Open access Protocol Intensive rehabilitation programme for patients with subacute stroke in an inpatient rehabilitation facility: describing a protocol of a prospective cohort study Monique Messaggi Sartor ‍ ‍,1,2 Jennifer Grau-­Sánchez,3,4 Anna Guillén-­Solà,1,2,5 Roser Boza,1 Josep Puig,6 Cathy Stinear,7 Andrea Morgado-­Perez,1,2 Esther Duarte1,2,5 To cite: Sartor MM, Grau-­ ABSTRACT Sánchez J, Guillén-­Solà A, Strengths and limitations of this study Introduction Rehabilitation is recognised as a et al. Intensive rehabilitation cornerstone of multidisciplinary stroke care. Intensity of programme for patients with ►► This study will provide a description of an intensive therapy is related to functional recovery although there subacute stroke in an inpatient rehabilitation programme for patients with subacute is high variability on the amount of time and techniques rehabilitation facility: describing stroke delivered at our inpatient rehabilitation unit. a protocol of a prospective applied in therapy sessions. There is a need to better ►► Another crucial contribution of this study is that the cohort study. BMJ Open describe stroke rehabilitation protocols to develop a better clinical assessments of the patients are not limited 2021;11:e046346. doi:10.1136/ understanding of current practice increasing the internal to the inpatient period, but also extend to the long-­ bmjopen-2020-046346 validity and generalisation of clinical trial results. The term phase. aim of this study is to describe an intensive rehabilitation ►► Prepublication history and ►► One of the strengths of this study is that treatment programme for patients with stroke in an inpatient additional supplemental material registry data has been agreed between a multidis- for this paper are available rehabilitation facility, measuring the amount and type of ciplinary team of the rehabilitation unit, reflecting online. To view these files, therapies (physical, occupational and speech therapy) actual clinical practice. please visit the journal online provided and reporting functional outcomes. ►► The data collected in this study will rely on the in- (http://​dx.​doi.​org/​10.​1136/​ Methods and analysis This will be a prospective formation provided by the therapists, and although bmjopen-​2020-​046346). observational cohort study of patients with subacute stroke all participating therapists have agreed to provide admitted to our inpatient rehabilitation facility during Received 27 October 2020 reliable data when reporting therapy sessions, there 2 years. A therapy recording tool was developed in order Accepted 29 July 2021 might be a social desirability bias. to describe the rehabilitation interventions performed in ►► This study does not consider the assessments of our unit. This tool was designed using the Delphi method, patient-­centred aspects, which may limit the under- literature search and collaboration with senior clinicians. standing of patient’s experience. Therapists will record the time spent on different activities available in our unit during specific therapy sessions. Afterwards, the total time spent in each activity, and the total rehabilitation time for all activities, will be averaged rates in developed countries; however, the for all patients. Outcome variables were divided into three burden of stroke on individuals, caregivers different domains: body structure and function outcomes, and societies increases.3 Many stroke survi- activity outcomes and participation outcomes and will be vors experience motor, sensory, perceptual assessed at baseline (admission at the rehabilitation unit), at discharge from the rehabilitation unit and at 3 and 6 and cognitive deficits, needing rehabilitation months after stroke. in the following months after the stroke.4 Ethics and dissemination This study was approved by the Stroke rehabilitation aims to promote func- © Author(s) (or their Medical Research Committee at Hospital del Mar Research tional recovery and autonomy through resti- employer(s)) 2021. Re-­use Institute (Project ID: 34/C/2017). The results of this study tution, substitution and compensation of permitted under CC BY-­NC. No will be presented at national and international congress and functions to achieve the highest possible level commercial re-­use. See rights and permissions. Published by submitted for publication in peer-­reviewed journals. of functional recovery.5 Rehabilitation is a BMJ. Trial registration number NCT04191109. patient-­centred process delivered by a multi- For numbered affiliations see disciplinary team, including medical doctors, end of article. INTRODUCTION physical, occupational and speech therapists, Correspondence to Stroke is the second cause of death and nurses, social workers and neuropsycholo- Dr Monique Messaggi Sartor; disability worldwide.1 2 Improvements in acute gists.6 After discharge from the stroke unit, ​mosartor@​gmail.​com management have reduced stroke mortality the post-­ acute inpatient care services for Sartor MM, et al. BMJ Open 2021;11:e046346. doi:10.1136/bmjopen-2020-046346 1 Open access patients with stroke include rehabilitation facilities and studies have examined therapy content and defined long-­term care hospitals.6 Inpatient rehabilitation facil- which components or approaches are most effective for ities provide hospital-­level care and should offer inten- achieving the highest level of functional recovery.23–28 sive programmes of therapy.7 Patients treated in these Bode et al25 grouped activities within the rehabilitation inpatient rehabilitation facilities have better functional programme into the following categories: evaluation, outcomes and higher return rates to community living screening, function-­focused activities, impairment focus than those treated in general wards or long-­term care activities, discharge planning and case management. In hospitals.6 8–11 Factors such as age, the need of 24-­hour this study, therapists recorded the number of 15-­min units medical care, previous functional