<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04477252</url>
  </required_header>
  <id_info>
    <org_study_id>FIS-2020-02</org_study_id>
    <secondary_id>CORE-app</secondary_id>
    <nct_id>NCT04477252</nct_id>
  </id_info>
  <brief_title>Mobile App as a Guide to Exercises for Patients With Chronic Stroke</brief_title>
  <official_title>Mobile App as a Guide to Lumbopelvic Stability Exercises in Patients With Chronic Stroke: a Pilot Study of a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clínica de Neurorehabilitación</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clínica de Neurorehabilitación</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: Stroke continues to be one of the leading causes of disability in the Spanish&#xD;
      adult population with the presentation of impairments such as alteration of mobility and a&#xD;
      consequent reduction in quality of life. These sequelae, generally chronic, generates a&#xD;
      significant expense and saturation of social and health services. With the growth in the&#xD;
      number of cases, the development of new rehabilitation approaches and updating of the social&#xD;
      context becomes pertinent, such as the incorporation of telerehabilitation to assist&#xD;
      individuals with stroke.&#xD;
&#xD;
      Objectives: To analyze adherence to physical rehabilitation by mobile App and to evaluate the&#xD;
      effectiveness of lumbopelvic stability exercises performed at home with the App.&#xD;
&#xD;
      Material and methods: Randomized controlled single blind pilot study (n = 30). Participants&#xD;
      with Stroke (&lt;6 months) will be randomized between two groups (App for carrying out&#xD;
      lumbopelvic stability exercises + usual treatment versus usual treatment). The study will&#xD;
      last 3 months and App adherence, Quality Of Life, participation in Daily Life, functionality,&#xD;
      sitting balance, standing balance and gait will be taken as variables.&#xD;
&#xD;
      Expected results: It is thought that the use of an App can contribute to rehabilitation in&#xD;
      its chronic phase, monitorization and fallow-up the clinical evolution of the patient. Even&#xD;
      if chronicity leads us to think about the stabilization of the physical condition, It is&#xD;
      thought that the best results will be found among the subjects who will use the App.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The recruitment of participants will be done in a personalized way through a verbal&#xD;
      invitation from the responsible therapist.&#xD;
&#xD;
      The therapists of the center will be informed about the inclusion criteria in this study in&#xD;
      order to proceed with the personalized invitation.&#xD;
&#xD;
      In the case that the participant meet the inclusion criteria and wishes to participate in the&#xD;
      study, the professional evaluator is contacted to begin the process of submission in this&#xD;
      study.&#xD;
&#xD;
      The professional evaluator has the responsibility to explain to the participant what the&#xD;
      study consists of The professional evaluator is responsible for giving the participant the&#xD;
      study information sheet (approved by the ethics committee and the management of the center&#xD;
      where the study will be conducted).&#xD;
&#xD;
      The professional evaluator is responsible for collecting the signature of the informed&#xD;
      consent to participate in this study (approved by the ethics committee and the management of&#xD;
      the center where the study will be conducted).&#xD;
&#xD;
      A numerical code (from 1 to 30) will be assigned to each patient according to the order of&#xD;
      recruitment to keep their identity secret.&#xD;
&#xD;
      The code attributed to each participant will appear in the individual data collection&#xD;
      notebook The association between the participant's identity and the attributed code will be&#xD;
      known by the professional evaluator The code attributed to each participant will be entered&#xD;
      in the spreadsheet where the collected data and results of the assessment tests will be&#xD;
      uploaded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">March 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>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). 30 participants will be recruited. 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 program and with the following interventions</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
    <masking_description>The therapist responsible for the conventional treatment of the patient and the therapist who performs the assessment will not have access to information about the study group the patient encounters. Since the randomization of patients, access to the intervention of the Experimental Group will be facilitated by the researcher on an occasion other than the initial assessment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence: Scale of System Uses</measure>
