Early Occupational Therapy Intervention in the Hospital Discharge After Stroke: Study Protocol for a Randomized Controlled Trial
Phase: NA
Conditions: Stroke
Sponsor: University of Malaga

STUDY PROTOCOL WITH SAP 
 
Early occupational 
therapy intervention in the 
hospital discharge 
process after suffering a 
stroke 
 
P García-Pérez
1,2, JP Lara
1, C de la Cruz-Cosme
3, MC Rodríguez-Martínez
2  
 
1Brain Health Unit CIMES-IBIMA-University of Malaga; 
2Health Sciences School- 
University of Málaga; 
3Neurology Department, Virgen de la Victoria University 
Hospital of Málaga  
 
 
ClinicalTrials.gov ID NCT04835363 
Information provided by Patricia García-Perez, University of 
Malaga (Responsible Party) 
Document date 2021-02-01 
Last Update Posted 2023-05-06 
 
 

Research background  
We call a stroke or cerebrovascular accident (CVA) those sudden episodes of the 
circulatory system that compromise the stability of an affected brain area, whether 
permanently or temporarily. In this way, we will use the defined terms to refer to 
cerebral infarction, as well as intracerebral and subarachnoid hemorrhages (1). 
Stroke is a cerebrovascular disease that has a great health and social impact due 
to its high incidence and prevalence, and is the leading cause of acquired 
disability in adults in developed countries. Its incidence in Spain is 187.4/100,000 
inhabitants/year. It represents a great burden, not only from a health point of view, 
but also from a personal and family point of view, due to its impact on the lives of 
people who suffer from it and their caregivers (2, 3).  
It is also one of the main causes of hospital stay and death in our country. The 
relevance of stroke is given by its mortality data, as well as the dependency of 
survivors. In the acute phase of stroke, mortality rises to 25% of cases, appearing 
more frequently in hemorrhagic strokes (up to 50% of deaths) than ischemic 
strokes (25%). Studies show that in the first six months after the circulatory event, 
many of these deaths are caused by cardiopulmonary complications; however, 
after this stage, significant clinical and functional stabilization is achieved. Of the 
total survivors, 30-40% will present some serious sequelae, up to 60% of users 
will present minor sequelae or no sequelae, and only 6% of cases with severe 
initial paralysis will completely recover mobility. These data demonstrate the 
importance of rehabilitation to facilitate the relearning of these patients, having 
been shown in previous studies to be useful in the user's recovery in terms of 
functional autonomy, also increasing the frequency of return home and reducing 
hospital stay. Similarly, a caregiver-mediated program has been shown to have 
the potential to improve bodily function, activity, and participation outcomes for 
these individuals with stroke.  
In addition, caregivers participate more actively in the rehabilitation process, 
which can increase feelings of empowerment, reducing caregiver burden levels 
and easing the transition from hospital to home (4).  
Generally, initial assistance in stroke begins with a call to the 061 or 112 services 
and arrival at the Emergency Department. Subsequently, the user is admitted to 
the Stroke Unit and once stabilized, they are transferred to the neurology ward. 
The importance of rehabilitation in the acute phase is given by the existence of a 
therapeutic window during which interventions can truly modify the course of the 
disease and achieve neuronal reactivation. This improvement may be due to the 
existence of an area of penumbra in the periphery of the ischemic zone, whose 
damage is potentially reversible, although it can only be achieved for a short and 
variable time of up to 24 hours if reperfusion of said tissue is achieved, as well as 
the resolution of diaschisis (transsynaptic failure of neurons connected to the 
damaged area). However, there is a brain reorganization that can be modulated 
by rehabilitation techniques through the phenomenon of neuronal plasticity, 
which determines the importance of an efficient interdisciplinary intervention (4, 
5).  

