Mobile App as a Guide to Lumbopelvic Stability Exercises in Patients With Chronic Stroke: a Pilot Study of a Randomized Clinical Trial
Phase: NA
Conditions: Telerehabilitation, Stroke Sequelae, Therapeutic Adherence and Compliance, Mobile Phone Use, Physical Disability, Neurologic Disorder
Sponsor: Clínica de Neurorehabilitación

STUDY PROTOCOL
Study Number: FIS-2020-02
Protocol version: 1.0
Presentation date: 13.07.2020
Department: Health Sciences
Research line: Physiotherapy
Research title: Using one App as a guide to lumbopelvic stability exercises in patients with
chronic stroke: a pilot study of a randomized clinical trial
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1. Glossary of acronyms
QoL: Quality of Life
App: Mobile application
ADL: Activities of Daily Living
2. Introduction:
Stroke continues to be one of the leading causes of death and disability in the
Spanish adult population, with the presentation of various sequelae, such as impaired
mobility and a consequent reduction in Quality of Life (QoL). These sequelae, which can
be chronic, generate significant spending and a saturation of social and health services.
With  the  growth  in  the  number  of  cases,  the  development  of  new  rehabilitation
approaches and updating to the current social context becomes pertinent, such as the
incorporation of telerehabilitation to assist individuals who have suffered a stroke.
3. Background and current status of the topic:
Stroke, defined by the World Health Organization as the rapid development of
clinical signs of local or global disturbance of brain function, for more than 24 hours or
leading to death, without any other apparent cause than vascular origin, it is the most well-
known  and  frequent  cerebrovascular  disease  in  the  adult  population  (1).  In  Spain,
according  to  data  from  the  National  Statistics  Institute,  death  in  adults  from
cerebrovascular disease  continues to be one of the leading  causes of death in our
country, with about 30% of cases (2) .
Stroke is also one of the leading causes of disability in the adult population,
generating a significant expense and saturation of social and health services, both in the
acute and chronic phase, since its symptoms are usually permanent to a greater or lesser
extent. degree. Among these symptoms one can find language disorders or cognitive
alterations, but the most common is the sensory-motor alteration of the half of the body
opposite to the brain injury(3) . These alterations lead to a significant reduction in QoL
since they provide the patient with great disabilities in different areas of their life. In 2013,
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Schmid et al. Associated the balance deficit and the risk of falls with a low QoL level in
patients with stroke in its chronic phase (4) .
Faced  with  the  possible  sequelae  of  stroke,  survivors  often  attend
neurorehabilitation  programs  in  which  physical  therapy,  psychology,  speech  therapy,
among others, depending on the needs of the individual, participate. In relation to sensory
and motor rehabilitation, which is usually the responsibility of physiotherapy, one of the
fundamental therapeutic objectives is to achieve optimal trunk control and sitting balance
since it is known that the low performance of the trunk musculature, specifically  its
delayed and asynchronous activation due to the resulting hemiparesis, is associated with
poor postural balance and gait instability (5) . Known studies support the idea that trunk
stability plays a critical role in maintaining balance both in sitting and standing, functional
mobility, gait, and increased  QoL in individuals with stroke (6,7,8).
Being aware of the growth in the number of cases, the impact on the health of
individuals and their resulting disability, it would be advisable to study and develop new
effective means to respond to the growing demand for individuals with stroke, such as the
use of digital technologies for therapeutic exercises to intensify rehabilitation even at
home.  Its  use  can  facilitate  access  to  information  and  guidelines  for  rehabilitative
treatment  by  patients  and  their  families  or  caregivers,  provide  greater  intensity  to
therapies and increase the involvement of individuals in the rehabilitation process. On the
other hand, it would also allow continuous therapeutic follow-up without the need for
displacement and the perpetuation of the rehabilitation of permanent sequelae and their
secondary sequelae. With this vision and knowing that the use of electronic and digital
devices, such as the smartphone or tablet, is becoming more frequent, it is hoped that
these will be considered as a possible therapeutic resource.
From this concept telerehabilitation arises, as a rehabilitation method in which
professionals use telecommunications devices to provide intervention, assessment and
support strategies for disabled people who are at home. This is a feasible method and has
the advantages of providing flexibility of time and space, reducing inequality in medical
care,  improving  the  quality  of  care,  and  reducing  costs  in  human  resources,
transportation, and facilities (9) . In the market you can find mobile applications (App) for
neurorehabilitation such as language rehabilitation, cognitive disorders and incentives for
physical activity. However, these apps are usually incomplete and depersonalized, and
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their results compared to conventional therapies in a clinical setting are inconclusive (10) .
In  a  current  systematic  review,  published  in  2018,  no  App  has  been  found  that
contemplates personalized functional physical rehabilitation for individuals with Stroke
(11) . For this reason, it is convenient to find an App that contemplates motor rehabilitation
customized to the abilities of users with Stroke. 