independence, cogni- spent primarily in each activity throughout the hospital tive deficits and severity are taken into account to admit stay. Lang et al26 registered the number of activity repeti- patients in inpatient rehabilitation facilities. However, tions during physical and occupational therapy sessions. hospital bed availability and health insurance coverage The Stroke Physiotherapy Intervention Recording tool determine access to inpatient rehabilitation facilities.11 (SPIRIT) is a recording system developed by Tyson and In most European countries, stroke rehabilitation Selley27 that includes all the interventions physiothera- services are not homogeneously distributed in the terri- pists use to treat postural control post stroke. Activities tory, existing a wide range of rehabilitation centres with were divided into six categories: upper extremity move- different admission criteria12 that vary across countries ments, lower extremity movements, gait, stair climbing, and regions within the same country. Therefore, it is transfers and balance activities. Veerbeek et al28 tested crucial to continue investigating inpatient rehabilitation the effectiveness of different physiotherapy interven- facilities’ benefits and claim for the financial resources tions classified into seven domains based on a consensus needed to ensure the most optimal and effective care. between authors. This classification comprised gait and In the following weeks after the stroke, there is a mobility, arm–hand activities, activities of daily living, time-­limited period of increased plasticity that favours physical fitness, other interventions, the intensity of prac- the establishment of new connections and forms of tice and neurological treatment approaches. Aside from experience-­dependent plasticity.13 One of the biggest these studies, there is a shortage of registries with prospec- challenges in rehabilitation is to understand how to tive uniform, repeated and time-­fixed measurements of modulate the mechanisms of increased plasticity through determinants and measures of functional outcomes after the different elements of the rehabilitation process. In stroke and none have been carried out in Spain (PSROP, this vein, the intensity and the type of therapeutical activ- CERISE, UDS).29–31 In Catalonia, the Stroke Programme ities are central elements that influence the degree of created a stroke population-­based registry (SONIIA) with functional recovery.14 external monitoring of data completeness assessing the The relationship between the amount of therapy and quality of reperfusion therapies delivered to patients with recovery has been extensively documented in animal ischaemic stroke since 2011. However, this database does models and in some clinical studies.8 14–16 Intensive not yet include specific information regarding the reha- rehabilitation facilities usually provide rehabilitation bilitation process and long-­term functional outcomes. programmes that comprise 3 hours of therapy per day The study aims to describe an intensive rehabilitation following international standards.6 Training intensity is a programme for patients with stroke at our inpatient relevant component of learning, but 3 hours of therapy rehabilitation facility, measuring the amount and type of do not guarantee 3 hours of training. Time is lost in therapies (physical, occupational and speech therapy) transportation within the facility, preparation of activ- and reporting functional outcomes. Based on previous ities and tasks and other activities that are not directly research, we hypothesise that the amount of therapy deliv- related to practice.15 17 Different studies measuring the ered is less than what it is planned, and that most therapy amount of practice in stroke rehabilitation describe that activities will be directed to reduce deficits in body func- the training dose provided differs substantially from what tions. In this vein, we also expect that patients show major it is prescribed.18 There is a need to investigate current improvements on body functions during their stay at practice models in inpatient rehabilitation facilities and our inpatient rehabilitation facility, and that recovery of describe how intensive rehabilitation programmes are autonomy in activities of daily living will be more promi- implemented.19 20 nent at 3-­months and 6-­months post discharge. In the literature, therapeutical plans are usually reported by defining their aims, but activities and tasks during therapy sessions are often weakly described. Inter- METHODS AND ANALYSIS ventions and the content of sessions are highly variable Design between studies, limiting the generalisation of results This will be a prospective observational cohort study of and contributing to what is known as the ‘black box’ of patients with subacute stroke admitted to our inpatient rehabilitation.21 For this reason, there is a need to better rehabilitation facility during 2 years. This protocol will describe stroke rehabilitation protocols to develop a be described following the Strengthening the Reporting better understanding of the current practice, the internal of Observational Studies in Epidemiology guidelines.32 validity and generalisation of clinical trial results.22 Few This cohort will be part of the BRAIN-­CONNECTS study, 2 Sartor MM, et al. BMJ Open 2021;11:e046346. doi:10.1136/bmjopen-2020-046346 Open access which is a multicentre prospective study to determine the Participants value of brain connectivity analysis in predicting func- Patients with subacute stroke involved in an inpatient tional outcomes in the rehabilitation of patients with intensive rehabilitation programme at the Department of subacute stroke. The BRAIN-­CONNECTS: Brain Connec- Physical Medicine and Rehabilitation at the Hospitals del tivity during Stroke Recovery and Rehabilitation study is Mar i de l’Esperança will be screened for recruitment. Eligi- approved by the Ethics Committee of the Hospital del Mar bility criteria will be: (1) aged 