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/NCT05984095</url>
    </required_header>
    <id_info>
      <org_study_id>Fisioterapia1907</org_study_id>
      <nct_id>NCT05984095</nct_id>
    </id_info>
    <brief_title>Multiple Sclerosis Pelvic Floor Telerehabilitation</brief_title>
    <official_title>Pelvic Floor Rehabilitation in Females With Multiple Sclerosis: Comparison of Two Telerehabilitation Protocols</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Trieste</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Trieste</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 clinical trial is to compare the effects of two different pelvic floor&#xD;
        telerehabilitation protocols on selected measures of quality of life and health in females&#xD;
        with relapsing-remitting Multiple Sclerosis (rrMS). The main questions it aims to answer are:&#xD;
  &#xD;
          -  Is telerehabilitation sufficient to improve quality of life and health in females with&#xD;
             rrMS, in particular dedicated to pelvic floor training?&#xD;
  &#xD;
          -  Are self-administered training protocols or remotely-supervised training protocols&#xD;
             equally effective?&#xD;
  &#xD;
        Participants will be randomized to two intervention groups: a self-administered training&#xD;
        protocol (SELF) and a remotely-supervised (REMOTE) training protocol. Both protocols will&#xD;
        consist in 10 sessions of pelvic floor training lasting 45 min each, once every 5 days.&#xD;
  &#xD;
        At the start and at the end of the protocol, all participants will complete 6 questionnaires&#xD;
        regarding pain, quality of life and health.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, the authors aim to evaluate the efficacy of two telerehabilitation protocols&#xD;
        dedicated to pelvic floor and urogynecological health in females with relapsing-remitting&#xD;
        Multiple Sclerosis (rrMS).&#xD;
  &#xD;
        In particular, the included participants will be randomized to:&#xD;
  &#xD;
          -  SELF protocol: 10 sessions of pelvic floor exercises, self-administered with a set of&#xD;
             videos where a physiotherapist showed the different exercises in order to complete a 45&#xD;
             minutes session.&#xD;
  &#xD;
          -  REMOTE protocol: 10 sessions of pelvic floor exercises, remotely conducted and&#xD;
             supervised by a physiotherapist with a one-to-one videocall, showing and monitoring the&#xD;
             exercises in order to complete a 45 minutes session.&#xD;
  &#xD;
        One week before the first session and one week after the last session, all the participants&#xD;
        will be asked to complete a set of surveys and questionnaires to investigate participants'&#xD;
        pain perception, reported quality of life and health-related parameters.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 15, 2023</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 (Outcomes Assessor)</masking>
      <masking_description>The investigator in charge of reviewing the questionnaires and calculating the scores was not informed about the group of the participant.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Pain perception</measure>
      <time_frame>At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)</time_frame>
      <description>Quantification of the perceived pain with a numeric rating scale (NRS, score 0-10 where 10 means unbearable plain), and a body chart</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Depression symptoms</measure>
      <time_frame>At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)</time_frame>
      <description>Evaluation of depression symptoms with the Beck Depression Inventory Scale (BDI, 0-63, higher the score worse the depression)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Perceived quality of life</measure>
      <time_frame>At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)</time_frame>
      <description>Evaluation of the perceived quality of life with the Short Form Health Survey 36 (SF-36, 0-100 for each domain, higher the score better the quality of life)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sexual health</measure>
      <time_frame>At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)</time_frame>
      <description>Evaluation of the perceived sexual health with the female sexual function index (FSFI, 1-5 for each item, greater score indicating greater levels of sexual functioning)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Urinary incontinence symptoms</measure>
      <time_frame>At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)</time_frame>
      <description>Evaluation of urinary incontinence symptoms with the International Consultation on Incontinence Questionnaire (ICIQ, 0-21, higher the score worse the symptoms)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">28</enrollment>
    <condition>Multiple Sclerosis</condition>
    <arm_group>
      <arm_group_label>SELF</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>All the participants in the SELF group were asked to participate in 10 sessions of 45 minutes of pelvic floor training and exercises, once every 5 days. The exercises were available in pre-recorded videos and the participants were allowed to access it when and where they preferred, respecting the requested frequency. No supervision was provided during the trainings.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>REMOTE</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All the participants in the REMOTE group were asked to participate in 10 sessions of 45 minutes of pelvic floor training and exercises, once every 5 days. The exercises were shown and monitored remotely during a one-to-one videocall with a physiotherapist.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Telerehabilitation</intervention_name>
      <description>The intervention was administered in a telerehabilitation fashion through a videocall on the phone or tablet, by a physiotherapist, in a one-to-one session.</description>
      <arm_group_label>REMOTE</arm_group_label>
      <arm_group_label>SELF</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  diagnosis of relapsing remitting Multiple Sclerosis confirmed by a neurologist and&#xD;
               based on the McDonald criteria from not less than 1 y&#xD;
  &#xD;
            -  EDSS &lt;4.5&#xD;
  &#xD;
            -  self reported symptoms of urinary incontinency&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  females in menopause&#xD;
  &#xD;
            -  previous history of bladder or urogynaecological surgery&#xD;
  &#xD;
            -  previous history of major abdominal surgery&#xD;
  &#xD;
            -  females with a delivery &lt; 6 months from the start of the study&#xD;
  &#xD;
            -  BMI &gt; 30&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Paolo Manganotti, MD PhD</last_name>
      <role>Study Chair</role>
      <affiliation>University of Trieste</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Manuela Deodato, PT PhD</last_name>
      <phone>040/3996584</phone>
      <email>mdeodato@units.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>CdL in Fisioterapia</name>
        <address>
          <city>Trieste</city>
          <zip>34100</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Manuela Deodato, PT PhD</last_name>
        <phone>040/3996584</phone>
        <email>mdeodato@units.it</email>
      </contact>
      <investigator>
        <last_name>Manuela Deodato, PT PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Paolo Manganotti, MD PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Arianna Sartori, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Mia Fornasaro, PT student</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Trieste</investigator_affiliation>
      <investigator_full_name>Alex Buoite Stella</investigator_full_name>
      <investigator_title>Research fellow</investigator_title>
    </responsible_party>
    <keyword>Multiple Sclerosis</keyword>
    <keyword>Pelvic Floor</keyword>
    <keyword>Telerehabilitation</keyword>
    <keyword>Exercise</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>
  
