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/NCT06010849</url>
    </required_header>
    <id_info>
      <org_study_id>ipkkrmc</org_study_id>
      <nct_id>NCT06010849</nct_id>
    </id_info>
    <brief_title>Trunk Control and Extremity Functions in Stroke</brief_title>
    <official_title>The Relationship of Trunk Control With Balance, Upper Extremity and Lower Extremity Functions in Stroke Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kahramanmaras Sutcu Imam University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kahramanmaras Sutcu Imam University</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 trunk is the key point of the body. Proximal trunk control is essential for distal&#xD;
        extremity movements, balance and functional activities. The aim of the study is to examine&#xD;
        the relationship of trunk control with balance, upper extremity and lower extremity functions&#xD;
        in stroke patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Stroke is the third leading cause of death in developed countries after heart disease and&#xD;
        cancer. In adults, it ranks first among neurological diseases in terms of causing death and&#xD;
        disability (1).&#xD;
  &#xD;
        About one-third of stroke patients experience permanent physical dysfunction. This situation&#xD;
        has a negative impact on the economic, social, psychological life and general quality of life&#xD;
        of the patient and his family (2). Stroke is one of the leading causes of long-term&#xD;
        disability in adults due to problems such as activity limitations and participation&#xD;
        restrictions caused by disorders in body functions (3). At this point, rehabilitation in&#xD;
        stroke patients has an important place in ensuring the social participation of the patient&#xD;
        and minimizing the disorders.&#xD;
  &#xD;
        When the literature is examined, it is stated that the best functional results are revealed&#xD;
        by a good postural control. Because the trunk is the key point of the body. Proximal trunk&#xD;
        control is essential for distal extremity movements, balance and functional activities. It&#xD;
        provides trunk control, static and dynamic posture, upright posture of the body, and&#xD;
        selective trunk movements (4).&#xD;
  &#xD;
        There are many treatment approaches to increase trunk stabilization. Gaining early trunk&#xD;
        control is one of the basic principles of Bobath, which adopts the neurodevelopmental&#xD;
        behavior model from neurophysiological approaches.&#xD;
  &#xD;
        In recent years, core stabilization exercises, which play an active role in trunk&#xD;
        stabilization, have started to be included in the rehabilitation program of stroke patients.&#xD;
        Haruyama et al. demonstrated the effectiveness of core stabilization exercises on trunk&#xD;
        control, standing, and mobility. This study also indicated the importance of trunk&#xD;
        stabilization in balance and mobility (5).&#xD;
  &#xD;
        Trunk control means more than just sitting balance. Organization of postural and correction&#xD;
        reactions, stability required for the creation of extremity movements, rotation, appropriate&#xD;
        gait pattern, proximal stabilization to contribute to distal movement, establishment of the&#xD;
        connection between shoulder and pelvis are provided by good trunk control. The trunk, which&#xD;
        makes up 60% of our body mass, is necessary for controlling the force created in our body and&#xD;
        for optimum movement in the extremities. The holistic system that includes the lower&#xD;
        extremities, pelvis, trunk and upper extremities is called the kinetic chain. The creation,&#xD;
        collection and transfer of the force required for extremity movements from the lower&#xD;
        extremity to the upper extremity are made possible by this system. Thus, these segments,&#xD;
        which are independent from each other from proximal to distal, work in a certain interaction&#xD;
        and harmony during functional activities (6).&#xD;
  &#xD;
        The aim of the study is to examine the effect of trunk control on balance, upper extremity&#xD;
        and lower extremity functions in stroke patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 1, 2021</start_date>
    <completion_date type="Actual">January 15, 2022</completion_date>
    <primary_completion_date type="Actual">December 30, 2021</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The Trunk Impairment Scale</measure>
      <time_frame>at baseline</time_frame>
      <description>The Trunk Impairment Scale (TIS) consists of 3 parts: 3 items as static sitting balance, 10 items as dynamic sitting balance, and 4 items as coordination. The maximum points received are 7, 10 and 6 points respectively. The total score of TIS is between 0 and 23. High scores indicate good trunk control (6). Turkish validity and reliability study of TIS was also conducted</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Berg Balance Scale (BBS)</measure>
      <time_frame>at baseline</time_frame>
      <description>BBS: It is the gold standard scale that clinically evaluates balance and postural control (Downs, Marquez, &amp; Chiarelli, 2013; Sahin et al., 2013). It is a 14-item scale that measures the ability to maintain balance while performing functional tasks. Each item is scored between 0 and 4. If the total score is 56 and above, the balance is considered good.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fugl meyer lower extremity test</measure>
      <time_frame>at baseline</time_frame>
      <description>FML: It includes subsections that evaluate hip, knee, ankle joint movements, coordination and reflex activities. The highest score that can be obtained from this assessment is 34.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fugl meyer upper extremity test</measure>
      <time_frame>at baseline</time_frame>
      <description>FMU: It includes subsections that evaluate joint movements, coordination and reflex activities related to shoulder, elbow, forearm, wrist and hand. The highest score that can be obtained from this assessment is 66.</description>
    </primary_outcome>
    <enrollment type="Actual">36</enrollment>
    <condition>Stroke</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Trunk control</intervention_name>
      <description>Trunk control</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Stroke patients&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Inclusion criteria; He was 55-85 years old, had an ischemic stroke at least 6 months ago,&#xD;
          was at stage 2 according to brunstroma, had a mini-mental test score above 22, could stand&#xD;
          independently for 3-4 seconds, and had no orthopedic problems.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>zekiye ipek katırcı kırmacı</last_name>
      <role>Principal Investigator</role>
      <affiliation>kahramanmaras sütçü imam university</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Kahramanmaraş Sütçü Imam University</name>
        <address>
          <city>Kahramanmaraş</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kahramanmaras Sutcu Imam University</investigator_affiliation>
      <investigator_full_name>Zekiye İpek KATIRCI KIRMACI</investigator_full_name>
      <investigator_title>ass. prof</investigator_title>
    </responsible_party>
    <keyword>Stroke</keyword>
    <keyword>Trunk Control</keyword>
    <keyword>Balance</keyword>
    <keyword>Function</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
    </condition_browse>
    <!-- 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/NCT06010849
  org study id: ipkkrmc
  nct id: NCT06010849
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The trunk is the key point of the body. Proximal trunk control is essential for distal
        extremity movements, balance and functional activities. The aim of the study is to examine
        the relationship of trunk control with balance, upper extremity and lower extremity functions
        in stroke patients.
  Stroke is the third leading cause of death in developed countries after heart disease and
        cancer. In adults, it ranks first among neurological diseases in terms of causing death and
        disability (1).
  
