Views of Service Users, Their Family or Carers, and Health Care Professionals on Telerehabilitation for People With Neurological Conditions in Ghana: Qualitative Study.

BACKGROUND: Up to 50% of people in low- and middle-income countries do not receive the rehabilitation they require. Telerehabilitation has the potential to improve access to neurorehabilitation services especially in low- and middle-income countries. Although there are reports of the barriers and facilitators to telerehabilitation in such settings, almost all are anecdotal. Furthermore, family or carers have a significant influence on the adoption and success of telerehabilitation, but their views have not been reported. OBJECTIVE: This study aimed to investigate the views of service users, their family or carers, and health care professionals (HCPs) on telerehabilitation for people with neurological conditions in Ghana. METHODS: Two focus groups were held at Komfo Anokye Hospital in Kumasi, Ghana: one in person for service users (n=11) and their family or carers (n=9), conducted in the Ghanaian language of Twi, and one hybrid for HCPs (n=18) conducted in English. The mean (SD) age of the service users was 59.8 (8.6) years; 5 users had a stroke and 6 had Parkinson disease. The HCP group consisted of 7 speech and language therapists, 3 physiotherapists, 3 occupational therapists, 3 medical staff, 1 nurse, and 1 industry representative. Focus groups were semi-structured and explored previous experiences of telerehabilitation, perceived benefits and challenges, and solutions to overcome these challenges. Focus groups were audio transcribed, and the service user transcript was translated into English. The resulting transcripts were analyzed using thematic analysis. RESULTS: Overall, participants were positive about the role of telerehabilitation but recommended hybrid delivery, with in-person rehabilitation in the early stages and telerehabilitation in the later stages. In relation to telerehabilitation in Ghana, there were 3 main themes: benefits, challenges or barriers, and implementation. Benefits included the convenience and lower cost for service users, the higher dose of therapy possible, and increased access for people in remote areas. However, challenges included lack of a stable internet connection, cost of phones and data packages, and low levels of literacy. Implementation issues included cultural relevance, information governance, and the platform used to deliver telerehabilitation, with most participants being familiar with WhatsApp. CONCLUSIONS: Telerehabilitation has the potential to be a useful method of delivering rehabilitation to people with neurological conditions in Ghana, especially in a hybrid rehabilitation model with telerehabilitation augmenting in-person sessions. However, many people were unaware of telerehabilitation, and challenges such as a reliable internet connection, cultural relevance, and costs need to be addressed. Clinical trials of low-cost telerehabilitation interventions contextualized to the specific user group are required.

Data mining versus manual screening to select papers for inclusion in systematic reviews: a novel method to increase efficiency.

Systematic reviews rely on identification of studies, initially through electronic searches yielding potentially thousands of studies, and then reviewer-led screening studies for inclusion. This standard method is time- and resource-intensive. We designed and applied an algorithm written in Python involving computer-aided identification of keywords within each paper for an exemplar systematic review of arm impairment after stroke. The standard method involved reading each abstract searching for these keywords. We compared the methods in terms of accuracy in identification of keywords, abstracts' eligibility, and time taken to make a decision about eligibility. For external validation, we adapted the algorithm for a different systematic review, and compared eligible studies using the algorithm with those included in that review. For the exemplar systematic review, the algorithm failed on 72 out of 2,789 documents retrieved (2.6%). Both methods identified the same 610 studies for inclusion. Based on a sample of 21 randomly selected abstracts, the standard screening took 1.58 ±â€…0.26 min per abstract. Computer output screening took 0.43 ±â€…0.14 min per abstract. The mean difference between the two methods was 1.15 min ( P  < 0.0001), saving 73% per abstract. For the other systematic review, use of the algorithm resulted in the same studies being identified. One study was excluded based on the interpretation of the comparison intervention. Our purpose-built software was an accurate and significantly time-saving method for identifying eligible abstracts for inclusion in systematic reviews. This novel method could be adapted for other systematic reviews in future for the benefit of authors, reviewers and editors.

Supporting stroke survivors to meet their personal rehabilitation needs in community-based arm rehabilitation: development of initial programme theories to explore what may work for whom, how and under what circumstances.

