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/NCT05973279</url>
    </required_header>
    <id_info>
      <org_study_id>KarabukUNI</org_study_id>
      <nct_id>NCT05973279</nct_id>
    </id_info>
    <brief_title>The Relationship Between Lower Limb Functionality, Knee Joint Position Sense, Balance and Falls in Haemiplegic Patients</brief_title>
    <official_title>The Relationship Between Lower Limb Functionality, Knee Joint Position Sense, Balance and Falls in Haemiplegic Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Karabuk University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Bolu Izzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Karabuk 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>
        Stroke is defined as a neurological disorder attributed to acute focal damage of the central&#xD;
        nervous system from a vascular cause, including cerebral infarction, intracerebral&#xD;
        haemorrhage and subarachnoid haemorrhage. The World Health Organisation defines stroke as a&#xD;
        focal and sometimes global impairment of cerebral function that lasts longer than 24 hours or&#xD;
        ends in death, develops rapidly, has no demonstrable cause other than a vascular cause.&#xD;
        Evaluation of muscle strength and balance ability of affected patients is critical for the&#xD;
        recovery of lower extremity motor functions.&#xD;
  &#xD;
        Proprioception encompasses various sensory perception modalities such as force, effort,&#xD;
        movement and limb position. Impairment of sensory function in patients with haemiplegia can&#xD;
        hinder the ability of muscles to recover during walking. Accurate and effective assessment of&#xD;
        gait and balance functions and their subsequent improvement is one of the primary goals of&#xD;
        stroke rehabilitation programmes. Studies comparing the effects of lower extremity&#xD;
        functionality and knee joint position sense on balance and falls are available in various&#xD;
        versions in the literature. However, there is no study in which 'Restorative Therapies RT300&#xD;
        leg/arm/cor' device was used to measure functionality, 'Humac Norm Isokinetic Machine' was&#xD;
        used to measure knee joint position sense, and 'Tecno Body Prokin Isokinetic Balance System'&#xD;
        was used to measure balance in a single simultaneous study. Therefore, the aim of this study&#xD;
        was to investigate the relationship between lower limb functionality and knee joint position&#xD;
        sense with balance and fall parameters in patients with hemiplegia using various devices.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>Balance and knee joint position</measure>
      <time_frame>First day</time_frame>
      <description>Knee joint position sense is related to balance in haemiplegic patients.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lower extremity functionality and balance</measure>
      <time_frame>First day</time_frame>
      <description>In haemiplegic patients, the level of lower extremity functionality is related to balance.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Falling and knee joint position</measure>
      <time_frame>First day</time_frame>
      <description>Knee joint position sense is associated with falls in haemiplegic patients.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lower extremity functionality and falling</measure>
      <time_frame>First day</time_frame>
      <description>Lower extremity functionality is associated with falls in haemiplegic patients.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Haemiplegic Patients</condition>
    <condition>Balance</condition>
    <condition>Knee Joint Position Sensation</condition>
    <condition>Lower Limb Functionality</condition>
    <arm_group>
      <arm_group_label>Hemiplegic patients</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Tecno Body Prokin Isokinetic Balance System</intervention_name>
      <description>It provides objectively measurable data in static and dynamic balance measurements. The moving balance platform of the system, which is driven by air piston servo motors, can measure at a working angle of 15 degrees in all directions. The results can be monitored and recorded live on the screen on the device. From these data, each individual's static and dynamic balance score is obtained by summing the forward-backward standard deviation and right-left standard deviation.</description>
      <arm_group_label>Hemiplegic patients</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Restorative Therapies RT300 leg/arm/cor:</intervention_name>
      <description>RT300 is a motorised treatment system. In general there are 3 systems; Passive therapy, Active therapy and a combination of active therapy with some assistance from the motor. The device can be used from a chair, wheelchair or bed and there are two variants that can be used separately; Leg system, Arm system. Electrodes placed on the skin over specific muscle groups are connected via a cable or wirelessly to the RT300. These are used to stimulate peripheral motor nerves, causing the muscles to work. The software of the SAGE controller unit of the RT300 monitors the treatment process, including the stimulation patterns sent to the arms or legs, and the operation of the ergometer motor to produce smooth cycling motion. Contraindicated in the presence of lower limb fractures or pregnancy.</description>
      <arm_group_label>Hemiplegic patients</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>CSMI (CYBEX) Humac Norm Isokinetic Test and Exercise System</intervention_name>
      <description>22 isolated joint movement models, 4 resistance modes (isokinetic, isotonic, isometric and passive) and a large number of reports to meet the measurement and exercise needs of today's clinicians and researchers. The exercise modes of the device include; Continuous passive movement, multi-angle isometry, proprioception training, standard and eccentric focused isokinetic strengthening, deceleration training, dynamic isotonic training, strength training. Test modes of the device include; Proprioceptive, co-measured, standard isokinetic, concentric/eccentric isokinetic, intermittent stroke isokinetic test.</description>
      <arm_group_label>Hemiplegic patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Hemiplegic patients&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Individuals over 18 years of age&#xD;
  &#xD;
            -  Volunteering to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Hip and knee prosthesis&#xD;
  &#xD;
            -  Being diagnosed with vertigo&#xD;
  &#xD;
            -  Having a history of serious neurological diseases such as Parkinson's disease,&#xD;
               multiple sclerosis except hemiplegia&#xD;
  &#xD;
            -  Having a previous operation for the lower limb&#xD;
  &#xD;
            -  Poor co-operation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Adnan Demirel</last_name>
      <role>Study Director</role>
      <affiliation>Izzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fatma Hale Altınkaya</last_name>
      <phone>05312013899</phone>
      <email>f.hale.altinkaya@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tarık Ozmen</last_name>
      <phone>05063028740</phone>
      <email>tarikozmen@karabuk.edu.tr</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Karabuk University</investigator_affiliation>
      <investigator_full_name>Fatma Hale Altınkaya</investigator_full_name>
      <investigator_title>INVESTIGATOR</investigator_title>
    </responsible_party>
    <keyword>Proprioception</keyword>
    <keyword>Joint Position Sense</keyword>
    <keyword>Hemiplegia</keyword>
    <keyword>Lower Limb Functionality</keyword>
    <keyword>Balance</keyword>
    <keyword>Fall</keyword>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05973279
  org study id: KarabukUNI
  nct id: NCT05973279
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Stroke is defined as a neurological disorder attributed to acute focal damage of the central
        nervous system from a vascular cause, including cerebral infarction, intracerebral
        haemorrhage and subarachnoid haemorrhage. The World Health Organisation defines stroke as a
        focal and sometimes global impairment of cerebral function that lasts longer than 24 hours or
        ends in death, develops rapidly, has no demonstrable cause other than a vascular cause.
