Effects of Telerehabilitation on the Occupational Performance of Stroke Patients Treated by an Occupational Therapy Service: a Randomized Clinical Trial
Phase: NA
Conditions: Stroke
Sponsor: University of Sao Paulo

Institute of Physical Medicine and Rehabilitation 
Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo 
 
 
RESEARCH PLAN 
 
 
 
 
Effects of telerehabilitation on occupational performance of stroke patients treated by 
the Occupational Therapy service: a randomized clinical trial. 
 
 
Principal Investigator: André Tadeu Sugawara 
Associate Researchers: Paulo Vitor Rodrigues da Silva, Gracinda Rodrigues Tsukimoto, Denise 
Rodrigues Tsukimoto, Tatiana Amodeo Tuacek 
 
 
 
Department/Institute: Department of Legal Medicine, Bioethics, Occupational Medicine, and 
Physical Medicine and Rehabilitation / Institute of Physical Medicine and Rehabilitation of the 
Hospital das Clínicas 
 
 
 
 
CAAE: 86185525.8.0000.0068 
Version: 3 
Opinion Number: 7.441.169 
Location: São Paulo, Brazil 
Date of approval: August 21, 2025 
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Institute of Physical Medicine and Rehabilitation 
Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo 
 
 
RESEARCH PLAN 
 
 
SUMMARY 
Stroke represents a health problem with increasing incidence in the world population. 
The consequences of the injury are not limited to physical deficits, but also encompass 
significant biopsychosocial changes. This study aims to evaluate the effect of using telehealth, 
specifically telerehabilitation, correlated with the practice of Occupational Therapy for the 
population affected by stroke. To this end, a randomized study will be conducted, which will 
involve data collection through a structured sociodemographic questionnaire and standardized 
scales: Scale of Instrumental Activities of Daily Living, Katz Scale, and the Motor Activity Log, 
which will be applied to the intervention group and the control group. Participants will be users 
of the Unified Health System (SUS) who are on the waiting list, with an indication for 
Occupational Therapy services in an outpatient or inpatient setting at the Institute of Physical 
Medicine and Rehabilitation of the Hospital das Clínicas of the Faculty of Medicine of the 
University of São Paulo (IMREA FMUSP). The intervention group is expected to show improved 
occupational performance in response to the guidance provided to patients and caregivers. 
Keywords: Stroke (D020521), Digital Public Health (DDCS060401), Telemedicine (D017216), 
Occupational Therapy (D009788). 
 
INTRODUCTION 
A stroke is a significant neurological injury, characterized by an abrupt change in brain 
function, and is currently the leading cause of disability worldwide (Steinmetz et al., 2024). It 
can be caused by two distinct pathophysiological mechanisms: ischemic, accounting for 85% of 
cases, and hemorrhagic, accounting for 15%(Vieira et al., 2020). In 2020, the total costs to the 
public health system for stroke in Brazil amounted to 416 million Brazilian Reais (BRL) (Reis; 
Chaoubah, 2024). The estimated incidence of this pathology in the country is 232,000 to 
344,000 new cases per year (Ministry of Health, 2021). The sequelae caused by stroke can lead 
to loss of autonomy and independence for the individual, making it impossible to perform Basic 
Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL), impacting their 
family and social interactions, due to the need for assistance, in many cases, to perform various 
tasks (Vieira et al., 2020; Castro; Martins; Colto; Reis, 2018). 
Post-stroke treatment involves a wide range of care and should be intensive, timely, and 
multidisciplinary (Langhorne; Sandercock; Prasad, 2009). Therefore, efficient treatment has a 
significant impact on costs, making access to specialized post-stroke treatment services 
important (Fonseca et al., 2018). Ensuring access to rehabilitation services is fundamental to 
the recovery process, as it contributes to social reintegration and the resumption of 
occupational performance (Platz, 2021). However, several barriers impede access, ranging from 
the organization of health services, due to a lack of material or human resources, to financial 
resources and the family dynamics of the stroke victim (Santos et al., 2022). In this context, 
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Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo 
 