    <time_frame>week 12</time_frame>
    <description>Adherence to the use of the mobile App using Scale of System Uses. Minimum Score:0 Maximum Score: 100 (higher scores mean a better result)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence: Administration panel of the App</measure>
    <time_frame>week 12</time_frame>
    <description>Adherence to the use of the mobile App using the data extracted by the administration panel of the App. Consider 5 days / week the optimal use (100%) and a total use of 0 to 20 days in 12 weeks will be considered low adherence (0-33%), 21 to 41 days (33-66%) regular adherence and 42 to 60 days (66-100% :) good adherence.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Quality of Life: EuroQol test</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Quality of Life using EuroQol 5d5l. This questionnaire is made up of two parts. Part I: One part with 5 questions scored from 1 to 5 (1 represents absence of problem and 5 the absolute limitation). The total score ranges from 5 to 25 in which higher results represent a worse outcome.&#xD;
Part II: Consisting of a numerical scale from 0 to 100 on the general state of health, in which 0 represents the worst level of health and 100 the best level of health that individuals can perceive.</description>
  </other_outcome>
  <other_outcome>
    <measure>Participation in Activity of Daily Living: Barthel Index</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Participation in Activity of Daily Living using Barthel Index Scale. Minimum Score: 0; Maximum Score: 100. Higher score means better outcomes</description>
  </other_outcome>
  <other_outcome>
    <measure>Functionality: Rankin scale</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Functionality using Rankin Scale. Minimum Score: 0; Maximum Score: 6. Higher score means worse outcomes</description>
  </other_outcome>
  <other_outcome>
    <measure>Sitting balance: Spanish versions of the Trunk Impairment Scale 2.0</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Sitting balance using Spanish versions of the Trunk Impairment Scale 2.0. Minimum Score: 0; Maximum Score: 26. Higher score means better outcomes</description>
  </other_outcome>
  <other_outcome>
    <measure>Sitting balance: Function in Sitting Test</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Sitting balance using Function in Sitting Test. Minimum Score: 0; Maximum Score: 56. Higher score means better outcomes</description>
  </other_outcome>
  <other_outcome>
    <measure>Standing balance: Berg Balance Scale</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Standing balance using Berg Balance Scale. Minimum Score: 0; Maximum Score: 56. Higher score means better outcomes</description>
  </other_outcome>
  <other_outcome>
    <measure>Standing balance: Spanish version of the Postural Assessment Scale for stroke patients</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Standing balance using Spanish version of the Postural Assessment Scale for Stroke patients. Minimum Score: 0; Maximum Score: 36. Higher score means better outcomes</description>
  </other_outcome>
  <other_outcome>
    <measure>G-Walk accelerometer system: Duration of double and individual support</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Duration of double and individual support (%). The software provides the values from subjects and the mean values of the population. It will be take into account the difference between the subject values and the mean in the population without pathology. Higher scores means worse results.</description>
  </other_outcome>
  <other_outcome>
    <measure>G-Walk accelerometer system: Duration of support and swing gait phases from right anda left lower limb</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Duration of support and swing gait phases from right anda left lower limb(%). The software provides the values from subjects and the mean values of the population. It will be take into account the difference between the subject values and the mean in the population without pathology. Higher scores means worse results.</description>
  </other_outcome>
  <other_outcome>
    <measure>G-Walk accelerometer system: Cadence of stride</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Cadence of stride (steps/minutes). The software provides the values from subjects and the mean values of the population. It will be take into account the difference between the subject values and the mean in the population without pathology. Higher scores means worse results.</description>
  </other_outcome>
