xml: <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/NCT06016374</url>
    </required_header>
    <id_info>
      <org_study_id>2022 474</org_study_id>
      <nct_id>NCT06016374</nct_id>
    </id_info>
    <brief_title>Development and Validation of a Structured Tele-rehabilitation Programme of Brain Injured Patients</brief_title>
    <acronym>TELERE</acronym>
    <official_title>Development and Validation of a Structured Tele-rehabilitation Programme to Improve the Treatment of Brain Injured Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</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>
        The goal of this research project is to develop a tele-rehabilitation programme, which will&#xD;
        constitute an original care pathway for brain damaged patients. It will aim to improve their&#xD;
        impairments, activities and social participation. The programme will deliver a therapeutic&#xD;
        education and self-education programme targeting the upper and lower limbs, and will assess&#xD;
        the patients by means of a diary and self-evaluation questionnaires.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        According to WHO (1997), telemedicine is defined as &quot;the part of medicine that uses the&#xD;
        transmission of medical information (images, reports, recordings, etc.) by telecommunication,&#xD;
        with a view to obtaining at a distance a diagnosis, a specialised opinioń, continuous&#xD;
        monitoring of a patient, a therapeutic decision&quot;. More specifically, tele-rehabilitation is&#xD;
        defined as &quot;a set of interventions carried out at a distance and using communication&#xD;
        technologies and information services, with the aim of improving the health or well-being of&#xD;
        the persons involved&quot;. In other words, tele-rehabilitation is a form of health care practice&#xD;
        that uses information and communication technologies to exchange information between&#xD;
        rehabilitation providers and patients.&#xD;
  &#xD;
        Tele-rehabilitation programmes typically include self-rehabilitation. Self-rehabilitation&#xD;
        consists of a personalised therapeutic programme during which the patient performs&#xD;
        rehabilitation exercises independently. The patient is supervised by a clinician (e.g.&#xD;
        physiotherapist or occupational therapist) throughout the programme. Initially to explain the&#xD;
        programme and teach the patient how to use the technology. Then, to coach them regularly.&#xD;
        Tele-rehabilitation programmes can be delivered in hospitals, rehabilitation centres or at&#xD;
        home.&#xD;
  &#xD;
        Stroke affects 19,000 people per year in Belgium and is the leading cause of acquired&#xD;
        disability in adults in industrialised countries. After a stroke, patients recover some of&#xD;
        their functional abilities through spontaneous recovery. Rehabilitation improves this&#xD;
        functional recovery, in terms of impairments, but especially in terms of activities and&#xD;
        social participation, according to the International Classification of Functioning,&#xD;
        Disability and Health. This rehabilitation must be intense, early and interdisciplinary, to&#xD;
        promote cerebral neuroplasticity. However, more than half of these patients retain sequelae&#xD;
        in terms of locomotion or function of the paretic upper limb.&#xD;
  &#xD;
        Current literature indicates that functional rehabilitation after stroke can be further&#xD;
        optimised. On the one hand, current recommendations show that rehabilitation should be&#xD;
        intensive and task-oriented to promote brain neuroplasticity and motor relearning. Currently,&#xD;
        the intensity of treatment is generally insufficient in both the acute and chronic phases and&#xD;
        may vary depending on the management setting. In Belgium, patients typically receive 2 hours&#xD;
        of rehabilitation per working day in the acute and subacute phasë, and 30 minutes in the&#xD;
        chronic phase. These patients are therefore globally not active enough.&#xD;
  &#xD;
        On the other hand, complementary treatments to classical rehabilitation have shown their&#xD;
        effectiveness in recent years. Thus, several scientific publications have shown that&#xD;
        tele-rehabilitation, which mainly includes remotely supervised self-rehabilitation&#xD;
        programmes, is effective in improving impairments and activities in people who have had a&#xD;
        stroke, either as a complement or a substitute for conventional rehabilitation. In 2018,&#xD;
        Tchéro et al. showed that tele-rehabilitation was comparable in effectiveness to conventional&#xD;
        treatments. A recent Cochrane review also showed that tele-rehabilitation was as effective as&#xD;
        standard care, with a low to moderate level of evidence, on independence in daily activities,&#xD;
        balance or quality of life. In addition to being able to intensify treatment,&#xD;
        tele-rehabilitation is inexpensive and can also facilitate access to care for patients who do&#xD;
        not have a physiotherapy practice or rehabilitation centre in their immediate vicinity.&#xD;
  &#xD;
        A structured telemedicine programme for stroke rehabilitation should include different&#xD;
        elements.&#xD;
  &#xD;
          -  Therapeutic education: Texts or videos that allow the patient and his or her relatives&#xD;
             to better understand the condition and to know what they can do to improve it, for&#xD;
             example, in terms of lifestyle, secondary prevention or rehabilitation.&#xD;
  &#xD;
          -  Self-education exercise programmes: physical exercises adapted to the patient's health&#xD;
             problem are presented in the form of commented videos.&#xD;
  &#xD;
          -  Assessment: patients' functional abilities are assessed using PROMS-type questionnaires.&#xD;
  &#xD;
          -  A space for instant communication between the patient and the rehabilitation team.&#xD;
  &#xD;
        This programme should be configured, personalised and regularly updated for each patient by a&#xD;
        health professional.&#xD;
  &#xD;
        Telemedicine has recently been developed in Belgium in the context of the COVID19 crisis. It&#xD;
        has made it possible to ensure the continuity of rehabilitation care. Different technical&#xD;
        solutions are available to implement telemedicine. They must comply with different&#xD;
        regulations to ensure the security and confidentiality of health data.&#xD;