 
RESEARCH PLAN 
 
telehealth is a service modality that has been used to address these shortcomings (Luz, 2022; 
Silva et al., 2023). 
The term telehealth is comprehensive, encompassing teleconsultation, telemonitoring, 
teleconsulting services, telemedicine, telerehabilitation, among others, to provide remote health 
services through telecommunications and digital information technologies (COFFITO, 2020; 
Cason, 2012). Telerehabilitation, specifically, is a field of telehealth correlated with the provision 
of remote rehabilitation services to users, using Information and Communication Technologies 
(ICTs) (Noorani, Picot, 2001). This type of care was boosted by the global health crisis of the 
COVID-19 pandemic, becoming promising for cost reduction and optimization of access to 
health services (Garfan et al., 2021). Thus, it enables the provision of health care in remote 
areas, regions with a shortage of professionals, without the need for a robust care 
infrastructure. In the context of post-stroke rehabilitation, telerehabilitation can overcome 
significant barriers, such as dependence on caregivers, financial problems, lack of regional 
medical resources, and transportation challenges, by making rehabilitation feasible for stroke 
survivors in adverse settings (Chumbler et al., 2012; Sarfo et al., 2018). 
In the context of telerehabilitation, multidisciplinary intervention is also a fundamental 
factor in ensuring the quality of treatment in stroke services (Clarke; Forster, 2015). The 
multidisciplinary team for post-stroke treatment is composed of multiple health professionals, 
many of whom include an occupational therapist. Occupational Therapy is a field of knowledge 
and profession focused on occupation and aimed at strengthening support for the individual to 
achieve performance, aiming at the acquisition of "new patterns that meet their personal needs 
and desires" (Kielhofner, 2006, p. 66). In the context of physical rehabilitation and post-stroke 
treatment, this objective translates into the recovery of skills necessary for performance in 
ADLs and IADLs. 
It is estimated that 22.6% of healthcare costs are allocated to musculoskeletal 
dysfunctions (Briggs et al., 2018), indicating the significant demand for rehabilitation services. 
However, there is a mismatch between supply and demand, resulting in extensive waiting lists in 
healthcare services (Meneses; Silva; Silva, 2020). From this perspective, the importance of 
specific strategies for managing, regulating, and optimizing waiting lists is evident, since early 
intervention for individuals affected by stroke is essential for a good prognosis (Zeiler, 2019). It 
is also important to consider that the post-stroke recovery process is multifactorial, with 
genetic, pathophysiological, environmental, and therapeutic factors determining the overall 
course of recovery (Wlodarczyk et al., 2021). 
There is still no formal structure for telehealth, so access to this type of service can 
occur in various ways (Galea, 2019), and studies on its applicability are needed. It is also 
important to consider that access to specialized care is still a major bottleneck; the average 
waiting time for care in universal systems can exceed 10 months (Edwards; Hensher, 1998; Katz 
et al., 2020). Given the increasing use of telehealth by occupational therapists in the Brazilian 
Unified Health System (SUS) and the incorporation of digital technologies in the health field, it 
presents a potentially effective strategy to optimize the efficiency of rehabilitation services 
(Eroğlu et al., 2020). 
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Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo 
 
 
RESEARCH PLAN 
 
 
HYPOTHESES 
This study will examine the effect of using telerehabilitation as an occupational therapy 
intervention strategy for stroke patients, as clinically indicated, who are awaiting in-person care 
from this same professional category, whether outpatient or inpatient, at the Institute of 
Physical Medicine and Rehabilitation of the Hospital das Clínicas of the Faculty of Medicine of 
the University of São Paulo (IMREA HCFMUSP). 
 
GENERAL OBJECTIVE 
To determine the effects of Occupational Therapy services provided through 
telerehabilitation for the population with sequelae from CVA who are awaiting outpatient or 
inpatient inpatient care. 
 
SPECIFIC OBJECTIVES 
To establish the occupational performance of participants through the application of 
specific scales, using occupational therapy intervention via telerehabilitation; 
To demonstrate and analyze the challenges and limitations during the application of 
telerehabilitation services to stroke patients participating in the study; 
To identify telerehabilitation as a strategy for optimizing care and access to public 
rehabilitation services. 
 
METHODS 
In order to answer the research objectives, a randomized controlled trial study was 
chosen. This is a pilot study that will be developed through the proposal of telerehabilitation 
sessions for patients on a waiting list, with a medical prescription, for Occupational Therapy 
care at the IMREA FMUSP, linked to the Lucy Montoro Rehabilitation Network. 
A convenience sample will be used (20 users, divided equally into two groups), 
considering that patients awaiting care will be subject to the research eligibility criteria and will 
be selected in descending order (selected in reverse chronological order from the waiting list) 
to allow sufficient time for the intervention. If a study participant, regardless of the group to 
which they belong, is called to begin in-person Occupational Therapy care, a final assessment 
will be applied, concluding the follow-up. 
Data collection for initial and final assessments will be conducted by an independent 
researcher, not involved in the study, allowing for a single-blind study. Participants will be 
divided into two groups using randomization: intervention and control. The first group 
(intervention) will participate in one 45-minute session per week for eight weeks. During this 
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Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo 
 
 
RESEARCH PLAN 
 
time, participants will receive guidance and perform therapeutic activities to improve 
occupational performance. The second group (control) will remain on the waiting list, without a 
specific intervention, as they were already waiting for care. Both groups will undergo initial 
assessments in the first session and final assessments in the last session. Jerry Dallal's 
randomization tool (Dallal, 2020) will be used to classify participants into the first and second 
groups. Allocation, at a 1:1 ratio, will be conducted by an independent researcher who will not 
participate in data collection or statistical analysis. The concealed allocation will be 
implemented using sequentially numbered, opaque, and sealed envelopes. A blind evaluator will 
open the sealed envelopes after the Informed Consent Form (ICF) has been signed and will 
conduct the evaluation of the participant in person. Those participants selected by lottery, 
belonging to the intervention group, will be given a schedule with the dates and topics that will 
be addressed in each session. Participants in the control group will sign the ICF and complete 
the structured questionnaire and rating scales. 
The following research protocols will be used as data collection instruments: Katz Scale 
(Lino et al., 2008) for assessing ADLs; Scale of Instrumental Activities of Daily Living (Dos 
Santos; Júnior, 2008) for measuring performance in IADLs; and Motor Activity Log (MAL) for 
assessing hand motor function (Saliba et al., 2011). The study will be conducted according to 
the Consolidated Standards of Reporting Trials (CONSORT) and the Standard Protocol Items: 
Recommendations for Interventional Trials (SPIRIT). 
Participants will also be given a structured sociodemographic questionnaire, developed 
by the researcher, to collect demographic data, including age, sex, educational level, and other 
data. Similarly, clinical data will be collected, such as the duration of hemiplegia, laterality of 
the affected body, etiology, hand preference, risk factors, and motor stages according to the 
Brunnstrom model (Naghdi, 2010). The questionnaire will be administered by the independent 
researcher at the time of randomization. 
Thus, based on the research instruments presented, the research will be structured in 
five stages: i) recruitment of eligible patients; ii) randomization; iii) application of scales and 
structured questionnaire (intervention and control groups); iv) occupational therapy intervention 
via telerehabilitation (intervention group); v) final evaluation (intervention and control groups); 
vi) data processing and analysis. 
Inclusion criteria 
Adult patients, clinically stable, regardless of sex, race/color, aged 18 years or older, 
who present with sequelae of stroke, regardless of the Rankin scale score (Rankin, 1957), on a 
waiting list and according to medical indication for Occupational Therapy care at IMREA 
HCFMUSP. Individuals must also have access to a computer, tablet, and smartphone with an 
internet connection that allows for video calls, understand the Portuguese language, and have 
the assistance of a caregiver during therapy sessions, if necessary. 
 
