<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/NCT03015714</url>
  </required_header>
  <id_info>
    <org_study_id>&quot;Moriggia-Pelascini&quot; Hospital</org_study_id>
    <nct_id>NCT03015714</nct_id>
  </id_info>
  <brief_title>Aquatic Therapy for Freezing of Gait in Parkinson's Disease Patients</brief_title>
  <acronym>AT-FOG</acronym>
  <official_title>Effectiveness of Aquatic Therapy for Parkinson's Disease Patients in the Context of a Multidisciplinary, Intensive Rehabilitation Treatment</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of the effectiveness of aquatic therapy for the treatment of freezing of gait in&#xD;
      Parkinson's disease patients undergoing a multidisciplinary and intensive rehabilitation&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Freezing of gait (FoG) is an often dramatic, disabling episodic gait pattern that is common&#xD;
      in Parkinson's disease (PD). FoG highly impairs mobility, causes falls, and reduces quality&#xD;
      of life. Given the limited effectiveness of both the dopaminergic therapy and the deep brain&#xD;
      stimulation on this symptom, it represents a challenge in the field of rehabilitation. In the&#xD;
      last years, some studies described the effectiveness of aquatic therapy on balance&#xD;
      dysfunction in patients with PD, correlating it to the safe conditions offered by the aquatic&#xD;
      environment and to the physical properties of water. Nevertheless, the issues concerning the&#xD;
      feasibility and the effectiveness of aquatic therapy for the treatment of FoG have never been&#xD;
      addressed before. The aquatic environment may act on the sensorial peripheral receptors, thus&#xD;
      widely stimulating the proprioceptive system. PD patients show an altered processing of the&#xD;
      proprioceptive information that could potentially underline FoG. The investigators aim at&#xD;
      investigating the effects of aquatic therapy for the treatment of FoG in PD patients&#xD;
      undergoing a Multidisciplinary Intensive Rehabilitation Treatment (MIRT), whose effectiveness&#xD;
      on several motor and functional parameters has been already demonstrated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Freezing of Gait Questionnaire (FOGQ)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Assess FoG frequency, disturbances in gait and relationship to clinical features conceptually associated with gait and motor aspects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Unified Parkinson's Disease Rating Scale tot (UPDRS tot)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Clinician-scored monitored patient's global evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unified Parkinson's Disease Rating Scale Part III (UPDRS III)</measure>
    <time_frame>4 weeks</time_frame>
    <description>UPDRS subpart: clinician-scored monitored patient's motor evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unified Parkinson's Disease Rating Scale Part II (UPDRS II)</measure>
    <time_frame>4 weeks</time_frame>
    <description>UPDRS subart: clinician-scored monitored patient's activitied daily life evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Scale (BBS)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Motor-functional test for balance evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed Up and Go Test (TUG)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Motor-functional test for sit to stand, walking and turning evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six Minutes Walking Test (6MWT)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Motor-functional test for gait endurance</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Gait Disorders, Neurologic</condition>
  <condition>Gait Disorder, Sensorimotor</condition>
  <arm_group>
    <arm_group_label>MIRT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group will undergo a 4-week Multidisciplinary Intensive Rehabilitation Treatment (MIRT).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MIRT-AT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group will undergo a 4-week Multidisciplinary Intensive Rehabilitation Treatment associated with Aquatic Therapy (MIRT-AT).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MIRT</intervention_name>
    <description>MIRT consists of a 4-week rehabilitation program in a hospital setting, which entails four daily sessions of physical therapy for five days and one hour of physical exercise on the sixth day. On the seventh day the patient rests. The duration of each session, including recovery periods, is about one hour. The first session consists of a one-to-one session with a physical therapist. The second session includes aerobic exercises to improve balance and gait, using different devices: a stabilometric platform with visual cues, a treadmill plus and a cycloergometer. The third session consists of occupational therapy, the fourth one includes one hour of speech therapy.</description>
    <arm_group_label>MIRT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MIRT-AT</intervention_name>
    <description>Patients in the MIRT-AT group will undergo the land-based therapy described in MIRT plus three sessions per week (Monday, Wednesday, Friday) of aquatic therapy. On days of aquatic therapy the first session of MIRT was not provided. The aquatic therapy program included aerobic exercises and physical activities to improve balance, motor skills, coordination and joints mobility. The water sessions were divided into 3 phases: i) Warm Up Exercises, ii) Central session Training, iii) Cool-down.</description>
    <arm_group_label>MIRT-AT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of PD according to Gelb et al;&#xD;
&#xD;
          -  Hoehn &amp; Yahr (H&amp;Y) stage 2.5-3;&#xD;
&#xD;
          -  Presence of FOG confirmed in the patient assessment prior to participation in the&#xD;
             study;&#xD;
&#xD;
          -  Stable pharmacological treatment for the last 8 weeks and during the rehabilitation&#xD;
             period;&#xD;
&#xD;
          -  Mini Mental State Examination (MMSE) ≥ 24;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac, pulmonary, vestibular and orthopedic diseases;&#xD;
&#xD;
          -  Urinary incontinence;&#xD;
&#xD;
          -  Severe dyskinesias;&#xD;
&#xD;
          -  Patients treated with deep brain stimulation;&#xD;
&#xD;
          -  Visual deficits;&#xD;
&#xD;
          -  Comorbilities other than PD determining reduction of motor autonomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giuseppe Frazzitta, MD</last_name>
    <role>Study Director</role>
    <affiliation>&quot;Moriggia-Pelascini&quot; Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>&quot;Moriggia-Pelascini&quot; Hospital</name>
      <address>
        <city>Gravedona Ed Uniti</city>
        <state>Como</state>
        <zip>22015</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>January 7, 2017</study_first_submitted>
  <study_first_submitted_qc>January 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>December 27, 2017</last_update_submitted>
  <last_update_submitted_qc>December 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2017</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>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Gait Disorders, Neurologic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03015714
org study id: "Moriggia-Pelascini" Hospital
nct id: NCT03015714
lead sponsor: 
has dmc: No
Evaluation of the effectiveness of aquatic therapy for the treatment of freezing of gait in
      Parkinson's disease patients undergoing a multidisciplinary and intensive rehabilitation
      treatment.
