Moving stroke rehabilitation evidence into practice: a systematic review of randomized controlled trials.

OBJECTIVE: The aim of this study was to investigate the effectiveness of interventions aimed at moving research evidence into stroke rehabilitation practice through changing the practice of clinicians. DATA SOURCES: EMBASE, CINAHL, Cochrane and MEDLINE databases were searched from 1980 to April 2019. International trial registries and reference lists of included studies completed our search. REVIEW METHODS: Randomized controlled trials that involved interventions aiming to change the practice of clinicians working in stroke rehabilitation were included. Bias was evaluated using RevMan to generate a risk of bias table. Evidence quality was evaluated using GRADE criteria. RESULTS: A total of 16 trials were included (250 sites, 14,689 patients), evaluating a range of interventions including facilitation, audit and feedback, education and reminders. Of which, 11 studies included multicomponent interventions (using a combination of interventions). Four used educational interventions alone, and one used electronic reminders. Risk of bias was generally low. Overall, the GRADE criteria indicated that this body of literature was of low quality. This review found higher efficacy of trials which targeted fewer outcomes. Subgroup analysis indicated moderate-level GRADE evidence (103 sites, 10,877 patients) that trials which included both site facilitation and tailoring for local factors were effective in changing clinical practice. The effect size of these varied (odds ratio: 1.63-4.9). Education interventions alone were not effective. CONCLUSION: A large range of interventions are used to facilitate clinical practice change. Education is commonly used, but in isolation is not effective. Multicomponent interventions including facilitation and tailoring to local settings can change clinical practice and are more effective when targeting fewer changes.

Mechanisms of change of a novel weight loss programme provided by a third sector organisation: a qualitative interview study.

BACKGROUND: There is a need for theory-driven studies that explore the underlying mechanisms of change of complex weight loss programmes. Such studies will contribute to the existing evidence-base on how these programmes work and thus inform the future development and evaluation of tailored, effective interventions to tackle overweight and obesity. This study explored the mechanisms by which a novel weight loss programme triggered change amongst participants. The programme, delivered by a third sector organisation, addressed both diet and physical activity. Over a 26 week period participants engaged in three weekly sessions (education and exercise in a large group, exercise in a small group and a one-to-one education and exercise session). Novel aspects included the intensity and duration of the programme, a competitive selection process, milestone physical challenges (e.g. working up to a 5 K and 10 K walk/run during the programme), alumni support (face-to-face and online) and family attendance at exercise sessions. METHODS: Data were collected through interviews with programme providers (n = 2) and focus groups with participants (n = 12). Discussions were audio-recorded, transcribed and analysed using NVivo10. Published behaviour change frameworks and behaviour change technique taxonomies were used to guide the coding process. RESULTS: Clients' interactions with components of the weight loss programme brought about a change in their commitment, knowledge, beliefs about capabilities and social and environmental contexts. Intervention components that generated these changes included the competitive selection process, group and online support, family involvement and overcoming milestone challenges over the 26 week programme. The mechanisms by which these components triggered change differed between participants. CONCLUSIONS: There is an urgent need to establish robust interventions that can support people who are overweight and obese to achieve a healthy weight and maintain this change. Third sector organisations may be a feasible alternative to private and public sector weight loss programmes. We have presented findings from one example of a novel community-based weight loss programme and identified how the programme components resulted in change amongst the participants. Further research is needed to robustly test the effectiveness, and cost-effectiveness, of this programme.

Mechanisms of action of an implementation intervention in stroke rehabilitation: a qualitative interview study.