Exclusion criteria 
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Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo 
 
 
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Clinically unstable patients, such as frail elderly individuals with decompensated chronic 
diseases and high-risk pregnant women and individuals under 18 years of age who are not on a 
waiting list for Occupational Therapy at IMREA HCFMUSP, in accordance with medical 
indication. Individuals who do not have access to a computer, tablet, or smartphone with an 
internet connection, and who do not have a caregiver when needed during therapy sessions, will 
also be excluded. 
 
RISK ANALYSIS 
The research presents a low risk of harm to participants, as it involves remote guidance, 
not exposing the user to any type of invasive procedure or risk associated with travel for 
appointments. However, the nature of stroke can result in significant variations in the cognitive 
and physical abilities of patients, which may interfere with adherence to and development of 
therapeutic interventions through telerehabilitation. Regarding the proposal to conduct remote 
appointments via video call platforms, there is a risk that sessions may be compromised due to 
technical and connection problems at the time of the sessions, potentially leading to difficulties 
in understanding and hindering the visualization and interpretation of instructions, inhibiting or 
hindering participation. Interruption of remote appointments will occur due to health problems 
and personal issues of the patient that prevent their participation; recurring technical issues 
that prevent the patient from accessing sessions; lack of interest from the research participant 
in continuing treatment; as well as the start of in-person Occupational Therapy appointments. 
To minimize such risks, a set of measures and/or procedures will be taken to ensure the privacy, 
confidentiality, and security of participants and their information. These are: i) data collection 
through scales and the structured questionnaire will be carried out manually, and only the 
researchers involved in the research will have access; ii) data collected manually will be 
digitized and stored on institutional servers; iii) personal information of participants related to 
the information provided will not be part of the research records, including any information that 
could be used to establish, identify, or reveal the participant's identity, or any other data that 
may be requested by the participant will be discarded from the research records; iv) depending 
on the degree of difficulty the patient has in performing the activities through telerehabilitation, 
it will be necessary for them to have a family member or caregiver present during the session; v) 
the participant will have complete freedom not to participate or to withdraw their consent at any 
time, even after the conclusion of the research, without any penalty, and will have confidentiality 
and privacy. vi) Nevertheless, in the event of harm or distress, the researcher is committed to 
providing support and referring participants to the physician responsible for the patient, without 
any expenses for the participants. 
 
BENEFITS 
The benefit of this research to individuals diagnosed with stroke and to occupational 
therapists working in the rehabilitation field within the Brazilian Unified Health System (SUS) is 
direct. For patients, it represents a possible structuring of another healthcare pathway in the 
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Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo 
 
 
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rehabilitation process. For professionals, the research is linked to expanding knowledge about 
the use of telehealth for rehabilitation interventions within the SUS. The benefits for other 
professional categories are indirect, through support for research aimed at developing and 
improving the skills necessary for providing virtual healthcare services. 
 
DATA ANALYSIS 
The data collected through assessments and the structured questionnaire will be 
organized and classified according to their variables in digital spreadsheets. Subsequently, this 
data will be stratified using STATA software for statistical analysis. The effects of telehealth 
and the occupational performance of the participants will be determined by comparing the 
means between the intervention and control groups, as observed in the study assessments. The 
analysis method will be defined as either the Student's t-test or the Wilcoxon test, depending on 
whether the data are parametric or non-parametric, after normality tests using Shapiro-Wilk and 
evaluation of histograms or q-q plots. The other objectives will be analyzed descriptively. The 
information obtained will be correlated with the bibliographic material collected, aiming to 
integrate the results and draw conclusions about the use of telerehabilitation by occupational 
therapists. 
 
FINANCIAL RESOURCES 
The research will not receive direct public or private funding. Expenses related to 
equipment, personnel, materials and supplies, among other costs necessary for the project, are 
already integrated into the routine of the health service. Thus, these costs will not represent an 
additional burden on the institution's operation. 
 