        About one-third of stroke patients experience permanent physical dysfunction. This situation
        has a negative impact on the economic, social, psychological life and general quality of life
        of the patient and his family (2). Stroke is one of the leading causes of long-term
        disability in adults due to problems such as activity limitations and participation
        restrictions caused by disorders in body functions (3). At this point, rehabilitation in
        stroke patients has an important place in ensuring the social participation of the patient
        and minimizing the disorders.
  
        When the literature is examined, it is stated that the best functional results are revealed
        by a good postural control. Because the trunk is the key point of the body. Proximal trunk
        control is essential for distal extremity movements, balance and functional activities. It
        provides trunk control, static and dynamic posture, upright posture of the body, and
        selective trunk movements (4).
  
        There are many treatment approaches to increase trunk stabilization. Gaining early trunk
        control is one of the basic principles of Bobath, which adopts the neurodevelopmental
        behavior model from neurophysiological approaches.
  
        In recent years, core stabilization exercises, which play an active role in trunk
        stabilization, have started to be included in the rehabilitation program of stroke patients.
        Haruyama et al. demonstrated the effectiveness of core stabilization exercises on trunk
        control, standing, and mobility. This study also indicated the importance of trunk
        stabilization in balance and mobility (5).
  
        Trunk control means more than just sitting balance. Organization of postural and correction
        reactions, stability required for the creation of extremity movements, rotation, appropriate
        gait pattern, proximal stabilization to contribute to distal movement, establishment of the
        connection between shoulder and pelvis are provided by good trunk control. The trunk, which
        makes up 60% of our body mass, is necessary for controlling the force created in our body and
        for optimum movement in the extremities. The holistic system that includes the lower
        extremities, pelvis, trunk and upper extremities is called the kinetic chain. The creation,
        collection and transfer of the force required for extremity movements from the lower
        extremity to the upper extremity are made possible by this system. Thus, these segments,
        which are independent from each other from proximal to distal, work in a certain interaction
        and harmony during functional activities (6).
  
        The aim of the study is to examine the effect of trunk control on balance, upper extremity
        and lower extremity functions in stroke patients.
  observational model: Other
  time perspective: Prospective
  measure: The Trunk Impairment Scale
  time frame: at baseline
  description: The Trunk Impairment Scale (TIS) consists of 3 parts: 3 items as static sitting balance, 10 items as dynamic sitting balance, and 4 items as coordination. The maximum points received are 7, 10 and 6 points respectively. The total score of TIS is between 0 and 23. High scores indicate good trunk control (6). Turkish validity and reliability study of TIS was also conducted
  measure: Berg Balance Scale (BBS)
  time frame: at baseline
  description: BBS: It is the gold standard scale that clinically evaluates balance and postural control (Downs, Marquez, & Chiarelli, 2013; Sahin et al., 2013). It is a 14-item scale that measures the ability to maintain balance while performing functional tasks. Each item is scored between 0 and 4. If the total score is 56 and above, the balance is considered good.
  measure: Fugl meyer lower extremity test
  time frame: at baseline
  description: FML: It includes subsections that evaluate hip, knee, ankle joint movements, coordination and reflex activities. The highest score that can be obtained from this assessment is 34.
  measure: Fugl meyer upper extremity test
  time frame: at baseline
  description: FMU: It includes subsections that evaluate joint movements, coordination and reflex activities related to shoulder, elbow, forearm, wrist and hand. The highest score that can be obtained from this assessment is 66.
  intervention type: Diagnostic Test
  intervention name: Trunk control
  description: Trunk control
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: 85 Years
  last name: zekiye ipek katırcı kırmacı
  role: Principal Investigator
  affiliation: kahramanmaras sütçü imam university
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Kahramanmaras Sutcu Imam University
  investigator full name: Zekiye İpek KATIRCI KIRMACI
  investigator title: ass. prof
  mesh term: Stroke