Objective: This study explored what worked for whom, how and under what circumstances in a community-based augmented arm rehabilitation programme that was designed to enable stroke survivors to meet their personal rehabilitation needs. Design: A mixed methods realist-informed study of data from a randomised controlled feasibility trial, comparing augmented arm rehabilitation after stroke with usual care. The analysis was designed to develop initial programme theories and refine these through triangulation of qualitative and quantitative trial data. Participants with a confirmed stroke diagnosis and stroke-related arm impairment were recruited from five health boards in Scotland. Only data from participants in the augmented group were analysed. The augmented intervention comprised evidence-based arm rehabilitation (27 additional hours over 6 weeks) including self-managed practice, and focused on individual rehabilitation needs identified through the Canadian Occupational Performance Measure (COPM). The COPM indicated to which extent rehabilitation needs were met following the intervention, the Action Research Arm Test provided data on changes in arm function, and qualitative interviews provided information about the context and potential mechanisms of action. Findings: Seventeen stroke survivors (11 males, age range 40-84 years, NIHSS median (IQR) 6 (8)) were included. Median (IQR) COPM Performance and Satisfaction scores (min.1-max.10) improved from pre-intervention 2 (5) to post-intervention 5 (7). Findings suggested that meeting rehabilitation needs was facilitated by strengthening participants' sense of intrinsic motivation (through grounding exercises in everyday activities linked to valued life roles, and enabling them to overcome barriers to self-managed practice), and via therapeutic relationships (through trust and expertise, shared decision-making, encouragement and emotional support). Collectively, these mechanisms enabled stroke survivors to build confidence and gain mastery experience necessary to engage in new self-managed practice routines. Conclusion: This realist-informed study enabled the development of initial programme theories to explain how and in what circumstances the augmented arm rehabilitation intervention may have enabled participants to meet their personal rehabilitation needs. Encouraging participants' sense of intrinsic motivation and building therapeutic relationships appeared instrumental. These initial programme theories require further testing, refinement, and integration with the wider literature.

WeWalk: walking with a buddy after stroke-a pilot study evaluating feasibility and acceptability of a person-centred dyadic behaviour change intervention.

BACKGROUND: Evidence for benefits of physical activity after stroke is unequivocal. However, many people with stroke are inactive, spending > 80% of waking hours sedentary even when they have physical capacity for activity, indicating barriers to physical activity participation that are not physical. WeWalk is a 12-week person-centred dyadic behaviour change intervention in which a person with stroke (PWS) and a walking buddy form a dyad to work together to support the PWS to increase their physical activity by walking outdoors. This pilot study examined the feasibility of recruiting dyads, explored their perceptions of acceptability and their experiences using WeWalk, to identify required refinements before progression to a clinical trial. METHODS: Design: A single-arm observational pilot study with qualitative evaluation. INTERVENTION: WeWalk involved facilitated face-to-face and telephone sessions with a researcher who was also a behaviour change practitioner, supported by intervention handbooks and diaries, in which dyads agreed walking goals and plans, monitored progress, and developed strategies for maintaining walking. EVALUATION: Descriptive data on recruitment and retention were collected. Interview data were collected through semi-structured interviews and analysed using thematic analysis, guided by a theoretical framework of acceptability. RESULTS: We recruited 21 dyads comprising community dwelling PWS and their walking buddies. Ten dyads fully completed WeWalk before government-imposed COVID-19 lockdown. Despite lockdown, 18 dyads completed exit interviews. We identified three themes: acceptability evolves with experience, mutuality, and person-centredness with personally relevant tailoring. As dyads recognised how WeWalk components supported walking, perceptions of acceptability grew. Effort receded as goals and enjoyment of walking together were realised. The dyadic structure provided accountability, and participants' confidence developed as they experienced physical and psychological benefits of walking. WeWalk worked best when dyads exhibited relational connectivity and mutuality in setting and achieving goals. Tailoring intervention components to individual circumstances and values supported dyads in participation and achieving meaningful goals. CONCLUSION: Recruiting dyads was feasible and most engaged with WeWalk. Participants viewed the dyadic structure and intervention components as acceptable for promoting outdoor walking and valued the personally tailored nature of WeWalk. Developing buddy support skills and community delivery pathways are required refinements. ISCTRN number: 34488928.

Co-creating Digital Stories With UK-Based Stroke Survivors With the Aim of Synthesizing Collective Lessons From Individual Experiences of Interacting With Healthcare Professionals.