The idea of introducing telerehabilitation in the physiotherapy services of care for
chronic patients, has the intention of improving health care services and optimizing human
resources while promoting the rehabilitation process of the sequelae of individuals. Apart
from the continuous contact channel between medical personnel and users and means of
monitoring clinical evolution, it becomes pertinent to study this type of digital tools as a
means of personalized prescription of therapeutic exercise for the home, especially in
chronic situations that saturate rehabilitation services. This research study will provide
information on the effectiveness of using an App as a means of personalized prescription
of therapeutic exercises to be carried out at home, especially lumbopelvic stabilization
exercises whose evidence is known. Thus, it is expected to study the level of adherence
to telerehabilitation by individuals with stroke in its chronic phase, along with analyzing
clinical results related to balance and its influence on participation in Activities of Daily
Living (ADL)  and QoL.
4. Objectives:
This project has the following proposed objectives:

To analyze the adherence to the treatment of the App

To evaluate the effectiveness of an intervention of lumbopelvic stability exercises
performed at home, through the use of an App, compared to usual therapy.
5. Hypothesis:
The hypothesis of the present study project is: to. The use of an App, adapted to
the abilities and needs of individuals with stroke, improves adherence to its use for
carrying  out  specific  therapeutic  exercises.  b.  Muscular  stability  exercises  of  the
lumbopelvic  area  performed  at  home  monitored  by  means  of  an  App  improve  the
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perception of the QoL of individuals who have suffered a stroke in the chronic phase of
their evolution compared to the usual follow-up of this type of individuals. c. Muscular
stability exercises of the lumbopelvic area performed at home monitored by an App
increase the functionality and participation in the ADL of individuals who have suffered a
stroke in the chronic phase of their evolution compared to the usual follow-up of this type
of individuals. d. Muscular stability exercises of the lumbopelvic area performed at home
monitored by an App improve the balance in sitting and standing and reduce the number
of falls of individuals who have suffered a stroke in the chronic phase of their evolution
compared to the usual monitoring of this type of individuals.  and. Muscular stability
exercises of the lumbopelvic area performed at home monitored by means of an App
improve the gait of individuals who have suffered a stroke in the chronic phase of their
evolution compared to the usual follow-up of this type of individuals. 
6. Material and methods:
For this study, the Farmalarm App of the Inmovens group - Vall d´Hebrón Hospital
will be used, adapted and updated by the main researchers of this study. The App will
have the “rehabilitation” option where the user can consult the description of the exercise
and  view  a  demonstration  video  so  that  it  can  be  carried  out  correctly  at  home,
independently or with the help of a third person. The researchers will be responsible for
The researcher of this study will also be registered as administrator of the App with
permission  to  create  users,  contact  them  directly  through  chat  or  video-call  and
personalize the exercise program for each user. On the other hand, they will also have
permission to consult the use data of the App by users. The App will also contemplate the
option of confirming the completion of each proposed exercise and a small survey related
to the effort used to complete it. The data obtained from these options will facilitate the
customization of the exercise program. 
The exercises that will be carried out with the App, in this study phase (Table 1),
are described in previous works by the author Rosa Cabanas and colobradores (6). All
possible  exercises  (description  and  demonstration  video)  will  be  included  in  the
administration platform of the App and according to the capabilities of each user, the
prescription of some exercises or others will be made, respecting their progression. In this
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way, the aim is to personalize the therapeutic exercise program for each user, as well as
modify the number of repetitions suggested and add facilitating or hindering suggestions
to the same exercise.
Table 1: Stability exercises of the lumbopelvic region
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In this simple blind randomized controlled pilot study, participants will be recruited
from  users  of  the  rehabilitation  center  where  the  study  will  be  carried  out
(Neurorehabilitation Clinic - Sant Cugat del Vallés). To carry out this study, there is
already an agreement signed between the Neurorehabilitation Clinic and the International
University of Catalonia.
The following participation criteria have been defined for this pilot study Inclusion
criteria:
•  Medical  diagnosis  of  stroke  with  cortical  or  subcortical,  ischemic  or  hemorrhagic
involvement with more than 6 months of evolution
• Clinical symptoms of hemiplegia or hemiparesis
• Over 18 years of age
• Ability to understand and execute simple instructions
• Score equal to or less than 10 in the Spanish version of the Trunk Impairment Scale 2.0
• Be a frequent user of smartphone or tablet. Failing this, the direct family member /
caregiver is considered. 
Exclusion criteria:
• Appearance of any disease or aggravation of any of the comorbidities that the patient 
presents that prevents rehabilitation (example: dialysis)
• Suffer a second episode of Stroke.
• Fractures in any of the lower extremities or important structural alterations in the trunk.