BACKGROUND: Despite best evidence demonstrating the effectiveness of increased intensity of exercise after stroke, current levels of therapy continue to be below those required to optimise motor recovery. We developed and tested an implementation intervention that aims to increase arm exercise in stroke rehabilitation. The aim of this study was to illustrate the use of a behaviour change framework, the Behaviour Change Wheel, to identify the mechanisms of action that explain how the intervention produced change. METHODS: We implemented the intervention at three stroke rehabilitation units in the United Kingdom. A purposive sample of therapy team members were recruited to participate in semi-structured interviews to explore their perceptions of how the intervention produced change at their work place. Audio recordings were transcribed and imported into NVivo 10 for content analysis. Two coders separately analysed the transcripts and coded emergent mechanisms. Mechanisms were categorised using the Theoretical Domains Framework (TDF) (an extension of the Capability, Opportunity, Motivation and Behaviour model (COM-B) at the hub of the Behaviour Change Wheel). RESULTS: We identified five main mechanisms of action: 'social/professional role and identity', 'intentions', 'reinforcement', 'behavioural regulation' and 'beliefs about consequences'. At the outset, participants viewed the research team as an external influence for whom they endeavoured to complete the study activities. The study design, with a focus on implementation in real world settings, influenced participants' intentions to implement the intervention components. Monthly meetings between the research and therapy teams were central to the intervention and acted as prompt or reminder to sustain implementation. The phased approach to introducing and implementing intervention components influenced participants' beliefs about the feasibility of implementation. CONCLUSIONS: The Behaviour Change Wheel, and in particular the Theoretical Domains Framework, were used to investigate mechanisms of action of an implementation intervention. This approach allowed for consideration of a range of possible mechanisms, and allowed us to categorise these mechanisms using an established behaviour change framework. Identification of the mechanisms of action, following testing of the intervention in a number of settings, has resulted in a refined and more robust intervention programme theory for future testing.

Investigating measures of intensity during a structured upper limb exercise program in stroke rehabilitation: an exploratory study.

OBJECTIVES: To use 3 measures of intensity­time, observed repetitions, and wrist accelerometer activity counts­to describe the intensity of exercise carried out when completing a structured upper limb exercise program, and to explore whether a relationship exists between wrist accelerometer activity counts and observed repetitions. DESIGN: Observational study design. SETTING: Rehabilitation center research laboratory. PARTICIPANTS: Community-dwelling stroke survivors (N=13) with upper limb hemiparesis. INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: Time engaged in exercise, total repetitions, and accelerometer activity counts for the affected upper limb. RESULTS: Mean session time ± SD was 48.5±7.8 minutes. Participants were observed to be engaged in exercises for 63.8%±7.5% of the total session time. The median number of observed repetitions per session was 340 (interquartile range [IQR], 199-407), of which 251 (IQR, 80-309) were purposeful repetitions. Wrist accelerometers showed the stroke survivors' upper limbs to be moving for 75.7%±15.9% of the total session time. Purposeful repetitions and activity counts were found to be significantly correlated (ρ=.627, P<.05). CONCLUSIONS: Stroke survivors were not actively engaged in exercises for approximately one third of each exercise session. Overall session time may not be the most accurate measure of intensity. Counting repetitions was feasible when using a structured exercise program and provides a clinically meaningful way of monitoring intensity and progression. Wrist accelerometers provided an objective measure for how much the arm moves, which correlated with purposeful repetitions. Further research using repetitions and accelerometers as measures of intensity is warranted.

Evaluating the Dissemination and Implementation Impact of a Rehabilitation Intervention: The Graded Repetitive Arm Supplementary Program (GRASP).

Purpose: To evaluate the dissemination and implementation impacts of a rehabilitation intervention. Methods: Systematic evaluation of data sources including academic publishing metrics, publications, and surveys was used to describe the dissemination and implementation impact of the graded repetitive arm supplementary program (GRASP). Three categories in the Payback Framework were evaluated: knowledge production and dissemination, benefits to future research and research use, and real-world uptake and implementation. Results: In the Knowledge production and dissemination category, seven publications, authored by the GRASP research team, were associated with the GRASP, and there were approximately 17,000 download counts of GRASP manuals from the website from 120 countries. In the Benefits to future research and research use category, 15 studies and 8 registered clinical trials, authored by researchers outside of the GRASP team, have used GRASP as an intervention. In the real-world uptake and implementation category, GRASP has informed recommendations in 2 clinical guidelines and 20 review papers, and had high implementation uptake (e.g., 35% [53/154] of UK therapists surveyed had used GRASP; 95% [649/681] who downloaded GRASP had used it). More than 75% of those who had used GRASP identified that GRASP provides more intensity in upper extremity rehabilitation, is evidence-based and easy to implement, and the equipment and manual are easy to obtain. Conclusion: The Payback Framework is useful to evaluate the dissemination and implementation impacts of a rehabilitation intervention. GRASP has been implemented extensively in clinical practice and community in a relatively short time since it has been developed.

Implementation of increased physical therapy intensity for improving walking after stroke: Walk 'n watch protocol for a multisite stepped-wedge cluster-randomized controlled trial.

