<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/NCT04427670</url>
  </required_header>
  <id_info>
    <org_study_id>201/2020</org_study_id>
    <nct_id>NCT04427670</nct_id>
  </id_info>
  <brief_title>Implementation &amp; Feasibility Study of Patients With Dysarthria Following Stroke &amp; Their Carers in Pakistan</brief_title>
  <official_title>Implementation and Feasibility Study of Group Intervention for Patients With Dysarthria Following Stroke and Their Carers in Pakistan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Isra University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Isra University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Dysarthria is a common problem in Pakistan. therefore the current study aims to translate the&#xD;
      dysarthria communication tools into urdu language for better understanding the population and&#xD;
      the problem&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dysarthria is the inefficiency or restricted capability to form intelligible speech because&#xD;
      of the inability of motor control on the speech structures. There are many therapeutic&#xD;
      approaches in Pakistan that are in use for the patients with dysarthria following stroke. One&#xD;
      of them is one to one intervention which may include one dysarthria client along with the&#xD;
      speech therapist. The therapist delivers step by step instructions to the client. The&#xD;
      essential assessments are being held to initiate the treatment. The application of this&#xD;
      intervention approach leaves some drawbacks, such as, the patients find it difficult to&#xD;
      relate and adapt to the treatment offered. Generalization also seems to be complicated. The&#xD;
      patients express a lack in motivation and support. The other mode of approach is group&#xD;
      intervention, in which multiple dysarthria clients along with their caregivers &amp; speech&#xD;
      therapist are included. In the later one, there are greater chances of recovery for patients&#xD;
      as they get peer support and build confidence through newfound friends, peer communication&#xD;
      with realistic social setting, learning through teaching, increased awareness of skills and&#xD;
      it is time constraints. The culture of practicing group sessions with dysarthria patients is&#xD;
      lacked in Pakistan, which intends to meet and compensate for all the drawbacks and lacks of&#xD;
      one on one intervention. By including the Dysarthria patients, therapist and the caregivers&#xD;
      in the group intervention, there're greater chances of reduced anxiety for both patients &amp;&#xD;
      caregivers regarding disorder &amp; its recovery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 12, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 15, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>RCT with intervention having experimental group. random Allocation of participants.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>efficacy of group intervention for Patients With Dysarthria will be assessed by the translated version of Roberston Dysarthria Profile.</measure>
    <time_frame>6 months</time_frame>
    <description>Roberston Dysarthria Profile take responses on 5 point likert scale where 1 for worst and 5 for better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>efficacy of group intervention for Patients With Dysarthria will be assessed by translated version of Communication Effectivness Measure</measure>
    <time_frame>6 months</time_frame>
    <description>Communication Effectivness Measure is seven point scale arranging from 1 to 7 where 1 for worst outcome and 7 for better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of group intervention for Patients With Dysarthria will be assessed by the translated version of Communicative Participation Item Bank.</measure>
    <time_frame>6 months</time_frame>
    <description>Communicative Participation Item Bank is four point scale arranging from 0 to 3 where 0 for better communication participation and 3 for worst communication participation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of group intervention for Patients With Dysarthria will be assessed by Gernal Health Questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>Gernal Health Questionnaire is four point scale in which responses 1 means better and 4 for worst condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of group intervention for Patients With Dysarthria will be assessed by Speech Intelligiblity Test</measure>
    <time_frame>6 months</time_frame>
    <description>Speech Intelligiblity Test is three point scale where 2 stands for correct utterances and 0 shows wrong production of sounds.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Dysarthria as Late Effect of Stroke</condition>
  <arm_group>
    <arm_group_label>Regular speech therapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Regular speech therapy will be provided to the controlled group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group intervention will be provided to the experimental group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group intervention</intervention_name>
    <description>Group intervention programme designed for stroke survivors with dysarthria and their carers. The programme was eight weeks long, with weekly two sessions, each session lasting for two hours, lead by speech language therapist and was comprised of activities which addressed participants education about their dysarthria and stroke. The role of family , peer and professional was to provide support and communication practice.</description>
    <arm_group_label>Group intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Regular speech therapy</intervention_name>
    <description>Regular speech therapy will be provided to the controlled group.Regular speech therapy is one to one speech therapy session,conducted twice a week for the duration of eight weeks.This intervention is implemented to patients with dysarthria following stroke in a format of one patient and one therapist per session.</description>
    <arm_group_label>Regular speech therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 40 to 70 years age ranges&#xD;
&#xD;
