A Pilot Cluster Randomised Controlled Trial, of an Implicit Learning Approach (ILA) Versus Standard Care, on Recovery of Mobility Following Stroke
Phase: NA
Conditions: Stroke
Sponsor: The Royal Bournemouth Hospital

                                                                           
 
1 
IMPS Protocol v6 18.08.2020 
 
The IMPS Study Protocol 
[Implicit Learning in Stroke] 
 
A pilot cluster randomised controlled trial, of an implicit 
learning approach (ILA) versus standard care, on recovery of 
mobility following stroke. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Sponsor: 
 
 
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust 
RM&G Office 
5th Floor, Rm R501 
Royal London House  
Bournemouth University 
Christchurch Road 
Bournemouth, BH1 3LT 
 
Sponsor Representative:  
Caroline Jamieson-Leadbitter (Head of Research) 
 
 
 
 
E: Caroline.jamieson-leadbitter@rbch.nhs.uk 
 
 
 
 
T: 01202 962381 
 
Co-Sponsor:   
 
 
University of Southampton 
Faculty of Health Sciences 
Highfield Campus 
Southampton 
SO17 1BJ 
 
Co-Sponsor Representative(s): Professor Jane Burridge  
 
Dr Sara Demain 
 
 
 
 
E: J.H.Burridge@soton.ac.uk 
 
S.H.Demain@soton.ac.uk  
 
 
 
 
T: (023) 8059 8885 
 
 
 
 
 
Chief Investigator: 
 
Dr Louise Johnson 
Stroke Unit 
Royal Bournemouth Hospital 
Castle Lane East 
Bournemouth 
Dorset, BH7 7DW 
E: Louise.johnson@rbch.nhs.uk 
T: (01202) 303 626 ext 5528 
 
Statistician: 
 
 
Dr Sean Ewings 
University of Southampton 
E: Sean.ewings@soton.ac.uk 
T: (023) 8059 7638 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Contents 
1 
Study Synopsis ........................................................................................................................................ 5 
2 
Abbreviations .......................................................................................................................................... 6 
3 
Background and Rationale ...................................................................................................................... 7 
4 
Trial Details ............................................................................................................................................. 8 
4.1 
Aim(s) .............................................................................................................................................. 8 
4.2 
Study Design.................................................................................................................................... 8 
4.3 
Understanding and Describing Baseline ......................................................................................... 8 
4.4 
Recruitment of Clusters .................................................................................................................. 8 
4.4.1 
Eligibility Criteria for Clusters (Stroke Units)........................................................................... 8 
4.4.2 
Consent for Clusters ................................................................................................................ 9 
4.4.3 
Randomisation ........................................................................................................................ 9 
4.5 
Recruitment of Individual Participants ........................................................................................... 9 
4.5.1 
Eligibility Criteria for Participants ........................................................................................... 9 
4.5.2 
Consent for Patient Participants ............................................................................................. 9 
4.5.3 
Consent for Participants Deemed to Lack Capacity .............................................................. 10 
4.6 
Trial Flowchart .............................................................................................................................. 13 
4.7 
Intervention .................................................................................................................................. 14 
4.8 
Control .......................................................................................................................................... 15 
4.9 
Duration of Treatment .................................................................................................................. 15 
4.10 
Training for Intervention Sites ...................................................................................................... 15 
4.11 
Bias Protection .............................................................................................................................. 15 
4.12 
Measures ....................................................................................................................................... 15 
4.13 
Proposed Sample Size ................................................................................................................... 16 
4.14 
Criteria for Premature Withdrawal ............................................................................................... 16 
4.15 
Monitoring Fidelity (Feasibility) .................................................................................................... 17 
4.16 
Analysis ......................................................................................................................................... 17 
5 
Process Evaluation ................................................................................................................................ 17 
5.1 
Patient Interviews ......................................................................................................................... 17 
5.1.1 
Consent Process for Interviews that are conducted remotely ............................................. 18 
5.2 
Therapist Discussion Groups ......................................................................................................... 18 
6 
Ethical Issues ......................................................................................................................................... 18 
6.1 
Cluster Randomised Design .......................................................................................................... 18 
7 
Monitoring ............................................................................................................................................ 19 