The role of the occupational therapist has its place at all levels of stroke 
intervention, both in direct action with the user, as well as in counseling and family 
or social support. Occupational intervention is initially directed at sensorimotor 
and perceptual-cognitive performance skills, as well as re-education and training 
in basic and instrumental activities of daily living (ADL); Subsequently, an 
intervention more oriented towards the social and labor integration of the person 
is proposed (6). Occupational Therapy (OT) intervenes on function, using specific 
procedures and activities to develop, maintain, improve and/or recover the 
performance of functions and activities necessary in daily life, compensate for 
dysfunctions and/or promote health and well-being. Based on the framework for 
occupational therapy practice, we classify this function into areas of occupation 
(basic and instrumental ADLs, rest and sleep, education, work, play, leisure, and 
social participation) and performance skills (motor skills and praxis, sensory-
perceptual skills, emotional regulation skills, cognitive skills, and social and 
communication skills). Therefore, the initial objective of an intervention plan 
carried out from OT is to improve the user's independence in carrying out ADLs, 
achieving the highest possible level of autonomy and promoting their well-being 
and quality of life (6, 7).  
According to a study published in 2015, the prognosis of stroke in Spain has 
changed in recent years. Both survival and functional outcome have improved as 
a result of the introduction of a new model of care. This new model, based on 
stroke units, early reperfusion therapies, physiotherapy and secondary 
prevention, has been promoted by the stroke strategy of the Spanish National 
Health Service in coordination with regional health authorities and healthcare 
professionals. health. However, this model does not take into account the 
intervention of OT in the discharge process, as other countries with positive 
results in functional independence do, among others (8).  
Finally, it should be remembered that this pathology also has a relevant economic 
impact on the direct national health cost, plus those derived from its work and 
socio- family repercussions. According to a recently published study, the cost of 
patients admitted to stroke units in Spain is €27,711 per patient/year. More than 
two- thirds are social costs, mainly informal care (9).  
Foundation  
The early supported discharge (ESD) model for rehabilitation was introduced in 
the late 1990s and includes a well- resourced interdisciplinary team that 
coordinates discharge and plans, monitors, and continues rehabilitation in the 
hospital setting. home (10).  
Based on randomized controlled trials conducted, there is evidence that early 
discharge with hospital follow-up (ESD) and with continued rehabilitation at home 
has beneficial effects in stroke users; However, the effects of the ESD service in 
routine clinical practice in Spain have not been investigated (11, 12). Likewise, 
there is a lack of published data regarding the impact of Occupational Therapy in 
the hospital discharge process along with conventional care and rehabilitation in 
terms of patient functional outcomes, caregiver burden, and health care costs. 
during the first six months after the stroke (13).  

It is important to take into account the involvement of the family in the 
rehabilitation process, as well as their knowledge regarding the patient's illness 
and care to provide a stimulating and safe environment at home that reduces the 
risk of ulcers, muscle or tissue shortening. soft joints, dislocations, etc., in patients 
with sequelae motor deficit. The treatment provided in current public healthcare 
is insufficient, which may be worrying due to the limited recovery after stroke and 
the difficulty in community reintegration. This is why certain variables are of 
special interest when trying to assess the effectiveness of this type of action, such 
as motor improvement and the importance of functional mobility of the upper 
extremities, which can contribute to a better quality of life for patients. stroke 
survivors (13, 14).  
There are at least three important perspectives to take into account in any project 
to assess actions on the consequences of stroke: the personal, the social and 
public health. From a personal perspective, returning home after a hospital stay 
for stroke and being able to participate in rehabilitation planning, as well as 
deciding goals, results in patient empowerment and greater satisfaction, 
improving mood and promoting well-being. From a social perspective, it helps the 
family feel less distressed when support is provided at home, it reduces the risk 
of readmission and stress-induced symptoms in family members, which is also 
an opportunity to improve the caregiver quality of life and reduce their risk of 
illness, as family members often report feeling a great burden as caregivers. From 
a public health perspective, making it safe to discharge with occupational therapy 
support means decreased costs. There are no studies in our environment that 
demonstrate whether discharge with OT support is effective and profitable, 
whether it increases the safety of patients and families, or whether patients 
perceive less anxiety and depression, higher levels of functional independence 
and a better quality of life. (5).  
Research objectives  
General Objective  
The general objective of the present study is to determine if the early intervention 
of occupational therapy (OT) together with usual care in the hospital discharge 
process after stroke has a positive effect on the quality of functional 
independence of the patient, comparing it with the control group that will have the 
assistance regular care and rehabilitation.  
We designed a four-week early OT intervention program for patients who have 
suffered a stroke with the aim of improving quality of life and facilitating their 
return home by providing them and their caregiver with knowledge about specific 
care and neurorehabilitation.  
Specific Objectives  
Primary outcome: Quality of life. Secondary results: Functional independence 
and support needs in activities of daily living, sensory-motor skills, perceptual-
cognitive skills, communication skills, anxiety and depression levels.  