Background: Stroke survivor narratives can provide valuable insight into experiences of healthcare and beyond. There is need to further understand collective lessons from stroke survivor narratives, yet prior studies utilizing digital storytelling tend to not synthesize lessons from individual experiences. This study aims to develop a novel method to co-create digital stories with stroke survivors that will aim to synthesize and portray important collective lessons from individual stroke survivors' experiences of interacting with healthcare professionals. Methods: This study follows-up a qualitative study conducted with 30 stroke survivors exploring factors that help or hinder survivors to positively reconfigure their identity post-stroke. Five co-creation workshops were conducted with a subset of UK-based stroke survivors from this previous study. Participants were invited to join through: online workshops, an online bulletin board, and as an advisor. A four-stage workshop framework was developed through the integration of UK Design Council's Double Diamond method, digital storytelling strategies and the Behavior Change Wheel (BCW) framework for developing behavioral change interventions. Findings: Six online workshop participants (three male, three female; aged 33-63; time since stroke 2-16 years) co-created digital stories that share six collective lessons aimed at increasing empathy and encouraging behavior change in healthcare professionals (HCPs) working with stroke survivors. Online bulletin board participants (n = 1) and advisors (n = 5) supported the co-creation process. Collective lessons identified were: (1) Stroke has a variety of symptoms that must all be considered; (2) Stroke can affect anyone of any age and not just the elderly; (3) Assumptions should not be made about a survivor's lifestyle or habits; (4) It is important to acknowledge the person behind the stroke and ensure that they are communicated with and listened to; (5) Stroke survivors can often feel unprepared for the reality of life after stroke; (6) Adapting to life after stroke is a long-term process requiring long-term support. Conclusion: Stroke survivor stories highlighted preconceptions, attitudes and behaviors embedded within healthcare that negatively impacted their experiences and recovery. The novel methodology employed in this study enabled these stories to be synthesized into collective lessons to bring about improvements in these behaviors in future.

A real-time algorithm for the detection of compensatory movements during reaching.

Introduction: Interactive game systems can motivate stroke survivors to engage with their rehabilitation exercises. However, it is crucial that systems are in place to detect if exercises are performed correctly as stroke survivors often perform compensatory movements which can be detrimental to recovery. Very few game systems integrate motion tracking algorithms to monitor performance and detect such movements. This paper describes the development of algorithms which monitor for compensatory movements during upper limb reaching movements in real-time and provides quantitative metrics for health professionals to monitor performance and progress over time. Methods: A real-time algorithm was developed to analyse reaching motions in real-time through a low-cost depth camera. The algorithm segments cyclical reaching motions into component parts, including compensatory movement, and provides a graphical representation of task performance. Healthy participants (n = 10) performed reaching motions facing the camera. The real-time accuracy of the algorithm was assessed by comparing offline analysis to real-time collection of data. Results: The algorithm's ability to segment cyclical reaching motions and detect the component parts in real-time was assessed. Results show that movement types can be detected in real time with accuracy, showing a maximum error of 1.71%. Conclusions: Using the methods outlined, the real-time detection and quantification of compensatory movements is feasible for integration within home-based, repetitive task practice game systems for people with stroke.

We Walk: a person-centred, dyadic behaviour change intervention to promote physical activity through outdoor walking after stroke-an intervention development study.

OBJECTIVES: To develop We Walk, a theoretically informed, 12-week person-centred dyadic behaviour change intervention to increase physical activity (PA) in community-dwelling people with stroke (PWS) through outdoor walking. DESIGN: Three-phase intervention development study. Phase 1: we reviewed literature on barriers and facilitators to PA after stroke and mapped them to the Behaviour Change Wheel and Theoretical Domains Framework to define intervention components. The Health Action Process Approach determined intervention structure underpinned by person-centred principles. Phase 2: stakeholder focus groups involving PWS, their companions and health professionals reviewed the draft intervention, and experts in behaviour change were consulted. Phase 3: informed by phases 1 and 2, the intervention and form of delivery were refined, with final review through patient and public involvement. SETTING: Three Scottish community rehabilitation stroke services. PARTICIPANTS: Twenty-three ambulatory community-dwelling PWS and their companions, thirty-seven health and exercise professionals, seven behaviour change experts. RESULTS: Phase 1 determined key intervention components: information about benefits of walking; developing motivation and confidence to walk; facilitating dyadic goal setting and making plans together; monitoring walking, overcoming challenges; and maintaining walking behaviour. Phase 2 review by stakeholder focus groups and behaviour change experts endorsed intervention components and structure, emphasising dyadic relational aspects as central to potential success. In phase 3, intervention content and handbooks for PWS and buddies were finalised. Healthcare professionals proposed third-sector delivery as most appropriate for intervention delivery. A detailed delivery manual was developed. Participants preferred facilitated face-to-face and telephone delivery. CONCLUSIONS: Our multilens intervention development approach ensured this novel intervention was evidence-informed, person-centred, theoretically coherent provided appropriate social support, and addressed issues of concern to PWS. This study established intervention components and structure and identified operational issues critical to future success. Future research will pilot and refine We Walk and evaluate acceptability, feasibility, effectiveness and cost-effectiveness. TRIAL REGISTRATION NUMBER: ISRCTN34488928.

SaeboGlove therapy for upper limb disability and severe hand impairment after stroke (SUSHI): Study protocol for a randomised controlled trial.