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7.1 
Assessment of Safety .................................................................................................................... 19 
7.1.1 
Expected ILA Adverse Events ................................................................................................ 19 
7.1.2 
Stroke Related Expected Adverse Events ............................................................................. 19 
7.1.3 
Serious Adverse Event Reporting .......................................................................................... 20 
7.2 
Trial Steering Committee (TSC) ..................................................................................................... 20 
7.3 
Ethics and Regulatory Approvals .................................................................................................. 20 
8 
Data Handling ........................................................................................................................................ 20 
8.1 
Confidentiality ............................................................................................................................... 20 
9 
Finance .................................................................................................................................................. 21 
10 
Dissemination ................................................................................................................................... 21 
11 
References ........................................................................................................................................ 23 
12 
Appendices ........................................................................................................................................ 24 
12.1 
SwePASS ........................................................................................................................................ 24 
12.2 
Modified Rivermead Mobility Index ............................................................................................. 25 
12.3 
Fugl Meyer – Motor Leg Sub-Section ............................................................................................ 26 
12.4 
Modified Rankin Score .................................................................................................................. 27 
12.5 
Movement Specific Reinvestment Scale ....................................................................................... 29 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1 
Study Synopsis 
Title 
A pilot cluster randomised controlled trial, of an implicit learning 
approach (ILA) versus standard care, on recovery of mobility following 
stroke. 
Protocol Short Title/Acronym 
Implicit Learning in Stroke Study (IMPS) 
Protocol Version Number and 
Date 
V2 24/09/2018 
Study Phase 
Pilot (with embedded feasibility) 
Study Hypothesis 
None 
Study Duration 
24 months 
Methodology 
Cluster (Stroke Unit) randomised controlled pilot trial, with nested 
qualitative exploration of participant and therapist views. 
Sponsor Name 
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust 
and University of Southampton  
Chief Investigator 
Dr Louise Johnson 
REC Number 
[to be added] 
Medical condition under 
investigation 
Stroke 
Primary Objective 
To establish the feasibility of delivering an ILA during acute stroke 
rehabilitation (fidelity), and to test the integrity of the study protocol 
(pilot). 
Secondary Objective(s) 
To generate data to inform the design of a Phase III trial – including: 
• 
Identification of training requirements of clinical teams 
delivering ILA 
• 
Identification of most appropriate outcome measure 
• 
Estimation of expected rates of recruitment and retention 
• 
Estimation of effect size to enable future sample size calculation 
• 
Therapist and patient perceptions of the approach 
Number of Clusters 
6-8 
Number of Participants 
60 
End Point 
3 months post stroke 
Main Inclusion Criteria 
Clinical diagnosis of stroke; presenting with hemiplegia 
Within 14 days of stroke onset 
Medically stable 
Able to 
• 
tolerate daily therapy for a minimum of 30 minutes per session 
• 
sit for more than 5 seconds without support 
• 
understand and follow 1 stage commands 
Primary Outcome Measure 
Change in modified Rivermead Mobility Index score at 4 weeks. 
Statistical Methodology and 
Analysis 
Within group change scores for all outcome measures with 95% 
confidence interval 
 

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2 
Abbreviations 
 
AI 
 
Adverse Incident 
HASU  
Hyperacute Stroke Unit 
ILA 
 
Implicit Learning Approach 
FM-LL  
Fugl Meyer Assessment – Lower Limb Section 
MDT 
 
Multidisciplinary Team  
mRMI  
Modified Rivermead Mobility Index 
MSRS  
Movement Specific Reinvestment Scale 
SU 
 
Stroke Unit  
SwePASS 
Modified (Swedish) Postural Adjustment in Stroke Scale 
 
 

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3 
Background and Rationale  
Around 80% of stroke survivors present with a motor impairment, which affects the control of movement 
on one side of the body [1]. Much of the focus of rehabilitation, and in particular the work of 
physiotherapists and occupational therapists, is the recovery of this impaired movement and the 
associated functions. Yet specific evidence relating to the components of practice that are most effective 
in promoting motor recovery following stroke is limited.  
Regaining the ability to stand, step and walk are important goals for people who have experienced a 
stroke, and are a common focus during early rehabilitation. Given that one of the key criteria for early 
discharge from inpatient stroke care is the ability to transfer from bed to chair (+/- assistance) [3], 
interventions that facilitate the achievement of mobility goals more quickly are also key to reducing 
length of stay in hospital. 
This process of functional recovery post-stroke is underpinned by theories of motor learning, of which 
there are two broad categories – explicit and implicit. Explicit learning occurs when someone is thinking 
about what to do, and about how to move – it is a conscious form of learning.  Implicit learning occurs 
through trial and error, and without thinking specifically about how to move – it is a sub-conscious form 
of learning. There is, already, agreement that two practice conditions are particularly important when 
differentiating explicit from implicit learning. These are: 
a) the quantity of instructions/feedback that therapists give, and  
b) the focus of attention derived from these instructions/feedback [4].  
Experts consider that high quantity of information and/or promotion of an internal focus of attention (i.e. 
focussing on body movements) are synonymous with an explicit learning model, and that reduced 
quantity of information and/or an external focus of attention (i.e. focussing on the environment) are 
synonymous an implicit learning model [4]. Bias toward one or the other form of learning can therefore 
be mediated by what the therapist says to a patient.   
Implicit and explicit approaches have been well investigated with healthy participants. Research has 
shown that tasks learnt explicitly are less robust and are less likely to be retained over time, than those 
learnt implicitly [see 9]. Equally, research in sport has consistently shown that giving excessive verbal 
information during task practice reduces movement automaticity [5, 6]; and that reduced frequency 
feedback during task practice can enhance learning [7, 8].  There is strong evidence that people master 
skills more effectively if they are prompted to focus their attention toward the environment, rather than 
on their body [see 9 for a review].  Based on current evidence relating to motor learning in stroke, we 
hypothesise that the ILA will be more effective than standard care (and at a minimum, will be equivalent).  
There is no evidence, theoretical or empirical, to suggest that utilising an ILA will be detrimental to 
recovery. 
The body of evidence favouring implicit learning is persuasive, and should lead us to challenge current 
rehabilitation practice, which is known to be highly explicit in nature [1, 10, 11]. However, the reported 
studies typically involve healthy young adults performing sporting activities. Direct transferability to 
stroke rehabilitation, which is invariably more complex, requires evaluation. 