  <other_outcome>
    <measure>G-Walk accelerometer system: Gait speed</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Gait speed (metres/second).The software provides the values from subjects and the mean values of the population. It will be take into account the difference between the subject values and the mean in the population without pathology. Higher scores means worse results.</description>
  </other_outcome>
  <other_outcome>
    <measure>G-Walk accelerometer system: Step length</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Step length (%). The software provides the values from subjects and the mean values of the population. It will be take into account the difference between the subject values and the mean in the population without pathology. Higher scores means worse results.</description>
  </other_outcome>
  <other_outcome>
    <measure>G-Walk accelerometer system</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Stride length (meters). The software provides the values from subjects and the mean values of the population. It will be take into account the difference between the subject values and the mean in the population without pathology. Higher scores means worse results.</description>
  </other_outcome>
  <other_outcome>
    <measure>number of falls in the last six weeks</measure>
    <time_frame>0, 6, 12 weeks</time_frame>
    <description>Balance. Higher scores means worse outcomes</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Telerehabilitation</condition>
  <condition>Stroke Sequelae</condition>
  <condition>Therapeutic Adherence and Compliance</condition>
  <condition>Mobile Phone Use</condition>
  <condition>Physical Disability</condition>
  <condition>Neurologic Disorder</condition>
  <arm_group>
    <arm_group_label>App group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of the Mobile App for the daily performance (Monday to Friday) of lumbopelvic stability exercises apart from the usual physiotherapy treatment for 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional physiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>usual physiotherapy treatment for 3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>App-core</intervention_name>
    <description>Farmalarm App of the Inmovens group - Vall d´Hebrón Hospital will be used, adapted and updated by the main researcher. The App will have the &quot;rehabilitation&quot; 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 help. The administrator therapist of the App has the permission to create users, contact them directly through chat or video-call and personalize the exercise program.&#xD;
The exercises that will be carried out in this study phase, are described in previous studies by the author Rosa Cabanas et al. All possible exercises will be included in the administration platform, and according to of each user, the prescription of some exercises or others will be made.</description>
    <arm_group_label>App group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional physiotherapy</intervention_name>
    <description>Conventional physiotherapy is considered neuromotor development therapy as the most frequently used therapy in the management of stroke patients and in the center where the study is performed.</description>
    <arm_group_label>conventional physiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medical diagnosis of stroke with cortical or subcortical, ischemic or hemorrhagic&#xD;
             involvement with more than 6 months of evolution&#xD;
&#xD;
          -  Clinical symptoms of hemiplegia or hemiparesis&#xD;
&#xD;
          -  Over 18 years of age&#xD;
&#xD;
          -  Ability to understand and execute simple instructions&#xD;
&#xD;
          -  Score equal to or less than 10 in the Spanish version of the Trunk Impairment Scale&#xD;
             2.0&#xD;
&#xD;
          -  Be a frequent user of smartphone or tablet. Failing this, the direct family member /&#xD;
             caregiver is considered.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Appearance of any disease or aggravation of any of the comorbidities that the patient&#xD;
             presents that prevents rehabilitation (example: dialysis)&#xD;
&#xD;
          -  Suffer a second episode of Stroke.&#xD;
&#xD;
          -  Fractures in any of the lower extremities or important structural alterations in the&#xD;
             trunk.&#xD;
&#xD;
          -  Death&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carina F Salgueiro, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clínica de Neurorehabilitación</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinica de neurorehabilitacion SL</name>
      <address>
        <city>Sant Cugat Del Valles</city>
        <state>Barcelona</state>
