate the importance of selecting technologies for stroke survivors on the basis of individual needs and abilities, as well as optimizing the accessibility of technologies for the target user group. Facilitating changes in stroke survivors' beliefs and attitudes toward rehabilitation technologies may enhance adoption. Further work is needed to understand how technology can be optimized to benefit those with more severe stroke.

Telerehabilitation for people with physical disabilities and movement impairment: development and evaluation of an online toolkit for practitioners and patients.

PURPOSE: Telerehabilitation has increasingly been used since the COVID-19 pandemic but with limited guidance available on undertaking physical assessments using remote methods. We aimed to provide such guidance by developing a Telerehab Toolkit, an online information and training resource for practitioners, patients, and carers on telerehabilitation for people with physical disabilities and movement impairment. MATERIALS AND METHODS: Development and evaluation of the toolkit were informed by the Knowledge to Action framework and took place iteratively in two phases-knowledge creation and action. Information was collated from various sources including literature review, online survey, service evaluation, and focus group discussions. The toolkit has been evaluated using think-aloud interviews, e-mail and social media feedback from users, and analytics data on user engagement with the website. RESULTS: The Telerehab Toolkit focuses on remote physical assessments, and contains information on technology, digital skills, remote assessment tools, information governance, and safety for telerehabilitation. Resources include top tips from practitioners and patients, how-to guides, checklists, videos, and links to evidence. CONCLUSIONS: The Telerehab Toolkit has been well-received by practitioners, healthcare students, patients, and carers, is being disseminated widely, and is freely available (www.plymouth.ac.uk/research/telerehab). IMPLICATIONS FOR REHABILITATIONTelerehabilitation has been increasingly used since the COVID-19 pandemic, but with limited guidance and training for practitioners on undertaking safe and effective remote physical assessments.The Telerehab Toolkit has been developed iteratively using the Knowledge to Action framework; it is a free online resource for practitioners and patients with specific guidance on telerehabilitation for physical disabilities and movement impairment.It is anticipated that the resource will help to improve the knowledge, skills, and confidence of the current and future rehabilitation workforce.

Principles into Practice: An Observational Study of Physiotherapists use of Motor Learning Principles in Stroke Rehabilitation.

OBJECTIVE(S): To describe a) how motor learning principles are applied during post stroke physiotherapy, with a focus on lower limb rehabilitation; and b) the context in which these principles are used, in relation to patient and/or task characteristics. DESIGN: Direct non-participation observation of routine physiotherapy sessions, with data collected via video recording. A structured analysis matrix and pre-agreed definitions were used to identify, count and record: type of activity; repetitions; instructional and feedback statements (frequency and type); strategies such as observational learning and augmented feedback. Data was visualised using scatter plots, and analysed descriptively. SETTING: 6 UK Stroke Units PARTICIPANTS: 89 therapy sessions were observed, involving 55 clinicians and 57 patients. RESULTS: Proportion of time spent active within each session ranged from 26% to 98% (mean 85, SD 19). The frequency of task repetition varied widely, with a median of 3.7 repetitions per minute (IQR 2.1-8.6). Coaching statements were common (mean 6.46 per minute), with 52% categorised as instructions, 14% as feedback, and 34% as verbal cues/motivational statements. 13% of instructions and 6% of feedback statements were externally focussed. Examining the use of different coaching behaviours in relation to patient characteristics found no associations. Overall, practice varied widely across the dataset. CONCLUSIONS: To optimise the potential for motor skill learning, therapists must manipulate features of their coaching language (what they say, how much and when) and practice design (type, number, difficulty and variability of task). There is an opportunity to implement motor learning principles more consistently, to benefit motor skill recovery following stroke. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov (NCT03792126). CONTRIBUTION OF THE PAPER.

The application, character, and effectiveness of person-centred care with service-users, and the community within the discipline of podiatry: a scoping review.

