<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/NCT03763955</url>
  </required_header>
  <id_info>
    <org_study_id>H_F_D_PD_MIRT</org_study_id>
    <nct_id>NCT03763955</nct_id>
  </id_info>
  <brief_title>Effectiveness of MIRT on Hand and Finger Dexterity in PD Patients</brief_title>
  <acronym>H_F_ D_PD_MIRT</acronym>
  <official_title>Effectiveness of MIRT on Hand and Finger Dexterity in PD Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ospedale Generale Di Zona Moriggia-Pelascini</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ospedale Generale Di Zona Moriggia-Pelascini</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>
      Aims of the study are (1) to evaluate the effectiveness of a specific OT treatment aimed to&#xD;
      enhance finger and hand dexterity and (2) its impact on daily living autonomy of PD patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Reduction in hand functionality and finger dexterity are significant, but often overlooked,&#xD;
      symptoms of Parkinson's Disease (PD). They are strictly correlated with loss of patient's&#xD;
      autonomy, due to their significant impact on Activities of Daily Living (ADL) and,&#xD;
      consequently in patient's Quality of life (QoL). No studies investigated the effectiveness of&#xD;
      a specific and functional-based Occupational Therapy (OT) treatment in improving hand&#xD;
      functionality and finger dexterity in PD patients.&#xD;
&#xD;
      Aims of tthe study are to evaluate the effectiveness of a specific OT treatment aimed to&#xD;
      enhance finger and hand dexterity and its impact on daily living autonomy of PD patients.&#xD;
&#xD;
      Retrospectively, 482 PD patients, hospitalized for a 4-week Multidisciplinary Intensive&#xD;
      Rehabilitation Treatment (MIRT) between January 2015 and January 2018 were identified. All&#xD;
      patients underwent 1h/day OT treatment. The outcome measure was the O'Connor finger dexterity&#xD;
      test; secondary outcome measures were Minnesota dexterity test, UPDRS II and SPDDS scale.&#xD;
      These measures were assessed at admission (T0) and discharge (T1).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">August 1, 2018</completion_date>
  <primary_completion_date type="Actual">August 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>O'Connor Finger Dexterity Test</measure>
    <time_frame>4 weeks</time_frame>
    <description>peg-placement test aimed to evaluate the ability to manipulate small objects</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Minnesota Manual Dexterity Test</measure>
    <time_frame>4 weeks</time_frame>
    <description>test aimed to evaluate the reach-to-grasp movements, gros manual dexterity and left vs right manual impairment</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">482</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Dexterity</condition>
  <condition>Rehabilitation</condition>
  <arm_group>
    <arm_group_label>PD patients</arm_group_label>
    <description>PD patients at 1-5 H&amp;Y stage undergoes 4week Multidisciplinary Intensive Rehabilitation Treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MIRT</intervention_name>
    <description>4 week MIRT provide:&#xD;
front to front treatment (1 hour/day for 5 days/week)&#xD;
treatment with robotic devices (1 hour/day for 5 days/week)&#xD;
occupational therapy (1 hour/day for 5 days/week)</description>
    <arm_group_label>PD patients</arm_group_label>
    <other_name>Multidisciplinary Intensive Rehabilitation Treatment</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Parkinsonian inpatients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of Parkinson's Disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other neurological disease&#xD;
&#xD;
          -  psychosis&#xD;
&#xD;
          -  auditive or visual deficit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 2, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>December 2, 2018</last_update_submitted>
  <last_update_submitted_qc>December 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</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>Parkinson Disease</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/NCT03763955
org study id: H_F_D_PD_MIRT
nct id: NCT03763955
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aims of the study are (1) to evaluate the effectiveness of a specific OT treatment aimed to
      enhance finger and hand dexterity and (2) its impact on daily living autonomy of PD patients.
Reduction in hand functionality and finger dexterity are significant, but often overlooked,
      symptoms of Parkinson's Disease (PD). They are strictly correlated with loss of patient's
      autonomy, due to their significant impact on Activities of Daily Living (ADL) and,
      consequently in patient's Quality of life (QoL). No studies investigated the effectiveness of
      a specific and functional-based Occupational Therapy (OT) treatment in improving hand
      functionality and finger dexterity in PD patients.

      Aims of tthe study are to evaluate the effectiveness of a specific OT treatment aimed to
      enhance finger and hand dexterity and its impact on daily living autonomy of PD patients.

      Retrospectively, 482 PD patients, hospitalized for a 4-week Multidisciplinary Intensive
      Rehabilitation Treatment (MIRT) between January 2015 and January 2018 were identified. All
      patients underwent 1h/day OT treatment. The outcome measure was the O'Connor finger dexterity
      test; secondary outcome measures were Minnesota dexterity test, UPDRS II and SPDDS scale.
      These measures were assessed at admission (T0) and discharge (T1).
observational model: Cohort
time perspective: Other
measure: O'Connor Finger Dexterity Test
time frame: 4 weeks
description: peg-placement test aimed to evaluate the ability to manipulate small objects
measure: Minnesota Manual Dexterity Test
time frame: 4 weeks
description: test aimed to evaluate the reach-to-grasp movements, gros manual dexterity and left vs right manual impairment
arm group label: PD patients
description: PD patients at 1-5 H&Y stage undergoes 4week Multidisciplinary Intensive Rehabilitation Treatment
intervention type: Behavioral
intervention name: MIRT
description: 4 week MIRT provide:
front to front treatment (1 hour/day for 5 days/week)
treatment with robotic devices (1 hour/day for 5 days/week)
occupational therapy (1 hour/day for 5 days/week)
arm group label: PD patients
other name: Multidisciplinary Intensive Rehabilitation Treatment
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Parkinson Disease