RATIONALE: Clinical practice guidelines support structured, progressive protocols for improving walking after stroke. Yet, practice is slow to change, evidenced by the little amount of walking activity in stroke rehabilitation units. Our recent study (n = 75) found that a structured, progressive protocol integrated with typical daily physical therapy improved walking and quality-of-life measures over usual care. Research therapists progressed the intensity of exercise by using heart rate and step counters worn by the participants with stroke during therapy. To have the greatest impact, our next step is to undertake an implementation trial to change practice across stroke units where we enable the entire unit to use the protocol as part of standard of care. AIMS: What is the effect of introducing structured, progressive exercise (termed the Walk 'n Watch protocol) to the standard of care on the primary outcome of walking in adult participants with stroke over the hospital inpatient rehabilitation period? Secondary outcomes will be evaluated and include quality of life. METHODS AND SAMPLE SIZE ESTIMATES: This national, multisite clinical trial will randomize 12 sites using a stepped-wedge design where each site will be randomized to deliver Usual Care initially for 4, 8, 12, or 16 months (three sites for each duration). Then, each site will switch to the Walk 'n Watch phase for the remaining duration of a total 20-month enrolment period. Each participant will be exposed to either Usual Care or Walk 'n Watch. The trial will enroll a total of 195 participants with stroke to achieve a power of 80% with a Type I error rate of 5%, allowing for 20% dropout. Participants will be medically stable adults post-stroke and able to take five steps with a maximum physical assistance from one therapist. The Walk 'n Watch protocol focuses on completing a minimum of 30 min of weight-bearing, walking-related activities (at the physical therapists' discretion) that progressively increase in intensity informed by activity trackers measuring heart rate and step number. STUDY OUTCOME(S): The primary outcome will be the change in walking endurance, measured by the 6-Minute Walk Test, from baseline (T1) to 4 weeks (T2). This change will be compared across Usual Care and Walk 'n Watch phases using a linear mixed-effects model. Additional physical, cognitive, and quality of life outcomes will be measured at T1, T2, and 12 months post-stroke (T3) by a blinded assessor. DISCUSSION: The implementation of stepped-wedge cluster-randomized trial enables the protocol to be tested under real-world conditions, involving all clinicians on the unit. It will result in all sites and all clinicians on the unit to gain expertise in protocol delivery. Hence, a deliberate outcome of the trial is facilitating changes in best practice to improve outcomes for participants with stroke in the trial and for the many participants with stroke admitted after the trial ends.

Clinical reality of measuring upper-limb ability in neurologic conditions: a systematic review.

OBJECTIVE: To review the psychometric properties and clinical utility of upper-limb measurement tools in people with neurologic conditions to provide recommendations for practice. DATA SOURCES: MEDLINE, CINAHL, EMBASE, PEDro, and AMED. STUDY SELECTION: Independent reviewers searched, selected, and extracted data from articles that assessed reliability, validity, ability to detect change, and clinical utility of measures of the upper limb in adult neurologic conditions. DATA EXTRACTION: Measures with good psychometrics and 8 or higher (out of 10) clinical utility scores were recommended. DATA SYNTHESIS: The searches identified 31 measures of the upper limb. However, only 2 measures fulfilled all of the psychometric and clinical utility criteria; the Box and Block Test and the Action Research Arm Test. CONCLUSIONS: The Box and Block and the Action Research Arm Tests produce robust data and are feasible for use in clinical practice. Future development of new or existing measures should ensure the construct and content validity of the measure is clearly identified, standardized guidelines are easily available, and ensure that it is individualized and contemporary. Attention to measures of upper-limb activity for people who are unable to grip objects is also needed.

Do clinical guidelines guide clinical practice in stroke rehabilitation? An international survey of health professionals.