BACKGROUND: The concept of person-centred care is embedded within healthcare policy, focusing on long-term conditions and multimorbidity. The evidence that person-centred care is being operationalised effectively across all areas of healthcare is limited. The aim of this scoping review was to explore the application, features, and effectiveness of person-centred care with service-users, carers, and the community within podiatry. METHODS: The scoping review was based upon Arksey and Malley's five stage framework. The following databases were searched between January 2010 and March 2021: AMED, CINAHL, Embase, Cochrane library, SocINDEX, British Education Index, Business Source Complete, MEDLINE (EBSCO), and the EThOS 'Global electronic thesis and dissertation' repository, Prospero, and reference lists of included papers. Primary research articles were included if they reported on a person-centred care focused intervention with podiatry. Research terms were developed, appropriate databases identified, and an initial search resulted in 622 papers which, following removal of duplicates and critical appraisal, resulted in 18 eligible papers. Data extracted involved the types of person-centred care utilised, intervention details, motivations for engaging in person-centred care interventions, and intervention barriers and challenges. RESULTS: Eighteen articles were included in the review. The main type of person-centred care utilised was patient/carer activities around self-management. None of the studies considered the role of the podiatrist as a person-centred care agent. The data on interventions generated the following themes 'service facilitated person-centred care' where a change has been made to service delivery, 'direct clinician delivery' where the intervention is delivered by the clinician with the patient present and 'patient instigated participation' where patient motivation is required to engage with an activity beyond the consultation. Outcome measures associated with quality of care and effectiveness were absent. CONCLUSION: There is a lack of congruency between the concept of person-centred care and how it is operationalised. A whole system approach that considers commissioning, organisational leadership, the role of the practitioners and patients has not been considered. There is immense scope for the podiatrist to play an important part in the personalised-care agenda, but currently research that can evidence the effectiveness of person-centred care in podiatry is absent. REVIEW REGISTRATION: Open Science Framework ( osf.io/egjsd ).

The importance of self-efficacy and negative affect for neurofeedback success for central neuropathic pain after a spinal cord injury.

EEG-based neurofeedback uses mental behaviours (MB) to enable voluntary self-modulation of brain activity, and has potential to relieve central neuropathic pain (CNP) after a spinal cord injury (SCI). This study aimed to understand neurofeedback learning and the relationship between MB and neurofeedback success. Twenty-five non-CNP participants and ten CNP participants received neurofeedback training (reinforcing 9-12 Hz; suppressing 4-8 Hz and 20-30 Hz) on four visits. Participants were interviewed about the MB they used after each visit. Questionnaires examined the following factors: self-efficacy, locus of control, motivation, and workload of neurofeedback. MB were grouped into mental strategies (a goal-directed mental action) and affect (emotional experience during neurofeedback). Successful non-CNP participants significantly used more imagination-related MS and reported more negative affect compared to successful CNP participants. However, no mental strategy was clearly associated with neurofeedback success. There was some association between the lack of success and negative affect. Self-efficacy was moderately correlated with neurofeedback success (r = < 0.587, p = < 0.020), whereas locus of control, motivation, and workload had low, non-significant correlations (r < 0.300, p > 0.05). Affect may be more important than mental strategies for a successful neurofeedback performance. Self-efficacy was associated with neurofeedback success, suggesting that increasing confidence in one's neurofeedback abilities may improve neurofeedback performance.

Telerehabilitation for physical disabilities and movement impairment: A service evaluation in South West England.

RATIONALE, AIMS AND OBJECTIVES: Telerehabilitation was used to ensure continued provision of care during the COVID-19 pandemic, but there was a lack of guidance on how to use it safely and effectively for people with physical disabilities and movement impairment. In this service evaluation, we aimed to collate information on practitioner and patient experiences, challenges and facilitators, and examples of best practice to inform the development of an online toolkit and training package. METHODS: Guided discussions were carried out with 44 practitioners, 7 patients and 2 carers from five health and social care organisations in South West England, and analysed thematically. RESULTS: Practitioners and patients had positive experiences of telerehabilitation and were optimistic about its future use. Recognized benefits for people with physical disabilities included greater flexibility, reduced travel and fatigue, having appointments in a familiar environment and ease of involving family members. Challenges encountered were: technological (usability issues, access to technology and digital skills); difficulties seeing or hearing patients; the lack of 'hands-on' care; and safety concerns. Facilitators were supported by colleagues or digital champions, and family members or carers who could assist patients during their appointments. Key themes in best practice were: person-centred and tailored care; clear and open communication and observation and preparation and planning. Practitioners shared tips for remote physical assessments; for example, making use of patient-reported outcomes, and asking patients to wear bright and contrasting coloured clothing to make it easier to see movement. CONCLUSION: Telerehabilitation holds promise in health and social care, but it is necessary to share good practice to ensure it is safe, effective and accessible. We collated information and recommendations that informed the content of the Telerehab Toolkit (https://www.plymouth.ac.uk/research/telerehab), a practical resource for practitioners, patients and carers, with a focus on remote assessment and management of physical disabilities and movement impairment.