• Death 
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30 participants will be recruited. No sample calculation will be performed as it is a
convenience sample for a pilot study and it is a value very close to the total number of
users with Strokes of the center where the study will be carried out. Another limiting factor
of the sample is that the users will be monitored daily or weekly by an investigator
assuming a ratio of 30 users / 1 therapist. In the recruitment process, patients will be
informed  about  the  study, they will  be asked  to  sign  an  informed  consent and  the
randomization between the experimental group and the control group will be done by
computerized lottery and with the following interventions:
Experimental  Group:  Use  of  App  for  the  daily  performance  (Monday  to  Friday)  of
lumbopelvic stability exercises (Table 1) apart from the usual physiotherapy treatment for
3 months.
Control Group: Regular physical therapy treatment.
The information on the usual physiotherapy treatment will be collected together
with the variables to be studied. At the end of the study, the description of the usual
treatment, neuromotor development treatment, will be disclosed, which usually includes
techniques  for  modulating  the  muscle  tone  of  the  affected  body,  postural  control
exercises, facilitation of functional movement and practice of tasks including walking.
To guarantee the blinding characteristic, the evaluations will be carried out by a
third non-investigating person. The following variables will be studied through selected
tests and questionnaires:
    • Adherence to the use of the App by individuals from the EG: Data extracted by the
administration panel of the App and System Usability Scale. Optimal use (100%) is
considered 5 days / week, that is, a use from 0 to 20 days in 12 weeks months will be
considered low adherence (0-33%), from 21 to 40 days (33-66%) regular adherence and
41 to 60 days (66-100% :) good adherence.
    • QoL: EuroQol 5 dimensions 5 levels.
    • Participation in AVD: Barthel Index.
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    • Functionality: Rankin scale.
    • Sitting balance: Spanish versions of the Trunk Impairment Scale 2.0 and Function in
Sitting Test.
    • Standing balance: Spanish version of the Postural Assessment Scale for Stroke
Patients, Berg Scale
    • Record of the number of falls.
    • Gait: stepping section of the Brunel Balance Assessment test and if they reach a
score of 6 they will be evaluated with the G-Walk accelerometer (duration of double and
individual support, cadence of the step, gait speed, stride length, length of step and
elaborate steps).
For statistical analysis, all subjects will be included, regardless of subsequent
events  such  as  protocol  violations,  lost  data,  or  loss  to  follow-up.  Qualitative  and
quantitative descriptive statistics will be used to characterize the sample depending on
categorical (eg.: sex) or numerical (eg.: age) variables. In the analysis of results, the
missing data will be imputed applying the imputation criterion of the last observation
made. The distribution of the sample will be calculated according to the Shapiro-Wilk test
and parametric and / or non-parametric tests will be used to calculate the significance of
the results. The significance level (p) will be 0.05, that is, a confidence level of 95% and
5% of acceptable error. For the purpose of this study, it is proposed to analyze the
difference between means and standard deviations of the variables both at the initial time
and at 6 and 12 weeks. Its statistical significance will be calculated by the Student's t test
or the Mann-Whitney U test for paired data. For the analysis of the effectiveness of the
interventions, the  evolution obtained in the different groups will be compared with the
same  statistical  tests  for  independent  samples.  To  assess  the  correlation  between
variables, the calculation of Pearson's coefficient and / or Spearman's coefficient will be
used.
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7. Analysis of results:
According to the existing literature, performing muscle exercises for lumbopelvic
stabilization  leads  to  improvements  in  the  balance  in  sitting,  standing  and  gait  in
individuals with stroke. These results can be translated into the increase in participation in
the ADL and the increase in the CV, factors to be taken into account in these individuals
since their sequelae are usually highly limiting and chronic.
Usually, individuals who have suffered a stroke receive rehabilitation, by different
disciplines where we find physiotherapy, according to their conditions and needs and with
the common objective of achieving the maximum level of autonomy. Knowing that stroke
patients can present chronic sequelae, their rehabilitation is perpetuated over time. It is
thought that the use of an App can provide continuity to rehabilitation in its chronic phase,
monitor and accompany the clinical evolution of the patient by the therapist. On the other
hand, one can think that perhaps it is a method that allows reducing the resources,
expenses in transfers and occupation of the rehabilitation center by chronic users.
The App will provide specific guidelines for carrying out lumbo-pelvic stabilization
exercises and the possibility of viewing demonstration videos, with this it is intended to
facilitate  and  encourage  the  performance  of  muscle  exercises  by  the  patient
independently or with the help of a family member or caregiver. On the other hand, the
patient will find a means that allows him to be in direct contact with the therapist in case of
doubts about his rehabilitation process, as well as the therapist can contact the patient to
monitor and follow up. In case of observing high levels of adherence to the use of the App
as well as better results compared to conventional therapy, the use of the App as a new
tool in neurorehabilitation can be considered. Even if chronicity leads us to think about
maintaining physical condition, it is planned to find better results among individuals who
will use the App as a therapeutic accompaniment for autonomous performance of muscle
exercises for lumbopelvic stabilization adjacent to regular physical therapy. 
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