PURPOSE: To identify health professionals awareness of stroke rehabilitation guidelines, and factors perceived to influence guideline use internationally. METHODS: Online survey study. Open-ended responses were thematically analysed, guided by the Consolidated Framework for Implementation Research. RESULTS: Data from 833 respondents from 30 countries were included. Locally developed guidelines were available in 22 countries represented in the sample. Respondents from high-income countries were more aware of local guidelines compared with respondents from low- and middle-income countries.Local contextual factors such as management support and a culture of valuing evidence-based practice were reported to positively influence guideline use, whereas inadequate time and shortages of skilled staff inhibited the delivery of guideline-recommended care. Processes reported to improve guideline use included education, training, formation of workgroups, and audit-feedback cycles. Broader contextual factors included accountability (or lack thereof) of health professionals to deliver rehabilitation consistent with guideline recommendations. CONCLUSION: While many health professionals were aware of clinical guidelines, they identified multiple barriers to their implementation. Efforts should be made to raise awareness of local guidelines in low- and middle-income countries. More attention should be paid to addressing local contextual factors to improve guideline use internationally, going beyond traditional strategies focused on individual health professionals.IMPLICATIONS FOR REHABILITATIONSystems are required so people and organisations are held accountable to deliver evidence-based care in stroke rehabilitation.Locally developed stroke rehabilitation guidelines should be promoted to boost awareness of these guidelines in low- and middle-income countries.In all regions, strategies to influence or adapt to the local setting, are required to optimise guideline use.

Implementing the PREP2 Algorithm to Predict Upper Limb Recovery Potential After Stroke in Clinical Practice: A Qualitative Study.

OBJECTIVE: Predicting motor recovery after stroke is a key factor when planning and providing rehabilitation for individual patients. The Predict REcovery Potential (PREP2) prediction tool was developed to help clinicians predict upper limb functional outcome. In parallel to further model validation, the purpose of this study was to explore how PREP2 was implemented in clinical practice within the Auckland District Health Board (ADHB) in New Zealand. METHODS: In this case study design using semi-structured interviews, 19 interviews were conducted with clinicians involved in stroke care at ADHB. To explore factors influencing implementation, interview content was coded and analyzed using the consolidated framework for implementation research. Strategies identified by the Expert Recommendations for Implementing Change Project were used to describe how implementation was undertaken. RESULTS: Implementation of PREP2 was initiated and driven by therapists. Key factors driving implementation were as follows: the support given to staff from the implementation team; the knowledge, beliefs, and self-efficacy of staff; and the perceived benefits of having PREP2 prediction information. Twenty-six Expert Recommendations for Implementing Change strategies were identified relating to 3 areas: implementation team, clinical/academic partnerships, and training. CONCLUSIONS: The PREP2 prediction tool was successfully implemented in clinical practice at ADHB. Barriers and facilitators to implementation success were identified, and implementation strategies were described. Lessons learned can aid future development and implementation of prediction models in clinical practice. IMPACT: Translating evidence-based interventions into clinical practice can be challenging and slow; however, shortly after its local validation, PREP2 was successfully implemented into clinical practice at the same site in New Zealand. In parallel to further model validation, organizations and practices can glean useful lessons to aid future implementation.

Factors influencing implementation of aerobic exercise after stroke: a systematic review.

OBJECTIVES: This systematic review aimed to explore the perspectives of healthcare, exercise, and fitness professionals working with people post-stroke regarding the factors affecting the implementation of aerobic exercise after stroke. DATA SOURCES: OVID SP MEDLINE, OVID SP EMBASE, and CINAHL were searched from inception to December 2018 using a combination of search terms with synonyms of stroke, aerobic exercise and barriers/facilitators. REVIEW METHODS: Studies focusing on the factors affecting implementation of aerobic exercise after stroke from staff perspectives were included with no restriction on the types of study design. For inclusivity, a broad definition of aerobic exercise was used. Review authors independently extracted data from included studies using domains from the Consolidated Framework for Implementation Research, then synthesised using a framework synthesis approach. Retrospective automated screening was conducted using Rayyan software. RESULTS: Twenty studies were included. Four reported on implementation of aerobic exercise, sixteen on general exercise interventions, all post-stroke. Factors identified as influencing implementation of aerobic exercise after stroke included professionals' self-efficacy and knowledge about stroke, patients' needs, communication and collaboration within and between organisations and resources such as equipment, staff and training. CONCLUSIONS: Key factors influencing the implementation of aerobic exercise after stroke included characteristics of the staff and intervention and system-level issues, some of which are modifiable. Further research should evaluate strategies which specifically target these modifiable factors to facilitate implementation in practice.IMPLICATIONS FOR REHABILITATIONAerobic exercise after stroke is an effective intervention but there are challenges to implementation from a staff and system perspective.Any changes to the identified factors should be tailored to suit the staff group and setting.Provision of training and knowledge-sharing could improve staff's confidence in the prescription and delivery of aerobic exercise after stroke though other implementation strategies should also be considered.