TIMELINE​
 
The planned research schedule will be executed, as per Table 1, if the project is 
approved by the CEP/CONEP System. The same will occur within a period of 11 months. 
Stage Identification 
Month 
0
1 
0
2 
0
3 
0
4 
0
5 
0
6 
0
7 
0
8 
0
9 
1
0 
1
1 
Field research - participant recruitment and 
randomization 
X 
X 
 
 
 
 
 
 
 
 
 
Field research - initial application of questionnaires 
and scales (group, intervention, and control) 
X 
X 
 
 
 
 
 
 
 
 
 
Field research - occupational therapy intervention 
via telerehabilitation (intervention group) 
 
X 
X 
X 
X 
 
 
 
 
 
 
Field research  - application of final assessments 
(group, intervention, and control) 
 
 
 
X 
X 
 
 
 
 
 
 
Bibliographic research 
 
 
 
 
X 
X 
 
 
 
 
 
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Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo 
 
 
RESEARCH PLAN 
 
Data analysis 
 
 
 
 
X 
X 
X 
 
 
 
 
Research report 
 
 
 
 
 
 
X 
X 
X 
 
 
Development of Residency Completion Project 
 
 
 
 
 
 
X 
X 
X 
X 
X 
 
PROCEDURES AFTER COMPLETING THE RESEARCH 
Following the conclusion of the research, the researchers commit to the public 
dissemination of the results, whether favorable or unfavorable, either through the development 
of a scientific article or presentations at academic events such as congresses, symposia, and 
others. This commitment relates to the dedication to scientific dissemination so that the 
research has a significant impact on the advancement of knowledge and the improvement of 
healthcare for patients with stroke sequelae. 
​
​
​
​
​
​
 
REFERENCES 
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32.​URBANIAK, G. C.; PLOUS, S. Research randomizer [Computer software]. Social Psychology. 
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36.​ZEILER, S. R. Should we care about early post-stroke rehabilitation? Not yet, but soon. 
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APPENDICES 
 
1. Scale of Instrumental Activities of Daily Living (Brazilian version) 
 
This interview aims to identify your functional status level by assessing possible difficulties in performing activities of your daily life. Please try 
to recall for each activity if you perform it without help, with some assistance, or if you do not perform it at all. 
 
Regarding telephone use...  
a) Telephone  
[ ]³ receives and makes calls without assistance  
[ ]² requires assistance to make telephone calls  
[ ]¹ does not have the habit or is unable to use the telephone 
 
Regarding travel… 
b) Travel  
[ ]³ travels alone  
[ ]² only travels when accompanied  
[ ]¹ does not have the habit or is unable to travel 
 
Regarding shopping...  
c) Shopping  
[ ]³ does shopping, when transportation is provided  
[ ]² only does shopping when accompanied 
[ ]¹ does not have the habit or is unable to go shopping 
 
Regarding meal preparation...  
d) Meal preparation  
[ ]³ plans and cooks full meals  
[ ]² prepares only small meals or when receiving help  
[ ]¹ does not have the habit or is unable to go shopping* (Note: The original text in the image repeats "unable to go shopping" instead of "unable to 
prepare meals"). 
 
Regarding housework...  
e) Housework  
[ ]³ performs heavy tasks  
[ ]² performs light tasks, requiring help with heavy ones  
[ ]¹ does not have the habit or is unable to perform housework 
 
Regarding medication use...  
f) Medications  
[ ]³ takes medications without assistance  
[ ]² requires reminders or assistance  
[ ]¹ is unable to manage medication use alone 
 
Regarding money management...  
g) Money  
[ ]³ fills out checks and pays bills without assistance  
[ ]² requires assistance using checks and bills  
[ ]¹ does not have the habit of dealing with money or is unable to manage money, bills... 
 
Classification 
[ ] Total dependence = ≤5 (P₂₅)  
[ ] Partial dependence = >5 < 21 (>P₂₅ < P₁₀₀)  
[ ] Independence = 21 (P₁₀₀) 
2. Motor Activity Log (Brazilian version) 
 
Dominant side:______________  Affected side:______________ 
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Quantitative 
Scale 
Qualitative 
Scale 
 
1) Turn the light on using the switch 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
2) Open a drawer 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
3) Taking a piece of clothing out of the drawer 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
4) Take the phone off the hook 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
5) Wipe down (clean) the kitchen countertop 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
6) Exiting the car (includes only the movement 
necessary to get up from the seat and stand outside the 
car after the door is open) 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
7) Open the refrigerator 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
8) Open a door by turning the doorknob 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
9) Using the TV remote control 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
10)Washing hands (includes lathering and rinsing 
hands; opening/closing a hand tap) 
 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
11) Opening and closing a screw or lever tap 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
12) Dry your hands 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
13) Put on the socks 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
14) Take off your socks 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
15) Putting on the shoes (includes tying the laces and 
adjusting the Velcro or straps) 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
16) Taking off your shoes (includes untying laces and 
loosening Velcro or straps) 
 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
17)To stand up from a chair with armrests 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
18) Move the chair away from the table before sitting 
down 
 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
19) Pulling the chair towards the table after being 
seated 
 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
20) Raise a glass, bottle (glass or plastic) or can (does 
not need to include drinking) 
 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
21) Brushing your teeth (does not include preparing the 
toothbrush or brushing dentures, unless the dentures 
are brushed inside the mouth) 
 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
22) Applying foundation, lotion, or shaving cream to the 
face 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
 
23) Using a key to unlock a door 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
24) Writing on paper (if the hand used for writing before 
the stroke is the most affected, score the item; if the 
hand that did not write before the stroke is the most 
affected, skip the item and mark N/A) 
 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
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RESEARCH PLAN 
 
25) Carrying an object in your hand (hanging an item 
over your arm is not acceptable) 
 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
26) Using a fork or spoon to eat (refers to the action of 
bringing food to the mouth with a fork or spoon) 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
27) Comb your hair 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
 
28) Lifting a cup by the handle 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
 
29) Buttoning a shirt 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
 
30) Eating half of a sandwich, appetizer, or snack (any 
food that is eaten with your hands). 
_______ 
_______ 
If not, why? (use code)__ 
Comments _______________ 
 
TOTAL: 
_______ 
_______ 
 
 
Codes for recording "no" responses 
 
1. "I used my unaffected arm the entire time" (check "0"). 
2. "Someone else did it for me." (mark "0"). 
3. "I never do this activity, with or without help from others, because it's impossible." For example, combing hair 
on bald people. (mark "N/A" and remove from the list of items). 
 
