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/NCT06001424</url>
    </required_header>
    <id_info>
      <org_study_id>P.T.REC/012/001987</org_study_id>
      <nct_id>NCT06001424</nct_id>
    </id_info>
    <brief_title>Effect of Life Kinetik Training on Lower Limb Coordination in Ataxic Patients</brief_title>
    <official_title>Effect of Life Kinetik Training on Lower Limb Coordination in Ataxic Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo 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>
        Coordination is essential for the performance of most daily motor activities. Coordination&#xD;
        problems are common in MS patients. One of the most commonly reported symptoms is dysmetria&#xD;
        (limb ataxia). Ataxia is thought to occur in about 80% of MS patients. It leads to&#xD;
        limitations in daily life activities. Aim of Study: to investigate the effect of life kinetik&#xD;
        training on lower limb coordination in MS patients with ataxia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Methods: Thirty remitting relapsing Multiple Sclerosis (RRMS) patients from both sexes with&#xD;
        ataxic symptoms, will be recruited from multiple sclerosis specialized clinic in the&#xD;
        Neurology department, Faculty of Medicine, Cairo University with EDSS score will be ranged&#xD;
        from 2 to 4 and SARA score will be ranged from 1 to 10. Lower Extremity Motor Coordination&#xD;
        Test (LEMOCOT) will be used to assess lower limb motor coordination. They will be randomly&#xD;
        assigned into two equal groups; control group (GI) will receive selected physical therapy&#xD;
        program and study group (GII) will receive same program of (GI) in addition to life kinetik&#xD;
        training.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 24, 2018</start_date>
    <completion_date type="Actual">May 29, 2021</completion_date>
    <primary_completion_date type="Actual">April 30, 2021</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>
      <intervention_model_description>randomized controlled trail</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Lower Extremity Motor Coordination Test (LEMOCOT)</measure>
      <time_frame>at baseline</time_frame>
      <description>test to assess lower limb coordination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lower Extremity Motor Coordination Test (LEMOCOT)</measure>
      <time_frame>post intervention (after one month)</time_frame>
      <description>test to assess lower limb coordination</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Four Square Step Test (FSST)</measure>
      <time_frame>at baseline</time_frame>
      <description>test to assess dynamic balance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Four Square Step Test (FSST)</measure>
      <time_frame>post intervention (after one month)</time_frame>
      <description>test to assess dynamic balance</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Multiple Sclerosis</condition>
    <condition>Ataxia</condition>
    <arm_group>
      <arm_group_label>study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>will receive physical therapy program of in addition to life kinetik training.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>will receive physical therapy program</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>physical therapy</intervention_name>
      <description>Frenkel's exercises for lower limb, Proprioceptive neuromuscular facilitation for upper limb in the form of rhythmic stabilization</description>
      <arm_group_label>control</arm_group_label>
      <arm_group_label>study group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>life kinetic exercises</intervention_name>
      <description>A multimodal training that combines coordinative, cognitive and visual tasks.</description>
      <arm_group_label>study group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  MS from both sexes&#xD;
  &#xD;
            -  Patients' age will be ranged from 20 to 45 years&#xD;
  &#xD;
            -  Expanded disability scale (EDSS) score ranging from &quot;two&quot; to &quot;four&quot;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with Ataxia caused by other cause rather than MS&#xD;
  &#xD;
            -  Patients with other neurological disease or orthopedic deformities may affect movement&#xD;
  &#xD;
            -  Patients with cardiovascular and pulmonary diseases that make exercise unsafe&#xD;
  &#xD;
            -  Patients with cognitive impairment or psychiatric disorders&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Moshera H Darwish, Prf. Dr</last_name>
      <role>Study Director</role>
      <affiliation>Professor of Physical therapy for Neurology</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Faculty of Physical Therapy</name>
        <address>
          <city>Giza</city>
          <zip>11432</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Edwards EM, Fritz NE, Therrien AS. Cerebellar Dysfunction in Multiple Sclerosis: Considerations for Research and Rehabilitation Therapy. Neurorehabil Neural Repair. 2022 Feb;36(2):103-106. doi: 10.1177/15459683211065442. Epub 2021 Dec 21.</citation>
      <PMID>34931569</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>January 17, 2021</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>heba ahmed khalifa</investigator_full_name>
      <investigator_title>Ass. Prof. Dr. of Physical therapy for Neurology</investigator_title>
    </responsible_party>
    <keyword>Multiple Sclerosis</keyword>
    <keyword>ataxia</keyword>
    <keyword>coordination</keyword>
    <keyword>life kinetic exercises</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Sclerosis</mesh_term>
      <mesh_term>Ataxia</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/NCT06001424
  org study id: P.T.REC/012/001987
  nct id: NCT06001424
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Coordination is essential for the performance of most daily motor activities. Coordination
        problems are common in MS patients. One of the most commonly reported symptoms is dysmetria
        (limb ataxia). Ataxia is thought to occur in about 80% of MS patients. It leads to
        limitations in daily life activities. Aim of Study: to investigate the effect of life kinetik
        training on lower limb coordination in MS patients with ataxia.
  Methods: Thirty remitting relapsing Multiple Sclerosis (RRMS) patients from both sexes with
        ataxic symptoms, will be recruited from multiple sclerosis specialized clinic in the
        Neurology department, Faculty of Medicine, Cairo University with EDSS score will be ranged
        from 2 to 4 and SARA score will be ranged from 1 to 10. Lower Extremity Motor Coordination
        Test (LEMOCOT) will be used to assess lower limb motor coordination. They will be randomly
        assigned into two equal groups; control group (GI) will receive selected physical therapy
        program and study group (GII) will receive same program of (GI) in addition to life kinetik
        training.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: randomized controlled trail
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Lower Extremity Motor Coordination Test (LEMOCOT)
  time frame: at baseline
  description: test to assess lower limb coordination
  measure: Lower Extremity Motor Coordination Test (LEMOCOT)
  time frame: post intervention (after one month)
  description: test to assess lower limb coordination
  measure: Four Square Step Test (FSST)
  time frame: at baseline
  description: test to assess dynamic balance
  measure: Four Square Step Test (FSST)
  time frame: post intervention (after one month)
  description: test to assess dynamic balance
  arm group label: study group
  arm group type: Experimental
  description: will receive physical therapy program of in addition to life kinetik training.
  arm group label: control
  arm group type: Active Comparator
  description: will receive physical therapy program
  intervention type: Other
  intervention name: physical therapy
  description: Frenkel's exercises for lower limb, Proprioceptive neuromuscular facilitation for upper limb in the form of rhythmic stabilization
  arm group label: control
  arm group label: study group
  intervention type: Other
  intervention name: life kinetic exercises
  description: A multimodal training that combines coordinative, cognitive and visual tasks.
  arm group label: study group
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 45 Years
  healthy volunteers: No
  last name: Moshera H Darwish, Prf. Dr
  role: Study Director
  affiliation: Professor of Physical therapy for Neurology
  facility: 
  country: Egypt
  citation: Edwards EM, Fritz NE, Therrien AS. Cerebellar Dysfunction in Multiple Sclerosis: Considerations for Research and Rehabilitation Therapy. Neurorehabil Neural Repair. 2022 Feb;36(2):103-106. doi: 10.1177/15459683211065442. Epub 2021 Dec 21.
  PMID: 34931569
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: heba ahmed khalifa
  investigator title: Ass. Prof. Dr. of Physical therapy for Neurology
  mesh term: Multiple Sclerosis
  mesh term: Ataxia
  mesh term: Sclerosis
  sharing ipd: No