<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/NCT04430504</url>
  </required_header>
  <id_info>
    <org_study_id>EMoK</org_study_id>
    <nct_id>NCT04430504</nct_id>
  </id_info>
  <brief_title>Goal Attainment Evaluation of Multidisciplinary Telerehabilitation After Traumatic Brain Injury</brief_title>
  <official_title>Goal Attainment Evaluation of Multidisciplinary Telerehabilitation After Traumatic Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vetrea Terveys Oy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vetrea Terveys Oy</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 purpose of the study is to evaluate the outcome of a multidiscplinary telerehabilitation&#xD;
      after traumatic brain injury assessed by the patient and the therapists with respect to the&#xD;
      overall feasibility of the therapy protocol and the effects on psychological well-being and&#xD;
      quality of life..&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients from 18 to 60 years of age recovering after traumatic brain injury are recruited to&#xD;
      participate in a multidisciplinary telerehabilitation containing total of 20 video meetings&#xD;
      over a period of 4-5 months. The study design consists of a 3-day visit in rehabilitation&#xD;
      ward for the pre-treatment clinical assessments and education on the telerehabilitation&#xD;
      protocol. A self-exercise program is supervised and monitored using a health platform&#xD;
      application on a tablet computer through weekly video meetings. A digital diary recordings&#xD;
      enable the therapists to track on the progress of therapies. The primary goal is to achieve&#xD;
      the individual goals set in the Goal Attainment Scaling. The secondary goals are related to&#xD;
      the improvement of psychological well-being (BDI) and quality of life (WHOQOL-Bref).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 16, 2020</start_date>
  <completion_date type="Anticipated">February 2022</completion_date>
  <primary_completion_date type="Anticipated">November 2021</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>
    <intervention_model_description>Case series of eligible patients</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Goal Attainment Scaling</measure>
    <time_frame>20 weeks</time_frame>
    <description>Outcome scaling: -2 (worse expected outcome), -1 (less than expected outcome), 0 (expected outcome), +1 (more than expected outcome), +2 (best expected outcome)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory</measure>
    <time_frame>20 weeks</time_frame>
    <description>21-question inventory to yield a total score 0-63: 0-13 (no depression), 14-19 (mild depression), 20-28 (moderate depression), 29-63 (severe depression)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WHOQOL-Bref</measure>
    <time_frame>20 weeks</time_frame>
    <description>26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items). Each domain scoring 0-100 (0 = worst, 100= best possible) to compare with age-related mean values.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Telerehabilitation (TR)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multidisciplinary, weekly video meetings, self-exercises at home, digital diary recordings, follow-up assessments</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>multidisciplinary telerehabilitation</intervention_name>
    <description>weekly video meetings to instruct and monitor self-exercises at home</description>
    <arm_group_label>Telerehabilitation (TR)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  sequelae of traumatic brain injury&#xD;
&#xD;
          -  capable of doing self exercises at home and participating in video meetings&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  moderate or severe aphasia&#xD;
&#xD;
          -  poor recovery potential for return to school or working life based on clinical&#xD;
             assessment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kauko Pitkänen, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>VetreaNeuron</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kauko Pitkänen, MD, PhD</last_name>
    <phone>0505965289</phone>
    <phone_ext>358</phone_ext>
    <email>kauko.pitkanen@vetrea.fi</email>
  </overall_contact>
  <location>
    <facility>
      <name>VetreaNeuron</name>
      <address>
        <city>Kuopio</city>
        <state>North Savo</state>
        <zip>70820</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kauko Pitkänen</last_name>
      <phone>0505965289</phone>
      <email>kauko.pitkanen@vetrea.fi</email>
    </contact>
    <investigator>
      <last_name>Leena Korhonen, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>November 16, 2020</last_update_submitted>
  <last_update_submitted_qc>November 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Telerehabilitation</keyword>
  <keyword>Case series</keyword>
  <keyword>Traumatic brain injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Wounds and 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>


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/NCT04430504
org study id: EMoK
nct id: NCT04430504
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to evaluate the outcome of a multidiscplinary telerehabilitation
      after traumatic brain injury assessed by the patient and the therapists with respect to the
      overall feasibility of the therapy protocol and the effects on psychological well-being and
      quality of life..
Patients from 18 to 60 years of age recovering after traumatic brain injury are recruited to
      participate in a multidisciplinary telerehabilitation containing total of 20 video meetings
      over a period of 4-5 months. The study design consists of a 3-day visit in rehabilitation
      ward for the pre-treatment clinical assessments and education on the telerehabilitation
      protocol. A self-exercise program is supervised and monitored using a health platform
      application on a tablet computer through weekly video meetings. A digital diary recordings
      enable the therapists to track on the progress of therapies. The primary goal is to achieve
      the individual goals set in the Goal Attainment Scaling. The secondary goals are related to
      the improvement of psychological well-being (BDI) and quality of life (WHOQOL-Bref).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Case series of eligible patients
primary purpose: Treatment
masking: None (Open Label)
measure: Goal Attainment Scaling
time frame: 20 weeks
description: Outcome scaling: -2 (worse expected outcome), -1 (less than expected outcome), 0 (expected outcome), +1 (more than expected outcome), +2 (best expected outcome)
measure: Beck Depression Inventory
time frame: 20 weeks
description: 21-question inventory to yield a total score 0-63: 0-13 (no depression), 14-19 (mild depression), 20-28 (moderate depression), 29-63 (severe depression)
measure: WHOQOL-Bref
time frame: 20 weeks
description: 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items). Each domain scoring 0-100 (0 = worst, 100= best possible) to compare with age-related mean values.
arm group label: Telerehabilitation (TR)
arm group type: Experimental
description: Multidisciplinary, weekly video meetings, self-exercises at home, digital diary recordings, follow-up assessments
intervention type: Behavioral
intervention name: multidisciplinary telerehabilitation
description: weekly video meetings to instruct and monitor self-exercises at home
arm group label: Telerehabilitation (TR)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Kauko Pitkänen, MD, PhD
role: Study Director
affiliation: VetreaNeuron
last name: Kauko Pitkänen, MD, PhD
phone: 0505965289
phone ext: 358
email: kauko.pitkanen@vetrea.fi
facility: 
status: Recruiting
contact: 
investigator: 
country: Finland
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries
sharing ipd: No