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/NCT06000345</url>
    </required_header>
    <id_info>
      <org_study_id>CLF22/07</org_study_id>
      <nct_id>NCT06000345</nct_id>
    </id_info>
    <brief_title>Effect of Action Observation and Motor Imagery on Arthrogenic Muscle Inhibition of the Quadriceps in Patients With End-stage Knee Gonarthrosis.</brief_title>
    <official_title>Effect of Action Observation and Motor Imagery on Arthrogenic Muscle Inhibition of the Quadriceps in Patients With End-stage Knee Gonarthrosis.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istituto Clinico Humanitas</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istituto Clinico Humanitas</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 study aims at evaluating the effects of one session of Action Observation Training (AOT)&#xD;
        and Motor Imagery (MI) on arthrogenic muscle inhibition (AMI) of the quadriceps (QF) in&#xD;
        subjects with end-stage gonarthrosis.&#xD;
  &#xD;
        30 patients with end-stage knee osteoarthritis were enrolled. Patients were randomized in two&#xD;
        groups (experimental group and control group).&#xD;
  &#xD;
        Experimental group performed one 6-minutes AOT and MI session with motor content of&#xD;
        concentric and isometric QF contractions, whereas control group underwent a 6-minute sham AOT&#xD;
        and MI session. Every patient was evaluated to assess the percentage of AMI on the QF before&#xD;
        (T0) and after (T1) the treatment following the gold standard Twitch Interpolated Technique.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study aims at evaluating the effects of one session of Action Observation Training (AOT)&#xD;
        and Motor Imagery (MI) on arthrogenic muscle inhibition (AMI) of the quadriceps (QF) in&#xD;
        subjects with end-stage gonarthrosis.&#xD;
  &#xD;
        30 patients with end-stage knee osteoarthritis were enrolled. Patients were randomized in two&#xD;
        groups (experimental group and control group).&#xD;
  &#xD;
        Experimental group performed one AOT and MI session with motor content of concentric and&#xD;
        isometric QF contractions, whereas control group underwent a 6-minute sham AOT and MI&#xD;
        session. Every patient was evaluated to assess the percentage of AMI on the QF before (T0)&#xD;
        and after (T1) the assigned treatment following the gold standard Twitch Interpolated&#xD;
        Technique. Both groups sat on an isometric dynamometric chair (COR1, OT-Bioelettronica,&#xD;
        Torino) with a load cell (FORZA, OT-Bioelettronica, Torino) designed to detect and map the&#xD;
        strenght generated by the QF muscle. Upper body movements were limited by crossover shoulder&#xD;
        harnesses, a belt across the abdomen and the subjects were asked to keep their arms crossed&#xD;
        holding onto the harness while performing the evaluation.&#xD;
  &#xD;
        Three large electrodes (10x13cm) were positioned over the quadriceps muscle belly. Two sEMG&#xD;
        electrodes (FREEEMG, BTS, Italy) were positioned on the Vastus Medialis and Vastus Lateralis&#xD;
        using the SENIAM protocol.&#xD;
  &#xD;
        Right after the first evaluation (T0), both groups performed an AOT session. The experimental&#xD;
        group was shown a video (4 minutes) in which a subject (matched for age, sex, and limb&#xD;
        affected) performed, in third person view, quadriceps concentric contractions for 2 minutes&#xD;
        and isometric contractions for 2 minutes. The video contained visual elements indicating the&#xD;
        maximality of the effort. After both concentric movement video and isometric movement video&#xD;
        the subjects performed a MI session (2 sessions, 1 minute in length each), in which they were&#xD;
        asked to imagine in first person the action just seen in the video.&#xD;
  &#xD;
        On the other hand, the control group was shown a video of landscapes (4 minutes in length).&#xD;
        Halfway through and at the end of the video they were asked to imagine what they had just&#xD;
        seen for 1 minute. After the session of AOT and MI (T1) both groups were re-evaluated in the&#xD;
        same way as previously described.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 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>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in arthrogenic muscle inhibition (estimated through Interpolated Twitch Technique)</measure>
      <time_frame>1- Before AOT+MI session; 2- Immediately after AOT+MI session</time_frame>
      <description>Changes in arthrogenic muscle inhibition (AMI) of the quadriceps muscle before and after AOT and MI session on patients with advanced stage gonarthrosis.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Knee Osteoarthritis</condition>
    <condition>Arthrogenic Muscle Inhibitions</condition>
    <arm_group>
      <arm_group_label>AOT + MI group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The AOT + MI group was shown a video (4 minutes) in which a subject (matched for age, sex, and limb affected) performed, in third person view, quadriceps concentric contractions for 2 minutes and isometric contractions for 2 minutes. The video contained visual elements indicating the maximality of the effort. After both concentric and isometric movement video the subjects performed a MI session (1 minute in length each), in which they were asked to imagine in first person the action previously observed in the video.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>The control group was shown a video of landscapes (4 minutes in length). Halfway through and at the end of the video they were asked to imagine what they had just seen for 1 minute.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>AOT + MI</intervention_name>
      <description>During the AOT session, the patients were shown a video containing motor contents. In particular, the video demonstrated quadriceps concentric and isometric contractions, presented in the third person perspective. At the conclusion of each video, the patients were asked to spend 1 minute imagining what they had just seen.</description>
      <arm_group_label>AOT + MI group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control AOT + MI</intervention_name>
      <description>The control group was shown a video of landscapes (4 minutes in length). Halfway through and at the end of the video they were asked to imagine what they had just seen for 1 minute.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with end-stage knee ostheoarthritis undergoing primary total knee&#xD;
               arthroplasty&#xD;
  &#xD;
            -  Active knee flexion &gt; 45°&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous lower limb orthopedic surgery&#xD;
  &#xD;
            -  Concomitant neurological, orthopedic, cardiovascular disorders&#xD;
  &#xD;
            -  Cognitive impairments or psychiatric disorders&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Roberto Gatti</last_name>
      <phone>0282245610</phone>
      <email>roberto.gatti@hunimed.eu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Istituto Clinico Humanitas</name>
        <address>
          <city>Rozzano</city>
          <zip>20089</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>roberto gatti</last_name>
        <phone>0282245610</phone>
        <email>roberto.gatti@hunimed.eu</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</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/NCT06000345
  org study id: CLF22/07
  nct id: NCT06000345
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study aims at evaluating the effects of one session of Action Observation Training (AOT)
        and Motor Imagery (MI) on arthrogenic muscle inhibition (AMI) of the quadriceps (QF) in
        subjects with end-stage gonarthrosis.
  
