Title: A pilot cluster randomised controlled trial, of an implicit learning approach (ILA) versus standard care, on recovery of mobility following stroke.
Funder: Health Education England

Abstract: BackgroundMotor recovery following stroke is underpinned by the concepts of motor learning. This can be either explicit (conscious learning) or implicit (sub-conscious learning). During rehabilitation, bias toward one type of learning is created by the therapists' use of coaching statements (instruction and feedback). Experts agree that frequent coaching statements that focus attention toward the body (e.g. how to move) will bias explicit learning. Fewer coaching statements, and a focus toward the environment, will bias implicit learning. In sport, implicit learning has been shown to be preferential. Skills learnt implicitly are more robust, and are more likely to be retained over time. Theories propose that providing excessive information, as in explicit learning, interrupts the automatic processes that normally control movement, and results in less effective learning. Despite this, observational studies have shown therapy practice to be highly explicit in nature. This is the first study to test the concept of implicit learning within the acute phase following stroke. Research Question Can the rate of functional motor recovery following stroke be improved by delivering therapy using an implicit learning approach (ILA) during the acute phase? Aims To compare the ILA to standard care in the acute phase following stroke, in order to generate data and insights to inform the design of a definitive trial. To understand patient and therapist perceptions of the ILA.Plan of Investigation A multicentre, assessor blind, pilot cluster randomised controlled trial comparing the ILA to standard care in the acute phase following stroke (n=60). Eight Stroke Units will be randomised to deliver therapy using the ILA, or to control. At the intervention sites, therapy teams will be trained in the ILA, which involves a) reducing the quantity of coaching statements, and b) promoting an external focus of attention, during rehabilitation. Intervention sites will adopt the ILA approach, for all patients, as standard practice, for the duration of their involvement. Eligible patients at both sites will be invited to provide individual consent to participate in additional measures, and for their data to be used for study purposes. To monitor fidelity of the interventions, treatment sessions will be video recorded. A sample of 1 in 6 will be randomly selected for analysis, based on a previously validated method. The primary outcome measure is change in the Berg Balance Scale at 4 weeks post stroke. Secondary measures are the Postural Adjustment in Stroke Scale, Modified Rankin Scale, Stroke Impact Scale, and care requirements on discharge. Primary measures will be recorded at baseline, 2, 4, 6 and 12 weeks post enrolment. At the end of the study, therapist and patient perceptions of the ILA will be sought through focus groups (therapists, n=32) or semi structured interviews (patients, n=20). Focus groups and interviews will be audio recorded, transcribed verbatim, and thematically analysed. Focus group analysis will be underpinned by the concepts of Normalisation Process Theory. Potential Benefits to Patients and the NHS Around 150,000 people suffer a stroke in the UK each year. About 80% of these will have weakness on one side of their body. Although we know that this rehabilitation is effective, understanding of the exact components that contribute to this benefit is limited. If the findings from sport are replicated in stroke, this will lead to important changes to therapist communication practices. Given that being able to transfer from bed to chair with assistance of one person is one of the key criteria for early discharge from hospital following stroke, interventions which promote faster recovery will have important benefits to the health service, as well as the individual patient receiving rehabilitation.

Lay abstract: Aim: To find out whether providing fewer and simpler instructions and feedback during rehabilitation improves movement recovery in people with stroke. Background: In the UK, around 150,000 people suffer a stroke each year. About 80% of these will have weakness on one side of their body. This can vary from a mild loss of muscle strength, to a complete inability to move. This weakness occurs because the damaged part of the brain is no longer able to send strong enough signals to the muscles to make them move. However, with rehabilitation, the brain can adapt, so that movement can be recovered. Re-learning how to stand, step and walk are common goals for people who have suffered a stroke. During rehabilitation, therapists often tell people how to move. For example, straighten your knee when you're standing, or lift your foot as you step. However, theories suggest that it is better to learn movements through trial and error, rather than being told exactly what to do. This is because movements such as stepping are normally automatic we don't think about how to do them. If someone is prompted to think about how they are stepping, the automatic processes that would normally control the movement are disrupted, and they don't step as well. Therefore, reducing the number of instructions or using simpler instructions can help people to move better, and learn faster. Although there is strong evidence to support this approach in some areas (e.g. sport), it has never been properly tested in people with stroke. This study will see whether patients recover the ability stand, step and walk following stroke better when they are given fewer and simpler instructions. This approach is called Implicit Learning. Design and Methods: We will invite eight Stroke Units (hospital wards that care for people with stroke) to take part in the study. Four units will continue to deliver usual rehabilitation, without any input from the research team. Four units will adopt an Implicit Learning Approach (ILA) for the duration of a trial (approximately 4 months). Which one of the two approaches the unit delivers will be chosen at random. At the ILA sites, therapists will be trained to deliver rehabilitation using fewer and less complex instructions. All patients attending a single unit will receive the same rehabilitation care. This helps to ensure that the therapy teams manage to properly deliver the interventions. We will ask individual patients for permission to complete extra assessments, which form part of the study. Participants will be interviewed at the end of the study, to find out what they thought about the ILA. It is important that patient views on the approach are considered, as this will help with the design of future research. This is a pilot study, meaning that we are testing how well this works as a research method. This means we will not know for certain which approach is best, but it will tell us how we should design a larger trial that will give a clear answer. Patient and Public Involvement: People with stroke have worked closely with us to develop this research programme. We have developed four levels of Patient and Public Involvement, so that people can be involved at a level that suits them. For example, by receiving newsletter and commenting on documents from home; through to being part of the research team, where they may provide guidance on running the project, or involved in analysing the findings. Dissemination: If the ILA is found to enable patients to recover better and/or more quickly, therapists could change their approach with minimal cost. In fact, if patients recover more quickly, it could save money. But in order for this happen we need to tell therapists, patients and people responsible for providing healthcare about what we have discovered. We will do this through publications and presentations, and through the development of training materials and courses. Information will also be sent to patient organisations like the Stroke Association and Different Strokes.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: STROKE