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4 
Trial Details 
This trial will compare an Implicit Learning Approach (ILA) to usual care, during the rehabilitation of 
mobility post stroke. It is a pilot trial, with embedded feasibility and qualitative evaluations. 
4.1 
Aim(s) 
• 
To establish the feasibility of delivering ILA during acute stroke rehabilitation. 
• 
To test the integrity of the study protocol (pilot) 
• 
To generate data to inform the design of a Phase III trial. 
4.2 
Study Design 
This is a multicentre, assessor blind, cluster randomised controlled pilot trial, with embedded feasibility 
study.  It also includes a nested qualitative evaluation, designed to explore the views of participants and 
therapists. 
A cluster randomised design is being used, as it is the only way to protect against contamination between 
treatment arms. Information about the exact detail of the ILA will only be shared once randomisation has 
taken place, with the sites who will be delivering the intervention.  Standard care clusters will not have 
access to the trial materials (e.g. treatment manual), or details about the specific elements of the 
intervention. 
4.3 
Understanding and Describing Baseline  
In order to understand current practice within each unit, we will conduct a small observational study at 
the beginning of the trial.  Between 6-10 standard care treatment sessions will be video recorded at each 
site.  This will take place before randomisation has taken place, and therefore before clinicians have 
received any training.  We will use non-probability sampling to video record between 6-10 patient-
therapist pairs (exact number to be agreed locally, depending on the size of the Unit/Team).  Each 
recorded session will involve a different patient-therapist pair, but the individual patients/therapists may 
be recorded more than once.  Therapists will be asked to continue with a routine therapy session, aimed 
at improving sit to stand, stepping or gait.   
We will analyse the content of these recorded sessions using a previously validated method [1].  This will 
give us an indication of the likely content of standard care in each participating organisation, and will help 
us to tailor the required training (for the intervention sites).  By later comparing the collective content of 
these recordings to those taken during the trial, we will also get insight into the differences between the 
trial interventions and standard care. 
These video recordings will be made before recruitment to the pilot trial commences.  Patients involved 
in this stage will not be recruited into the pilot study.  A separate Participation Information Sheet and 
consent form is provided. 
4.4 
Recruitment of Clusters 
4.4.1 
Eligibility Criteria for Clusters (Stroke Units) 
Criteria for stroke unit eligibility are - a dedicated unit that 
i) 
routinely admits patients with acute stroke; and  
ii) 
has a dedicated therapy (OT/PT) service for at least 5 days per week. 
 

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Stroke Units do not need to provide hyper-acute care to be involved, but must admit patients within 5 
days of stroke onset.  We aim to recruit 6-8 Stroke Units to the trial. 
4.4.2 
Consent for Clusters  
Written informed consent will be obtained by the cluster guardian (senior clinician) at each site. 
The cluster guardian is consenting for the Stroke Unit to take part in the trial, and to be randomised to 
either ILA or standard care.  Within clusters, individual patients who meet the eligibility criteria will be 
approached, and will be invited to take part in the trial, for which they will provide informed consent (see 
4.5.2).   
4.4.3 
Randomisation 
The unit of randomisation (cluster) is the Stroke Unit. The trial statistician (SE) will use an online 
randomisation system to allocate sites to control or intervention. 
4.5 
Recruitment of Individual Participants 
4.5.1 
Eligibility Criteria for Participants  
 
Inclusion criteria 
• 
Clinical diagnosis of stroke; presenting with hemiplegia 
• 
Within 14 days of stroke onset 
• 
Medically stable 
• 
Able to 
o tolerate daily therapy for a minimum of 30 minutes per session 
o sit for more than 5 seconds without support 
o understand and follow 1 stage commands 
 
Exclusion criteria 
• 
Previous stroke with residual impairments 
• 
Other neurological diagnosis (e.g. PD, MS) 
• 
Clinically relevant pre-morbid disability levels 
 
4.5.2 
Consent for Patient Participants 
Individual participant informed consent will be taken for participation in the trial.  Participants are 
consenting to receive their rehabilitation using the assigned approach (ILA or standard care), and for 
collection of data, and completion of additional assessments.   
The Easy Read version of the PIS will be used to facilitate a conversation with any potential participant 
who finds the format of the standard PIS difficult to follow/digest.  It is intended as a conversation 
support tool, to ensure that information about the trial is available in an accessible format for all patients, 
but particularly those with an impairment of communication or cognition. 
All new stroke admissions will be screened for eligibility within 72 hours of admission.  Those that meet 
the criteria will be provided with verbal and written information, which they will be given 24 hours to 
consider. Those willing to participate will be asked to sign a consent form.  
There may be individuals who do not meet the inclusion criteria at the beginning of their Stroke Unit stay, 
but regain enough function to meet the criteria at a later date.  We will continue to monitor potential 
participants, and will recruit up to 14 days post stroke, if eligibility changes.   

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The process of recruitment and consent will be led by the research practitioner(s) at each site.  
Recruitment will take place across an approximate period of four-months at each Unit.  
4.5.3 
Consent for Participants Deemed to Lack Capacity 
Following stroke, is it likely that a proportion of potential participants will be unable to independently 
make a decision about taking part in the trial (i.e. lack capacity), but otherwise meet the inclusion criteria.  
This is particularly relevant in the early phase following stroke, where capacity may be borderline or 
fluctuating, but the person is otherwise engaging in their rehabilitation.  For example, an individual may 
be able to understand the general nature of the research and what participation would involve, but may 
not fully understand that their data will be used for a research study. 
To maintain relevance and ensure generalisability of the findings, it is important to be as inclusive as 
possible when inviting people to take part. The trial will therefore include participants who do not have 
capacity to consent to participation.  This is deemed appropriate given that: 
 
• 
Risks associated with the study intervention are negligible 
• 
The trial is not testing a new or novel approach to delivering physiotherapy, but is separating out and 
comparing approaches that are already in routine use. 
 