          2. History of dysarthria previous six monthes&#xD;
&#xD;
          3. Primary level of education&#xD;
&#xD;
          4. Functional hearing and visual ablities -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient with age below 40 to 70&#xD;
&#xD;
          2. Patients with diagnosis severe psychological illness&#xD;
&#xD;
          3. Patient with developmental dysarthria&#xD;
&#xD;
          4. Patient who come alone without any attendent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sheikh Zayed medical Complex</name>
      <address>
        <city>Lahore</city>
        <state>Punjab</state>
        <zip>54000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Muhammad Suhail, M.Phil</last_name>
      <phone>+924299237024</phone>
      <email>szmcirb1@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>March 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Isra University</investigator_affiliation>
    <investigator_full_name>Saima maratab</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Dysarthia</keyword>
  <keyword>Intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Dysarthria</mesh_term>
  </condition_browse>
  <!-- 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/NCT04427670
org study id: 201/2020
nct id: NCT04427670
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Dysarthria is a common problem in Pakistan. therefore the current study aims to translate the
      dysarthria communication tools into urdu language for better understanding the population and
      the problem
Dysarthria is the inefficiency or restricted capability to form intelligible speech because
      of the inability of motor control on the speech structures. There are many therapeutic
      approaches in Pakistan that are in use for the patients with dysarthria following stroke. One
      of them is one to one intervention which may include one dysarthria client along with the
      speech therapist. The therapist delivers step by step instructions to the client. The
      essential assessments are being held to initiate the treatment. The application of this
      intervention approach leaves some drawbacks, such as, the patients find it difficult to
      relate and adapt to the treatment offered. Generalization also seems to be complicated. The
      patients express a lack in motivation and support. The other mode of approach is group
      intervention, in which multiple dysarthria clients along with their caregivers & speech
      therapist are included. In the later one, there are greater chances of recovery for patients
      as they get peer support and build confidence through newfound friends, peer communication
      with realistic social setting, learning through teaching, increased awareness of skills and
      it is time constraints. The culture of practicing group sessions with dysarthria patients is
      lacked in Pakistan, which intends to meet and compensate for all the drawbacks and lacks of
      one on one intervention. By including the Dysarthria patients, therapist and the caregivers
      in the group intervention, there're greater chances of reduced anxiety for both patients &
      caregivers regarding disorder & its recovery.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: RCT with intervention having experimental group. random Allocation of participants.
primary purpose: Treatment
masking: Single (Participant)
measure: efficacy of group intervention for Patients With Dysarthria will be assessed by the translated version of Roberston Dysarthria Profile.
time frame: 6 months
description: Roberston Dysarthria Profile take responses on 5 point likert scale where 1 for worst and 5 for better outcome.
measure: efficacy of group intervention for Patients With Dysarthria will be assessed by translated version of Communication Effectivness Measure
time frame: 6 months
description: Communication Effectivness Measure is seven point scale arranging from 1 to 7 where 1 for worst outcome and 7 for better outcome.
measure: Efficacy of group intervention for Patients With Dysarthria will be assessed by the translated version of Communicative Participation Item Bank.
time frame: 6 months
description: Communicative Participation Item Bank is four point scale arranging from 0 to 3 where 0 for better communication participation and 3 for worst communication participation.
measure: Efficacy of group intervention for Patients With Dysarthria will be assessed by Gernal Health Questionnaire
time frame: 6 months
description: Gernal Health Questionnaire is four point scale in which responses 1 means better and 4 for worst condition
measure: Efficacy of group intervention for Patients With Dysarthria will be assessed by Speech Intelligiblity Test
time frame: 6 months
description: Speech Intelligiblity Test is three point scale where 2 stands for correct utterances and 0 shows wrong production of sounds.
arm group label: Regular speech therapy
arm group type: Other
description: Regular speech therapy will be provided to the controlled group.
arm group label: Group intervention
arm group type: Other
description: Group intervention will be provided to the experimental group.
intervention type: Other
intervention name: Group intervention
description: Group intervention programme designed for stroke survivors with dysarthria and their carers. The programme was eight weeks long, with weekly two sessions, each session lasting for two hours, lead by speech language therapist and was comprised of activities which addressed participants education about their dysarthria and stroke. The role of family , peer and professional was to provide support and communication practice.
arm group label: Group intervention
intervention type: Other
intervention name: Regular speech therapy
description: Regular speech therapy will be provided to the controlled group.Regular speech therapy is one to one speech therapy session,conducted twice a week for the duration of eight weeks.This intervention is implemented to patients with dysarthria following stroke in a format of one patient and one therapist per session.
arm group label: Regular speech therapy
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Isra University
investigator full name: Saima maratab
investigator title: principle investigator
mesh term: Stroke
mesh term: Dysarthria