BACKGROUND: Impaired active digital extension is common after stroke, hindering functional rehabilitation, and predicting poor recovery. The SaeboGlove assists digital extension and may improve outcome after stroke. We recently performed a single group, open, pilot trial of the SaeboGlove early after stroke which demonstrated satisfactory safety, feasibility and acceptability. An adequately powered randomised clinical trial is now needed to assess the clinical effectiveness of the SaeboGlove. METHODS: SUSHI is a pragmatic, multicentre, parallel-group, randomised controlled trial with blinded outcome assessment, and embedded process and economic evaluations. Adults, 7-60 days post-stroke, with upper limb disability and severe hand impairment, including reduced active digital extension, will be recruited from NHS inpatient stroke services in Scotland. Participants will be randomised on a 1:1 basis to receive 6 weeks of self-directed, repetitive, functional-based practice involving a SaeboGlove plus usual care, or usual care only. The primary outcome is upper limb function measured by the Action Research Arm Test (ARAT) at 6 weeks. Secondary outcomes will be measured at 6 and 14 weeks. A process evaluation will be performed via interviews with 'intervention' participants, and their carers and clinical therapists. A within-trial cost-effectiveness analysis will be performed. 110 participants are required to detect a difference between groups of 9 in the ARAT with 90% power at a 5% significance level allowing for 11% attrition. DISCUSSION: SUSHI will determine if SaeboGlove self-directed, repetitive, functional-based practice improves upper limb function after stroke, whether it is acceptable to stroke survivors and whether it is cost-effective.

Interventions for reducing sedentary behaviour in people with stroke.

BACKGROUND: Stroke survivors are often physically inactive as well as sedentary,and may sit for long periods of time each day. This increases cardiometabolic risk and has impacts on physical and other functions. Interventions to reduce or interrupt periods of sedentary time, as well as to increase physical activity after stroke, could reduce the risk of secondary cardiovascular events and mortality during life after stroke. OBJECTIVES: To determine whether interventions designed to reduce sedentary behaviour after stroke, or interventions with the potential to do so, can reduce the risk of death or secondary vascular events, modify cardiovascular risk, and reduce sedentary behaviour. SEARCH METHODS: In December 2019, we searched the Cochrane Stroke Trials Register, CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, Conference Proceedings Citation Index, and PEDro. We also searched registers of ongoing trials, screened reference lists, and contacted experts in the field. SELECTION CRITERIA: Randomised trials comparing interventions to reduce sedentary time with usual care, no intervention, or waiting-list control, attention control, sham intervention or adjunct intervention. We also included interventions intended to fragment or interrupt periods of sedentary behaviour. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies and performed 'Risk of bias' assessments. We analyzed data using random-effects meta-analyses and assessed the certainty of the evidence with the GRADE approach. MAIN RESULTS: We included 10 studies with 753 people with stroke. Five studies used physical activity interventions, four studies used a multicomponent lifestyle intervention, and one study used an intervention to reduce and interrupt sedentary behaviour. In all studies, the risk of bias was high or unclear in two or more domains. Nine studies had high risk of bias in at least one domain. The interventions did not increase or reduce deaths (risk difference (RD) 0.00, 95% confidence interval (CI) -0.02 to 0.03; 10 studies, 753 participants; low-certainty evidence), the incidence of recurrent cardiovascular or cerebrovascular events (RD -0.01, 95% CI -0.04 to 0.01; 10 studies, 753 participants; low-certainty evidence), the incidence of falls (and injuries) (RD 0.00, 95% CI -0.02 to 0.02; 10 studies, 753 participants; low-certainty evidence), or incidence of other adverse events (moderate-certainty evidence). Interventions did not increase or reduce the amount of sedentary behaviour time (mean difference (MD) +0.13 hours/day, 95% CI -0.42 to 0.68; 7 studies, 300 participants; very low-certainty evidence). There were too few data to examine effects on patterns of sedentary behaviour. The effect of interventions on cardiometabolic risk factors allowed very limited meta-analysis. AUTHORS' CONCLUSIONS: Sedentary behaviour research in stroke seems important, yet the evidence is currently incomplete, and we found no evidence for beneficial effects. Current World Health Organization (WHO) guidelines recommend reducing the amount of sedentary time in people with disabilities, in general. The evidence is currently not strong enough to guide practice on how best to reduce sedentariness specifically in people with stroke. More high-quality randomised trials are needed, particularly involving participants with mobility limitations. Trials should include longer-term interventions specifically targeted at reducing time spent sedentary, risk factor outcomes, objective measures of sedentary behaviour (and physical activity), and long-term follow-up.