18 or over, (2) first-­ever intra- Medical Research Institute (Barcelona, Spain; Project ID: cerebral ischaemic or haemorrhagic stroke confirmed by 34/C/2017). neuroimaging, (3) less than 3 weeks since stroke onset, (4) moderate-­ to-­severe impairment (National Institute Study setting of Health Stroke Scale(NIHSS) score between 4 and 13), This study will be conducted at the Physical Medicine (5) functional independence before the stroke (Rankin and Rehabilitation Department of Hospitals del Mar ≤2), (6) no major cognitive deficits affecting comprehen- i l’Esperança, a tertiary referral hospital in the city of sion (MoCA ≥20) and (7) ability to understand Spanish Barcelona (Catalonia, Spain). This centre offers intensive and/or Catalan. Patients with any other neurological or inpatient rehabilitation programmes for patients with psychiatric condition will be excluded. stroke who have a good functional prognosis according The recruitment of patients will be performed by the to the following criteria: (i) no major cognitive deficits medical doctors of the unit, who will provide oral and affecting comprehension (Montreal Cognitive Assess- written information to patients and caregivers. Patients ment (MoCA) ≥20), (ii) low comorbidity (Charlson Index who agree to participate will sign an informed consent <3) and (iii) functional independence before the stroke form. The sample size is calculated with the GRAMO (Modified Rankin Scale (mRS) ≤2). programme,34 using Stroke Impact Scale mobility domain In Catalonia, after the acute care patients with stroke as the main variable of interest. Accepting an alpha risk of may be discharged to: (a) hospital with intensive inpa- 0.05 and a beta risk lower than 0.2 in a bilateral contrast, tient rehabilitation programmes, (b) social-­health centres 63 participants are required to detect an increase over (convalescence or long-­stay centres) or (c) home with time of at least 4.5 points, assuming a SD of 12 points and community rehabilitation (outpatient, daycare or home a 10% loss to follow-­up. care). Catalonia has a population of 7.5 million and an organised and highly territorialised stroke care system Patient and public involvement administered by the Stroke Programme, an organisation Patients or the public were not involved in the design, created in 2004 by the Catalan Health Department.33 The conduct, reporting or dissemination plans of our research. code stroke protocol covers all the territory and has been a key element to ensure the fast transfer to hospitals with Intensive inpatient rehabilitation programme stroke units, and the availability of intravenous throm- The intensive inpatient rehabilitation programme for bolysis or endovascular therapy. Besides the transfer patients with subacute stroke aims at regaining lost body network, a rehabilitation advisory group within the Stroke functions and recovering autonomy in basic activities Programme agreed to a set of inclusion criteria for each of daily life. The rehabilitation programme is a patient-­ rehabilitation setting and established a territorial organ- centred process with cyclic stages that include (i) evalua- isation to access intensive rehabilitation services. The tion of the patient’s need, (ii) collaborative goal setting, Neurological Rehabilitation Unit, part of the Physical (iii) therapeutical interventions and (iv) re-­evaluation.35 Medicine and Rehabilitation Department of Hospitals del Each patient has an assigned medical doctor, and a phys- Mar i l’Esperança, was accredited as a reference centre ical, occupational and speech therapist. At the patient’s in Barcelona area for intensive inpatient rehabilitation arrival to the Neurological Rehabilitation Unit, the programmes admitting patients with stroke from three patient meets with the medical doctor, who performs a tertiary hospitals (Hospital del Mar, Hospital Clínic and global neurological and functional evaluation, provides Hospital de Sant Pau i la Santa Creu). This unit admits general information about the stay at the unit and yearly around 150 acute and early patients with subacute discusses short-­term goals with the patient and family. stroke (average time from stroke onset in 2018: 8.7 days), A non-­instrumental swallowing assessment is performed who receive intensive inpatient rehabilitation (≥3 hours to screen for signs and symptoms of dysphagia, which, if daily) with early supported discharge (average length of positive, is completed with a videofluoroscopic swallowing stay in 2018: 16.37 days). The Neurological Rehabilitation study. Physical, occupational and speech therapists Unit has 18 beds, three medical doctors specialised in interview the patient and perform specific evaluations physical medicine and rehabilitation, four physiothera- regarding the patient’s mobility, performance in activi- pists, two occupational therapists, one speech therapist, ties of daily life and communication, respectively. Within one social worker and one neuropsychologist. A team of the first days of the patient’s stay, a neuropsychologist nurses and nurse assistants trained in neurological reha- performs a comprehensive evaluation focused on exam- bilitation take care of patients during the hospital stay ining orientation, attention, executive functions, visu- (ie, medication, early mobilisation, sphincter control and ospatial function, memory and language deficits. The dysphagia). results of all these evaluations are used to set specific Sartor MM, et al. BMJ Open 2021;11:e046346. doi:10.1136/bmjopen-2020-046346 3 Open access goals with the patient. The team meets weekly to review therapy) was developed on the basis of the proposals of the patient’s progress and redefine specific goals, and Bode et al25 and Veerbeek et al.28 An advisory group formed uses clinical management software to share information by one medical doctor, two physiotherapists, one occu- about each patient. pational therapist and one speech therapist proposed a The intervention consists of at least three