4. "I sometimes do this activity, but I haven't had the opportunity since the last time I answered these questions." 
(repeat the last value assigned for this activity). 
5. Non-dominant hand hemiparesis. (only applicable to question 24; mark “N/A” and remove from the list of items). 
 
 
 
 
 
 
 
 
 
14 
 
QUANTITATIVE SCALE 
QUANTITATIVE SCALE 
0 - I didn't use my weaker arm (I didn't use it). 
0 - The weaker arm was never used for that activity. 
0.5 
0.5 
1- I occasionally used my weaker arm, but only very rarely (very 
rarely). 
1 - The weaker arm moved during that activity, but it wasn't helpful 
(too weak). 
1.5 
1.5 
2 - Sometimes I used my weaker arm, but I did the activity mostly 
with my stronger arm (rarely). 
2 - The weaker arm was of some use during this activity, however, 
it needed help from the stronger arm or moved very slowly or with 
difficulty (weak). 
2.5 
2.5 
3- I used my weaker arm approximately half as often as I did 
before the stroke (half as I did before the stroke). 
3- The weaker arm was used for the intended purpose, but the 
movements were slow or performed only with some (good) effort. 
3.5 
3.5 
4- I used my weaker arm almost as much as before the stroke (3/4 
pre-stroke). 
4- The movements made by the weaker arm were almost normal, 
but they weren't as fast or precise as normal (almost normal). 
4.5 
4.5 
5- I used my weaker arm with the same frequency as before the 
stroke (even before the stroke). 
5- The ability to use the weaker arm for this activity was as good 
as before the stroke (normal). 

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RESEARCH PLAN 
 
3. Katz Scale (Brazilian version) 
For each functional area listed below, check the description that applies (the word "help" means supervision, guidance, or personal assistance). 
Functional Area                                                                                                                                                                     Independent (I) / Dependent (D) 
 
Taking a bath (bed, bathtub or shower) 
[   ] does not receive assistance (gets in and out of the bathtub alone, if this is the usual way of bathing)                                                                 (I) 
[   ] receives help to wash only a part of the body (such as the back or a leg)                                                                                                                 (I) 
[   ] receives help washing more than one part of the body, or cannot bathe alone                                                                                                        (D)  
 
Getting dressed (retrieving clothes, including underwear, from closets and drawers, and handling fasteners, including those of orthotics and 
prosthetics, when used) 
[   ] The patient picks up their clothes and dresses completely without help                                                                                                                   (I)  
[   ] The patient picks up their clothes and dresses without help, except for tying shoes                                                                                               (I)  
[   ] receives help to get clothes or get dressed, or remains partially or completely unclothed                                                                                     (D) 
 
Use of the toilet (going to the bathroom or equivalent place to defecate and urinate; personal hygiene and tidying clothes) 
[   ] Goes to the bathroom or equivalent place, cleans himself/herself and adjusts his/her clothes without help (may use objects for support such 
as a cane, walker or wheelchair and may use a bedpan or urinal at night, emptying it in the morning)                                                                       (I)  
[   ] receives assistance to go to the bathroom or equivalent location, or to clean themselves, or to adjust their clothes after defecation or 
urination, or to use a bedpan or urinal at night.                                                                                                                                                                  (D)  
[   ] does not go to the bathroom or equivalent for physiological eliminations.                                                                                                              (D) 
 
Transfer 
[   ] Gets out of bed and lies down, sits down and stands up from a chair without assistance (may be using an object for support, such as a cane 
or walker)                                                                                                                                                                                                                                (I)  
[   ] lies down and gets out of bed and/or sits down and gets up from a chair with help.                                                                                             (D) 
[   ] doesn't get out of bed                                                                                                                                                                                                     (D)  
 
Continence 
[   ] It completely controls urination and defecation                                                                                                                                                           (I) [   
] There are occasional "accidents".                                                                                                                                                                                 (D)  
[   ] needs help to maintain control of urination and defecation; uses a catheter or is incontinent.                                                                             (D)  
 
Food 
[   ] The patient feeds themselves without help                                                                                                                                                                    (I)                                
[   ] The patient feeds themselves, but receives help cutting meat or spreading butter on bread                                                                                   (I)                                
[   ] receives assistance with feeding, or is fed partially or completely through the use of catheters or intravenous fluids.                                      (D)                                
 
Interpretation (Katz & Apkom): 
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RESEARCH PLAN 
 