4.5.3.1 
Process of Assessing Capacity  
Potential participants will initially be approached about the trial by a member of the direct clinical team, 
or a Research Practitioner.  If the clinician/research practitioner expresses doubt about the person’s 
ability to provide informed consent for the study, they will notify the Principal Investigator.  A capacity 
assessment will only be completed if the individual meets the criteria, as laid out in the Mental Capacity 
Act. 
The capacity assessment will be completed by the PI at the study site, or a member of the 
clinical/research team to whom they have delegated responsibility (such as a Research Practitioner or 
Consultant Physician).  The person to whom responsibility had been delegated must have up to date GCP 
training and have a detailed understanding of the trial protocol.   They will be listed on the Delegation 
Log. 
Where appropriate, the person completing the capacity assessment may request assistance from a 
member of the clinical team, such as a Speech and Language Therapist (SLT) or Psychologist, to aid with 
the assessment. SLT will provide particular expertise to ensure that people with a language impairment as 
a result of their stroke are given appropriate and individualised support to understand the information 
that is presented to them, and to communicate their thoughts and wishes.  The Easy Read version of the 
PIS will be used to support this process. 
Irrespective of whether or not someone has capacity, the views expressed by the person will be given 
precedence when deciding whether or not to proceed.  In people who are deemed to lack capacity, any 
views that are expressed through the facilitated conversation will be given priority when deciding 
whether or not to pursue a consultee declaration.  For example, if the patient expresses anxiety about 
any part of this process, such as being video recorded, then we will not proceed with seeking a consultee 
declaration.  We will not enrol anyone in the trial who communicates that they do not wish to participate 
in any aspect of the study. 
 

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The capacity assessment will be documented in the patient’s medical notes.   
 
Figure 1: Recruitment Process for Individuals Lacking Capacity 
 
 
 
 
 
 
 
 
 

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4.5.3.2 
Process for Gaining a Consultee Declaration 
 
If a potential participant is deemed unable to consent to the study (i.e. they lack capacity), then a 
personal consultee (usually the next of kin) will be asked to consider whether they would be willing to 
provide consent on their behalf, based on the presumed wishes of the potential participant.   
 
The full version of the Participant Information Sheet will be shared with the identified consultee, along 
with the Easy Read PIS.  If they are willing to do so, they will be asked to sign the consultee declaration 
form, on behalf of their relative/friend. 
 
In the event that a personal consultee cannot be found for someone who is deemed to lack capacity, a 
professional consultee would not be used.  In these circumstances, the person lacking capacity would not 
be able to participate in the study.    
 
At all times, the wishes of the participant will be upheld.  For example, they will not be video recorded if 
they express that they do not wish for this to happen.   
4.5.3.3 
Process if a participant regains capacity during the study 
 
It is feasible that a participant who did not have capacity to provide informed consent at the beginning of 
the study, regains the ability to do so at some point during the study. The therapists who are delivering 
the treatment interventions, as well as the research team, will be briefed with regards to this. They will 
be asked to inform the Research Practitioner and local PI if they feel that a participant’s ability to consent 
has changed. This will then be reassessed. If, at this point, the person is deemed to have capacity to make 
a decision regarding participation in the research, they will be provided with the study information and 
will be supported to make this decision. If they opt to withdraw from the study, they can do so, without 
consequence. Data collected up to this point will be included in the final analysis, unless the individual 
explicitly asks for it not to be.  
 
Therefore, the Consultee Declaration only applies for as long as the participant lacks capacity.  Stroke 
teams manage issues relating to capacity on a frequent basis, and are therefore typically very aware of 
the principles of the Mental Capacity Act, capacity assessments and informed consent. 
 
4.5.3.4 
Process if a participant loses capacity during the study 
 
Although unlikely, a participant who gave informed consent at the point of recruitment, may lose capacity 
during the course of the research.  It is likely that any loss of capacity at this stage reflects medical 
instability - such as a further stroke, or an infection.   
 
The study will adhere to the principles, as laid out and defined in the Mental Capacity Act (2005).  At the 
time of the person consenting to the trial, they have expressed a wish to participate.  Therefore, the 
person will remain in the study, as long as it is appropriate clinically, and there is no observable or 
communicated evidence that they do not wish to continue.   
If the individual is communicating that they do not wish to continue in the trial, or are demonstrating an 
unwillingness to participate in any of the trial interventions (e.g. assessments, video recording, or therapy 
treatment sessions), then they will be withdrawn  

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The most likely cause of loss of capacity is a further stroke, or another medical event.  In these 
circumstances, then (irrespective of capacity) the person will not be clinically appropriate to remain in the 
trial, and will be withdrawn.   
 
4.6 
Trial Flowchart 
 

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4.7 
Intervention  
All mobility focussed rehabilitation sessions will utilise the ILA, as usual care.  This includes rehabilitation 
(delivered by a physiotherapist, occupational therapist or therapy assistant) that focusses on sitting, sit to 
stand, standing, stepping, transfers and walking. The content of therapy will be based on the treatment 
guidelines and intervention manual, which have been developed by an international expert group (using 
Delhi methodology).  As this is a clinically grounded, pragmatic trial, therapists will have freedom to tailor 
the specific content of each treatment session to patient need, whilst remaining true to the ILA. Other 
therapy interventions, such as upper limb rehabilitation, will be provided as usual. Whilst the content of 
this additional therapy will not be monitored, the quantity of other therapy, outside of the trial 
interventions, will be recorded and compared between groups. Frequency of treatment will be based on 
the usual practice of the treating hospital. The actual number of sessions received by each participant will 
be recorded.   
Specific details relating to the IMPS intervention will be shared with intervention sites, once 
randomisation has taken place.  Standard care sites will continue to delivery rehabilitation as normal, but 
will be asked to recruit eligible patients for data collection.  An overview is given in table 1.  
 
