<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/NCT04413682</url>
  </required_header>
  <id_info>
    <org_study_id>MS-TeleRehab2019</org_study_id>
    <nct_id>NCT04413682</nct_id>
  </id_info>
  <brief_title>Telerehabilitation vs Supervised Exercises in MS</brief_title>
  <official_title>Effectiveness of Structured Exercise Program on Quality of Life and Activities of Daily Living in Persons With Multiple Sclerosis: Telerehabilitation vs Supervised Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Istanbul University - Cerrahpasa (IUC)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medipol University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istanbul University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multiple sclerosis (MS) is a complex neurodegenerative autoimmune disease. People with MS&#xD;
      (PwMS) have low quality of life (QoL) and activities of daily living (ADL). Exercise is a&#xD;
      safe and effective rehabilitation tool for PwMS. A structured and personalized exercise&#xD;
      program can improve physical fitness, functional capacity, quality of life and modifiable&#xD;
      disorders in PwMS. On the other hand, Telerehabilitation is an alternative rehabilitation&#xD;
      method in PwMS. The purpose of this study is to investigate the effectiveness of exercise&#xD;
      programs and telerehabilitation on ADL and QoL in PwMS, and compare the effects of supervised&#xD;
      exercise and home-based exercise programs for the PwMS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants are randomly assigned to the structured supervised exercise or structured&#xD;
      home-based groups. Interventions in Group 1 (n=15) includes one session per day, 3 days a&#xD;
      week over a 12-weeks structured exercise program under the supervision of a physical&#xD;
      therapist. Group 2 (n=15) includes a 12-week structured home-based exercise program checked&#xD;
      and controlled through telerehabilitation three times a week. All measurements pre-post&#xD;
      intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">May 30, 2020</completion_date>
  <primary_completion_date type="Actual">February 10, 2020</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants will randomly assign to the structured supervised exercise or structured home-based groups. Randomization are done using Microsoft Excel 'RAND()' function.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Functional Independence Measure (FIM)</measure>
    <time_frame>Changes after 12 weeks</time_frame>
    <description>FIM is a tool used for evaluation of primary ADL of people with disability. FIM items include self care, sphincter control, transfers, locomotion, communication, and social cognition subgroups. Grading is based on 7 points. 7: complete independence, 6: modified independence, 5, 4 and 3: modified dependence, 2 and 1: complete dependence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nottingham Health Profile, First section (NHP-I)</measure>
    <time_frame>Changes after 12 weeks</time_frame>
    <description>NHP is a tool used for measuring and definition of QoL regarding the health status in general. NHP-I contains 38 yes/no statements, focusing on different aspects of the general health problems, including six dimensions of subjective health defined as physical abilities, pain, sleep, energy, emotional reaction, energy level and social isolation. Questions are evaluated according to the patients' yes/no responses and are scored between 0 and 100. High scores indicate high level health status in the specified item. Total scores are summed in all fields.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life scale (QoLS)</measure>
    <time_frame>Changes after 12 weeks</time_frame>
    <description>QoLS is a standardized interview consisting of 41 questions clustered in four subscales: functional and economic scale, social and recreational scale, affect and life in general scale, and medical problems scale. Each question in the scale is evaluated over 5 points. (1 is negative at all times and 5 is the best response).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Supervised Exercise Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One session per day, 3 days per week over a 12-weeks structured exercise program under supervision of a physical therapist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telerehabilitation Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One session per day, 3 days per week over a 12-weeks structured exercise program through Telerehabilitation</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Structured Supervised Exercise</intervention_name>
    <description>Structured Exercise Program under the supervision of Physical Therapist</description>
    <arm_group_label>Supervised Exercise Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Structured telerehabilitation</intervention_name>
    <description>Structured Exercise Program checked and controlled through telerehabilitation</description>
    <arm_group_label>Telerehabilitation Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        patients with:&#xD;
&#xD;
          1. Stable period at the time of application to the clinic&#xD;
&#xD;
          2. Expanded Disability Status Scale Levels between 2 - 6.5&#xD;
&#xD;
          3. Appropriate cognitive level to understand the exercises&#xD;
&#xD;
          4. No diseases to affect their participation in exercise programs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        patients with:&#xD;