  &#xD;
        A new tele-rehabilitation programme for post-stroke patients could meet the clinical needs to&#xD;
        intensify treatment and improve accessibility to health care. Over the past few months, our&#xD;
        team has been developing a tele-rehabilitation programme for stroke patients. This programme,&#xD;
        called TeleRe, is a novel care pathway for stroke patients. It will aim to improve their&#xD;
        impairments, activities and social participation, and ultimately their quality of life.&#xD;
  &#xD;
        After a stroke, neurorehabilitation varies from one patient to another, and over time for the&#xD;
        same patient. The rehabilitation plan is established for each patient, with his or her&#xD;
        agreement, at the beginning of his or her treatment and then regularly updated. Typically,&#xD;
        the personalised treatment plan includes physiotherapy, occupational therapy, speech therapy&#xD;
        and neuropsychology. Our TeleRé programme would be in addition to these standard treatments.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 21, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>usability</measure>
      <time_frame>The test will be administered only once at the end of the intervention. So, 4 weeks after the start of the experiment, during the last session.</time_frame>
      <description>At the end of the trial, subjects will complete the System Usability Scale (SUS), a ten-item questionnaire evaluated on a Likert scale. This questionnaire is used to assess the usability of the TéléRé program.&#xD;
  The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking.&#xD;
  Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average, however the best way to interpret your results involves &quot;normalizing&quot; the scores to produce a percentile ranking.&#xD;
  It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Brain Injury, Vascular</condition>
    <condition>Hemorrhagic Stroke</condition>
    <condition>Ischemic Stroke</condition>
    <arm_group>
      <arm_group_label>telerehabilitation for post stroke patient</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>During the study, the patient will be asked to use the TeleRé programme on the devices on a regular, daily basis, either in a hospital room or at home. They will also be asked to evaluate the programme via various questionnaires and assessments.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>telerehabilitation</intervention_name>
      <description>During this study, the patient will be asked to use the &quot;TeleRé&quot; programme at least 5 times a week for 30 minutes for one month. Through the programme, they will have access to exercises in video format and thus self-rehabilitation as well as serious therapeutic games. The self-education games and videos target the functional and motor recovery of the upper limb. In addition, cognitive functions (attention, memory, etc.) will also be stimulated via the programme. Therapeutic education modules and PROMS assessments will also be available.</description>
      <arm_group_label>telerehabilitation for post stroke patient</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Present with an acute, subacute or chronic ischemic or hemorrhagic stroke,&#xD;
  &#xD;
            -  Be at least 18 years old,&#xD;
  &#xD;
            -  To be hospitalised in the neurorehabilitation unit.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Other neurological or musculoskeletal disease limiting their functional capacities,&#xD;
  &#xD;
            -  Pain in the upper limb making it impossible to mobilise.&#xD;
  &#xD;
            -  Inadaptability of the device to the patient's physiological position, especially in&#xD;
               cases of contracture or severe spasticity.&#xD;
  &#xD;
            -  Severe cognitive disorders preventing the understanding of instructions.&#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>Thierry Lejeune, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cliniques universitaires Saint-Luc</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Thierry Lejeune, MD, PhD</last_name>
      <phone>+3227641648</phone>
      <email>thierry.lejeune@saintluc.uclouvain.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mathilde Van Durme</last_name>
      <phone>+3227641675</phone>
      <email>mathilde.vandurme@saintluc.uclouvain.be</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Clinique Universitaires Saint-Luc</name>
        <address>
          <city>Brussel</city>
          <state>Woluwé-Saint-Lambert</state>
          <zip>1200</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Thierry Lejeune, MD, PhD</last_name>
        <phone>+3227641648</phone>
        <email>thierry.lejeune@saintluc.uclouvain.be</email>
      </contact>
      <contact_backup>
        <last_name>Mathilde Van Durme</last_name>
        <phone>+3227641675</phone>
        <email>mathilde.vandurme@saintluc.uclouvain.be</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
      <mesh_term>Brain Injuries</mesh_term>
      <mesh_term>Ischemic Stroke</mesh_term>
      <mesh_term>Hemorrhagic Stroke</mesh_term>
      <mesh_term>Cerebrovascular Trauma</mesh_term>
      <mesh_term>Vascular System Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016374
  org study id: 2022 474
  nct id: NCT06016374
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this research project is to develop a tele-rehabilitation programme, which will
        constitute an original care pathway for brain damaged patients. It will aim to improve their
        impairments, activities and social participation. The programme will deliver a therapeutic
        education and self-education programme targeting the upper and lower limbs, and will assess
        the patients by means of a diary and self-evaluation questionnaires.
  According to WHO (1997), telemedicine is defined as "the part of medicine that uses the
        transmission of medical information (images, reports, recordings, etc.) by telecommunication,
        with a view to obtaining at a distance a diagnosis, a specialised opinioń, continuous
        monitoring of a patient, a therapeutic decision". More specifically, tele-rehabilitation is
        defined as "a set of interventions carried out at a distance and using communication
        technologies and information services, with the aim of improving the health or well-being of
        the persons involved". In other words, tele-rehabilitation is a form of health care practice
        that uses information and communication technologies to exchange information between
        rehabilitation providers and patients.
  