The effectiveness of quality improvement collaboratives in improving stroke care and the facilitators and barriers to their implementation: a systematic review.

BACKGROUND: To successfully reduce the negative impacts of stroke, high-quality health and care practices are needed across the entire stroke care pathway. These practices are not always shared across organisations. Quality improvement collaboratives (QICs) offer a unique opportunity for key stakeholders from different organisations to share, learn and 'take home' best practice examples, to support local improvement efforts. This systematic review assessed the effectiveness of QICs in improving stroke care and explored the facilitators and barriers to implementing this approach. METHODS: Five electronic databases (MEDLINE, CINAHL, EMBASE, PsycINFO, and Cochrane Library) were searched up to June 2020, and reference lists of included studies and relevant reviews were screened. Studies conducted in an adult stroke care setting, which involved multi-professional stroke teams participating in a QIC, were included. Data was extracted by one reviewer and checked by a second. For overall effectiveness, a vote-counting method was used. Data regarding facilitators and barriers was extracted and mapped to the Consolidated Framework for Implementation Research (CFIR). RESULTS: Twenty papers describing twelve QICs used in stroke care were included. QICs varied in their setting, part of the stroke care pathway, and their improvement focus. QIC participation was associated with improvements in clinical processes, but improvements in patient and other outcomes were limited. Key facilitators were inter- and intra-organisational networking, feedback mechanisms, leadership engagement, and access to best practice examples. Key barriers were structural changes during the QIC's active period, lack of organisational support or prioritisation of QIC activities, and insufficient time and resources to participate in QIC activities. Patient and carer involvement, and health inequalities, were rarely considered. CONCLUSIONS: QICs are associated with improving clinical processes in stroke care; however, their short-term nature means uncertainty remains as to whether they benefit patient outcomes. Evidence around using a QIC to achieve system-level change in stroke is equivocal. QIC implementation can be influenced by individual and organisational level factors, and future efforts to improve stroke care using a QIC should be informed by the facilitators and barriers identified. Future research is needed to explore the sustainability of improvements when QIC support is withdrawn. TRIAL REGISTRATION: Protocol registered on PROSPERO ( CRD42020193966 ).

Factors Influencing the Delivery of Intensive Rehabilitation in Stroke: Patient Perceptions Versus Rehabilitation Therapist Perceptions.

BACKGROUND: Despite increasing evidence regarding the benefit of intensive task-specific practice and aerobic exercise in stroke rehabilitation, implementation remains difficult. The factors influencing implementation have been explored from therapists' perspectives; however, despite an increased emphasis on patient involvement in research, patients' perceptions have not yet been investigated. OBJECTIVE: The study aimed to investigate factors influencing implementation of higher intensity activity in people with stroke and to compare this with therapists' perspectives. DESIGN: The design was a cross-sectional qualitative study. METHODS: The study used semistructured interviews with people with stroke who were part of a randomized clinical trial, the Determining Optimal post-Stroke Exercise study, which delivered a higher intensity intervention. An interview guide was developed and data analyzed using implementation frameworks. Factors emerging from interviews with people with stroke were compared and contrasted with factors perceived by rehabilitation therapists. RESULTS: Ten people with stroke were interviewed before data saturation was reached. Participants had a positive attitude regarding working hard and were satisfied with the graded exercise test, high intensity intervention, and the feedback-monitoring devices. Therapists and patients had contrasting perceptions about their beliefs regarding intensive exercise and the content of the intervention, with therapists more focused on the methods and patients more focused on the personal interactions stemming from the therapeutic relationship. CONCLUSIONS: People with stroke perceived no barriers regarding the implementation of higher intensity rehabilitation in practice and were positive towards working at more intense levels. Contrastingly, from the therapists' perspective, therapists' beliefs about quality of movement and issues around staffing and resources were perceived to be barriers. In addition, therapists and people with stroke perceived the contents of the intervention differently, highlighting the importance of involving patients and clinicians in the development and evaluation of rehabilitation interventions.

A survey of the current practice of intramuscular Botulinum toxin injections for hemiplegic shoulder pain in the UK.