        Evaluation of muscle strength and balance ability of affected patients is critical for the
        recovery of lower extremity motor functions.
  
        Proprioception encompasses various sensory perception modalities such as force, effort,
        movement and limb position. Impairment of sensory function in patients with haemiplegia can
        hinder the ability of muscles to recover during walking. Accurate and effective assessment of
        gait and balance functions and their subsequent improvement is one of the primary goals of
        stroke rehabilitation programmes. Studies comparing the effects of lower extremity
        functionality and knee joint position sense on balance and falls are available in various
        versions in the literature. However, there is no study in which 'Restorative Therapies RT300
        leg/arm/cor' device was used to measure functionality, 'Humac Norm Isokinetic Machine' was
        used to measure knee joint position sense, and 'Tecno Body Prokin Isokinetic Balance System'
        was used to measure balance in a single simultaneous study. Therefore, the aim of this study
        was to investigate the relationship between lower limb functionality and knee joint position
        sense with balance and fall parameters in patients with hemiplegia using various devices.
  observational model: Other
  time perspective: Other
  measure: Balance and knee joint position
  time frame: First day
  description: Knee joint position sense is related to balance in haemiplegic patients.
  measure: Lower extremity functionality and balance
  time frame: First day
  description: In haemiplegic patients, the level of lower extremity functionality is related to balance.
  measure: Falling and knee joint position
  time frame: First day
  description: Knee joint position sense is associated with falls in haemiplegic patients.
  measure: Lower extremity functionality and falling
  time frame: First day
  description: Lower extremity functionality is associated with falls in haemiplegic patients.
  arm group label: Hemiplegic patients
  intervention type: Other
  intervention name: Tecno Body Prokin Isokinetic Balance System
  description: It provides objectively measurable data in static and dynamic balance measurements. The moving balance platform of the system, which is driven by air piston servo motors, can measure at a working angle of 15 degrees in all directions. The results can be monitored and recorded live on the screen on the device. From these data, each individual's static and dynamic balance score is obtained by summing the forward-backward standard deviation and right-left standard deviation.
  arm group label: Hemiplegic patients
  intervention type: Other
  intervention name: Restorative Therapies RT300 leg/arm/cor:
  description: RT300 is a motorised treatment system. In general there are 3 systems; Passive therapy, Active therapy and a combination of active therapy with some assistance from the motor. The device can be used from a chair, wheelchair or bed and there are two variants that can be used separately; Leg system, Arm system. Electrodes placed on the skin over specific muscle groups are connected via a cable or wirelessly to the RT300. These are used to stimulate peripheral motor nerves, causing the muscles to work. The software of the SAGE controller unit of the RT300 monitors the treatment process, including the stimulation patterns sent to the arms or legs, and the operation of the ergometer motor to produce smooth cycling motion. Contraindicated in the presence of lower limb fractures or pregnancy.
  arm group label: Hemiplegic patients
  intervention type: Other
  intervention name: CSMI (CYBEX) Humac Norm Isokinetic Test and Exercise System
  description: 22 isolated joint movement models, 4 resistance modes (isokinetic, isotonic, isometric and passive) and a large number of reports to meet the measurement and exercise needs of today's clinicians and researchers. The exercise modes of the device include; Continuous passive movement, multi-angle isometry, proprioception training, standard and eccentric focused isokinetic strengthening, deceleration training, dynamic isotonic training, strength training. Test modes of the device include; Proprioceptive, co-measured, standard isokinetic, concentric/eccentric isokinetic, intermittent stroke isokinetic test.
  arm group label: Hemiplegic patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Adnan Demirel
  role: Study Director
  affiliation: Izzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
  last name: Fatma Hale Altınkaya
  phone: 05312013899
  email: f.hale.altinkaya@gmail.com
  last name: Tarık Ozmen
  phone: 05063028740
  email: tarikozmen@karabuk.edu.tr
  responsible party type: Principal Investigator
  investigator affiliation: Karabuk University
  investigator full name: Fatma Hale Altınkaya
  investigator title: INVESTIGATOR
  sharing ipd: Undecided