        <zip>08195</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7. Erratum In: Stroke. 2019 Aug;50(8):e239.</citation>
    <PMID>23652265</PMID>
  </reference>
  <reference>
    <citation>Brewer L, Horgan F, Hickey A, Williams D. Stroke rehabilitation: recent advances and future therapies. QJM. 2013 Jan;106(1):11-25. doi: 10.1093/qjmed/hcs174. Epub 2012 Sep 27.</citation>
    <PMID>23019591</PMID>
  </reference>
  <reference>
    <citation>Schmid AA, Van Puymbroeck M, Altenburger PA, Miller KK, Combs SA, Page SJ. Balance is associated with quality of life in chronic stroke. Top Stroke Rehabil. 2013 Jul-Aug;20(4):340-6. doi: 10.1310/tsr2004-340.</citation>
    <PMID>23893833</PMID>
  </reference>
  <reference>
    <citation>Isho T, Usuda S. Association of trunk control with mobility performance and accelerometry-based gait characteristics in hemiparetic patients with subacute stroke. Gait Posture. 2016 Feb;44:89-93. doi: 10.1016/j.gaitpost.2015.11.011. Epub 2015 Nov 26.</citation>
    <PMID>27004638</PMID>
  </reference>
  <reference>
    <citation>Cabanas-Valdes R, Bagur-Calafat C, Girabent-Farres M, Caballero-Gomez FM, Hernandez-Valino M, Urrutia Cuchi G. The effect of additional core stability exercises on improving dynamic sitting balance and trunk control for subacute stroke patients: a randomized controlled trial. Clin Rehabil. 2016 Oct;30(10):1024-1033. doi: 10.1177/0269215515609414. Epub 2015 Oct 8.</citation>
    <PMID>26451007</PMID>
  </reference>
  <reference>
    <citation>Cabanas-Valdes R, Bagur-Calafat C, Girabent-Farres M, Caballero-Gomez FM, du Port de Pontcharra-Serra H, German-Romero A, Urrutia G. Long-term follow-up of a randomized controlled trial on additional core stability exercises training for improving dynamic sitting balance and trunk control in stroke patients. Clin Rehabil. 2017 Nov;31(11):1492-1499. doi: 10.1177/0269215517701804. Epub 2017 Mar 29.</citation>
    <PMID>28351168</PMID>
  </reference>
  <reference>
    <citation>Cabanas-Valdes R, Cuchi GU, Bagur-Calafat C. Trunk training exercises approaches for improving trunk performance and functional sitting balance in patients with stroke: a systematic review. NeuroRehabilitation. 2013;33(4):575-92. doi: 10.3233/NRE-130996.</citation>
    <PMID>24018373</PMID>
  </reference>
  <reference>
    <citation>Chen Y, Abel KT, Janecek JT, Chen Y, Zheng K, Cramer SC. Home-based technologies for stroke rehabilitation: A systematic review. Int J Med Inform. 2019 Mar;123:11-22. doi: 10.1016/j.ijmedinf.2018.12.001. Epub 2018 Dec 11.</citation>
    <PMID>30654899</PMID>
  </reference>
  <reference>
    <citation>Zhou X, Du M, Zhou L. Use of mobile applications in post-stroke rehabilitation: a systematic review. Top Stroke Rehabil. 2018 Sep 13:1-11. doi: 10.1080/10749357.2018.1482446. Online ahead of print.</citation>
    <PMID>30209991</PMID>
  </reference>
  <reference>
    <citation>Sanchez Rodriguez MT, Collado Vazquez S, Martin Casas P, Cano de la Cuerda R. Neurorehabilitation and apps: A systematic review of mobile applications. Neurologia (Engl Ed). 2018 Jun;33(5):313-326. doi: 10.1016/j.nrl.2015.10.005. Epub 2015 Dec 17. English, Spanish.</citation>
    <PMID>26703120</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 27, 2021</last_update_submitted>
  <last_update_submitted_qc>July 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clínica de Neurorehabilitación</investigator_affiliation>
    <investigator_full_name>Carina Francisco Salgueiro</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Mobile Applications</keyword>
  <keyword>Telerehabilitation</keyword>
  <keyword>Stroke</keyword>
  <keyword>Therapeutics</keyword>
  <keyword>Functional recovery</keyword>
  <keyword>Neurorehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>It is intended to share the data with other researchers such as the statistical team through encrypted e-mail.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 13, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT04477252/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT04477252/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04477252
org study id: FIS-2020-02
secondary id: CORE-app
nct id: NCT04477252
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Introduction: Stroke continues to be one of the leading causes of disability in the Spanish
      adult population with the presentation of impairments such as alteration of mobility and a
      consequent reduction in quality of life. These sequelae, generally chronic, generates a
      significant expense and saturation of social and health services. With the growth in the
      number of cases, the development of new rehabilitation approaches and updating of the social
      context becomes pertinent, such as the incorporation of telerehabilitation to assist
      individuals with stroke.