scheduled first set of therapy interventions. Only interventions and hours of therapy (physical, occupational and speech activities available in our rehabilitation programme were therapy) per day, 6 days per week. Physiotherapy sessions included, together with those that the group considered address global mobility, balance, transfers and walking. that should be added since they are part of our daily During occupational therapy sessions, body functions practice. Finally, the list was revised to reach enough such as movement, sensation, perception and cognition consensus between the group. This register allows a daily are trained as well as activities of daily living. Speech recording of the number of minutes performed in each therapy sessions are focused on dysphagia management, activity stratified by discipline during specific treatment enhancing language skills and recovering from motor sessions and thus know what interventions are carried speech disorders. Sessions are individual, tailored to the out and how much time is dedicated to each of them patient’s needs and graded by difficulty. (supplementary file: online supplemental file 1: registry Occupational therapy sessions are sometimes performed tool OT, online supplemental file 2: registry tool SL in the patient’s room, especially when training dressing, therapy and online supplemental file 3: registry tool PT). eating, toilet use, personal hygiene and transfers. Other- The therapist responsible for the patient’s treatment wise, sessions are carried out in the physical, occupational will be instructed to fill in the register, writing down the or speech therapy department, where, although working amount of time devoted to each activity during treatment individually, patients are together and can share their session. At the end of each session, the total time spent difficulties and progress with each other, promoting peer in each activity and the total time for all activities will be support. Therapy sessions are spread throughout the calculated. The total time spent in each activity and the day according to the patient’s tolerance and needs and total rehabilitation time for all activities will be averaged special attention is paid to provide sufficient rest periods for all patients. during the day. Patients are allowed to receive visits from family members and friends. Treatment compliance and safety During the stay, patients and caregivers are invited to Compliance will be assessed according to (i) attendance attend to a 1-­hour educational session led by an occu- rate (the number of planned sessions vs the number of pational therapist. This session aims to provide infor- sessions attended) and (ii) reasons for training interrup- mation, training and support on how to manage stroke tion (two or more days without training session) such deficits and consequences. This information and training as fatigue, dizziness or medical instability and training intervention has been shown to have a positive impact session modification (dose reduction or early termina- on patients’ and caregivers’ satisfaction and perceived tion of the individual session). Safety will be assessed by support.36 recording any adverse event related to the rehabilitation Since every patient has an assigned therapist for each programme. discipline, this allows the establishment of therapeutical relationships and patients can express their concerns and feelings during their hospital stay. Importantly, all Evaluation of patients members of the team are trained to provide emotional Baseline variables support to the patient and caregivers. Clinical and demographic variables will be collected The medical doctor together with the social worker at baseline (up to 48 hours after the admission at the coordinates the immediate post-­discharge care at home neurorehabilitation unit). These include age, sex, or in the community. Discharge is planned with the body mass index, level of education, social status and patient and caregiver and interviews are performed to handedness. Clinical history related to risk factors for gather information about the home environment and stroke, NIHSS score at discharge from the stroke unit, social support. Most of the patients continue receiving stroke location using Oxford classification and stroke outpatient rehabilitation at the hospital, which starts aetiology following the TOAST classification. Reperfu- the following day after discharge. Other patients might sion treatment, Charlson Index and sphincter control receive outpatient rehabilitation at different centres or at will be collected from medical records. Data about the home. In these cases, the social worker coordinates with premorbid functioning of the patient will be collected the receiving teams or community-­based agencies and the at admission on the intensive rehabilitation facility by medical doctor prepares a medical report to ensure conti- using the Barthel Index, which measures the individ- nuity in rehabilitation objectives and treatments. ual’s performance in activities of daily living,37 38 and the Functional Ambulation Category that is a clinical Register of the amount of therapy delivered gait assessment scale, which distinguishes six levels of The register of activities delivered in each scheduled walking ability based on the amount of physical therapy therapy (physiotherapy, speech and occupational required.39 4 Sartor MM, et al. BMJ Open 2021;11:e046346. doi:10.1136/bmjopen-2020-046346 Open access Outcomes mRS.49 50 Gait speed will be assessed with the 10 m test: According to the International Classification of Func- patients will walk a distance of 14 m (2 m acceleration tioning, Disability and Health (ICF, WHO, 2001), the and deceleration) twice at their maximum speed. The outcome variables are divided into three domains: body time will be measured and the mean speed calculated structure and function, activity level and participation (m/s).51 52 Arm function will be assessed using the Action measurements. Outcomes will be collected at baseline Research Arm Test, which is divided into four subtests for (within 48 hours of admission to the neurorehabilitation grasp, grip, pinch and gross arm movement. Performance unit), at discharge from the unit and at 3 and 6 months on each item is rated on a 4-­point ordinal scale from 0 to post stroke. 