'It feels it's wasting whatever time I've got left': A qualitative study of living with treatable but not curable cancer during the COVID-19 pandemic.

BACKGROUND: People living with cancer that is treatable but not curable have complex needs, often managing health at home, supported by those close to them. Challenges are likely to be exacerbated during the COVID-19 pandemic and the risk-reducing measures introduced in response. The impact of COVID-19 on those living with incurable, life-threatening conditions is little understood. AIM: To investigate the experiences and identify the impact of the COVID-19 pandemic for people living with treatable not curable cancer and their informal carers. DESIGN: Qualitative semi-structured phone interviews were conducted with 21 patients living with cancer that is treatable but not curable and 14 carers. SETTING/ PARTICIPANTS: Participants were part of a larger longitudinal qualitative study (ENABLE) on supported self-management for people living with cancer that is treatable but not curable. RESULTS: The COVID-19 pandemic magnified uncertainty and anxiety and led to loss of opportunities to do things important to patients in the limited time they have left to live. Lack of face-to-face contact with loved ones had a significant impact on patients' and carers' emotional wellbeing. Carers experienced increased responsibilities but less access to formal and informal support and respite. While changes to treatment led to some concern about longer-term impact on health, most patients felt well-supported by healthcare teams. CONCLUSION: The study provides rich insights into the nature of challenges, uncertainty and lost opportunities resulting from the COVID-19 pandemic for patients and carers living with cancer that is treatable but not curable, which has wider resonance for people living with other life-limiting conditions.

Development of lower limb training interventions that promote an external focus of attention in people with stroke: a modified Delphi survey.

OBJECTIVE: To produce guidance and validated examples of tasks that promote an external focus of attention, for use in lower limb rehabilitation in an inpatient stroke care setting. DESIGN: Electronic survey, using e-Delphi methodology. PARTICIPANTS: A multi-professional expert panel of 14 clinicians and researchers, with expertise in stroke rehabilitation and/or motor learning. METHOD: Each survey round consisted of two parts: 1) classification of specific exercise examples, shown using video and 2) the categorization of specific tratement adjuncts. The panel was asked to comment on: likely focus of attention of the performer; instructions that would promote an external focus of attention; and how the task set-up could be modified to promote an external focus of attention. Rounds 2 and 3 included a summary of results from the previous round, and revised/new examples. The panel were also asked to state their level of agreement with a series of statements that arose from the free text. Three rounds of survey were completed and the a priori threshold for agreement was set at 80%. RESULTS: Eighteen iterations of exercises were presented, and 12 were accepted as promoting an external focus of attention. In addition, six additional statements were generated based on open responses, leading to further specific guidance on facilitating an external focus of attention in clinical practice. CONCLUSIONS: Commonly used rehabilitation exercises can be adapted to promote an external focus of attention, by altering the therapist's use of instructions and/or altering the task set up. Treatment principles and examples of tasks that promote an external focus have been produced.

Telerehabilitation for People With Physical Disabilities and Movement Impairment: A Survey of United Kingdom Practitioners.