      Objectives: To analyze adherence to physical rehabilitation by mobile App and to evaluate the
      effectiveness of lumbopelvic stability exercises performed at home with the App.

      Material and methods: Randomized controlled single blind pilot study (n = 30). Participants
      with Stroke (<6 months) will be randomized between two groups (App for carrying out
      lumbopelvic stability exercises + usual treatment versus usual treatment). The study will
      last 3 months and App adherence, Quality Of Life, participation in Daily Life, functionality,
      sitting balance, standing balance and gait will be taken as variables.

      Expected results: It is thought that the use of an App can contribute to rehabilitation in
      its chronic phase, monitorization and fallow-up the clinical evolution of the patient. Even
      if chronicity leads us to think about the stabilization of the physical condition, It is
      thought that the best results will be found among the subjects who will use the App.
The recruitment of participants will be done in a personalized way through a verbal
      invitation from the responsible therapist.

      The therapists of the center will be informed about the inclusion criteria in this study in
      order to proceed with the personalized invitation.

      In the case that the participant meet the inclusion criteria and wishes to participate in the
      study, the professional evaluator is contacted to begin the process of submission in this
      study.

      The professional evaluator has the responsibility to explain to the participant what the
      study consists of The professional evaluator is responsible for giving the participant the
      study information sheet (approved by the ethics committee and the management of the center
      where the study will be conducted).

      The professional evaluator is responsible for collecting the signature of the informed
      consent to participate in this study (approved by the ethics committee and the management of
      the center where the study will be conducted).

      A numerical code (from 1 to 30) will be assigned to each patient according to the order of
      recruitment to keep their identity secret.

      The code attributed to each participant will appear in the individual data collection
      notebook The association between the participant's identity and the attributed code will be
      known by the professional evaluator The code attributed to each participant will be entered
      in the spreadsheet where the collected data and results of the assessment tests will be
      uploaded.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 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). 30 participants will be recruited. 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 program and with the following interventions
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
masking description: The therapist responsible for the conventional treatment of the patient and the therapist who performs the assessment will not have access to information about the study group the patient encounters. Since the randomization of patients, access to the intervention of the Experimental Group will be facilitated by the researcher on an occasion other than the initial assessment.
measure: Adherence: Scale of System Uses
time frame: week 12
description: Adherence to the use of the mobile App using Scale of System Uses. Minimum Score:0 Maximum Score: 100 (higher scores mean a better result)
measure: Adherence: Administration panel of the App
time frame: week 12
description: Adherence to the use of the mobile App using the data extracted by the administration panel of the App. Consider 5 days / week the optimal use (100%) and a total use of 0 to 20 days in 12 weeks will be considered low adherence (0-33%), 21 to 41 days (33-66%) regular adherence and 42 to 60 days (66-100% :) good adherence.
measure: Quality of Life: EuroQol test
time frame: 0, 6, 12 weeks
description: Quality of Life using EuroQol 5d5l. This questionnaire is made up of two parts. Part I: One part with 5 questions scored from 1 to 5 (1 represents absence of problem and 5 the absolute limitation). The total score ranges from 5 to 25 in which higher results represent a worse outcome.