3 with a maximum score of 57, a higher score indicating a better level of function.53 54 Body structure and function outcomes The Fugl-­ Meyer Assessment of motor recovery after Participation outcomes stroke will be used to evaluate upper and lower limb Health-­related quality of life will be assessed using the motor impairment. Performance is rated on a 3-­point Stroke Impact Scale-­ 16 which covers eight domains: ordinal scale from 0 to 2, with a maximum score of 66, strength (4 items), hand function (5 items), mobility (9 higher scores indicate minimal or no impairment.40 The items), activities of daily living (10 items), memory (7 MoCA will be used to assess the global cognitive status items), communication (7 items), emotion (9 items) and of patients. The MoCA is a brief cognitive screening with handicap.55 56 high sensitivity and specificity for detecting mild cogni- tive impairment.41 The Apathy Evaluation Scale will be Data analysis used to address characteristics of goal-­directed behaviour All patient’s clinical, demographic and assessment data that reflect apathy including behavioural, cognitive and will be kept in a secure database. Data on recruitment emotional indicators. This tool quantifies and character- and the transcription of the therapy dose register will ises apathy in adult patients using 18 specific items and also be included. Analyses will be carried out using IBM the score ranges from 18 to 72.42 The Western Aphasia SPSS Statistics V.24. The continuous variables will be Bedside test will be used to assess linguistic skills (infor- described with the mean and SD or with the median and mation content, fluency, auditory comprehension, repe- IQR, depending on their distribution. The categorical tition, naming and word-­finding, reading and writing) variables will be described as percentages. To describe and non-­linguistic skills (drawing, block design, calcula- the stroke rehabilitation programme, the amount of time tion and praxis) of adults with aphasia.43 The Motricity spent on each type of activity during the therapy sessions Index is an ordinal scale for limb strength, with six items will be reported as mean and SD. In order to minimise on each side (three for the arm and three for the leg). missing data, all questionnaires are user friendly and The maximum total arm score is 99+1 (range from 0 to collected electronically, and all personnel related to the 99), and the same for the leg.44 Swallowing assessment study are trained to identify and engage participants who will be performed in all patients admitted in the intensive may be at risk of dropout during follow-­up. ANOVA for rehabilitation facility with the volume viscosity test (VVT). repeated measures will be used to describe the changes in Patients with abnormal results in the VVT will undergo clinical assessment measures across the four-­time points. a videofluoroscopic swallowing study, which is the gold-­ The last observation carried forward will be used to deal standard tool to diagnose oropharyngeal dysphagia. The with missing value. 8-­point Penetration Aspiration Scale, Bolus Residue Scale and Functional Oral Intake Scale will be used to define swallow impairment in terms of aspiration/penetration DISCUSSION events, residue and oral intake.45–47 Anxiety and depres- This study will provide a description of an intensive reha- sion will be assessed with the Hospital Anxiety Depres- bilitation programme for patients with subacute stroke sion Scale (HADS), consisting of 14 items, which can be delivered at our inpatient rehabilitation unit. Focusing divided into two subscales of seven items each: the anxiety on the type of activities and the amount of therapy time, subscale (HADS-­A) and the depression subscale (HADS-­ the results of this study may bring out new perspectives D). The respondent rates each item on a 4-­point scale on how to describe stroke rehabilitation interventions. ranging from 0 (absence) to 3 (extreme presence). The Another crucial contribution of this study is that the clin- total score is out of 42 (21 per subscale). The total HADS ical assessments are not limited to the inpatient period, score may be regarded as a global measure of physiolog- but also extend to the long-­term phase. Nowadays, reha- ical distress.48 bilitation interventions are poorly described in research studies and it is often limited to measure the time spent Activity outcomes in each therapy without taking into account the type and The level of each patient’s activity will be assessed with the amount of activity and tasks performed.57 58 Barthel Index, which is a widely used standardised scale The amount of rehabilitation therapy contributes to for assessing functional disability in basic activities of daily functional recovery after stroke,59 but different studies living.26 27 Disability after stroke will be assessed with the have pointed out a discrepancy between the planned Sartor MM, et al. BMJ Open 2021;11:e046346. doi:10.1136/bmjopen-2020-046346 5 Open access therapy hours and the actual practice time.6 17–20 The represent a comprehensive view of the consequences of optimal dose-­response in stroke rehabilitation has not stroke and the effects of rehabilitation. been established and further research is needed to eluci- date and better understand the relationship between training intensity and recovery. Lohse et al60 reported a ETHICS AND DISSEMINATION positive relationship between the time scheduled for The study will follow the national and international ethical therapy and therapy outcomes, suggesting that large guidelines (Code of Ethics, Declaration of Helsinki) for doses of therapy lead to clinically meaningful improve- research