Control Group 
Standard Care* 
Experimental Group 
Implicit Learning Approach 
Quantity and 
Frequency of 
Coaching Statements 
(Instructions and 
Feedback) 
HIGH 
• 
Instructions given at the beginning 
and throughout the task (i.e 
during practice) 
• 
Feedback given during task 
practice – at least once for every 5 
repetitions of any given task 
LOW 
• 
Instructions only given at the 
beginning of task practice 
• 
Feedback or further instruction 
avoided throughout task practice 
Focus of Attention  
INTERNAL 
Direct attention to the action itself. 
Use the term “focus on [a reference 
within the body]”. 
Example: “Bend your knee and lift your 
foot onto the block.  Focus on moving 
your leg” 
 
 
EXTERNAL 
Direct attention to the effects of the 
action. 
Use the term “focus on [a reference in 
the environment]” 
Example: “Step onto the marker on the 
block.  Focus on the marker” 
Task Set Up 
Activity and environment set up to 
facilitate a focus on the person – i.e. 
without using external reference 
points/feedback. 
Activity and environment set up to 
facilitate a focus on the environment – 
through use of external reference 
points, markers, audio feedback. 
* Guidance for standard care is based on published observational studies describing usual practice in 
stroke rehabilitation [1, 10, 11].   
 
Table 1: Overview of Intervention 

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4.8 
Control 
Standard care, as per usual working practice for the stroke unit. Control stroke units will have minimal 
contact with the research team, other than for data collection.  They will be aware of the broad aims of 
the study, but not the specific detail of the intervention.   
4.9 
Duration of Treatment  
Patients will be recruited as soon as eligible, and up to 14 days of stroke onset. Trial interventions will be 
delivered for the duration of each participant’s inpatient stay, as deemed appropriate by the treating 
team. This approach is pragmatic and will ensure that the intervention can be fitted into the current care 
pathway, but accepting that discharge will be at different times for different patients. 
4.10 Training for Intervention Sites 
For sites randomised to the intervention arm, all physiotherapists, occupational therapists and therapy 
assistants will be trained in the ILA. Training is anticipated to last no more than 3 hours.  Additional 
training sessions will be offered if new members join the team during the recruitment phase. A manual 
including written, photographic and video resources will demonstrate how to adapt standard care 
interventions to the ILA. Therapists will be able to refer to the manual throughout their involvement in 
the study. 
Whilst the wider multidisciplinary team (e.g. nurses, doctors, other AHP’s) will not specifically be asked to 
change their approach with patients, those at intervention sites will be invited to attend a short 
education session to raise their awareness of the trial, and will be provided with written information 
about the study, and the concepts under investigation. As these professions wouldn’t typically be 
analysing movement or giving specific instructions/feedback, this level of engagement is deemed 
appropriate and realistic. 
The therapy team will be encouraged to give the MDT (particularly nurses) specific guidance about how 
to instruct an individual patient during movement (as part of a manual handling care plan, and in line with 
the ILA approach). These awareness raising sessions will support the MDT to understand and follow 
through these instructions. 
As part of the training, clinical staff will be reminded of the options to withdraw participants from the 
study, should there be concerns about the impact the ILA has on their recovery (see 7.1.1).   
4.11 Bias Protection 
Outcome assessors will be blind as to the intervention group. Video recording of outcome measures will 
be used to achieve this. Participants will be blind as to whether their Stroke Unit is providing control or 
intervention. Whether or not participants have guessed their treatment arm will be explored in the 
qualitative interviews. 
4.12 Measures 
Measures will be performed and recorded by the stroke research practitioner(s), or designated clinician, 
at each site.  As the research practitioner will not be blind to the intervention arm, all measures will be 
video recorded, and later scored by a blinded second assessor. Frequent measures are required to 
understand rate of change.  Outcome measures have been selected with consideration of international 
recommendations for measurement of sensorimotor recovery in stroke [12]. 
 

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At baseline: 
• 
Movement Specific Reinvestment Scale (Self-Report Questionnaire) (MSRS) 
At baseline, week 2, week 4, week 6 post enrolment (or up to the point of discharge): 
• 
Fugl Meyer – motor leg sub section 
• 
Modified Postural Adjustment in Stroke Scale (SwePASS) 
• 
Modified Rivermead Mobility Index (mRMI) 
• 
Able to sit for 1 minute unsupported? 
• 
Able to transfer from bed to chair independently? 
• 
Able to walk 10m independently? 
At point of discharge 
• 
Discharge destination and care requirements immediately on discharge (number of care visits per 
day multiplied by the number of carers required) 
• 
Fugl Meyer – motor leg sub section 
• 
Modified Postural Adjustment in Stroke Scale (SwePASS) 
• 
Modified Rivermead Mobility Index (mRMI) 
• 
Able to sit for 1 minute unsupported? 
• 
Able to transfer from bed to chair independently? 
• 
Able to walk 10m independently? 
• 
Movement Specific Reinvestment Scale (MSRS) 
At 3 months post enrolment: 
• 
Fugl Meyer – motor leg sub section 
• 
Modified Postural Adjustment in Stroke Scale (SwePASS) 
• 
Modified Rivermead Mobility Index (mRMI) 
• 
Able to sit for 1 minute unsupported? 
• 
Able to transfer from bed to chair independently? 
• 
Able to walk 10m independently? 
• 
Modified Rankin Scale (mRS)  
• 
EQ-5D 
• 
Movement Specific Reinvestment Scale (MSRS)  
4.13 Proposed Sample Size 
Our sample size calculation is based on estimated rates of recruitment and retention.  We are aiming to 
recruit 60 participants in total, across the 6-8 clusters.  Each cluster will therefore be required to recruit 7-
10 participants.   
4.14 Criteria for Premature Withdrawal 
If there is a significant deterioration in a participants clinical signs (for example, if they have a further 
neurological event), then they will be withdrawn from the study.  Reasons for withdrawal will be 
recorded. 