Methods  
Type and general design of the study  
This is a prospective, randomized, controlled clinical trial. The population to be 
represented is that of patients who are discharged from the neurology service of 
the Virgen de la Victoria University Hospital (Malaga) and who, after medical 
discharge, are referred to the rehabilitation service of the Maritime Hospital of 
Torremolinos as outpatients by decision of the neurology and rehabilitation 
departments, but will not be inpatients in the Physical Medicine and Rehabilitation 
Unit for intensive rehabilitation.  
Users who are referred to rehabilitation by obtaining a place as an inpatient, 
receive occupational therapy and physiotherapy daily for a period of maximum 
three months. However, patients who are referred to the rehabilitation service as 
an outpatient are taken home directly after discharge and are subsequently 
recalled for rehabilitation. The period that elapses from when they are discharged 
until they are called to begin their rehabilitation varies depending on the workload 
of the service, and can even be three months after discharge. Referral to external 
or intensive rehabilitation is made based on the rehabilitation potential, which 
takes into account certain criteria such as age, clinical situation and vascular 
injury existing at the time of discharge, social support, motivation and observed 
recovery. during admission. Patients assigned to the study program are included 
in an early occupational therapy intervention program and are compared with a 
control group that will receive usual care and rehabilitation.  
Sample selection and size  
The sample size “n” was calculated based on the main variable SAQOL-39 with 
the sample size determination formula for two independent groups, assuming a 
mean of 2.50, standard deviation of 0.75, significance level of 5%, a power of 
80% and a critical difference of 0.54, obtaining a sample of 30 participants per 
group.  
Therefore, two groups were formed: an intervention group of 30 patients who will 
receive the early Occupational Therapy program in addition to the rehabilitation 
that they would receive independently of this study, and a control group of 30 
patients who will receive the conventional rehabilitation.  
Eligible patients were assigned to EOTIPS or the control group according to a 
pre-established computer randomized designation in blocks of six.  
Inclusion and exclusion criteria  
All patients must have diagnostic confirmation of stroke with single or multiple 
vascular lesions that had occurred in the same time period, demonstrated by 
neuroimaging tests (CT or MRI), be over 18 years of age, go home on discharge 
and live within a maximum of 30 minutes away from the hospital center, with >2 
or <26 points on the National Institute of Health scale (NIHSS), 30–100 points on 
the Barthel Index (BI) on the second day after the stroke (with BI 100, the patient 

can be included if the Montreal Cognitive Assessment is <26) and having been 
referred to the rehabilitation service as an outpatient. Inclusion in the study occurs 
prior to hospital discharge, within a two- week interval after the stroke.  
Exclusion criteria are: NIHSS > 26, BI < 30, and life expectancy < 1 year. Also 
excluded are people with a previous stroke, dementia or other types of diseases 
that cause dementia and other neurological, psychiatric or medical diseases (for 
example, severe epilepsy, traumatic brain injury, schizophrenia, COPD, severe 
or unstable heart disease, sleep apnea) concomitants that could alter cognitive 
function, presence of moderate or severe aphasia, people who do not understand 
Spanish or English, as well as patients who have been referred to the Physical 
Medicine and Rehabilitation Unit as inpatients to receive intensive rehabilitation 
or who are discharged to a care home.  
The variables will take into account: age, sex, educational level, marital status, 
nationality, mother tongue, employment, vascular territory and lesion volume.  
List of results and evaluations  
 