        Tele-rehabilitation programmes typically include self-rehabilitation. Self-rehabilitation
        consists of a personalised therapeutic programme during which the patient performs
        rehabilitation exercises independently. The patient is supervised by a clinician (e.g.
        physiotherapist or occupational therapist) throughout the programme. Initially to explain the
        programme and teach the patient how to use the technology. Then, to coach them regularly.
        Tele-rehabilitation programmes can be delivered in hospitals, rehabilitation centres or at
        home.
  
        Stroke affects 19,000 people per year in Belgium and is the leading cause of acquired
        disability in adults in industrialised countries. After a stroke, patients recover some of
        their functional abilities through spontaneous recovery. Rehabilitation improves this
        functional recovery, in terms of impairments, but especially in terms of activities and
        social participation, according to the International Classification of Functioning,
        Disability and Health. This rehabilitation must be intense, early and interdisciplinary, to
        promote cerebral neuroplasticity. However, more than half of these patients retain sequelae
        in terms of locomotion or function of the paretic upper limb.
  
        Current literature indicates that functional rehabilitation after stroke can be further
        optimised. On the one hand, current recommendations show that rehabilitation should be
        intensive and task-oriented to promote brain neuroplasticity and motor relearning. Currently,
        the intensity of treatment is generally insufficient in both the acute and chronic phases and
        may vary depending on the management setting. In Belgium, patients typically receive 2 hours
        of rehabilitation per working day in the acute and subacute phasë, and 30 minutes in the
        chronic phase. These patients are therefore globally not active enough.
  