Part II: Consisting of a numerical scale from 0 to 100 on the general state of health, in which 0 represents the worst level of health and 100 the best level of health that individuals can perceive.
measure: Participation in Activity of Daily Living: Barthel Index
time frame: 0, 6, 12 weeks
description: Participation in Activity of Daily Living using Barthel Index Scale. Minimum Score: 0; Maximum Score: 100. Higher score means better outcomes
measure: Functionality: Rankin scale
time frame: 0, 6, 12 weeks
description: Functionality using Rankin Scale. Minimum Score: 0; Maximum Score: 6. Higher score means worse outcomes
measure: Sitting balance: Spanish versions of the Trunk Impairment Scale 2.0
time frame: 0, 6, 12 weeks
description: Sitting balance using Spanish versions of the Trunk Impairment Scale 2.0. Minimum Score: 0; Maximum Score: 26. Higher score means better outcomes
measure: Sitting balance: Function in Sitting Test
time frame: 0, 6, 12 weeks
description: Sitting balance using Function in Sitting Test. Minimum Score: 0; Maximum Score: 56. Higher score means better outcomes
measure: Standing balance: Berg Balance Scale
time frame: 0, 6, 12 weeks
description: Standing balance using Berg Balance Scale. Minimum Score: 0; Maximum Score: 56. Higher score means better outcomes
measure: Standing balance: Spanish version of the Postural Assessment Scale for stroke patients
time frame: 0, 6, 12 weeks
description: Standing balance using Spanish version of the Postural Assessment Scale for Stroke patients. Minimum Score: 0; Maximum Score: 36. Higher score means better outcomes
measure: G-Walk accelerometer system: Duration of double and individual support
time frame: 0, 6, 12 weeks
description: Duration of double and individual support (%). The software provides the values from subjects and the mean values of the population. It will be take into account the difference between the subject values and the mean in the population without pathology. Higher scores means worse results.
measure: G-Walk accelerometer system: Duration of support and swing gait phases from right anda left lower limb
time frame: 0, 6, 12 weeks
description: Duration of support and swing gait phases from right anda left lower limb(%). The software provides the values from subjects and the mean values of the population. It will be take into account the difference between the subject values and the mean in the population without pathology. Higher scores means worse results.
measure: G-Walk accelerometer system: Cadence of stride
time frame: 0, 6, 12 weeks
description: Cadence of stride (steps/minutes). The software provides the values from subjects and the mean values of the population. It will be take into account the difference between the subject values and the mean in the population without pathology. Higher scores means worse results.
measure: G-Walk accelerometer system: Gait speed
time frame: 0, 6, 12 weeks
description: Gait speed (metres/second).The software provides the values from subjects and the mean values of the population. It will be take into account the difference between the subject values and the mean in the population without pathology. Higher scores means worse results.
measure: G-Walk accelerometer system: Step length
time frame: 0, 6, 12 weeks
description: Step length (%). The software provides the values from subjects and the mean values of the population. It will be take into account the difference between the subject values and the mean in the population without pathology. Higher scores means worse results.
measure: G-Walk accelerometer system
time frame: 0, 6, 12 weeks
description: Stride length (meters). The software provides the values from subjects and the mean values of the population. It will be take into account the difference between the subject values and the mean in the population without pathology. Higher scores means worse results.
measure: number of falls in the last six weeks
time frame: 0, 6, 12 weeks
description: Balance. Higher scores means worse outcomes
arm group label: App group
arm group type: Experimental
description: Use of the Mobile App for the daily performance (Monday to Friday) of lumbopelvic stability exercises apart from the usual physiotherapy treatment for 3 months.
arm group label: conventional physiotherapy
arm group type: Active Comparator
description: usual physiotherapy treatment for 3 months
intervention type: Device
intervention name: App-core
description: Farmalarm App of the Inmovens group - Vall d´Hebrón Hospital will be used, adapted and updated by the main researcher. 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 help. The administrator therapist of the App has the permission to create users, contact them directly through chat or video-call and personalize the exercise program.
The exercises that will be carried out in this study phase, are described in previous studies by the author Rosa Cabanas et al. All possible exercises will be included in the administration platform, and according to of each user, the prescription of some exercises or others will be made.
arm group label: App group
intervention type: Other
intervention name: Conventional physiotherapy
description: Conventional physiotherapy is considered neuromotor development therapy as the most frequently used therapy in the management of stroke patients and in the center where the study is performed.
arm group label: conventional physiotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carina F Salgueiro, MSc
role: Principal Investigator
affiliation: Clínica de Neurorehabilitación
facility: 
country: Spain
citation: Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7. Erratum In: Stroke. 2019 Aug;50(8):e239.