PURPOSE: To describe the current UK practice for the use of intramuscular Botulinum Toxin type A injections to treat hemiplegic shoulder pain. METHOD: A UK-based cross-sectional study using an online survey. Participants (n = 68) were medical and non-medical practitioners recruited via the membership of the British Society for Rehabilitation Medicine and the British Neurotoxin Network. Data was analysed using descriptive statistics and content analysis. RESULTS: The majority of respondents would consider Botulinum Toxin type A for hemiplegic shoulder pain (86.8%), though most of these respondents inject for this goal infrequently (83.1%). Pectoralis major was most commonly selected to achieve this goal. Barriers to this intervention included difficulties determining the cause of pain (29.4%), difficulty isolating muscles (27.9%), and a lack of evidence (25%). The doses reported regularly deviated from guidelines and a substantial range in the volumes suggested was observed. Clinicians were mostly reliant on unstandardised measures to assess outcomes. CONCLUSIONS: Current UK practice of Botulinum Toxin type A injections for hemiplegic shoulder pain associated with spasticity is highly variable. There are large gaps between current practice and available evidence with regards to muscle selection and doses used. A number of areas for further investigation have been identified to progress current understanding of this intervention. Implications for rehabilitation There are wide variations in practice for this complex intervention and clinicians should consider that their individual decision-making could be based on their own beliefs rather than available evidence. Pectoralis major is most commonly injected to treat hemiplegic shoulder pain, but further evaluation is required to address whether it is the most effective. Clinicians most often use a limitation of shoulder abduction and external rotation, flexor patterning of the upper limb, and pain on passive movement to identify when hemiplegic shoulder pain is due to spasticity over other causes. Further research is needed to identify which patients are most likely to benefit from this intervention and at what stage post-stroke its use is most optimal.

Implementation-The Missing Link in the Research Translation Pipeline: Is It Any Wonder No One Ever Implements Evidence-Based Practice?

Despite the exponential growth in the evidence base for stroke rehabilitation, there is still a paucity of knowledge about how to consistently and sustainably deliver evidence-based stroke rehabilitation therapies in clinical practice. This means that people with stroke will not consistently benefit from research breakthroughs, simply because clinicians do not always have the skills, authority, knowledge or resources to be able to translate the findings from a research trial and apply these in clinical practice. This "point of view" article by an interdisciplinary, international team illustrates the lack of available evidence to guide the translation of evidence to practice in rehabilitation, by presenting a comprehensive and systematic content analysis of articles that were published in 2016 in leading clinical stroke rehabilitation journals commonly read by clinicians. Our review confirms that only a small fraction (2.5%) of published stroke rehabilitation research in these journals evaluate the implementation of evidence-based interventions into health care practice. We argue that in order for stroke rehabilitation research to contribute to enhanced health and well-being of people with stroke, journals, funders, policy makers, researchers, clinicians, and professional associations alike need to actively support and promote (through funding, conducting, or disseminating) implementation and evaluation research.

Implementing biomarkers to predict motor recovery after stroke.

BACKGROUND: There is growing interest in using biomarkers to predict motor recovery and outcomes after stroke. The PREP2 algorithm combines clinical assessment with biomarkers in an algorithm, to predict upper limb functional outcomes for individual patients. To date, PREP2 is the first algorithm to be tested in clinical practice, and other biomarker-based algorithms are likely to follow. PURPOSE: This review considers how algorithms to predict motor recovery and outcomes after stroke might be implemented in clinical practice. FINDINGS: There are two tasks: first the prediction information needs to be obtained, and then it needs to be used. The barriers and facilitators of implementation are likely to differ for these tasks. We identify specific elements of the Consolidated Framework for Implementation Research that are relevant to each of these two tasks, using the PREP2 algorithm as an example. These include the characteristics of the predictors and algorithm, the clinical setting and its staff, and the healthcare environment. CONCLUSIONS: Active, theoretically underpinned implementation strategies are needed to ensure that biomarkers are successfully used in clinical practice for predicting motor outcomes after stroke, and should be considered in parallel with biomarker development.

Delivering Intensive Rehabilitation in Stroke: Factors Influencing Implementation.