Economic evaluation of robot-assisted training versus an enhanced upper limb therapy programme or usual care for patients with moderate or severe upper limb functional limitation due to stroke: results from the RATULS randomised controlled trial.

OBJECTIVE: To determine whether robot-assisted training is cost-effective compared with an enhanced upper limb therapy (EULT) programme or usual care. DESIGN: Economic evaluation within a randomised controlled trial. SETTING: Four National Health Service (NHS) centres in the UK: Queen's Hospital, Barking, Havering and Redbridge University Hospitals NHS Trust; Northwick Park Hospital, London Northwest Healthcare NHS Trust; Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde; and North Tyneside General Hospital, Northumbria Healthcare NHS Foundation Trust. PARTICIPANTS: 770 participants aged 18 years or older with moderate or severe upper limb functional limitation from first-ever stroke. INTERVENTIONS: Participants randomised to one of three programmes provided over a 12-week period: robot-assisted training plus usual care; the EULT programme plus usual care or usual care. MAIN ECONOMIC OUTCOME MEASURES: Mean healthcare resource use; costs to the NHS and personal social services in 2018 pounds; utility scores based on EQ-5D-5L responses and quality-adjusted life years (QALYs). Cost-effectiveness reported as incremental cost per QALY and cost-effectiveness acceptability curves. RESULTS: At 6 months, on average usual care was the least costly option (£3785) followed by EULT (£4451) with robot-assisted training being the most costly (£5387). The mean difference in total costs between the usual care and robot-assisted training groups (£1601) was statistically significant (p<0.001). Mean QALYs were highest for the EULT group (0.23) but no evidence of a difference (p=0.995) was observed between the robot-assisted training (0.21) and usual care groups (0.21). The incremental cost per QALY at 6 months for participants randomised to EULT compared with usual care was £74 100. Cost-effectiveness acceptability curves showed that robot-assisted training was unlikely to be cost-effective and that EULT had a 19% chance of being cost-effective at the £20 000 willingness to pay (WTP) threshold. Usual care was most likely to be cost-effective at all the WTP values considered in the analysis. CONCLUSIONS: The cost-effectiveness analysis suggested that neither robot-assisted training nor EULT, as delivered in this trial, were likely to be cost-effective at any of the cost per QALY thresholds considered. TRIAL REGISTRATION NUMBER: ISRCTN69371850.

Quantifying upper limb tremor in people with multiple sclerosis using Fast Fourier Transform based analysis of wrist accelerometer signals.

INTRODUCTION: Tremor is a disabling symptom of Multiple Sclerosis (MS). The development of objective methods of tremor characterisation to assess intervention efficacy and disease progression is therefore important. The possibility of using a Fast Fourier Transform (FFT) method for tremor detection was explored. METHODS: Acceleration from a wrist-worn device was analysed using FFTs to identify and characterise tremor magnitude and frequency. Processing parameters were explored to provide insight into the optimal algorithm. Participants wore a wrist tri-axial accelerometer during 9 tasks. The FAHN clinical assessment of tremor was used as the reference standard. RESULTS: Five people with MS and tremor (57.6 ± 15.3 years, 3 F/2M) and ten disease-free controls (42.4 ± 10.9 years, 5 M/5F) took part. Using specific algorithm settings tremor identification was possible (peak frequency 3-15Hz; magnitude greater than 0.06 g; 2 s windows with 50% overlap; using 2 of 3 axes of acceleration), giving sensitivity 0.974 and specificity 0.971 (38 tremor occurrences out of 108 tasks, 1 false positive, 2 false negatives). Tremor had frequency 3.5-13.0 Hz and amplitude 0.07-2.60g. CONCLUSIONS: Upper limb tremor in people with MS can be detected using a FFT approach based on acceleration recorded at the wrist, demonstrating the possibility of using this minimally encumbering technique within clinical practice.

International consensus recommendations for outcome measurement in post-stroke arm rehabilitation trials.