PMID: 23652265
citation: Brewer L, Horgan F, Hickey A, Williams D. Stroke rehabilitation: recent advances and future therapies. QJM. 2013 Jan;106(1):11-25. doi: 10.1093/qjmed/hcs174. Epub 2012 Sep 27.
PMID: 23019591
citation: Schmid AA, Van Puymbroeck M, Altenburger PA, Miller KK, Combs SA, Page SJ. Balance is associated with quality of life in chronic stroke. Top Stroke Rehabil. 2013 Jul-Aug;20(4):340-6. doi: 10.1310/tsr2004-340.
PMID: 23893833
citation: Isho T, Usuda S. Association of trunk control with mobility performance and accelerometry-based gait characteristics in hemiparetic patients with subacute stroke. Gait Posture. 2016 Feb;44:89-93. doi: 10.1016/j.gaitpost.2015.11.011. Epub 2015 Nov 26.
PMID: 27004638
citation: Cabanas-Valdes R, Bagur-Calafat C, Girabent-Farres M, Caballero-Gomez FM, Hernandez-Valino M, Urrutia Cuchi G. The effect of additional core stability exercises on improving dynamic sitting balance and trunk control for subacute stroke patients: a randomized controlled trial. Clin Rehabil. 2016 Oct;30(10):1024-1033. doi: 10.1177/0269215515609414. Epub 2015 Oct 8.
PMID: 26451007
citation: Cabanas-Valdes R, Bagur-Calafat C, Girabent-Farres M, Caballero-Gomez FM, du Port de Pontcharra-Serra H, German-Romero A, Urrutia G. Long-term follow-up of a randomized controlled trial on additional core stability exercises training for improving dynamic sitting balance and trunk control in stroke patients. Clin Rehabil. 2017 Nov;31(11):1492-1499. doi: 10.1177/0269215517701804. Epub 2017 Mar 29.
PMID: 28351168
citation: Cabanas-Valdes R, Cuchi GU, Bagur-Calafat C. Trunk training exercises approaches for improving trunk performance and functional sitting balance in patients with stroke: a systematic review. NeuroRehabilitation. 2013;33(4):575-92. doi: 10.3233/NRE-130996.
PMID: 24018373
citation: Chen Y, Abel KT, Janecek JT, Chen Y, Zheng K, Cramer SC. Home-based technologies for stroke rehabilitation: A systematic review. Int J Med Inform. 2019 Mar;123:11-22. doi: 10.1016/j.ijmedinf.2018.12.001. Epub 2018 Dec 11.
PMID: 30654899
citation: Zhou X, Du M, Zhou L. Use of mobile applications in post-stroke rehabilitation: a systematic review. Top Stroke Rehabil. 2018 Sep 13:1-11. doi: 10.1080/10749357.2018.1482446. Online ahead of print.
PMID: 30209991
citation: Sanchez Rodriguez MT, Collado Vazquez S, Martin Casas P, Cano de la Cuerda R. Neurorehabilitation and apps: A systematic review of mobile applications. Neurologia (Engl Ed). 2018 Jun;33(5):313-326. doi: 10.1016/j.nrl.2015.10.005. Epub 2015 Dec 17. English, Spanish.
PMID: 26703120
responsible party type: Principal Investigator
investigator affiliation: Clínica de Neurorehabilitación
investigator full name: Carina Francisco Salgueiro
investigator title: Principal Investigator
mesh term: Stroke
mesh term: Nervous System Diseases
sharing ipd: No
ipd description: It is intended to share the data with other researchers such as the statistical team through encrypted e-mail.
provided document: 
provided document: 