BACKGROUND: Telerehabilitation is a feasible and potentially effective alternative to face-to-face rehabilitation. However, specific guidance, training, and support for practitioners who undertake remote assessments in people with physical disabilities and movement impairment are limited. OBJECTIVE: The aims of this survey of United Kingdom-based health and social care practitioners were to explore experiences, assess training needs, and collate ideas on best practices in telerehabilitation for physical disabilities and movement impairment. The aim will be to use the findings to inform a practical tool kit and training package for telerehabilitation use. METHODS: UK rehabilitation practitioners were invited to complete an online questionnaire from November to December 2020. Opportunity and snowball sampling were used to recruit participants from professional and educational networks, special interest groups, and via social media. Closed questionnaire items were analyzed using descriptive statistics. Qualitative inductive analysis using NVivo was used for open responses. RESULTS: There were 247 respondents, of which 177 (72%) were physiotherapists and occupational therapists. Most (n=207, 84%) had used video-based consultations (typically supported by telephone and email), and the use of this method had increased in frequency since the COVID-19 pandemic. Practitioners perceived telerehabilitation positively overall and recognized benefits for patients including a reduced infection risk, convenience and flexibility, and reduced travel and fatigue. Common obstacles were technology related (eg, internet connection), practical (eg, difficulty positioning the camera), patient related (eg, health status), practitioner related (eg, lack of technical skills), and organizational (eg, lack of access to technology). Support from family members or carers was a major facilitator for successful remote consultations. Of the 207 respondents who had used video-based consultations, 103 (50%) had assessed physical impairments using this method, 107 (52%) had assessed physical function, and 121 (59%) had used patient-reported outcome measures. Although practitioners generally felt confident in delivering video-based consultations, they felt less proficient in undertaking remote physical assessments, expressing concerns about validity, reliability, and safety. Only 46 of the 247 (19%) respondents had received any training in telerehabilitation or video consultations, and some felt they were "feeling their way in the dark." Practitioners desired training and guidance on physical assessment tools suitable for remote use, when to use video-based consultations or alternative methods, governance issues, digital platforms, and signposting to digital skills training for themselves and their patients. CONCLUSIONS: In response to the COVID-19 pandemic, practitioners rapidly adopted telerehabilitation for people with physical disabilities and movement impairment. However, there are technical, practical, and organizational obstacles to overcome, and a clear need for improved guidance and training in remote physical assessments. The findings of this survey will inform the development of a tool kit of resources and a training package for the current and future workforce in telerehabilitation.

A Systematic Review of Neurofeedback for the Management of Motor Symptoms in Parkinson's Disease.

BACKGROUND: Neurofeedback has been proposed as a treatment for Parkinson's disease (PD) motor symptoms by changing the neural network activity directly linked with movement. However, the effectiveness of neurofeedback as a treatment for PD motor symptoms is unclear. AIM: To systematically review the literature to identify the effects of neurofeedback in people with idiopathic PD; as defined by measurement of brain activity; motor function; and performance. DESIGN: A systematic review. Included Sources and Articles: PubMed; MEDLINE; Cinhal; PsychoInfo; Prospero; Cochrane; ClinicalTrials.gov; EMBASE; Web of Science; PEDro; OpenGrey; Conference Paper Index; Google Scholar; and eThos; searched using the Population-Intervention-Comparison-Outcome (PICO) framework. Primary studies with the following designs were included: randomized controlled trials (RCTs), non-RCTs; quasi-experimental; pre/post studies; and case studies. RESULTS: This review included 11 studies out of 6197 studies that were identified from the literature search. Neuroimaging methods used were fMRI; scalp EEG; surface brain EEG; and deep brain EEG; where 10-15 Hz and the supplementary motor area were the most commonly targeted signatures for EEG and fMRI, respectively. Success rates for changing one's brain activity ranged from 47% to 100%; however, both sample sizes and success criteria differed considerably between studies. While six studies included a clinical outcome; a lack of consistent assessments prevented a reliable conclusion on neurofeedback's effectiveness. Narratively, fMRI neurofeedback has the greatest potential to improve PD motor symptoms. Two main limitations were found in the studies that contributed to the lack of a confident conclusion: (1) insufficient clinical information and perspectives (e.g., no reporting of adverse events), and (2) limitations in numerical data reporting (e.g., lack of explicit statistics) that prevented a meta-analysis. CONCLUSIONS: While fMRI neurofeedback was narratively the most effective treatment; the omission of clinical outcome measures in studies using other neurofeedback approaches limits comparison. Therefore, no single neurofeedback type can currently be identified as an optimal treatment for PD motor symptoms. This systematic review highlights the need to improve the inclusion of clinical information and more robust reporting of numerical data in future work. Neurofeedback appears to hold great potential as a treatment for PD motor symptoms. However, this field is still in its infancy and needs high quality RCTs to establish its effectiveness. Review Registration: PROSPERO (ID: CRD42020191097).

Scope, context and quality of telerehabilitation guidelines for physical disabilities: a scoping review.