BACKGROUND: Existing randomized controlled trials (RCTs) of arm rehabilitation interventions after stroke use a wide range of outcome measures, limiting ability to pool data to determine efficacy. Published recommendations also lack stroke survivor, carer and clinician involvement specifically about perceived relevance and importance of outcomes and measures. AIM: To generate international consensus recommendations for selection of outcome measures for use in future stroke RCTs in arm rehabilitation, considering outcomes important to stroke survivors, carers and clinicians. The recommendations are the Standardizing Measurement in Arm Rehabilitation Trials (SMART) Toolbox. DESIGN: Two-round international e-Delphi Survey and consensus meeting. SETTING: Online and University. POPULATION: Fifty-five researchers and clinicians with expertise in stroke upper limb rehabilitation from 18 countries (e-Delphi); N.=13 researchers and clinicians, N.=2 stroke survivors, N.=1 carer (consensus meeting). METHODS: Using systematically identified outcome measures from published RCTs, we conducted a two-round international e-Delphi Survey with researchers and clinicians to identify the most important measures for inclusion in the toolbox. Measures that achieved ≥60% consensus were categorized using the International Classification of Functioning, Disability and Health Framework (ICF); psychometric properties were ascertained from literature and research resources. At a final consensus meeting, expert stakeholders selected measures for inclusion in the toolbox. RESULTS: e-Delphi participants recommended 28/170 measures for discussion at the final consensus meeting. Expert stakeholders (N.=16) selected the Visual Analogue Scale for pain/0-10 Numeric Pain Rating Scale, dynamometry, Action Research Arm Test, Wolf Motor Function Test, Barthel Index, Motricity Index and Fugl-Meyer Assessment (upper limb section of each), Box and Block Test, Motor Activity Log 14, Nine Hole Peg Test, Functional Independence Measure, EQ-5D, Canadian Occupational Performance Measure and Modified Rankin Scale for inclusion in the toolbox. CONCLUSIONS: The SMART Toolbox provides a refined selection of measures that capture outcomes considered important by stakeholders for each ICF domain. CLINICAL REHABILITATION IMPACT: The toolbox will facilitate data aggregation for efficacy analyses thereby strengthening evidence to inform clinical practice. Clinicians can also use the toolbox to guide selection of measures ensuring a patient-centered focus.

Evaluation of the enhanced upper limb therapy programme within the Robot-Assisted Training for the Upper Limb after Stroke trial: descriptive analysis of intervention fidelity, goal selection and goal achievement.

OBJECTIVE: To report the fidelity of the enhanced upper limb therapy programme within the Robot-Assisted Training for the Upper Limb after stroke (RATULS) randomized controlled trial, the types of goals selected and the proportion of goals achieved. DESIGN: Descriptive analysis of data on fidelity, goal selection and achievement from an intervention group within a randomized controlled trial. SETTING: Out-patient stroke rehabilitation within four UK NHS centres. SUBJECTS: 259 participants with moderate-severe upper limb activity limitation (Action Research Arm Test 0-39) between one week and five years post first stroke. INTERVENTION: The enhanced upper limb therapy programme aimed to provide 36 one-hour sessions, including 45 minutes of face-to-face therapy focusing on personal goals, over 12 weeks. RESULTS: 7877/9324 (84%) sessions were attended; a median of 34 [IQR 29-36] per participant. A median of 127 [IQR 70-190] repetitions were achieved per participant per session attended. Based upon the Canadian Occupational Performance Measure, goal categories were: self-care 1449/2664 (54%); productivity 374/2664 (14%); leisure 180/2664 (7%) and 'other' 661/2664 (25%). For the 2051/2664 goals for which data were available, 1287 (51%) were achieved, ranging between 27% by participants more than 12 months post stroke with baseline Action Research Arm Test scores 0-7, and 88% by those less than three months after stroke with scores 8-19. CONCLUSIONS: Intervention fidelity was high. Goals relating to self-care were most commonly selected. The proportion of goals achieved varied, depending on time post stroke and baseline arm activity limitation.

Experiences of augmented arm rehabilitation including supported self-management after stroke: a qualitative investigation.

OBJECTIVE: To explore the experiences of stroke survivors and their carers of augmented arm rehabilitation including supported self-management in terms of its acceptability, appropriateness and relevance. DESIGN: A qualitative design, nested within a larger, multi-centre randomized controlled feasibility trial that compared augmented arm rehabilitation starting at three or nine weeks after stroke, with usual care. Semi-structured interviews were conducted with participants in both augmented arm rehabilitation groups. Normalization Process Theory was used to inform the topic guide and map the findings. Framework analysis was applied. SETTING: Interviews were conducted in stroke survivors' homes, at Glasgow Caledonian University and in hospital. PARTICIPANTS: 17 stroke survivors and five carers were interviewed after completion of augmented arm rehabilitation. INTERVENTION: Evidence-based augmented arm rehabilitation (27 additional hours over six weeks), including therapist-led sessions and supported self-management. RESULTS: Three main themes were identified: (1) acceptability of the intervention (2) supported self-management and (3) coping with the intervention. All stroke survivors coped well with the intensity of the augmented arm rehabilitation programme. The majority of stroke survivors engaged in supported self-management and implemented activities into their daily routine. However, the findings suggest that some stroke survivors (male >70 years) had difficulties with self-management, needing a higher level of support. CONCLUSION: Augmented arm rehabilitation commencing within nine weeks post stroke was reported to be well tolerated. The findings suggested that supported self-management seemed acceptable and appropriate to those who saw the relevance of the rehabilitation activities for their daily lives, and embedded them into their daily routines.