Background: The evidence base for stroke rehabilitation recommends intensive and repetitive task-specific practice, as well as aerobic exercise. However, translating these -evidence-based interventions from research into clinical practice remains a major -challenge. Objective: The objective of this study was to investigate factors influencing implementation of higher-intensity activity in stroke rehabilitation settings. Design: This qualitative study used a cross-sectional design. Methods: Semi-structured interviews were conducted with rehabilitation therapists from 4 sites across 2 Canadian provinces who had experience in delivering a higher-intensity intervention as part of a clinical trial (Determining Optimal post-Stroke Exercise [DOSE]). An interview guide was developed, and data were analyzed using implementation frameworks. Results: Fifteen therapists were interviewed before data saturation was reached. Therapists and patients generally had positive experiences regarding high-intensity interventions. However, therapists felt they would adapt the protocol to accommodate their beliefs about ensuring movement quality. The requirement for all patients to have a graded exercise test and the use of sensors (eg, heart rate monitors) gave therapists confidence to push patients harder than they normally would. Paradoxically, a system that enables routine graded exercise testing and the availability of staff and equipment contribute challenges for implementation in everyday practice. Conclusions: Even therapists involved in delivering a high-intensity intervention as part of a trial wanted to adapt it for clinical practice; therefore, it is imperative that researchers are explicit regarding key intervention components and what can be adapted to help ensure implementation fidelity. Changes in therapists' beliefs and system-level changes (staffing and resources) are likely necessary to facilitate higher-intensity rehabilitation in practice.

Case Series of a Knowledge Translation Intervention to Increase Upper Limb Exercise in Stroke Rehabilitation.

BACKGROUND AND PURPOSE: Current approaches to upper limb rehabilitation are not sufficient to drive neural reorganization and maximize recovery after stroke. To address this evidence-practice gap, a knowledge translation intervention using the Behaviour Change Wheel was developed. The intervention involves collaboratively working with stroke therapy teams to change their practice and increase therapy intensity by therapists prescribing supplementary self-directed arm exercise. The purposes of this case series are: (1) to provide an illustrative example of how a research-informed process changed clinical practice and (2) to report on staff members' and patients' perceptions of the utility of the developed intervention. CASE DESCRIPTIONS: A participatory action research approach was used in 3 stroke rehabilitation units in the United Kingdom. The intervention aimed to change 4 therapist-level behaviors: (1) screening patients for suitability for supplementary self-directed arm exercise, (2) provision of exercises, (3) involving family and caregivers in assisting with exercises, and (4) monitoring and progressing exercises. Data on changes in practice were collected by therapy teams using a bespoke audit tool. Utility of the intervention was explored in qualitative interviews with patients and staff. OUTCOMES: Components of the intervention were successfully embedded in 2 of the 3 stroke units. At these sites, almost all admitted patients were screened for suitability for supplementary self-directed exercise. Exercises were provided to 77%, 70%, and 88% of suitable patients across the 3 sites. Involving family and caregivers and monitoring and progressing exercises were not performed consistently. CONCLUSIONS: This case series is an example of how a rigorous research-informed knowledge translation process resulted in practice change. Research is needed to demonstrate that these changes can translate into increased intensity of upper limb exercise and affect patient outcomes.

Granulocyte Colony Stimulating Factor and Physiotherapy after Stroke: Results of a Feasibility Randomised Controlled Trial: Stem Cell Trial of Recovery EnhanceMent after Stroke-3 (STEMS-3 ISRCTN16714730).

BACKGROUND: Granulocyte-colony stimulating factor (G-CSF) mobilises endogenous haematopoietic stem cells and enhances recovery in experimental stroke. Recovery may also be dependent on an enriched environment and physical activity. G-CSF may have the potential to enhance recovery when used in combination with physiotherapy, in patients with disability late after stroke. METHODS: A pilot 2 x 2 factorial randomised (1:1) placebo-controlled trial of G-CSF (double-blind), and/or a 6 week course of physiotherapy, in 60 participants with disability (mRS >1), at least 3 months after stroke. Primary outcome was feasibility, acceptability and tolerability. Secondary outcomes included death, dependency, motor function and quality of life measured 90 and 365 days after enrolment. RESULTS: Recruitment to the trial was feasible and acceptable; of 118 screened patients, 92 were eligible and 32 declined to participate. 60 patients were recruited between November 2011 and July 2013. All participants received some allocated treatment. Although 29 out of 30 participants received all 5 G-CSF/placebo injections, only 7 of 30 participants received all 18 therapy sessions. G-CSF was well tolerated but associated with a tendency to more adverse events than placebo (16 vs 10 patients, p = 0.12) and serious adverse events (SAE) (9 vs 3, p = 0.10). On average, patients received 14 (out of 18 planned) therapy sessions, interquartile range [12, 17]. Only a minority (23%) of participants completed all physiotherapy sessions, a large proportion of sessions (114 of 540, 21%) were cancelled due to patient (94, 17%) and therapist factors (20, 4%). No significant differences in functional outcomes were detected in either the G-CSF or physiotherapy group at day 90 or 365. CONCLUSIONS: Delivery of G-CSF is feasible in chronic stroke. However, the study failed to demonstrate feasibility for delivering additional physiotherapy sessions late after stroke therefore a definitive study using this trial design is not supported. Future work should occur earlier after stroke, alongside on-going clinical rehabilitation. TRIAL REGISTRATION: ISRCTN.com ISRCTN16714730.