        30 patients with end-stage knee osteoarthritis were enrolled. Patients were randomized in two
        groups (experimental group and control group).
  
        Experimental group performed one 6-minutes AOT and MI session with motor content of
        concentric and isometric QF contractions, whereas control group underwent a 6-minute sham AOT
        and MI session. Every patient was evaluated to assess the percentage of AMI on the QF before
        (T0) and after (T1) the treatment following the gold standard Twitch Interpolated Technique.
  The study aims at evaluating the effects of one session of Action Observation Training (AOT)
        and Motor Imagery (MI) on arthrogenic muscle inhibition (AMI) of the quadriceps (QF) in
        subjects with end-stage gonarthrosis.
  
        30 patients with end-stage knee osteoarthritis were enrolled. Patients were randomized in two
        groups (experimental group and control group).
  
        Experimental group performed one AOT and MI session with motor content of concentric and
        isometric QF contractions, whereas control group underwent a 6-minute sham AOT and MI
        session. Every patient was evaluated to assess the percentage of AMI on the QF before (T0)
        and after (T1) the assigned treatment following the gold standard Twitch Interpolated
        Technique. Both groups sat on an isometric dynamometric chair (COR1, OT-Bioelettronica,
        Torino) with a load cell (FORZA, OT-Bioelettronica, Torino) designed to detect and map the
        strenght generated by the QF muscle. Upper body movements were limited by crossover shoulder
        harnesses, a belt across the abdomen and the subjects were asked to keep their arms crossed
        holding onto the harness while performing the evaluation.
  
        Three large electrodes (10x13cm) were positioned over the quadriceps muscle belly. Two sEMG
        electrodes (FREEEMG, BTS, Italy) were positioned on the Vastus Medialis and Vastus Lateralis
        using the SENIAM protocol.
  
        Right after the first evaluation (T0), both groups performed an AOT session. The experimental
        group was shown a video (4 minutes) in which a subject (matched for age, sex, and limb
        affected) performed, in third person view, quadriceps concentric contractions for 2 minutes
        and isometric contractions for 2 minutes. The video contained visual elements indicating the
        maximality of the effort. After both concentric movement video and isometric movement video
        the subjects performed a MI session (2 sessions, 1 minute in length each), in which they were
        asked to imagine in first person the action just seen in the video.
  
        On the other hand, the control group was shown a video of landscapes (4 minutes in length).
        Halfway through and at the end of the video they were asked to imagine what they had just
        seen for 1 minute. After the session of AOT and MI (T1) both groups were re-evaluated in the
        same way as previously described.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: Changes in arthrogenic muscle inhibition (estimated through Interpolated Twitch Technique)
  time frame: 1- Before AOT+MI session; 2- Immediately after AOT+MI session
  description: Changes in arthrogenic muscle inhibition (AMI) of the quadriceps muscle before and after AOT and MI session on patients with advanced stage gonarthrosis.
  arm group label: AOT + MI group
  arm group type: Experimental
  description: The AOT + MI group was shown a video (4 minutes) in which a subject (matched for age, sex, and limb affected) performed, in third person view, quadriceps concentric contractions for 2 minutes and isometric contractions for 2 minutes. The video contained visual elements indicating the maximality of the effort. After both concentric and isometric movement video the subjects performed a MI session (1 minute in length each), in which they were asked to imagine in first person the action previously observed in the video.
  arm group label: Control group
  arm group type: Sham Comparator
  description: The control group was shown a video of landscapes (4 minutes in length). Halfway through and at the end of the video they were asked to imagine what they had just seen for 1 minute.
  intervention type: Other
  intervention name: AOT + MI
  description: During the AOT session, the patients were shown a video containing motor contents. In particular, the video demonstrated quadriceps concentric and isometric contractions, presented in the third person perspective. At the conclusion of each video, the patients were asked to spend 1 minute imagining what they had just seen.
  arm group label: AOT + MI group
  intervention type: Other
  intervention name: Control AOT + MI
  description: The control group was shown a video of landscapes (4 minutes in length). Halfway through and at the end of the video they were asked to imagine what they had just seen for 1 minute.
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Roberto Gatti
  phone: 0282245610
  email: roberto.gatti@hunimed.eu
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  sharing ipd: No