Assessments to be used in the study (all translated into Spanish)  
- Stroke and Aphasia Quality of Life Scale - 39, SAQOL-39 (Lata-Caneda, 
Piñeiro- Temprano, García-Fraga, García- Armesto, Barrueco-Egido, Meijide- 
Failde, 2009). SAQOL-39 was derived from the Stroke-Specific Quality of Life 
Scale and four additional items specifically targeting patients with aphasia, 
covering four domains: physical, psychosocial, communication, and energy.  
- Montreal Cognitive Assessment, MoCA (Lozano Gallego, Hernández Ferrándiz, 
Turró Garriga, Pericot Nierga, López- Pousa, Vilalta Franch, 2009). MoCA has 
been proposed as a screening tool that promises good sensitivity to deficits 
resulting from stroke and vascular cognitive impairment. MoCA includes sections 
on visuospatial/executive functions, naming, attention, language, abstraction, 

memory, and orientation. It is scored out of 30 (extra point for <13 years of 
education) and the recommended “normal” limit is ≥26.  
- Modified Rankin Scale, mRS (Van Swieten, Kodustaal, Visser, Schouten, Van 
Gijn, 1988). The mRS is used to describe disability in general. The scale ranges 
from 0 to 6, from perfect health with no symptoms to death.  
- Fugl-Meyer sensory motor assessment, FMA (Ferrer González, Zarco Periñán, 
Ruiz de Vargas, Docobo Durantez, 2015). It evaluates the upper extremity 
(maximum score of 66 which corresponds to normal motor function) and lower 
extremity (maximum score of 34). Tenderness, passive range of motion, and pain 
during passive joint movements are also evaluated.  
- Timed up and go,TUG (Hafsteinsdóttiret al, 2014). TUG assesses basic 
mobility, timing the time required for a person to stand up from a standardized 
chair, walk a distance of three meters, turn, return to the chair, and sit down again. 
A shorter time indicates better performance. It has been shown to be reliable and 
valid in this group of patients.  
- Berg Balance Scale, BBS (Kudlac, Sabol, Kaiser, Kane, Phillips, 2019). BBS 
assesses functional balance. Performance on this test is scored from 0 (unable 
to perform) to 4 (normal performance) on 14 different tasks, including the ability 
to sit, stand, reach, bend, turn, and step. The maximum score on the BBS is 56. 
A higher score indicates better balance skills.  
- Barthel Index, BI (Baztán, Pérez del Molino, Alarcón, San Cristobal, Izquierdo, 
Manzarbeitia, 1993). The Barthel Index measures the extent to which someone 
can function independently during basic activities of daily living (ADLs), i.e., 
feeding, bathing, grooming, dressing, bowel control, bladder control, grooming, 
chair transfers, ambulation and climbing stairs. Each performance element is 
rated on this scale with a given number of points assigned to each level. In this 
study, the modified version with 0–100 is used, where a lower score indicates 
dependence.  
- Stroke Impact Scale - 16, SIS-16 (Duncan, Lai, Bode, Perera, DeRosa, 2003). 
The usefulness of this scale is similar to that of the Barthel Index, although it is 
more sensitive than the latter for discriminating between patients with mild 
disabilities. It is designed especially for patients who have suffered a stroke, but 
it is also applicable to dementia. It is a reduced version of the Stroke Impact Scale 
version 3.0. The information can be obtained from the patient himself, or from the 
main caregiver (15) (16).  
- Communicative Activity Log, CAL (Pulvermüller & Berthier, 2008). Scale that 
allows obtaining information on the communication capacity in the activities of 
daily life referring to comprehensive and expressive aspects of language. It is 
composed of 36 items (Likert-type scale, 0-6) that evaluate both the quality (items 
1-18) and the quantity of patient communication (items 19-36). Performance is 
obtained through the sum of the scores on each item.  