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4.15 Monitoring Fidelity (Feasibility) 
All trial treatment sessions will be video recorded and a random sample (1 in 6) will be selected by the PI 
for analysis. A small and unobtrusive video camera will be used to do this.  To avoid observer bias, the 
treating therapists will be asked to set up the video camera for each session.  The sample will be analysed 
using a previously validated method, and will be compared for coherence with the written records of the 
treatment session. 
4.16 Analysis 
Data will be stored and managed using SPSS. Statistical support will be provided by the University of 
Southampton. Double data entry will be used for paper-based assessments. 
The unit of analysis is the individual patient. As this is a pilot study, analysis will primarily be descriptive. 
Descriptive methods will be used to estimate feasibility of factors relating to the protocol, such as 
recruitment (proportion of eligible people who consent to the study) and retention (completion of 
outcome measures at 4 weeks).  
Fidelity of the interventions will be established by comparing the number and type of coaching 
statements delivered to each group. We will describe the mean number of coaching statements per 
person (and the breakdown of these statements as externally- or internally-focussed) in each group. 
While we expect large differences, we will not formally test the difference as the study is not designed to 
do so; we will instead provide an estimate of the difference with corresponding 95% confidence interval.  
Differences in outcome and potential effect size for the Fugl Meyer, SwePASS and mRMI will be 
calculated using confidence interval estimation.  
5 
Process Evaluation 
To enable us to understand patient and therapist perceptions and experiences of the ILA, will we be 
inviting a sub-set of participants to take part in a qualitative evaluation of the ILA.   
5.1 
Patient Interviews 
We will invite 20 participants (10 from the intervention arm and 10 from the control arm) to take part in a 
semi-structured interview.  These will be carried out within 1 week of the final treatment session to 
ensure that the intervention is recent enough for the patient to recall.  
Interviews will be conducted by the Principal Investigator (PI).  They will focus on patients’ experiences of 
therapy and their perceptions of the benefits and disadvantages of the therapeutic style received. They 
will take place whilst the patient is in hospital or following their return home, will last for around 45 
minutes, and will be audio recorded.  Where necessary to comply with COVID-19 restrictions, interviews 
will be conducted remotely, over the telephone or via video call. 
We will use maximum variation sampling to identify the sample, to include those with differing stroke 
severities (including differing levels of language and cognitive impairments), ages, gender and family/care 
situations.  
Separate informed consent will be sought for the interview; participation in the clinical trial will not be 
dependent on participation in this qualitative evaluation. Participants from 4 of the clusters will be 
included. 

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5.1.1 
Consent Process for Interviews that are conducted remotely 
Where the patient remains an inpatient, the interviewer will liaise with the patient via the clinical team, 
to agree a mutually convenient date, time and method (phone or video call) for the interview.   
Where the patient has returned home, the clinical team will pass the patients name and contact details to 
the researcher, after seeking permission from the patient to do so.  The researcher will then contact the 
patient to explain more about the interview, and to agree a mutually convenient date, time and method 
(phone or video call) for the interview.   
On the day of the interview, consent will be sought verbally.  After discussing details of the purpose and 
nature of the interview, the researcher will inform the participating that the call is being audio recorded, 
and will then read each statement on the consent form, which they will seek verbal consent for.  The 
researcher will then sign the form, and two copies will be sent to the participant via post.  They will be 
asked to sign and return one copy in a pre-paid envelope.  Audio recording will capture the verbal 
consent process. 
5.2 
Therapist Discussion Groups  
Four discussion groups, (one at each intervention site), involving therapists who took part in the study, 
will take place at the end of the trial, after all treatment sessions have been delivered. All therapists and 
therapy assistants who are involved in delivering the ILA will be invited to take part. The insights gained 
from the discussion groups will give us a more valid understanding of the potential application of the 
Implicit Learning Approach in clinical practice. 
6 
Ethical Issues 
6.1 
Cluster Randomised Design 
The cluster randomised design presents its own unique ethical issues. Rather than individual patients 
providing consent prior to randomisation, whole Stroke Units (clusters) will be randomised to either the 
Implicit Learning Approach or control. Consent to participate in the study and be randomised will be given 
at Stroke Unit level, by a cluster guardian.  
Individual patients who meet the inclusion criteria, will be asked to give consent to take part in the trial, 
to have their data included in the study, and to complete additional measures. 
For units randomised to the ILA, therapy teams will be asked to adopt the ILA for participants who have 
agreed to take part in the trial.  For all other patients on that Unit, they will continue with standard care.  
However, because the therapists will have been trained in the ILA, and will be using it with trial 
participants, there is the possibility that elements of the ILA drift into the rehabilitation of non-trial 
patients.   Given that implicit learning approaches are used in standard practice already, it is acceptable 
that therapists may adopt elements of the ILA for non-trial patients.  This is entirely within their own 
professional autonomy and clinical judgement.   
This cluster randomised approach has been chosen to ensure fidelity of the intervention, and therefore to 
ensure that the study is most likely to provide useful insights and data - this in itself is ethically important. 
From an ethical point of view, this design is justifiable because: 