0: independent in all six functions; 1: independent in five functions and dependent in one function; 2: independent in four functions and 
dependent in two; 3: independent in three functions and dependent in three; independent in two functions and dependent in four; 5: independent 
in one function and dependent in five functions; 6: dependent in all functions. 
4. Structured questionnaire 
​
I - Identification 
1)​
Name: _________________________________________________________ 
2)​
Date of birth: ___ / ___ / ___ 
3)​
Medical record number:                                       
4)​
Age: _______ 
5)​
Nationality: 
6)​
Sex: (  )Male (  )Female 
7)​
Race/color: (  )Asian (  )Indigenous (  )White (  )Black  (  )Others 
8)​
City of residence: ___________________ 
9)​
Neighborhood: ___________________ 
10)​ Profession: ___________________ 
11)​ Current occupation: ___________________ 
12)​ Telephone: ___________________ 
13)​ E-mail: ___________________ 
14)​ Reference physician: ___________________ 
15)​ Caregiver/responsible family member: ___________________ 
16)​ Dominance: (  )Right (  )Left-handed (  )Ambidextrous 
​
II - Family 
17)​ Marital status: (  )Single  (  )Married/Living with partner (  ) Divorced/Separated (  )Widow(er) (  )Others 
18)​ Do you have children?: (  )Yes (  )No 
19)​ Number of Children: ___________________ 
20)​ Currently, where and how do you live?: (  )At home or in an apartment, alone (  ) At home or in an apartment, with parents 
and/or relatives (   )Living in a house or apartment with a spouse (  )In another type of housing 
21)​ Can you move around between the rooms of the house? (  )Yes ( )No  
22)​ Do you have a caregiver or family member who assists with daily tasks? (  )Yes  ( )No  
23)​ Do you have a family history of stroke? (  )Yes ( )No  
​
III - Education 
24)​ Level of education: (  )Illiterate (  )Can read and write (  )Elementary education (  )High School (  )Higher education (  
)Postgraduate studies 
IV - Income 
25)​ Do you have health insurance? (  )Yes ( )No  
26)​ Income: (  )less than minimum wage (  )up to one minimum wage (   )between 2 and 3 minimum wages (   )4 to 5 
minimum wages (  )more than 6 minimum wages 
V - Assistive Technology 
27)​ Assistive technology: (  )Wheelchair (  )Walker (  )Single-point cane (  )Forearm crutch (  )Shower chair (  )Hearing aid (  
)Orthosis (  )Other - Specify 
28)​ Do you wear corrective lenses?: (  )Yes ( )No  
29)​ Uses dentures: (  )Yes ( )No  
VI - Health condition 
30)​ Injury time:______________ 
31)​ Date of injury: ______________ 
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RESEARCH PLAN 
 
32)​ Type of stroke: (  )Ischemic (  )Hemorrhagic 
33)​ Medications: (  )Antihypertensive (  )Antiplatelet agent (  )Anti-inflammatory  (  )Antidepressant (  )Antipsychotic (  
)Antidiabetic (  )Anticonvulsant (  )Sedative (  )Analgesic (  )Diuretic (  )Other - Specify 
34)​ Associated diseases: (   )Rheumatological (   )Genitourinary (  )Endocrine (  ) Gastrointestinal (  )Cardiovascular (  
)Respiratory (  )Other - Specify 
35)​ Current pain?: (  )Yes ( )No  
36)​ Pain location: ______________ 
37)​ Presence of sensory alterations: (  )Yes ( )No  
38)​ Location of sensory alteration: ______________ 
39)​ Currently smokes: (  )Yes ( )No  
40)​ Former smoker: (  )Yes ( )No   
41)​ Consumes alcoholic beverages: (  )Yes ( )No  
 
5. Schedule of appointments (intervention group) 
 
Service Number 
Intervention Focus 
Duration 
(min) 
Description 
Responsible 
1 
Initial assessment (in person) 
60 
Application of the structured questionnaire, 
and the scales Instrumental Activities of 
Daily Living Scale, Katz Scale, and Motor 
Activity Log. 
Independent 
researcher 
2 
Guidelines on the importance of 
mobility/positioning/posture of 
the body and the affected upper 
limb (telehabilitation) 
45 
To provide guidance on the importance of 
body and affected upper limb 
mobility/positioning/posture for: prevention 
and treatment of muscle contractures; 
improvement of joint mobility; improvement 
of blood circulation; reduction of spasticity; 
prevention of secondary injuries; 
improvement of neuromuscular function 
and coordination; prevention of muscle 
atrophy. 
Researcher 
responsible 
 
3 
Nutrition; Mobilization; 
Cognitive/recreational activity 
(telerehabilitation) 
 
45 
Guidelines on techniques for independent 
feeding (opening packages, preparing and 
serving food). 
Researcher 
responsible 
4 
Self-care; Mobilization; 
Cognitive/recreational activity 
(telehabilitation) 
 
45 
Guidance on independent personal hygiene 
techniques (combing and tying hair, 
brushing teeth, shaving, applying makeup), 
positioning of the affected upper limb, and 
possible adaptations. 
Researcher 
responsible 
5 
Leisure; Mobilization; 
Cognitive/recreational activity 
(telerehabilitation) 
 
45 
Guidance and discussion about possible 
leisure activities. 
 
Researcher 
responsible 
6 
Bathing and toilet use; 
Mobilization; 
Cognitive/recreational activity 
(telerehabilitation) 
45 
Guidelines on techniques and adaptations 
for independent bathing and toilet use. 
Researcher 
responsible 
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RESEARCH PLAN 
 