in humans and will comply with the legal regu- ments, controlling for time after stroke. However, Lang lations on data confidentiality (Organic Law 15/1999, et al have found no evidence of a dose-­response effect of 13 December, on Personal Data Protection). Poten- of task-­specific training on functional capacity in people tial participants will receive oral and written informa- with long-­standing upper-­limb paresis post stroke.61 tion about the study’s objectives and procedures, before Therefore, we believe that an agreed description of deciding whether to provide written informed consent. the rehabilitation programme is the first step required to The BRAIN-­CONNECTS study has been evaluated and improve transparency, to ensure fidelity of implementa- accepted by the Medical Research Committee at Hospital tion and to investigate any aspect related to the dose of del Mar Research Institute (Project ID: 34/C/2017). All the stroke rehabilitation programme. patients invited to participate in this trial will be asked to The data collected in this study will rely on the informa- agree and sign the written consent in order to participate tion provided by the therapists, and although all partic- in the current study. ipating therapists have agreed to provide reliable data The findings will be disseminated in clinical seminars, when reporting therapy sessions, there might be a social scientific conferences and submitted for publication in desirability bias and inaccuracy. Indeed, we acknowledge peer-­reviewed journals. that the registry tool is just an estimation of the time spent on specific activities during therapies, which is not Author affiliations 1 comprehensive as far as therapies are concerned. Using Rehabilitation Research Group, Institut Hospital del Mar d'Investigacions Mediques, more objective tools to measure interventions such as Barcelona, Spain 2 Physiotherapy Degree, Universitat Autonoma de Barcelona, Barcelona, Spain video or auditing records of third parties may not guar- 3 Cognition and Brain Plasticity Unit, Department of Cognition, Development and antee that the information is more reliable. The therapy Educational Psychology, University of Barcelona and Bellvitge Biomedical Research activities and time spent in each of them will depend on Institute (IDIBELL), Barcelona, Spain 4 the individual deficits of each patient. This represents an Escola Universitària d’Infermeria i Teràpia Ocupacional de Terrassa (EUIT), inherent limitation for the generalisation of results in Autonomous University of Barcelona, Terrassa, Spain 5 Department of Physical Medicine and Rehabilitation, Hospitals del Mar i rehabilitation studies since interventions are tailored to l'Esperança, Parc de Salut Mar, Barcelona, Spain the patient. Another limitation could be the lack of qual- 6 Department of Radiology, Biomedical Research Institute Imaging Research Unit, itative assessments for the interventions. This study only Diagnostic Imaging Institute, Doctor Josep Trueta University Hospital of Girona, allows us to quantify the time allocated to each activity Girona, Spain 7 during specific treatment sessions, but does not register Centre for Brain Research, The University of Auckland, Auckland, New Zealand qualitative or patient-­centred aspects. For instance, we Acknowledgements AGAUR—this research has been partially supported by will not measure the motivation of the patient, which a grant from ‘Secretaria d'Universitats i Recerca del Departament d'Empresa i is an aspect that may influence the effectiveness of the Coneixement de la Generalitat de Catalunya’. We also would like to thank the therapies. Moreover, there are other elements of the multidisciplinary team of therapists of the Hopsital de L'Esperança (Norah Rueda, rehabilitation process that play a crucial role that will OT; Ruben Valero, FT and Sonia Nieto, SLP) that have helped in the design of the therapies activity registry. The authors would like to thank all the patients and for not be measured such as the therapeutical relationships participating in this study. established with the patient, the direct and non-­direct Contributors MMS led the conceptualisation, design and implementation of inputs during therapy sessions, how other staff members this research protocol, and was the primary author for this manuscript. AM-­P (physicians, nurses, nurse assistants, porters) interact contributed with the implementation, review of this research protocol. ED was with the patient in a supporting manner and environ- a leader in the conceptualisation, design and is a contributing author for this mental factors of our unit favouring recovery. In a similar manuscript. JG-­S together with ED was a leader in the conceptualisation of the project and also had a role in the design and implementation of the research vein, the therapist’s personal abilities to propose the right protocol and was the second author for this manuscript. RB and AG-­S participated combination of techniques for each patient and the team in the design and implementation of the research protocol. JP helped with funding workload distribution are aspects that are not controlled arrangement. CS contributed to refinement of the research protocol. All authors in this study.62 read and approved the final manuscript. One of the strengths of this study is that treatment Funding This Project is funded by Fundació La Marató TV3. registry data has been agreed between all members of Competing interests None declared. the rehabilitation team, reflecting actual clinical practice. Patient consent for publication Not applicable. However, future research would be needed in order to Provenance and peer review Not commissioned; externally peer reviewed. check how comprehensive this registry tool is and assess Supplemental material This content has been supplied by the author(s). It has its feasibility. The set of selected clinical outcomes take not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been into account all the dimensions of the ICF and therefore peer-­reviewed. Any opinions or recommendations discussed are solely those 6 Sartor MM, et al. BMJ Open 2021;11:e046346. doi:10.1136/bmjopen-2020-046346 Open access of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and 20 Bernhardt J, Hayward KS, Kwakkel G, et al. Agreed definitions and responsibility arising from any reliance placed on the content. Where the content a shared vision for new standards in stroke recovery research: the includes any translated material, BMJ does not warrant the accuracy and reliability stroke recovery and rehabilitation roundtable Taskforce. Neurorehabil of the translations (including but not limited to local regulations, clinical guidelines, Neural Repair 2017;31:793–9. 