<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/NCT03278639</url>
  </required_header>
  <id_info>
    <org_study_id>ERAEP2</org_study_id>
    <nct_id>NCT03278639</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety or Rhythmic Auditory Stimulation (RAS) for Gait and Balance Disorders in Parkinson's Disease</brief_title>
  <acronym>ERA-EP2</acronym>
  <official_title>Randomized, Blind, Controlled Clinical Trial to Assess the Efficacy and Safety or Rhythmic Auditory Stimulation (RAS) for Gait and Balance Disorders in Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pontifical Catholic University of Argentina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Council of Scientific and Technical Research, Argentina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Nacional Profesor Alejandro Posadas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Buenos Aires</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pontifical Catholic University of Argentina</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>
      Gait deficits are among the most characteristic and most functionally debilitating signs of&#xD;
      the motor neuropathology of Parkinson's disease (PD). Rhythmic Auditory Stimulation (RAS) is&#xD;
      a technique by which a series of auditory stimuli are presented at a fixed rhythm, so that&#xD;
      patients have to synchronize their movements to the rhythms. In this study, auditory stimuli&#xD;
      will be constituted by Tango musical pieces, which tempo is modified to adapt to patients'&#xD;
      walking cadence. Previous results suggested that RAS can increase Tinetti's gait and balance&#xD;
      and may also improve Health-Related Quality of Life. This will be a randomized, blind,&#xD;
      controlled clinical trial to further assess RAS efficacy and safety.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    We could not fund the study&#xD;
  </why_stopped>
  <start_date type="Anticipated">March 2021</start_date>
  <completion_date type="Anticipated">March 2023</completion_date>
  <primary_completion_date type="Anticipated">March 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>
    <intervention_model_description>randomized, prospective, blind, controlled clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Both investigators taking care of patients and outcomes assessors will be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>change from baseline in Tinetti scale total score</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>change from baseline in Tinetti scale Gait score</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline in Tinetti scale Balance score</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline in Tinetti scale total score</measure>
    <time_frame>6 months</time_frame>
    <description>training will last for the first 4 weeks. Assessments will be also performed at Month 6 to check lasting effects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline in Timed Up &amp; Go test (TUG)</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline in PDQ-39 scores</measure>
    <time_frame>4 weeks</time_frame>
    <description>PDQ-39 is a PD-specific scale for Health-related Quality of Life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline in MDS-UPDRS score</measure>
    <time_frame>4 weeks</time_frame>
    <description>MDS-UPDRS is a measure of disease severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline in Beck Depression Index (BDI)</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline in MMSE (Mini-Mental State Examination)</measure>
    <time_frame>4 weeks</time_frame>
    <description>MMSE is a measure of cognitive impairment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline in Fall diary</measure>
    <time_frame>4 weeks</time_frame>
    <description>patients will have to indicate the number of daily falls over a 15-d period</description>
  </secondary_outcome>
  <other_outcome>
    <measure>change from baseline in PD CRS</measure>
    <time_frame>4 weeks and 6 months</time_frame>
    <description>Parkinson's Disease Cognitive Rating Scale (PD CRS) measures cognitive performance</description>
  </other_outcome>
  <other_outcome>
    <measure>change from baseline in DRS</measure>
    <time_frame>4 weeks and 6 months</time_frame>
    <description>Dementia Rating Scale (DRS) measures cognitive performance</description>
  </other_outcome>
  <other_outcome>
    <measure>change from baseline in TUG</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>change from baseline in PDQ-39</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>change from baseline in MDS-UPDRS</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>change from baseline in BDI</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>change from baseline in MMSE</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>change from baseline in fall diary</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Rhythmic auditory stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each patient will receive training for 4 weeks, 3 times per week. Each training session will last 30 minutes. Training will be performed by music therapists board-certified in RAS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kinesiology</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each patient will receive training for 4 weeks, 3 times per week. Each training session will last 30 minutes. Training will be performed by board-certified kinesio therapists. The objectives of the training sessions will match those of RAS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Rhythmic Auditory Stimulation</intervention_name>
    <description>Training will be directed to ameliorate gait and balance</description>