OBJECTIVE: To identify the available guidance and training to implement telerehabilitation movement assessments for people (adults and children) with a physical disability, including those recovering from COVID-19. DESIGN: Rapid scoping review. INCLUDED SOURCES AND ARTICLES: PubMed, CINAHL, PsychInfo, Cochrane, Embase, Web of Science, PEDro, UK Health Forum, WHO, National Archives and NHS England were searched using the participant-concept-context framework from 2015 to August 2020. Primary studies that recruited individuals with physical disabilities and guidance documents aimed at providers to implement movement-related telerehabilitation were included. RESULTS: 23 articles (11 primary research studies, 3 systematic reviews and 9 guidance documents) were included out of 7857 that were identified from the literature search. Two main issues were found: (1) telerehabilitation guidance (from both research studies and guidance documents) was not specific to movement-related assessment and (2) most primary research studies provided neither guidance nor training of movement-specific assessment to practitioners. Of the COVID-19 related guidance, two articles reported COVID-19 management that only referred to identifying COVID-19 status without references to specific movement-related guidance. CONCLUSIONS: Telerehabilitation guidance and training have existed pre-COVID-19, yet the lack of specific movement-related information and provider support is surprising. This gap must be addressed to optimise effective implementation of remote assessments for those with physical disabilities. REVIEW REGISTRATION: Open Science Framework: osf.io/vm6sp.

Physical activity for people living with dementia: carer outcomes and side effects from the perspectives of professionals and family carers.

BACKGROUND: Adherence to physical activity is challenging for people living with dementia, and largely dependent on carers' involvement. Carers are likely to support physical activity based on their perceived balance between benefits and potential side effects of such intervention for both patients and themselves. Professionals also have a role in terms of optimising such interventions not only for people with dementia but also their carers. AIMS: The present study aimed to identify the priorities of carers and professionals regarding (1) outcomes of physical activity for people living with dementia on carers and (2) side effects on patients and carers. METHODS: This was a two-round prioritisation exercise. In round one, participants were asked to rank, from most to least important, 2 lists of outcomes generated in a previous systematic review and qualitative study: (i) 10 outcomes on carers; (ii) 17 side effects on patients and carers. In round two, participants were asked to consider their own ranking in round one against the overall group ranking and re-rank both lists. RESULTS: 36 carers and 39 professionals completed both rounds. The carer outcomes ranked as highest priority were "carer feeling positive and satisfied", "carer improving wellbeing" and "making lives of carers easier". The most undesirable side effects were "becoming agitated and confused", "falling over" and "feeling discomfort and pain". DISCUSSION AND CONCLUSIONS: Carers and professionals value the potential reduction in carer burden that may occur as a consequence of the person with dementia engaging in physical activity. Behavioural and psychological symptoms, falls and pain are the most undesirable side effects of physical activity. Future research should aim to address, and consistently report on these outcomes.

The ENABLE study protocol: Understanding and characterising the value and role of self-management support for people living with cancer that is treatable but not curable.

OBJECTIVE: Attention is turning to the needs of people living with treatable but incurable cancer, a group with complex needs, living with uncertainty over time. More research is needed to understand how this group self-manage the impact of cancer to strengthen the evidence base for interventions. This study aims to understand the value and outcomes of self-management support for people living with treatable but incurable cancer. METHODS: Qualitative longitudinal methods will examine how support needs change over time in relation to self-management and unpredictable disease trajectories. Thirty patients and 30 carers will be recruited from two hospitals, each participating in three interviews over 1 year. Patients will be purposively sampled according to age, gender, cancer type and anticipated survival. Carers will be recruited via nomination by patients but interviewed separately. One-off interviews will be conducted with 20 healthcare professionals, providing data from multiple perspectives. Based on interview findings, a modified Delphi process will map areas of consensus and disparity regarding conceptualisations and outcomes of self-management support. CONCLUSION: The key output will be practice recommendations in relation to self-management support, producing evidence to inform service innovation for those living with treatable but incurable cancer.

A Core Outcome Set to Evaluate Physical Activity Interventions for People Living With Dementia.