- Beck Depression Inventory, BDI-2 (Steer, Brown, 1996). It is a self- 
administered questionnaire that consists of 21 multiple-choice questions. It is one 
of the most commonly used instruments to measure the severity of depression.  
- Hamilton Anxiety Scale (Lobo et al, 2002). This scale evaluates the severity of 
anxiety globally in patients who meet criteria for anxiety or depression. In addition, 
this instrument is useful to monitor the response to treatment. It is composed of 
14 items, 13 referring to anxious signs and symptoms and the last one assessing 
the patient's behavior during the interview.  
The evaluations were carried out in both groups (control and intervention group) 
before discharge (after completion of the informed consent) and three months 
after the neurological event.  
Timeline and data collection  
Hospital discharge planning  
The rehabilitation and neurology departments were responsible for referring 
patients to the occupational therapist and including them in the study. Before 
starting rehabilitation, the occupational therapist and her family explored the 
patient's needs and desires and decide individual goals for the intervention 
period.  
Occupational 
Therapy 
intervention 
during 
the 
discharge 
process 
The intervention has a person-centered approach that is based on who the user 
is: their context, their history, their family members, their individual strengths and 
weaknesses. Individualized objectives will be established, taking into account the 
patient's potential and limitations. Examples of goals could be: being able to wash 
independently, hanging clothes or riding the bus, or how to manage bills. OT 
intervention may involve training in different activities or thinking about different 
ways to adapt to difficult situations to achieve a goal. For example, for some 
patients the intervention may consist of carrying out  
ADLs in which they have a limitation with the support of the occupational therapist 
with the aim of enhancing their sense of security during its performance. Data will 
be collected through note taking and analyzed with qualitative content analysis.  
The designed OT intervention includes: 
• Prior to discharge: Initial evaluation and a hospital session. 
• Post-discharge: A two-hour home visit, telephone follow-up, a one-hour 
visit one month after discharge and final evaluation three months later.  
This early OT intervention will be carried out independently of the usual care of 
the rehabilitation service of the Torremolinos Maritime Hospital.  
 
 

Time planning  
The project will begin in January 2021 and was estimated to last one year and 
three months (estimated completion in March 2022). Finally, the project was 
completed on November 2022.  
 
Results analysis plan  
The following analysis model was followed: to study the differences that may exist 
between one group and another, before and after the intervention, a repeated 
measures ANOVA was carried out; to check how some variables influence 
others, a multivariate analysis was carried out and, finally, to know the mean and 
normal distribution of the variables, descriptive statistics were performed. An 
intragroup analysis was included by performing paired T-test studies along with 
Wilcolxon for non-parametric measurements. The program used for data analysis 
was JAMOVI (version 2.3.26).  
Difficulties and limitations of the study  
Regarding the limitations of this study, it is worth highlighting the biases possibly 
derived from the adherence to treatment of the users and their caregivers, as well 
as the behavior and involvement of the family member in the process that will 
likely induce differences in the results. It is worth highlighting the importance of 
the word of the patient and the caregiver due to the telephone process of the 
intervention, since it can lead to differences in the instructions provided by the 
occupational therapist and, therefore, in the treatment and final result.  
Furthermore, an important limitation is the heterogeneity of the sample, since we 
are generally talking about patients who have had a stroke of any location, extent 
and volume. The random distribution of patients may result in the two groups 
having significant differences in the severity of their injuries or their potential for 
recovery. Also due to the heterogeneity of each patient's rehabilitation process, 
it is understood that, of the total sample size, certain patients will subsequently 
receive a greater number of conventional rehabilitation sessions than others, and 
some patients will probably not even receive any sessions. This is why it seems 

interesting to subsequently study the care received by each user three months 
after discharge, as well as their level of functionality and quality of life.  
Ethical considerations  
During data collection, the anonymity of users was guaranteed. Participants will 
be informed of the intervention and will be asked to sign an informed consent, 
with participation being voluntary and allowing the user to abandon whenever 
they wish.  
The principles of the Declaration of Helsinki (17) were taken into account. 
Authorization will be requested from the hospital, as well as approval from the 
provincial research ethics committee to which the center is attached.  
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