7 
Upper Clothing; Mobilization; 
Cognitive/Recreational Activity 
(telerehabilitation) 
45 
Guidelines on techniques and adaptations 
for autonomy in dressing upper limbs. 
Researcher 
responsible 
8 
Lower garment; Mobilization; 
Cognitive/recreational activity 
(telerehabilitation) 
45 
Guidelines on techniques and adaptations 
for independent dressing of lower limbs. 
Researcher 
responsible 
9 
Final instructions (for 
family/caregiver when 
necessary). Reinforcing safety 
aspects during activities 
(telerehabilitation). 
45 
Guidelines regarding finals, questions, and 
safety aspects. 
Researcher 
responsible 
10 
Final assessment (in person) 
60 
Final application of the Scale of 
Instrumental Activities of Daily Living, Katz 
Scale, and Motor Activity Log. 
Independent 
researcher 
 
6. Informed Consent Form 
RESEARCH DATA 
Research Title: Effects of telerehabilitation on the occupational performance of stroke patients treated by the Occupational Therapy service: a 
randomized clinical trial 
Principal Investigator: André Tadeu Sugawara 
Department/Institute: Department of Legal Medicine, Bioethics, Occupational Medicine and Physical Medicine and Rehabilitation / Institute of 
Physical Medicine and Rehabilitation of the Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo 
According to resolution 466/2012, the following content should be included in the explanations about the research 
1. Participation 
Invitation to participate – We invite you to participate in this research. The text below presents all the necessary information about what we 
intend to do. Your collaboration in this study will be very important to us, but if you withdraw at any time, this will not cause you any harm. The 
name of this document you are reading is the Informed Consent Form (ICF). Before deciding whether you wish to participate (of your own free 
will), you should read and understand all the content. At the end, if you decide to participate, you will be asked to sign it and you will receive a 
copy of the form. Before signing, ask questions about anything you did not understand well. The study team will answer your questions at any 
time, before, during and after the study. 
2. Justification and Objectives of the Study 
This study was designed to understand the effects of using remote healthcare services, specifically telehealth, specifically the telerehabilitation 
modality, performed by occupational therapy professionals with patients with sequelae from stroke (CVA), who are awaiting in-person care at 
the Institute of Physical Medicine and Rehabilitation of the Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo 
(IMREA HC-FMUSP). 
This study is justified by the lack of a formal structure for telerehabilitation. In addition, access to specialized care, such as post-stroke 
rehabilitation, remains a major challenge for the Brazilian Unified Health System (SUS), and the incorporation of digital technologies in 
healthcare emerges as a potentially effective strategy to optimize the efficiency of care. 
3. How will your participation in this study be? 
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RESEARCH PLAN 
 
During your participation in this study, you will be invited to perform some activities related to telerehabilitation in Occupational Therapy. Your 
name and any identifying information will not be disclosed, maintaining confidentiality. Research participants will be divided, by lottery, into two 
groups: the first, called the intervention group, and the second, the control group. The first group (intervention) will undergo initial and final 
assessments (to measure their health status for performing daily activities before and after the completion of all appointments) and will also 
receive telerehabilitation care, performed by an Occupational Therapy professional. The second group (control) will undergo initial and final 
assessments with the same purpose as the first group, however, they will not receive telerehabilitation care and will remain on the waiting list. 
Thus, your participation will be divided into different phases, as described below: 
I. Initial Assessment (Intervention Group and Control Group): You will undergo an initial assessment, in which information about 
your current condition will be collected, including medical history, Physical function of the upper limbs, and performance in carrying 
out daily activities. This assessment will help the research team understand your health condition and, if you are allocated to 
telerehabilitation, this information will be important for better structuring the treatment plan, initially common to all participants. 
II. Telerehabilitation (intervention group): If you are allocated to this group, you will receive the telerehabilitation intervention, and 
will be guided through virtual sessions with an occupational therapist. The sessions will take place at pre-arranged times, using the 
Hospital das Clínicas' video conferencing platform, and will aim to train and develop motor and cognitive skills necessary for 
carrying out basic and instrumental activities of daily living. During these sessions, you will also be guided to perform mobility and 
stretching exercises for the upper limbs, which can help improve your occupational performance, that is, in carrying out tasks in your 
daily life. 
III. Control (control group): If you are allocated to the control group, you will follow the standard treatment, without participating in 
telerehabilitation sessions, without changes to the waiting list order. In this case, you will also be monitored throughout the study to 
assess your occupational performance, in order to compare the results of the assessments between the intervention group and the 
control group. 
IV. Final assessments (intervention group and control group): Throughout the study, you will be invited to undergo periodic 
assessments to measure your progress and any changes in your occupational performance. These assessments may include 
questionnaires, functional tests, and interviews. This information will help the research team understand the effects of 
telerehabilitation and compare the results between the groups. 
V. Duration of Participation: The study will last approximately 3 months (to be specified), during which you will participate in 
telerehabilitation sessions (if allocated to this group) and will be monitored to track the progress of your occupational performance. 
4. Could your participation pose any risks? 
Participation in this study may generate a certain degree of discomfort due to the disclosure of information, related to aspects of personal 
history, such as descriptions and perceptions about your cognitive, physical, and social condition. However, in general, the research presents 
minimal risk, as the services are provided remotely, without invasive procedures or the need for travel. However, stroke can cause variations in 
the cognitive and physical capacity of participants, affecting adherence and the development of interventions. There is also the risk of technical 
problems during video calls, which may impair understanding of the instructions. 
Interruption of services may occur due to health issues, recurring technical problems, lack of interest, or the start of in-person services. To 
minimize these risks, security measures will be adopted, such as manual data collection, secure storage, and confidentiality of participants' 
personal information. In addition, if necessary, a family member or caregiver may accompany the patient. The participant may withdraw at any 
time without penalty and, in case of harm or embarrassment, will be referred to the responsible physician, free of charge. 
Thus, it is necessary to clarify their autonomy in the process, highlighting respect for the patient's personal limits and their willingness to 
continue participating or terminate it at any time. If there is any direct or indirect, immediate or subsequent harm caused by participation in the 
research, their family member may be compensated in accordance with CNS Resolution No. 466 of 2012, items II.6 and II.7. In accordance with 
items II.3.1 and II.3.2 of CNS Resolution No. 466 of 2012. In line with CNS Resolution No. 251 of 1997, access to the evaluation results will 
always be available. The participant will be required to participate in the study whenever requested and/or indicated. If this procedure may 
cause any type of embarrassment, you will not need to do it. 
5. What will be the benefits of your participation in this study? 
The expected benefits of your participation in this study lie in the possibility of improved performance in carrying out daily activities, and also in 
the possible structuring of another pathway (telerehabilitation) of health care in the rehabilitation process. This can result in significant 
improvements in your quality of life, physical and cognitive functionality, among other aspects. In addition, upon completion of this study, and in 
case of positive results, it is expected to contribute to the development of best practices in care for post-stroke patients. 
6. Withdrawal from the study 
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RESEARCH PLAN 
 