BACKGROUND AND OBJECTIVES: A core outcome set (COS) to evaluate physical activity (PA) interventions for people living with dementia is needed, as the development of guidelines is currently limited by important heterogeneity in this field of research. Development of COS often includes Delphi surveys, but people living with dementia are often excluded. This study aimed to reach consensus on this COS using a modified Delphi survey to enable the participation of people living with dementia. RESEARCH DESIGN AND METHODS: Two stakeholders groups took part in a Delphi survey (Group 1: people living with dementia and family caregivers; Group 2: professionals from different backgrounds, including physiotherapists, occupational therapists, and researchers). Caregivers and professionals completed the survey remotely. Participants living with dementia took part face-to-face, using a card sorting strategy. The consensus process was finalized with a consensus meeting. RESULTS: Ninety-five participants of both groups completed the modified Delphi. Of those, 11 attended the consensus meeting. The card sorting strategy was successful at including people living with dementia. Seven outcomes reached consensus: preventing falls; doing what you can do; staying healthy and fit; walking better, being able to stand up and climb stairs; feeling brighter; enjoying the moment; and, feeling useful and having a purpose. DISCUSSION AND IMPLICATIONS: Robust and innovative methodological strategies were used to reach a consensus on a COS (what to measure) to evaluate PA for people living with dementia. Future work will focus on the selection of the most appropriate tools to measure these outcomes (how to measure).

Outcomes of physical activity for people living with dementia: qualitative study to inform a Core Outcome Set.

BACKGROUND: The need for a Core Outcome Set to evaluate physical activity interventions for people living with dementia, across stages of disease and intervention settings has been established. This qualitative study precedes the consensus phase of developing this Core Outcome Set and aims to: (i) compare the outcomes identified by patients, carers and professionals to those previously reported in the literature; (ii) and understand why certain outcomes are considered important. DESIGN AND METHODS: In-depth semi-structured interviews were conducted with people living with dementia, family carers and professionals (n=29). The outcomes identified in the interviews were mapped to a list of outcomes reported in a recent literature review. An in-depth thematic analysis was conducted to understand the importance of physical activity in dementia care. RESULTS: A comprehensive, inductively derived list of 77 outcomes, common across stages of dementia and intervention setting, was put together for the consensus phase of this Core Outcome Set: ten of these were new outcomes generated by this qualitative study. Five themes explained why stakeholders perceived physical activity outcomes as important for people living with dementia: "being well and staying well", "having a role towards others", "maintaining identity", "being connected to the present" and "delivering good quality care". CONCLUSION: Ten new outcomes of physical activity, not previously reported in recent literature, were identified. Physical activity is considered important to people living with dementia due to its positive impact on multiple health outcomes for both patients and carers.

Comparing the Impact of an Implicit Learning Approach With Standard Care on Recovery of Mobility Following Stroke: Protocol for a Pilot Cluster Randomized Controlled Trial.

BACKGROUND: Although implicit and explicit learning approaches have been well investigated in healthy populations, there is less evidence regarding the relative benefits of each approach in clinical practice. Studies in stroke typically investigate single elements of an implicit learning approach (ILA; eg, reduced quantity feedback or an external focus of attention) within controlled environments. These studies predominantly evaluate performance, with few measuring this over time (ie, learning). The relevance and transferability of current research evidence into stroke rehabilitation is therefore limited. OBJECTIVE: The objective of this study was to compare the ILA with standard care in the acute phase following stroke, to generate data and insights to inform the design of a definitive trial, and to understand patient and therapist perceptions of the ILA. METHODS: This is a multicenter, assessor-blind, cluster randomized controlled pilot trial with nested qualitative evaluation. Stroke units (clusters) will be randomized to either ILA (intervention) or standard care (control) arms. Therapy teams at the intervention sites will be trained in the ILA and provided with an intervention manual. Those at the control sites will have minimal input from the research team, other than for data collection. Consent will be provided at the individual participant level. Once enrolled, participants will receive rehabilitation that focuses on lower limb recovery, using the designated approach. Measures will be taken at baseline, every 2 weeks until the point of discharge from hospital, and at 3 months post stroke onset. Measures include the Fugl Meyer Assessment (motor leg subsection), modified Rivermead Mobility Index, Swedish Postural Adjustment in Stroke Scale, and achievement of mobility milestones. Fidelity of the treatment approach will be monitored using observational video analysis. Focus groups and interviews will be used to gain insight into the perceptions of trial participants and clinical teams. RESULTS: The first site opened to recruitment in February 2019. The opening of a further 5 sites will be staggered throughout 2019. Results are expected in early 2021. CONCLUSIONS: The findings from this mixed methods pilot study will be used to inform the design of a definitive study, comparing the ILA with standard care in acute stroke rehabilitation. TRIAL REGISTRATION: ClinicalTrials.gov NCT03792126; https://clinicaltrials.gov/ct2/show/NCT03792126. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14222.