21 DeJong G, Horn SD, Conroy B, et al. Opening the black box of post-­ terminology, drug names and drug dosages), and is not responsible for any error stroke rehabilitation: stroke rehabilitation patients, processes, and and/or omissions arising from translation and adaptation or otherwise. outcomes. Arch Phys Med Rehabil 2005;86:1–7. Open access This is an open access article distributed in accordance with the 22 Lohse KR, Pathania A, Wegman R, et al. On the reporting of Creative Commons Attribution Non Commercial (CC BY-­NC 4.0) license, which experimental and control therapies in stroke rehabilitation trials: a permits others to distribute, remix, adapt, build upon this work non-­commercially, systematic review. Arch Phys Med Rehabil 2018;99:1424–32. 23 Ballinger C, Ashburn A, Low J, et al. Unpacking the black box and license their derivative works on different terms, provided the original work is of therapy – a pilot study to describe occupational therapy and properly cited, appropriate credit is given, any changes made indicated, and the use physiotherapy interventions for people with stroke. Clin Rehabil is non-­commercial. See: http://​creativecommons.​org/​licenses/​by-​nc/​4.​0/. 1999;13:301–9. 24 van Vliet PM, Lincoln NB, Robinson E. Comparison of the ORCID iD content of two physiotherapy approaches for stroke. Clin Rehabil Monique Messaggi Sartor http://​orcid.​org/​0000-​0002-​2807-​3266 2001;15:398–414. 25 Bode RK, Heinemann AW, Semik P, et al. Patterns of therapy activities across length of stay and impairment levels: peering inside the "black box" of inpatient stroke rehabilitation. Arch Phys Med REFERENCES Rehabil 2004;85:1901–8. 1 GBD 2013 DALYs and HALE Collaborators, Murray CJL, Barber 26 Lang CE, MacDonald JR, Gnip C. Counting repetitions: an RM, et al. Global, regional, and national disability-­adjusted life years observational study of outpatient therapy for people with hemiparesis (DALYs) for 306 diseases and injuries and healthy life expectancy post-­stroke. J Neurol Phys Ther 2007;31:3–10. (HALE) for 188 countries, 1990-­2013: quantifying the epidemiological 27 Tyson SF, Selley A. The development of the stroke physiotherapy transition. Lancet 2015;386:2145–91. intervention recording tool (spirit). Disabil Rehabil 2004;26:1184–8. 2 Hay SI, Abajobir AA, Abate KH, et al. Global, regional, and national 28 Veerbeek JM, van Wegen E, van Peppen R, et al. What is the disability-­adjusted life-­years (DALYs) for 333 diseases and injuries evidence for physical therapy poststroke? A systematic review and and healthy life expectancy (HALE) for 195 countries and territories, meta-­analysis. PLoS One 2014;9:e87987. 1990-­2016: a systematic analysis for the global burden of disease 29 Jette AM. The post-­stroke rehabilitation outcomes project. Arch Phys study 2016. Lancet 2017;390:1260–344. Med Rehabil 2005;86:124–5. 3 Hankey GJ. Stroke. The Lancet 2017;389:641–54. 30 Stummer C, Verheyden G, Putman K, et al. Predicting sickness 4 Buntin MB, Colla CH, Deb P, et al. Medicare spending and impact profile at six months after stroke: further results from outcomes after postacute care for stroke and hip fracture. Med Care the European multi-­center CERISE study. Disabil Rehabil 2010;48:776–84. 2015;37:942–50. 5 Krakauer JW, Carmichael ST, Corbett D, et al. Getting 31 Graham JE, Granger CV, Karmarkar AM, et al. The uniform data neurorehabilitation right: what can be learned from animal models? system for medical rehabilitation: report of follow-­up information on Neurorehabil Neural Repair 2012;26:923–31. patients discharged from inpatient rehabilitation programs in 2002-­ 6 Winstein CJ, Stein J, Arena R, et al. Guidelines for adult stroke 2010. Am J Phys Med Rehabil 2014;93:231–44. rehabilitation and recovery: a guideline for healthcare professionals 32 von Elm E, Altman DG, Egger M, et al. The strengthening the from the American heart Association/American stroke association. reporting of observational studies in epidemiology (STROBE) Stroke 2016;47:e98–169. statement: guidelines for reporting observational studies. J Clin 7 Miller EL, Murray L, Richards L, et al. Comprehensive overview of Epidemiol 2008;61:344–9. nursing and interdisciplinary rehabilitation care of the stroke patient: 33 Vivanco-­Hidalgo RM, Abilleira S, Salvat-­Plana M, et al. Innovation in a scientific statement from the American heart association. Stroke systems of care in acute phase of ischemic stroke. The experience of 2010;41:2402–48. the Catalan stroke programme. Front Neurol 2018;9:427. 8 Chan L, Sandel ME, Jette AM, et al. Does postacute care site 34 Marrugat J, Vila J, Pavesi M, et al. [Estimation of the sample matter? A longitudinal study assessing functional recovery after a size in clinical and epidemiological investigations]. Med Clin stroke. Arch Phys Med Rehabil 2013;94:622–9. 1998;111:267–76. 9 Wang H, Camicia M, DiVita M, et al. Early inpatient rehabilitation 35 Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. The admission and stroke patient outcomes. Am J Phys Med Rehabil Lancet 2011;377:1693–702. 2015;94:85–100. 