Participation is voluntary. You may withdraw from this research at any time by contacting one of the responsible researchers or the Ethics 
Committee, CAPPesq. 
7. Confidentiality of your information 
The information collected will be handled only by the researchers and access by other people will not be permitted. The data and instruments 
used will be kept under the responsibility of the researchers with the guarantee of maintaining secrecy and confidentiality, and archived for a 
period of 5 years; after this time they will be destroyed. The results of this work may be presented at scientific meetings or journals. However, it 
will only show the results obtained in their entirety, without revealing your personal data or any information related to your privacy. 
8. Clarification on the form of follow-up and assistance to which participants in the research will be entitled 
We clarify that your participation in the research will not be an obstacle to your access to the in-person services of IMREA HC-FMUSP, regardless 
of the group to which you were allocated (intervention group or control group). Your participation will take place during the period in which you 
await in-person appointments, whether outpatient or inpatient. If you are called to start in-person appointments before the end of 
telerehabilitation, the final assessments will be applied, and then you will continue with in-person appointments. All data collected will be 
treated with maximum confidentiality, respecting the highest ethical and regulatory standards. Guarantees of full freedom for the participant to 
refuse to participate or withdraw their consent at any stage of the research without any penalty, of secrecy and privacy. 
9. Guarantee that the participant will receive a copy of the consent form 
To ensure transparency and respect for participants' rights, a copy of the informed consent form (ICF) will be provided in duplicate during the 
consent process. The ICF will be prepared in two original copies, one for the participant and the other for the research records, under the 
responsibility of the researcher. Both copies will be initialed by the responsible researcher and the participant, indicating mutual consent and 
understanding of the terms of the study. 
10. Explicit statement of guarantees for reimbursement of expenses arising from the research and explicit statement of the guarantee of 
compensation for any damages arising from the research. 
To ensure the protection and well-being of research participants, clear guarantees of reimbursement for expenses arising from participation in 
the study will be provided, as recommended by Resolution 466/2012. In addition, the research will guarantee comprehensive coverage for any 
damages arising from participation, as established by ethical and regulatory protocols. In case of physical, psychological or other damages, 
participants will be supported and will receive adequate medical assistance at no cost to them. 
11. Information on the study results 
At any stage of the study, you will have access to the professionals responsible for the research to clarify any doubts. The principal investigator 
is Prof. Dr. André Tadeu Sugawara, who can be found at IMREA-HCFMUSP, at Rua Domingo de Soto, 100 – 3rd floor, Clinical Research Center - 
Vila Mariana - CEP 04116-030, São Paulo - SP, Brazil, telephone (011) 5180-7887, from 8 am to 5 pm, Monday to Friday, or by email: 
andre.sugawara@hc.fm.usp.br 
If you have any considerations or questions about the ethics of the research, you can contact the local Ethics Committee, CAPPesq, which 
approved this study. The Ethics Committee is an independent and non-profit entity that safeguards ethics in research with human beings and 
defends the interests of research participants, such as yourself, in their integrity and dignity, contributing to the development of our research 
within globally established ethical standards. CAPPesq is located at R. Dr. Ovídio Pires de Campos, 225, 6th floor - Cerqueira César, São Paulo - 
SP, 05403-010, opening hours: 7am - 4pm; Tel.: (11) 2661-1548 or (11) 2661-7585; Email: cappesq.adm@hc.fm.usp.br 
I have been sufficiently informed about the study “Effects of telerehabilitation on the occupational performance of stroke patients treated by the 
Occupational Therapy service: a randomized clinical trial”. 
I discussed the above information with the principal investigator, Prof. Dr. André Tadeu Sugawara, or person(s) designated by him 
__________________________________ about my decision to participate in this study. The objectives, procedures, potential discomforts, risks, and 
guarantees were made clear to me. I voluntarily agree to participate in this study, sign this consent form, and receive a copy initialed by the 
researcher. 
 
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