Identifying and Responding to Delirium in Acute Stroke: Clinical Team Members' Understandings.

Delirium is associated with increased mortality, morbidity, and length of hospital stay. In the acute stroke setting, delirium identification is challenging due to the complexity of cognitive screening in this patient group. The aim of this study was to explore how members of interprofessional stroke-unit teams identified and responded to a potential delirium in a patient. Online focus groups and interviews utilizing case vignettes were conducted with 15 participants: nurses, occupational therapists, speech and language therapists, and physiotherapists working in acute stroke services. Participants' understandings of delirium varied, most participants did not identify the symptoms of a possible hypoactive delirium, and nearly all participants discussed delirium symptoms in tentative terms. Aspects of interprofessional working were discussed through the expression of distinct roles around delirium identification. Although participants demonstrated an ethos of person-focused care, there are ongoing challenges involved in early identification and management of delirium in stroke survivors.

Robot-assisted training compared with an enhanced upper limb therapy programme and with usual care for upper limb functional limitation after stroke: the RATULS three-group RCT.

BACKGROUND: Loss of arm function is common after stroke. Robot-assisted training may improve arm outcomes. OBJECTIVE: The objectives were to determine the clinical effectiveness and cost-effectiveness of robot-assisted training, compared with an enhanced upper limb therapy programme and with usual care. DESIGN: This was a pragmatic, observer-blind, multicentre randomised controlled trial with embedded health economic and process evaluations. SETTING: The trial was set in four NHS trial centres. PARTICIPANTS: Patients with moderate or severe upper limb functional limitation, between 1 week and 5 years following first stroke, were recruited. INTERVENTIONS: Robot-assisted training using the Massachusetts Institute of Technology-Manus robotic gym system (InMotion commercial version, Interactive Motion Technologies, Inc., Watertown, MA, USA), an enhanced upper limb therapy programme comprising repetitive functional task practice, and usual care. MAIN OUTCOME MEASURES: The primary outcome was upper limb functional recovery 'success' (assessed using the Action Research Arm Test) at 3 months. Secondary outcomes at 3 and 6 months were the Action Research Arm Test results, upper limb impairment (measured using the Fugl-Meyer Assessment), activities of daily living (measured using the Barthel Activities of Daily Living Index), quality of life (measured using the Stroke Impact Scale), resource use costs and quality-adjusted life-years. RESULTS: A total of 770 participants were randomised (robot-assisted training, n = 257; enhanced upper limb therapy, n = 259; usual care, n = 254). Upper limb functional recovery 'success' was achieved in the robot-assisted training [103/232 (44%)], enhanced upper limb therapy [118/234 (50%)] and usual care groups [85/203 (42%)]. These differences were not statistically significant; the adjusted odds ratios were as follows: robot-assisted training versus usual care, 1.2 (98.33% confidence interval 0.7 to 2.0); enhanced upper limb therapy versus usual care, 1.5 (98.33% confidence interval 0.9 to 2.5); and robot-assisted training versus enhanced upper limb therapy, 0.8 (98.33% confidence interval 0.5 to 1.3). The robot-assisted training group had less upper limb impairment (as measured by the Fugl-Meyer Assessment motor subscale) than the usual care group at 3 and 6 months. The enhanced upper limb therapy group had less upper limb impairment (as measured by the Fugl-Meyer Assessment motor subscale), better mobility (as measured by the Stroke Impact Scale mobility domain) and better performance in activities of daily living (as measured by the Stroke Impact Scale activities of daily living domain) than the usual care group, at 3 months. The robot-assisted training group performed less well in activities of daily living (as measured by the Stroke Impact Scale activities of daily living domain) than the enhanced upper limb therapy group at 3 months. No other differences were clinically important and statistically significant. Participants found the robot-assisted training and the enhanced upper limb therapy group programmes acceptable. Neither intervention, as provided in this trial, was cost-effective at current National Institute for Health and Care Excellence willingness-to-pay thresholds for a quality-adjusted life-year. CONCLUSIONS: Robot-assisted training did not improve upper limb function compared with usual care. Although robot-assisted training improved upper limb impairment, this did not translate into improvements in other outcomes. Enhanced upper limb therapy resulted in potentially important improvements on upper limb impairment, in performance of activities of daily living, and in mobility. Neither intervention was cost-effective. FUTURE WORK: Further research is needed to find ways to translate the improvements in upper limb impairment seen with robot-assisted training into improvements in upper limb function and activities of daily living. Innovations to make rehabilitation programmes more cost-effective are required. LIMITATIONS: Pragmatic inclusion criteria led to the recruitment of some participants with little prospect of recovery. The attrition rate was higher in the usual care group than in the robot-assisted training or enhanced upper limb therapy groups, and differential attrition is a potential source of bias. Obtaining accurate information about the usual care that participants were receiving was a challenge. TRIAL REGISTRATION: Current Controlled Trials ISRCTN69371850. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 54. See the NIHR Journals Library website for further project information.