36 Aguirrezabal A, Duarte E, Rueda N, et al. Effects of information and 10 Deutsch A, Granger CV, Heinemann AW, et al. Poststroke training provision in satisfaction of patients and carers in stroke rehabilitation: outcomes and reimbursement of inpatient rehabilitation. NeuroRehabilitation 2013;33:639–47. rehabilitation facilities and subacute rehabilitation programs. Stroke 37 Mahoney FI, Barthel DW. Functional evaluation: the BARTHEL index. 2006;37:1477–82. Md State Med J 1965;14:61–5. 11 Sood N, Huckfeldt PJ, Grabowski DC, et al. The effect of prospective 38 Cid-­Ruzafa J, Damián-­Moreno J. Evaluating physical incapacity: the payment on admission and treatment policy: evidence from inpatient Barthel index. Rev Esp Salud Pública 1997;71:127–37. rehabilitation facilities. J Health Econ 2013;32:965–79. 39 Holden MK, Gill KM, Magliozzi MR. Gait assessment for 12 SAFE. SAFE annual report 2019, 2021. Available: https://www.​ neurologically impaired patients. standards for outcome assessment. safestroke.​eu/​2020/​01/​05/​safe-​annual-​report-​2019-​2/ Phys Ther 1986;66:1530–9. 13 Buma F, Kwakkel G, Ramsey N. Understanding upper limb recovery after stroke. Restor Neurol Neurosci 2013;31:707–22. 40 Page SJ, Fulk GD, Boyne P. Clinically important differences for 14 Kwakkel G, Kollen B, Lindeman E. Understanding the pattern of the upper-­extremity Fugl-­Meyer scale in people with minimal functional recovery after stroke: facts and theories. Restor Neurol to moderate impairment due to chronic stroke. Phys Ther Neurosci 2004;22:281–99. 2012;92:791–8. 15 Krakauer JW, Carmichael ST, Corbett D, et al. Getting 41 Nasreddine ZS, Phillips NA, Bédirian V, et al. The Montreal cognitive neurorehabilitation right: what can be learned from animal models? assessment, MoCA: a brief screening tool for mild cognitive Neurorehabil Neural Repair 2012;26:92. impairment. J Am Geriatr Soc 2005;53:695–9. 16 Wang H, Camicia M, Terdiman J, et al. Daily treatment time and 42 Marin RS, Biedrzycki RC, Firinciogullari S. Reliability and validity of functional gains of stroke patients during inpatient rehabilitation. Pm the apathy evaluation scale. Psychiatry Res 1991;38:143–62. R 2013;5:122–8. 43 Risser AH, Spreen O. The Western aphasia battery. J Clin Exp 17 Zeiler SR, Krakauer JW. The interaction between training and Neuropsychol 1985;7:463–70. plasticity in the poststroke brain. Curr Opin Neurol 2013;26:609–16. 44 Collin C, Wade D. Assessing motor impairment after stroke: a pilot 18 Connell LA, McMahon NE, Simpson LA, et al. Investigating measures reliability study. J Neurol Neurosurg Psychiatry 1990;53:576–9. of intensity during a structured upper limb exercise program in 45 Logemann JA. Measurement of swallow from videofluorographic stroke rehabilitation: an exploratory study. Arch Phys Med Rehabil studies. Austin: Pro-­ed, 1993. 2014;95:2410–9. 46 Rommel N, Borgers C, Van Beckevoort D, et al. Bolus residue 19 Bernhardt J, Borschmann K, Boyd L, et al. Moving rehabilitation scale: an easy-­to-­use and reliable videofluoroscopic analysis tool research forward: developing consensus statements for rehabilitation to score bolus residue in patients with dysphagia. Int J Otolaryngol and recovery research. Neurorehabil Neural Repair 2017;31:694–8. 2015;2015:1–7. Sartor MM, et al. BMJ Open 2021;11:e046346. doi:10.1136/bmjopen-2020-046346 7 Open access 47 Crary MA, Mann GDC, Groher ME. Initial psychometric assessment 55 Richardson M, Campbell N, Allen L, et al. The stroke impact of a functional oral intake scale for dysphagia in stroke patients. Arch scale: performance as a quality of life measure in a Phys Med Rehabil 2005;86:1516–20. community-­b ased stroke rehabilitation setting. Disabil Rehabil 48 Aben I, Verhey F, Lousberg R, et al. Validity of the Beck depression 2016;38:1425–30. inventory, hospital anxiety and depression scale, SCL-­90, and 56 Duncan PW, Wallace D, Lai SM, et al. The stroke impact scale Hamilton depression rating scale as screening instruments for version 2.0. Evaluation of reliability, validity, and sensitivity to change. depression in stroke patients. Psychosomatics 2002;43:386–93. Stroke 1999;30:2131–40. 49 van Swieten JC, Koudstaal PJ, Visser MC, et al. Interobserver 57 Glasziou P, Meats E, Heneghan C, et al. What is missing agreement for the assessment of handicap in stroke patients. Stroke from descriptions of treatment in trials and reviews? BMJ 1988;19:604–7. 2008;336:1472–4. 50 Bonita R, Beaglehole R. Recovery of motor function after stroke. 58 Hoffmann TC, Glasziou PP, Boutron I, et al. Better reporting of Stroke 1988;19:1497–500. interventions: template for intervention description and replication 51 Pohl M, Werner C, Holzgraefe M, et al. Repetitive locomotor training (TIDieR) checklist and guide. BMJ 2014;348:g1687. and physiotherapy improve walking and basic activities of daily living 59 Foley N, McClure JA, Meyer M, et al. Inpatient rehabilitation following after stroke: a single-­blind, randomized multicentre trial (Deutsche stroke: amount of therapy received and associations with functional gang trainer studie, DEGAS). Clin Rehabil 2007;21:17–27. recovery. Disabil Rehabil 2012;34:2132–8. 52 Perera S, Mody SH, Woodman RC, et al. Meaningful change and 60 Lohse KR, Lang CE, Boyd LA. Is more better? using metadata to responsiveness in common physical performance measures in older explore dose-­response relationships in stroke rehabilitation. Stroke adults. J Am Geriatr Soc 2006;54:743–9. 2014;45:2053–8. 53 Hsieh CL, Hsueh IP, Chiang FM, et al. Inter-­Rater reliability and 61 Lang CE, Strube MJ, Bland MD, et al. Dose response of validity of the action research arm test in stroke patients. Age Ageing task‐specific upper limb training in people at least 6 months 1998;27:107–13. poststroke: a phase II, single‐blind, randomized, controlled trial. 54 Lang CE, Wagner JM, Dromerick AW, et al. Measurement of upper-­ Ann Neurol 2016;80:342–54. extremity function early after stroke: properties of the action research 62 Negrini S. Evidence in rehabilitation medicine: between facts and arm test. Arch Phys Med Rehabil 2006;87:1605–10. Prejudices. Am J Phys Med Rehabil 2019;98:88–96. 8 Sartor MM, et al. BMJ Open 2021;11:e046346. doi:10.1136/bmjopen-2020-046346