The problem with self-management: Problematising self-management and power using a Foucauldian lens in the context of stroke care and rehabilitation.

Self-management is a concept which is now firmly established in Western healthcare policy and practice. However, the term remains somewhat ambiguous, multi-faceted and contentious. This is evident in stroke care and rehabilitation, in which a self-management approach is increasingly adopted and advocated, yet interpreted in different ways, resulting in contradictions and tensions around control, responsibility, power and discipline. This paper aims to further our understanding of tensions and contradictions in stroke self-management, by critically examining contemporary self-management practices. We use a Foucauldian theoretical lens to explore the various power dynamics in the operationalisation of self-management, in addition to the complexity of the term self-management itself. Conducting a secondary analysis of interview and focus group data from the Self-Management VOICED study, supplemented with analysis of relevant documentary evidence from policy and practice, we describe the multiple aspects of power in operation. These include rhetorical, hierarchical, personal and mutual forms of power, representing interweaving dynamics evident in the data. These aspects of power demonstrate underlying agendas and tacit and explicit understandings of self-management which exist in clinical practice. These aspects of power also give insight into the multiple identities of 'self-management', acting as a simultaneous repressor and liberator, directly in keeping with Foucauldian thinking. The findings are also consistent with Foucault's notions of bodily docility, discussions around governance and biopower, and contemporary discipline. Our analysis positions self-management as a highly nuanced and complex concept, which can fluctuate in its conceptualisation depending on the structures, routines, and the individual. We encourage healthcare professionals, policymakers and commissioners in the field of self-management to reflect on these complexities, to make transparent their assumptions and to explicitly position their own practice accordingly.

Validity, reliability and minimal detectable change of the balance evaluation systems test (BESTest), mini-BESTest and brief-BESTest in patients with end-stage renal disease.

PURPOSE: This study determined the validity, test-retest reliability and minimal detectable change of the balance evaluation systems test (BESTest), mini-balance evaluation systems test (Mini-BESTest) and brief-balance evaluation systems test (Brief-BESTest) in patients with end-stage renal disease. METHODS: A cross-sectional study with 74 patients with end-stage renal disease (male 66.2%; 63.9 ± 15.1 years old) was conducted. Participants were asked to report the number of falls during the previous 12 months and to complete the activity-specific balance confidence (ABC) scale. The BESTest was administered, and the Mini-BESTest and Brief-BESTest scores were computed based on the BESTest performance. Validity was assessed by correlating balance tests with each other and with the ABC scale. Test-retest relative reliability and agreement were explored with the intraclass correlation coefficient (ICC) equation (2,1) and the Bland and Altman method. Minimal detectable changes at the 95% confidence level were established. RESULTS: Balance test scores were significantly correlated with each other (spearman's correlation = 0.89-0.92) and with the ABC scale (spearman's correlation = 0.49-0.59). Balance tests presented high test-retest reliability (ICC = 0.84-0.94), with no evidence of bias. Minimal detectable change values were 10.8 (expressed as a percentage 13.5%), 5.3 (23.7%) and 5.6 (34%) points for the BESTest, Mini-BESTest and Brief-BESTest, respectively. CONCLUSIONS: All tests are valid and reliable to assess balance in patients with end-stage renal disease. Nevertheless, based on the minimal detectable changes found, BESTest and Mini-BESTest may be the most recommended tests for this specific population. Implications for Rehabilitation Balance evaluation systems test (BESTest), mini-balance evaluation systems test (Mini-BESTest) and brief-balance evaluation systems test (Brief-BESTest) are reliable and valid in patients with end stage renal disease (ESRD). The minimal detectable changes of 10.8 for the BESTest, 5.3 for the Mini-BESTest and 5.6 for the Brief-BESTest can be used by clinicians to identify a true change in balance over time or in response to interventions. Based on the minimal detectable changes found, BESTest and Mini-BESTest may be the most recommended; and the selection of one of them may be based on time and equipment availability.