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• 
Current therapy practice includes both implicit and explicit behaviours. These are not therefore 
novel or experimental concepts. This research is delineating two approaches already in use, to 
answer important questions about the effectiveness of each.   
• 
There are no significant risks to those individuals who will receive the ILA. 
• 
Only patients who provide consent to take part will receive the full ILA. 
No Unit will use the ILA wholly as its approach, and therefore there is still a risk that fidelity isn’t 
maximised for the trial participants.  This is an accepted limitation at this stage – it will be closely 
monitored in the study, and is one of the key feasibility questions.   
7 
Monitoring 
7.1 
Assessment of Safety 
7.1.1 
Expected ILA Adverse Events 
Although unlikely, there is a possibility that the ILA is perceived as less personal/motivating for patients, 
and this may be associated with a reduced willingness to participate in therapy.  We will monitor 
adherence with rehabilitation across all sites.  Non-compliance will be considered an AE if (i) a patient is 
declining to participate in rehabilitation sessions over a period of 5 days and (ii) the clinical team are 
unable to account for this in any other way.  This will be addressed on an individual basis through 
discussion with the patient and the clinical team.  If indicated, they will be withdrawn from the study.  
If the treating team have any concerns about using the ILA with an individual patient, for example, should 
they feel that a patient is not responding /recovering as expected, they should discuss this with the Chief 
Investigator.   If indicated, the participant will be withdrawn from the study, and their rehabilitation will 
revert to standard care.  This decision will be taken on an individual basis, following discussion with the 
clinical team, Chief Investigator and (if appropriate) the participant.  Withdrawal due to 
unanticipated/unexplained lack of progress in rehabilitation will be considered an AE.   
It is important to note that, whilst therapists at the intervention sites are encouraged to adhere as much 
as possible to the ILA guidance, this is a pragmatic trial, and they can use their own clinical judgement 
during each individual treatment session.  This is monitored as part of the feasibility aspect of this trial. 
7.1.2 
Stroke Related Expected Adverse Events 
In addition to the above, the following AE’s have been deemed as potentially relevant to the study.  They 
will therefore be recorded if they occur during the study, and will be monitored throughout the study as 
deemed appropriate by the PI/CI: 
• 
Death 
• 
Falls 
• 
Further vascular events 
• 
Cardiac events 
• 
Epileptic seizures 
• 
Infections 
• 
Pain 
• 
Mood disturbance 
• 
Deep Vein Thrombosis 

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If any of these adverse events occur then they will be recorded in the CRF and followed up until either 
resolution (if appropriate); the end of the study period for that participant, or until the PI deems the AE as 
stable, whichever is sooner.  
All adverse events listed in section 7.1.2 will be recorded from the date of consent, to the end of the trial 
intervention period (i.e. discharge from hospital).    
7.1.3 
Serious Adverse Event Reporting  
For this study (and in accordance with HRA guidance), a serious adverse event (SAE) is defined as an 
untoward occurrence that:  
(a) results in death 
(b) is life-threatening 
(c) requires hospitalisation or prolongation of existing hospitalisation 
(d) results in persistent or significant disability or incapacity 
(e) consists of a congenital anomaly or birth defect; 
(f) is otherwise considered medically significant by the investigator. 
Serious Adverse Events will be recorded in the medical notes and in the CRF.  If the event is deemed to be 
related to the intervention, the SAE will be submitted to the Sponsor immediately. The Sponsor or CI will 
inform the Research Ethics Committee within 15 days of the CI becoming aware of the event.  The 
acknowledgement of the receipt of the SAE will be sent to the RBCH R&D directorate.  SAEs which are not 
related to the intervention will be recorded as other AEs.  
For this study there are no expected adverse events.  
7.2 
Trial Steering Committee (TSC) 
A trial steering committee will oversee the delivery of the study.  The committee will meet at least 6 
monthly.  The TSC will include a patient partner, statistician, research expert(s) and clinical expert(s).   
7.3 
Ethics and Regulatory Approvals 
The study will undergo full REC Approval, as well as local R&D review/approval. 
8 
Data Handling 
8.1 
Confidentiality 
Patient confidentiality will be ensured by allocation of a unique identification number (ID). All data that 
links patient personal information with the ID will be kept in a separate locked filing cabinet.  Institutional 
guidelines for Research Governance procedures for good clinical practice in research will be followed. 
Video recordings will be transferred onto an encrypted memory card, which will be handed to the PI in 
person.  They will then be uploaded onto the secure NHS server, in a password protected file.   
Audiotapes from interviews and focus groups will be transcribed verbatim.  Transcripts will be 
anonymous.  Once data analysis is complete, original audio recordings will be deleted.  

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All records will be anonymised, and will be kept for a minimum of 10 years after the end of the trial, after 
which they will be destroyed. 
9 
Finance 
This trial is funded by the National Institute of Health Research, through a Clinical Lectureship, awarded 
to the Chief Investigator.  The funding will be managed by Royal Bournemouth and Christchurch NHS 
Foundation Trust. 
10 Dissemination 
Findings from this research study will be shared through open access publication, conference 
presentations and local training sessions.  All participants will be offered the opportunity to receive a 
summary of the research findings.   
All data will be anonymised prior to publication.  The support of the funding body will be acknowledged 
as follows: this research was funded by the National Institute of Health Research (NIHR), UK.  The views 
expressed are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of 
Health. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 1: Consort Diagram 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clusters assessed for eligibility (n= xx) 
Clusters Guardian Consent (n=6-8) 
Excluded (n=xx) 
• 
Not meeting criteria =  
• 
Declined to 
participate =  
• 
Other reasons = 
Clusters randomised to 
intervention (n= 3-4) 
• 
Number of clusters 
who delivered the 
intervention (n=  ) 
• 
Number of clusters 
who did not deliver the 
intervention (n = ) 
Clusters randomised to control 
(n= 3-4) 
Number of individuals screened 
for inclusion (n= xx) 
Number of individuals eligible 
to take part (n = xx) 
Number of individuals who 
consent for data to be included 
in the trial (n = ) 
Number of individuals screened 
for inclusion (n= xx) 
Number of individuals eligible 
to take part (n = xx) 
Number of individuals who 
consent for data to be included 
in the trial (n = ) 
Lost to follow-up (n = ) 
• 
Reasons…..  
Lost to follow-up (n = ) 
• 
Reasons…..  
Analysed (n = ) 
• 
Excluded from analysis 
(add reasons) n = …..  
Enrolment 
Allocation 
Follow Up 
Analysis 
Analysed (n = ) 
• 
Excluded from analysis 
(add reasons) n = …..  
Collect baseline video recordings (n=6-10) 

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11 References 
1.        Johnson, L., J.H. Burridge, and S.H. Demain, Internal and External Focus of Attention During 
Gait Re-Education: An Observational Study of Physical Therapist Practice in Stroke Rehabilitation. 
Physical Therapy, 2013. 93(7): p. 957-966. 
 