Activities to support the implementation of complex interventions as part of routine care: a review of the quality of reporting in cluster randomised controlled trials.

OBJECTIVE: To review a sample of cluster randomised controlled trials and explore the quality of reporting of (1) enabling or support activities provided to the staff during the trial, (2) strategies used to monitor fidelity throughout the trial and (3) the extent to which the intervention being tested was delivered as planned. DESIGN: A descriptive review. DATA SOURCES AND STUDY SELECTION: We searched MEDLINE for trial reports published between 2008 and 2014 with combinations of the search terms 'randomised', 'cluster', 'trial', 'study', 'intervention' and 'implement*'. We included trials in which healthcare professionals (HCPs) implemented the intervention being tested as part of routine practice. We excluded trials (1) conducted in non-health services settings, (2) where the intervention explicitly aimed to change the behaviours of the HCPs and (3) where the trials were ongoing or for which only trial protocols were available. DATA COLLECTION: We developed a data extraction form using the Template for Intervention Description and Replication (TIDieR checklist). Review authors independently extracted data from the included trials and assessed quality of reporting for individual items. RESULTS: We included 70 publications (45 results publications, 25 related publications). 89% of trials reported using enabling or support activities. How these activities were provided (75.6%, n=34) and how much was provided (73.3%, n=33) were the most frequently reported items. Less than 20% (n=8) of the included trials reported that competency checking occurred prior to implementation and data collection. 64% (n=29) of trials reported collecting measures of implementation. 44% (n=20) of trials reported data from these measures. CONCLUSIONS: Although enabling and support activities are reported in trials, important gaps exist when assessed using an established checklist. Better reporting of the supports provided in effectiveness trials will allow for informed decisions to be made about financial and resource implications for wide scale implementation of effective interventions.

Development of a behaviour change intervention to increase upper limb exercise in stroke rehabilitation.

BACKGROUND: Two thirds of survivors will achieve independent ambulation after a stroke, but less than half will recover upper limb function. There is strong evidence to support intensive repetitive task-oriented training for recovery after stroke. The number of repetitions needed is suggested to be in the order of hundreds, but this is not currently being achieved in clinical practice. In an effort to bridge this evidence-practice gap, we have developed a behaviour change intervention that aims to increase provision of upper limb repetitive task-oriented training in stroke rehabilitation. This paper aims to describe the systematic processes that took place in collaboratively developing the behaviour change intervention. METHODS: The methods used in this study were not defined a priori but were guided by the Behaviour Change Wheel. The process was collaborative and iterative with four stages of development emerging (i) establishing an intervention development group; (ii) structured discussions to understand the problem, prioritise target behaviours and analyse target behaviours; (iii) collaborative design of theoretically underpinned intervention components and (iv) piloting and refining of intervention components. RESULTS: The intervention development group consisted of the research team and stroke therapy team at a local stroke rehabilitation unit. The group prioritised four target behaviours at the therapist level: (i) identifying suitable patients for exercises, (ii) provision of exercises, (iii) communicating exercises to family/visitors and (iv) monitoring and reviewing exercises. It also provides a method for self-monitoring performance in order to measure fidelity. The developed intervention, PRACTISE (Promoting Recovery of the Arm: Clinical Tools for Intensive Stroke Exercise), consists of team meetings and the PRACTISE Toolkit (screening tool and upper limb exercise plan, PRACTISE exercise pack and an audit tool). CONCLUSIONS: This paper provides an example of how the Behaviour Change Wheel may be applied in the collaborative development of a behaviour change intervention for health professionals. The process involved was resource-intensive, and the iterative process was difficult to capture. The use of a published behaviour change framework and taxonomy will assist replication in future research and clinical use. The feasibility and acceptability of PRACTISE is currently being explored in two other stroke rehabilitation units.