        On the other hand, complementary treatments to classical rehabilitation have shown their
        effectiveness in recent years. Thus, several scientific publications have shown that
        tele-rehabilitation, which mainly includes remotely supervised self-rehabilitation
        programmes, is effective in improving impairments and activities in people who have had a
        stroke, either as a complement or a substitute for conventional rehabilitation. In 2018,
        Tchéro et al. showed that tele-rehabilitation was comparable in effectiveness to conventional
        treatments. A recent Cochrane review also showed that tele-rehabilitation was as effective as
        standard care, with a low to moderate level of evidence, on independence in daily activities,
        balance or quality of life. In addition to being able to intensify treatment,
        tele-rehabilitation is inexpensive and can also facilitate access to care for patients who do
        not have a physiotherapy practice or rehabilitation centre in their immediate vicinity.
  
        A structured telemedicine programme for stroke rehabilitation should include different
        elements.
  
          -  Therapeutic education: Texts or videos that allow the patient and his or her relatives
             to better understand the condition and to know what they can do to improve it, for
             example, in terms of lifestyle, secondary prevention or rehabilitation.
  
          -  Self-education exercise programmes: physical exercises adapted to the patient's health
             problem are presented in the form of commented videos.
  
          -  Assessment: patients' functional abilities are assessed using PROMS-type questionnaires.
  
          -  A space for instant communication between the patient and the rehabilitation team.
  
        This programme should be configured, personalised and regularly updated for each patient by a
        health professional.
  
        Telemedicine has recently been developed in Belgium in the context of the COVID19 crisis. It
        has made it possible to ensure the continuity of rehabilitation care. Different technical
        solutions are available to implement telemedicine. They must comply with different
        regulations to ensure the security and confidentiality of health data.
  
        A new tele-rehabilitation programme for post-stroke patients could meet the clinical needs to
        intensify treatment and improve accessibility to health care. Over the past few months, our
        team has been developing a tele-rehabilitation programme for stroke patients. This programme,
        called TeleRe, is a novel care pathway for stroke patients. It will aim to improve their
        impairments, activities and social participation, and ultimately their quality of life.
  
        After a stroke, neurorehabilitation varies from one patient to another, and over time for the
        same patient. The rehabilitation plan is established for each patient, with his or her
        agreement, at the beginning of his or her treatment and then regularly updated. Typically,
        the personalised treatment plan includes physiotherapy, occupational therapy, speech therapy
        and neuropsychology. Our TeleRé programme would be in addition to these standard treatments.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: usability
  time frame: The test will be administered only once at the end of the intervention. So, 4 weeks after the start of the experiment, during the last session.
  description: At the end of the trial, subjects will complete the System Usability Scale (SUS), a ten-item questionnaire evaluated on a Likert scale. This questionnaire is used to assess the usability of the TéléRé program.
  The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking.
  Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average, however the best way to interpret your results involves "normalizing" the scores to produce a percentile ranking.
  It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.
  arm group label: telerehabilitation for post stroke patient
  arm group type: Experimental
  description: During the study, the patient will be asked to use the TeleRé programme on the devices on a regular, daily basis, either in a hospital room or at home. They will also be asked to evaluate the programme via various questionnaires and assessments.
  intervention type: Other
  intervention name: telerehabilitation
  description: During this study, the patient will be asked to use the "TeleRé" programme at least 5 times a week for 30 minutes for one month. Through the programme, they will have access to exercises in video format and thus self-rehabilitation as well as serious therapeutic games. The self-education games and videos target the functional and motor recovery of the upper limb. In addition, cognitive functions (attention, memory, etc.) will also be stimulated via the programme. Therapeutic education modules and PROMS assessments will also be available.
  arm group label: telerehabilitation for post stroke patient
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Thierry Lejeune, MD, PhD
  role: Principal Investigator
  affiliation: Cliniques universitaires Saint-Luc
  last name: Thierry Lejeune, MD, PhD
  phone: +3227641648
  email: thierry.lejeune@saintluc.uclouvain.be
  last name: Mathilde Van Durme
  phone: +3227641675
  email: mathilde.vandurme@saintluc.uclouvain.be
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Belgium
  responsible party type: Sponsor
  mesh term: Stroke
  mesh term: Brain Injuries
  mesh term: Ischemic Stroke
  mesh term: Hemorrhagic Stroke
  mesh term: Cerebrovascular Trauma
  mesh term: Vascular System Injuries
  sharing ipd: No