&#xD;
          1. Poorly controlled diabetes, hypertension or other medical conditions to be&#xD;
             incompatible with study participation,&#xD;
&#xD;
          2. A new history of previous attacks&#xD;
&#xD;
          3. No reliable informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ela Tarakci, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>etarakci@istanbul.edu.tr</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul University-Cerrahpaşa</name>
      <address>
        <city>Istanbul</city>
        <zip>34815</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 30, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 30, 2020</last_update_submitted>
  <last_update_submitted_qc>May 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University - Cerrahpasa (IUC)</investigator_affiliation>
    <investigator_full_name>Ela Tarakci</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Multiple Sclerosis</keyword>
  <keyword>Telerehabilitation</keyword>
  <keyword>Supervised exercises</keyword>
  <keyword>Structured exercise</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Activities of Daily Living</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</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/NCT04413682
org study id: MS-TeleRehab2019
nct id: NCT04413682
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Multiple sclerosis (MS) is a complex neurodegenerative autoimmune disease. People with MS
      (PwMS) have low quality of life (QoL) and activities of daily living (ADL). Exercise is a
      safe and effective rehabilitation tool for PwMS. A structured and personalized exercise
      program can improve physical fitness, functional capacity, quality of life and modifiable
      disorders in PwMS. On the other hand, Telerehabilitation is an alternative rehabilitation
      method in PwMS. The purpose of this study is to investigate the effectiveness of exercise
      programs and telerehabilitation on ADL and QoL in PwMS, and compare the effects of supervised
      exercise and home-based exercise programs for the PwMS.
Participants are randomly assigned to the structured supervised exercise or structured
      home-based groups. Interventions in Group 1 (n=15) includes one session per day, 3 days a
      week over a 12-weeks structured exercise program under the supervision of a physical
      therapist. Group 2 (n=15) includes a 12-week structured home-based exercise program checked
      and controlled through telerehabilitation three times a week. All measurements pre-post
      intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: Participants will randomly assign to the structured supervised exercise or structured home-based groups. Randomization are done using Microsoft Excel 'RAND()' function.
measure: Functional Independence Measure (FIM)
time frame: Changes after 12 weeks
description: FIM is a tool used for evaluation of primary ADL of people with disability. FIM items include self care, sphincter control, transfers, locomotion, communication, and social cognition subgroups. Grading is based on 7 points. 7: complete independence, 6: modified independence, 5, 4 and 3: modified dependence, 2 and 1: complete dependence.
measure: Nottingham Health Profile, First section (NHP-I)
time frame: Changes after 12 weeks
description: NHP is a tool used for measuring and definition of QoL regarding the health status in general. NHP-I contains 38 yes/no statements, focusing on different aspects of the general health problems, including six dimensions of subjective health defined as physical abilities, pain, sleep, energy, emotional reaction, energy level and social isolation. Questions are evaluated according to the patients' yes/no responses and are scored between 0 and 100. High scores indicate high level health status in the specified item. Total scores are summed in all fields.
measure: Quality of life scale (QoLS)
time frame: Changes after 12 weeks
description: QoLS is a standardized interview consisting of 41 questions clustered in four subscales: functional and economic scale, social and recreational scale, affect and life in general scale, and medical problems scale. Each question in the scale is evaluated over 5 points. (1 is negative at all times and 5 is the best response).
arm group label: Supervised Exercise Group
arm group type: Experimental
description: One session per day, 3 days per week over a 12-weeks structured exercise program under supervision of a physical therapist.
arm group label: Telerehabilitation Group
arm group type: Experimental
description: One session per day, 3 days per week over a 12-weeks structured exercise program through Telerehabilitation
intervention type: Behavioral
intervention name: Structured Supervised Exercise
description: Structured Exercise Program under the supervision of Physical Therapist
arm group label: Supervised Exercise Group
intervention type: Behavioral
intervention name: Structured telerehabilitation
description: Structured Exercise Program checked and controlled through telerehabilitation
arm group label: Telerehabilitation Group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Ela Tarakci, Professor
role: Principal Investigator
affiliation: etarakci@istanbul.edu.tr
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul University - Cerrahpasa (IUC)
investigator full name: Ela Tarakci
investigator title: Professor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: No