Many people who have arm weakness following a stroke feel that insufficient attention is paid by rehabilitation services to recovery of their arm. Unfortunately, it is currently unclear how best to provide rehabilitation to optimise recovery, but robot-assisted training and therapy programmes that focus on practising functional tasks are promising and require further evaluation. The Robot-Assisted Training for the Upper Limb after Stroke (RATULS) trial evaluated three approaches to rehabilitation for people with moderate or severe difficulty using their arm. These approaches were robot-assisted training using the Massachusetts Institute of Technology-Manus robotic gym system (InMotion commercial version, Interactive Motion Technologies, Inc., Watertown, MA, USA), an enhanced upper limb therapy programme based on repetitive practice of functional tasks and usual care. Robot-assisted training and the enhanced upper limb therapy programme were provided in an outpatient setting for 45 minutes per session, three times per week, for 12 weeks, in addition to usual care. The Massachusetts Institute of Technology-Manus robotic gym system was selected as it was felt to be the best available technology. The participant sits at a table, places their affected arm onto the Massachusetts Institute of Technology-Manus arm support and attempts to move their arm to play a game on the computer screen. Movements are assisted by the Massachusetts Institute of Technology-Manus if the patient cannot perform the movements themselves. The results of the RATULS trial show that robot-assisted training did not result in additional improvement in stroke survivors' arm use when compared with the enhanced upper limb therapy programme or usual care. Stroke survivors who received enhanced upper limb therapy experienced meaningful improvements in undertaking activities of daily living, when compared with those participants who received either robot-assisted training or usual care. Participants who received enhanced upper limb therapy also experienced benefits in their mobility, compared with usual care participants. Participants and therapists found both therapies acceptable, and described various benefits. A health economic analysis found that neither robot-assisted training nor the enhanced upper limb therapy programme was a cost-effective treatment for the NHS.

Robot assisted training for the upper limb after stroke (RATULS): a multicentre randomised controlled trial.

BACKGROUND: Loss of arm function is a common problem after stroke. Robot-assisted training might improve arm function and activities of daily living. We compared the clinical effectiveness of robot-assisted training using the MIT-Manus robotic gym with an enhanced upper limb therapy (EULT) programme based on repetitive functional task practice and with usual care. METHODS: RATULS was a pragmatic, multicentre, randomised controlled trial done at four UK centres. Stroke patients aged at least 18 years with moderate or severe upper limb functional limitation, between 1 week and 5 years after their first stroke, were randomly assigned (1:1:1) to receive robot-assisted training, EULT, or usual care. Robot-assisted training and EULT were provided for 45 min, three times per week for 12 weeks. Randomisation was internet-based using permuted block sequences. Treatment allocation was masked from outcome assessors but not from participants or therapists. The primary outcome was upper limb function success (defined using the Action Research Arm Test [ARAT]) at 3 months. Analyses were done on an intention-to-treat basis. This study is registered with the ISRCTN registry, number ISRCTN69371850. FINDINGS: Between April 14, 2014, and April 30, 2018, 770 participants were enrolled and randomly assigned to either robot-assisted training (n=257), EULT (n=259), or usual care (n=254). The primary outcome of ARAT success was achieved by 103 (44%) of 232 patients in the robot-assisted training group, 118 (50%) of 234 in the EULT group, and 85 (42%) of 203 in the usual care group. Compared with usual care, robot-assisted training (adjusted odds ratio [aOR] 1·17 [98·3% CI 0·70-1·96]) and EULT (aOR 1·51 [0·90-2·51]) did not improve upper limb function; the effects of robot-assisted training did not differ from EULT (aOR 0·78 [0·48-1·27]). More participants in the robot-assisted training group (39 [15%] of 257) and EULT group (33 [13%] of 259) had serious adverse events than in the usual care group (20 [8%] of 254), but none were attributable to the intervention. INTERPRETATION: Robot-assisted training and EULT did not improve upper limb function after stroke compared with usual care for patients with moderate or severe upper limb functional limitation. These results do not support the use of robot-assisted training as provided in this trial in routine clinical practice. FUNDING: National Institute for Health Research Health Technology Assessment Programme.