Freezing of gait (FoG) is an often dramatic, disabling episodic gait pattern that is common
      in Parkinson's disease (PD). FoG highly impairs mobility, causes falls, and reduces quality
      of life. Given the limited effectiveness of both the dopaminergic therapy and the deep brain
      stimulation on this symptom, it represents a challenge in the field of rehabilitation. In the
      last years, some studies described the effectiveness of aquatic therapy on balance
      dysfunction in patients with PD, correlating it to the safe conditions offered by the aquatic
      environment and to the physical properties of water. Nevertheless, the issues concerning the
      feasibility and the effectiveness of aquatic therapy for the treatment of FoG have never been
      addressed before. The aquatic environment may act on the sensorial peripheral receptors, thus
      widely stimulating the proprioceptive system. PD patients show an altered processing of the
      proprioceptive information that could potentially underline FoG. The investigators aim at
      investigating the effects of aquatic therapy for the treatment of FoG in PD patients
      undergoing a Multidisciplinary Intensive Rehabilitation Treatment (MIRT), whose effectiveness
      on several motor and functional parameters has been already demonstrated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Freezing of Gait Questionnaire (FOGQ)
time frame: 4 weeks
description: Assess FoG frequency, disturbances in gait and relationship to clinical features conceptually associated with gait and motor aspects.
measure: Unified Parkinson's Disease Rating Scale tot (UPDRS tot)
time frame: 4 weeks
description: Clinician-scored monitored patient's global evaluation.
measure: Unified Parkinson's Disease Rating Scale Part III (UPDRS III)
time frame: 4 weeks
description: UPDRS subpart: clinician-scored monitored patient's motor evaluation
measure: Unified Parkinson's Disease Rating Scale Part II (UPDRS II)
time frame: 4 weeks
description: UPDRS subart: clinician-scored monitored patient's activitied daily life evaluation
measure: Berg Balance Scale (BBS)
time frame: 4 weeks
description: Motor-functional test for balance evaluation
measure: Timed Up and Go Test (TUG)
time frame: 4 weeks
description: Motor-functional test for sit to stand, walking and turning evaluation
measure: Six Minutes Walking Test (6MWT)
time frame: 4 weeks
description: Motor-functional test for gait endurance
arm group label: MIRT
arm group type: Active Comparator
description: Patients in this group will undergo a 4-week Multidisciplinary Intensive Rehabilitation Treatment (MIRT).
arm group label: MIRT-AT
arm group type: Active Comparator
description: Patients in this group will undergo a 4-week Multidisciplinary Intensive Rehabilitation Treatment associated with Aquatic Therapy (MIRT-AT).
intervention type: Other
intervention name: MIRT
description: MIRT consists of a 4-week rehabilitation program in a hospital setting, which entails four daily sessions of physical therapy for five days and one hour of physical exercise on the sixth day. On the seventh day the patient rests. The duration of each session, including recovery periods, is about one hour. The first session consists of a one-to-one session with a physical therapist. The second session includes aerobic exercises to improve balance and gait, using different devices: a stabilometric platform with visual cues, a treadmill plus and a cycloergometer. The third session consists of occupational therapy, the fourth one includes one hour of speech therapy.
arm group label: MIRT
intervention type: Other
intervention name: MIRT-AT
description: Patients in the MIRT-AT group will undergo the land-based therapy described in MIRT plus three sessions per week (Monday, Wednesday, Friday) of aquatic therapy. On days of aquatic therapy the first session of MIRT was not provided. The aquatic therapy program included aerobic exercises and physical activities to improve balance, motor skills, coordination and joints mobility. The water sessions were divided into 3 phases: i) Warm Up Exercises, ii) Central session Training, iii) Cool-down.
arm group label: MIRT-AT
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: Giuseppe Frazzitta, MD
role: Study Director
affiliation: "Moriggia-Pelascini" Hospital
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Nervous System Diseases
mesh term: Gait Disorders, Neurologic
sharing ipd: No