  
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/NCT05984095
  org study id: Fisioterapia1907
  nct id: NCT05984095
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare the effects of two different pelvic floor
        telerehabilitation protocols on selected measures of quality of life and health in females
        with relapsing-remitting Multiple Sclerosis (rrMS). The main questions it aims to answer are:
  
          -  Is telerehabilitation sufficient to improve quality of life and health in females with
             rrMS, in particular dedicated to pelvic floor training?
  
          -  Are self-administered training protocols or remotely-supervised training protocols
             equally effective?
  
        Participants will be randomized to two intervention groups: a self-administered training
        protocol (SELF) and a remotely-supervised (REMOTE) training protocol. Both protocols will
        consist in 10 sessions of pelvic floor training lasting 45 min each, once every 5 days.
  
        At the start and at the end of the protocol, all participants will complete 6 questionnaires
        regarding pain, quality of life and health.
  In this study, the authors aim to evaluate the efficacy of two telerehabilitation protocols
        dedicated to pelvic floor and urogynecological health in females with relapsing-remitting
        Multiple Sclerosis (rrMS).
  
        In particular, the included participants will be randomized to:
  
          -  SELF protocol: 10 sessions of pelvic floor exercises, self-administered with a set of
             videos where a physiotherapist showed the different exercises in order to complete a 45
             minutes session.
  
          -  REMOTE protocol: 10 sessions of pelvic floor exercises, remotely conducted and
             supervised by a physiotherapist with a one-to-one videocall, showing and monitoring the
             exercises in order to complete a 45 minutes session.
  
        One week before the first session and one week after the last session, all the participants
        will be asked to complete a set of surveys and questionnaires to investigate participants'
        pain perception, reported quality of life and health-related parameters.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: The investigator in charge of reviewing the questionnaires and calculating the scores was not informed about the group of the participant.
  measure: Pain perception
  time frame: At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
  description: Quantification of the perceived pain with a numeric rating scale (NRS, score 0-10 where 10 means unbearable plain), and a body chart
  measure: Depression symptoms
  time frame: At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
  description: Evaluation of depression symptoms with the Beck Depression Inventory Scale (BDI, 0-63, higher the score worse the depression)
  measure: Perceived quality of life
  time frame: At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
  description: Evaluation of the perceived quality of life with the Short Form Health Survey 36 (SF-36, 0-100 for each domain, higher the score better the quality of life)
  measure: Sexual health
  time frame: At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
  description: Evaluation of the perceived sexual health with the female sexual function index (FSFI, 1-5 for each item, greater score indicating greater levels of sexual functioning)
  measure: Urinary incontinence symptoms
  time frame: At baseline (1 week prior the first telerehabilitation session) and after the protocol (1 week after the last telerehabilitation session)
  description: Evaluation of urinary incontinence symptoms with the International Consultation on Incontinence Questionnaire (ICIQ, 0-21, higher the score worse the symptoms)
  arm group label: SELF
  arm group type: Active Comparator
  description: All the participants in the SELF group were asked to participate in 10 sessions of 45 minutes of pelvic floor training and exercises, once every 5 days. The exercises were available in pre-recorded videos and the participants were allowed to access it when and where they preferred, respecting the requested frequency. No supervision was provided during the trainings.
  arm group label: REMOTE
  arm group type: Experimental
  description: All the participants in the REMOTE group were asked to participate in 10 sessions of 45 minutes of pelvic floor training and exercises, once every 5 days. The exercises were shown and monitored remotely during a one-to-one videocall with a physiotherapist.
  intervention type: Other
  intervention name: Telerehabilitation
  description: The intervention was administered in a telerehabilitation fashion through a videocall on the phone or tablet, by a physiotherapist, in a one-to-one session.
  arm group label: REMOTE
  arm group label: SELF
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Paolo Manganotti, MD PhD
  role: Study Chair
  affiliation: University of Trieste
  last name: Manuela Deodato, PT PhD
  phone: 040/3996584
  email: mdeodato@units.it
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: University of Trieste
  investigator full name: Alex Buoite Stella
  investigator title: Research fellow
  mesh term: Multiple Sclerosis
  mesh term: Sclerosis
  sharing ipd: No