    <arm_group_label>Rhythmic auditory stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Kinesiology</intervention_name>
    <description>Training will be directed to ameliorate gait and balance</description>
    <arm_group_label>Kinesiology</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinically definitive or probable PD diagnosis&#xD;
&#xD;
          -  Gait disorders (MDS-UPDRS #2.12 =1)&#xD;
&#xD;
          -  Patients that can be reasonably expected to remain in ON-state during training&#xD;
             sessions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous use of RAS or kinesiology&#xD;
&#xD;
          -  MMSE &gt;= 24&#xD;
&#xD;
          -  BDI &gt;= 17&#xD;
&#xD;
          -  Patients having undergone PD surgical treatments.&#xD;
&#xD;
          -  Patients with auditory or visual handicaps&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <removed_countries>
    <country>Argentina</country>
  </removed_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 14, 2021</last_update_submitted>
  <last_update_submitted_qc>September 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pontifical Catholic University of Argentina</investigator_affiliation>
    <investigator_full_name>Santiago Perez Lloret</investigator_full_name>
    <investigator_title>MD PhD CPI</investigator_title>
  </responsible_party>
  <keyword>gait disorders</keyword>
  <keyword>balance disorders</keyword>
  <keyword>music</keyword>
  <keyword>tango</keyword>
  <keyword>rhythmic auditory stimulation</keyword>
  <keyword>health-related quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</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/NCT03278639
org study id: ERAEP2
nct id: NCT03278639
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Gait deficits are among the most characteristic and most functionally debilitating signs of
      the motor neuropathology of Parkinson's disease (PD). Rhythmic Auditory Stimulation (RAS) is
      a technique by which a series of auditory stimuli are presented at a fixed rhythm, so that
      patients have to synchronize their movements to the rhythms. In this study, auditory stimuli
      will be constituted by Tango musical pieces, which tempo is modified to adapt to patients'
      walking cadence. Previous results suggested that RAS can increase Tinetti's gait and balance
      and may also improve Health-Related Quality of Life. This will be a randomized, blind,
      controlled clinical trial to further assess RAS efficacy and safety.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized, prospective, blind, controlled clinical trial
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Both investigators taking care of patients and outcomes assessors will be blinded.
measure: change from baseline in Tinetti scale total score
time frame: 4 weeks
measure: change from baseline in Tinetti scale Gait score
time frame: 4 weeks
measure: change from baseline in Tinetti scale Balance score
time frame: 4 weeks
measure: change from baseline in Tinetti scale total score
time frame: 6 months
description: training will last for the first 4 weeks. Assessments will be also performed at Month 6 to check lasting effects.
measure: change from baseline in Timed Up & Go test (TUG)
time frame: 4 weeks
measure: change from baseline in PDQ-39 scores
time frame: 4 weeks
description: PDQ-39 is a PD-specific scale for Health-related Quality of Life
measure: change from baseline in MDS-UPDRS score
time frame: 4 weeks
description: MDS-UPDRS is a measure of disease severity
measure: change from baseline in Beck Depression Index (BDI)
time frame: 4 weeks
measure: change from baseline in MMSE (Mini-Mental State Examination)
time frame: 4 weeks
description: MMSE is a measure of cognitive impairment
measure: change from baseline in Fall diary
time frame: 4 weeks
description: patients will have to indicate the number of daily falls over a 15-d period
measure: change from baseline in PD CRS
time frame: 4 weeks and 6 months
description: Parkinson's Disease Cognitive Rating Scale (PD CRS) measures cognitive performance
measure: change from baseline in DRS
time frame: 4 weeks and 6 months
description: Dementia Rating Scale (DRS) measures cognitive performance
measure: change from baseline in TUG
time frame: 6 months
measure: change from baseline in PDQ-39
time frame: 6 months
measure: change from baseline in MDS-UPDRS
time frame: 6 months
measure: change from baseline in BDI
time frame: 6 months
measure: change from baseline in MMSE
time frame: 6 months
measure: change from baseline in fall diary
time frame: 6 months
arm group label: Rhythmic auditory stimulation
arm group type: Experimental
description: Each patient will receive training for 4 weeks, 3 times per week. Each training session will last 30 minutes. Training will be performed by music therapists board-certified in RAS.
arm group label: Kinesiology
arm group type: Active Comparator
description: Each patient will receive training for 4 weeks, 3 times per week. Each training session will last 30 minutes. Training will be performed by board-certified kinesio therapists. The objectives of the training sessions will match those of RAS.
intervention type: Behavioral
intervention name: Rhythmic Auditory Stimulation
description: Training will be directed to ameliorate gait and balance
arm group label: Rhythmic auditory stimulation
intervention type: Behavioral
intervention name: Kinesiology
description: Training will be directed to ameliorate gait and balance
arm group label: Kinesiology
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: No
country: Argentina
responsible party type: Principal Investigator
investigator affiliation: Pontifical Catholic University of Argentina
investigator full name: Santiago Perez Lloret
investigator title: MD PhD CPI
mesh term: Parkinson Disease
sharing ipd: No