2.  
Langhorne, P., F. Coupar, and A. Pollock, Motor recovery after stroke: a systematic review. 
The Lancet Neurology. 8(8): p. 741-754. 
 
3.  
Fisher, R.J., et al., A Consensus on Stroke: Early Supported Discharge. Stroke, 2011. 42(5): p. 
1392-1397. 
 
4.  
Kleynen, M., et al., Multidisciplinary Views on Applying Explicit and Implicit Motor Learning 
in Practice: An International Survey. PLOSone, 2015. 10(8): p. e0135522. 
 
5.  
Wulf, G. and W. Prinz, Directing attention to movement effects enhances learning: A review. 
Psychonomic bulletin & review, 2001. 8(4): p. 648-660. 
 
6.  
Poolton, J.M., et al., Benefits of an external focus of attention: common coding or conscious 
processing? J Sports Sci, 2006. 24(1): p. 89-99. 
 
 
7.  
Lai, Q. and C.H. Shea, Generalized Motor Program (GMP) Learning: Effects of Reduced 
Frequency of Knowledge of Results and Practice Variability. Journal of Motor Behavior, 1998. 
30(1): p. 51-59. 
 
8.  
Winstein, C. and R. Schmidt, Reduced frequency of knowledge of results enhances motor skill 
learning. Journal of Experimental Psychology: Learning, Memory and Cognition, 1990. 16: p. 
677-691. 
 
9.  
Wulf, G., Attentional focus and motor learning: a review of 15 years. International Review of 
Sport and Exercise Psychology, 2012. 6(1): p. 77-104. 
 
10.  
Durham, K., et al., Use of information feedback and attentional focus of feedback in treating 
the person with a hemiplegic arm. Physiotherapy Research International, 2009. 14(2): p. 77- 
90. 
 
11.  
Talvitie, U. and M. Reunanen, Interaction between Physiotherapists and Patients in 
physiotherapy. Physiotherapy 2002. 88(77-88). 
 
12.  
Kwakkel, G., Lannin, NA., Borschmann, K., English, C et al (2017) Standardized measurement of 
sensorimotor recovery in stroke trials: Consensus-based core recommendations from the Stroke 
Recovery and Rehabilitation Roundtable.  International Journal of Stroke, 12, 5. 
 
 
 

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12 Appendices 
12.1 SwePASS 
 

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12.2 Modified Rivermead Mobility Index 
 
 
 

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12.3 Fugl Meyer – Motor Leg Sub-Section 
 
 

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12.4 Modified Rankin Score 
 
 
 
 

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IMPS Protocol v6 18.08.2020 
12.5 Movement Specific Reinvestment Scale 
 
Movememet Specific Reinvestment Scale 
Directions: Below are a number of statemetns about your movemets in general.  Circle the answer that best describes how you feel for each question. 
 
1. I remember the times when my movements have failed me 
1 
2 
3 
4 
5 
6 
Strongly disagree 
Moderately disagree 
Weakly disagree 
Weakly agree 
Moderately agree 
Strongly agree 
 
 
2. If I see my reflection in a shop window, I will examine my movements 
1 
2 
3 
4 
5 
6 
Strongly disagree 
Moderately disagree 
Weakly disagree 
Weakly agree 
Moderately agree 
Strongly agree 
 
 
3. I reflect about my movement a lot 
1 
2 
3 
4 
5 
6 
Strongly disagree 
Moderately disagree 
Weakly disagree 
Weakly agree 
Moderately agree 
Strongly agree 
 
 
 
 

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4. I try to think about my movements when I carry them out 
1 
2 
3 
4 
5 
6 
Strongly disagree 
Moderately disagree 
Weakly disagree 
Weakly agree 
Moderately agree 
Strongly agree 
 
 
 
5. I am self conscious about the way I look when I am moving 
1 
2 
3 
4 
5 
6 
Strongly disagree 
Moderately disagree 
Weakly disagree 
Weakly agree 
Moderately agree 
Strongly agree 
 
 
 
6. I sometimes have the feeling that I am watching myself move 
1 
2 
3 
4 
5 
6 
Strongly disagree 
Moderately disagree 
Weakly disagree 
Weakly agree 
Moderately agree 
Strongly agree 
 
 
 
7. I am aware of the way my body works when I am carrying out a movement 
1 
2 
3 
4 
5 
6 
Strongly disagree 
Moderately disagree 
Weakly disagree 
Weakly agree 
Moderately agree 
Strongly agree 
 

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8. I am concerned about my style of moving 
1 
2 
3 
4 
5 
6 
Strongly disagree 
Moderately disagree 
Weakly disagree 
Weakly agree 
Moderately agree 
Strongly agree 
 
 
9. I try to figure out why my actions failed 
1 
2 
3 
4 
5 
6 
Strongly disagree 
Moderately disagree 
Weakly disagree 
Weakly agree 
Moderately agree 
Strongly agree 
 
 
 
10. I am concerned about what people think about me when I am moving 
1 
2 
3 
4 
5 
6 
Strongly disagree 
Moderately disagree 
Weakly disagree 
Weakly agree 
Moderately agree 
Strongly agree 
 
 
 
If the participant was unable to complete the assessment, please give reason: 
 
 
 
 

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