<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/NCT03228888</url>
  </required_header>
  <id_info>
    <org_study_id>PG/2014/17870</org_study_id>
    <nct_id>NCT03228888</nct_id>
  </id_info>
  <brief_title>Effects of Ecological Rythmic-acoustic Stimulation (E-RAS) on Motor Skills in Individuals With Parkinson's Disease</brief_title>
  <official_title>Effects of Ecological Rythmic-acoustic Stimulation (E-RAS) on Motor Skills in Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cagliari</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Cagliari</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 use of rhythmic auditory stimulation (RAS) has been proven useful in the management of&#xD;
      gait disturbances induced by Parkinson's disease (PD). Typically, the stimuli used to provide&#xD;
      RAS consist of metronome or music-based sounds, which are not related with the auditory&#xD;
      experience of walking. Based on previous laboratory research, it is hypothesized that the use&#xD;
      of ecological sounds deriving from biological motion (i.e., footstep sounds) could have a&#xD;
      greater impact compared to artificial sounds (i.e., metronome sounds), within a&#xD;
      rehabilitation program. In a double-blind experiment, it was investigated the effects of 5&#xD;
      weeks of supervised rehabilitation integrated with RAS. Thirty-two individuals affected by PD&#xD;
      (age 68.2 ± 10.5, Hoehn and Yahr 1,5-3) were randomly assigned to one of the two conditions&#xD;
      (artificial vs. ecological sounds). Spatio-temporal parameters of gait and clinical variables&#xD;
      were assessed before the rehabilitation period, at its end, and after a 3-month follow-up.&#xD;
      The results revealed that the rehabilitation program integrated with RAS had positive effects&#xD;
      on the majority of objective and subjective measures, independently of the type of sound.&#xD;
      However, when the two groups were examined separately, the patients assigned to the&#xD;
      ecological RAS condition were the only who improved both in terms of cadence and gait speed.&#xD;
      Overall, the hypothesized greater effect of the ecological sounds compared to artificial&#xD;
      sounds was only partially supported by data.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2014</start_date>
  <completion_date type="Actual">July 1, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</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>Participants were randomly assigned to one of the two groups (artificial or ecological RAS) and were evaluated in three moments: before the rehabilitative treatment (T0), at the end of the 5 week rehabilitative treatment (T5), and 3 months after the end of the treatment, namely 17 weeks after the first assessment (T17).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Walking speed</measure>
    <time_frame>5 weeks</time_frame>
    <description>Walking speed calculated on a 10 m path using motion-capture system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hip Flexion-extension</measure>
    <time_frame>5 weeks</time_frame>
    <description>Angle of flexion-extension of hip joint during a gait cycle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Flexion-extension</measure>
    <time_frame>5 weeks</time_frame>
    <description>Angle of flexion-extension of knee joint during a gait cycle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ankle Dorsi- Plantar-flexion</measure>
    <time_frame>5 weeks</time_frame>
    <description>Angle of dorsi- plantar-flexion of ankle joint during a gait cycle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GPS</measure>
    <time_frame>5 weeks</time_frame>
    <description>Gait Profile Score (synthetic index of deviation from a physiologic gait pattern)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Artificial Sounds</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were provided headphones and a portable MP3 device which played a metronome tick at specified rhythm calculated as follows: a) if a patient's cadence was below the normality, the BPM of the stimulus was set at a value of 10% higher than one's own cadence; b) if a patient's cadence was below, but close to normality (less than 10% difference), the BPM of the stimulus was set at normality values; c) if a patient's cadence was above the normality, the BPM of the stimulus was set at a value equal to one's own cadence.&#xD;
Participants performed daily 30 minutes of walking assisted by the rhythmic acoustic stimuli.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ecological Sounds</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were provided headphones and a portable MP3 device which played an ecological rhythmic sound obtained by actual footsteps of human at specified rhythm calculated as follows: a) if a patient's cadence was below the normality, the BPM of the stimulus was set at a value of 10% higher than one's own cadence; b) if a patient's cadence was below, but close to normality (less than 10% difference), the BPM of the stimulus was set at normality values; c) if a patient's cadence was above the normality, the BPM of the stimulus was set at a value equal to one's own cadence.&#xD;
Participants performed daily 30 minutes of walking assisted by the rhythmic acoustic stimuli.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Administration of rhytmic acoustic stimuli for gait training</intervention_name>
    <description>The intervention consist in 5 weeks, 20 min/day gait training assisted by rhythmic acoustic stimuli administered using a portable MP3 player</description>
    <arm_group_label>Artificial Sounds</arm_group_label>
    <arm_group_label>Ecological Sounds</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of PD according to the UK Brain Bank criteria;&#xD;
&#xD;
          -  ability to walk independently;&#xD;
&#xD;
          -  absence of relevant hearing impairments which could prevent the correct perception of&#xD;
             the auditory cues;&#xD;
&#xD;
          -  absence of significant cognitive impairment (i.e., Mini-Mental Status Examination&#xD;
             (MMSE) &gt; 24; Frontal Assessment Battery (FAB) &gt; 13);&#xD;
&#xD;
          -  absence of psychiatric or severe systemic illnesses;&#xD;
&#xD;
          -  mild-to-moderate disability assessed by means of the modified Hoehn and Yahr (H&amp;Y)&#xD;
             staging scale (1,5 ≤ H&amp;Y ≤ 3);&#xD;
&#xD;
          -  no engagement in any rehabilitative program in the 3 months before the beginning of&#xD;
             the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>General Hospital &quot;G. Brotzu&quot;</name>
      <address>
        <city>Cagliari</city>
        <zip>09100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cagliari</investigator_affiliation>
    <investigator_full_name>Massimiliano Pau</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Rhythm</keyword>
  <keyword>Ecological sounds</keyword>
  <keyword>Auditory stimuli</keyword>
  <keyword>rhythmic auditory stimulation</keyword>
  <keyword>Parkinson's Disease</keyword>
  <keyword>Gait</keyword>
  <keyword>Gait analysis</keyword>
  <keyword>Spatio-temporal parameters</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/NCT03228888
org study id: PG/2014/17870
nct id: NCT03228888
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The use of rhythmic auditory stimulation (RAS) has been proven useful in the management of
      gait disturbances induced by Parkinson's disease (PD). Typically, the stimuli used to provide
      RAS consist of metronome or music-based sounds, which are not related with the auditory
      experience of walking. Based on previous laboratory research, it is hypothesized that the use
      of ecological sounds deriving from biological motion (i.e., footstep sounds) could have a
      greater impact compared to artificial sounds (i.e., metronome sounds), within a
      rehabilitation program. In a double-blind experiment, it was investigated the effects of 5
      weeks of supervised rehabilitation integrated with RAS. Thirty-two individuals affected by PD
      (age 68.2 ± 10.5, Hoehn and Yahr 1,5-3) were randomly assigned to one of the two conditions
      (artificial vs. ecological sounds). Spatio-temporal parameters of gait and clinical variables
      were assessed before the rehabilitation period, at its end, and after a 3-month follow-up.
      The results revealed that the rehabilitation program integrated with RAS had positive effects
      on the majority of objective and subjective measures, independently of the type of sound.
      However, when the two groups were examined separately, the patients assigned to the
      ecological RAS condition were the only who improved both in terms of cadence and gait speed.
      Overall, the hypothesized greater effect of the ecological sounds compared to artificial
      sounds was only partially supported by data.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants were randomly assigned to one of the two groups (artificial or ecological RAS) and were evaluated in three moments: before the rehabilitative treatment (T0), at the end of the 5 week rehabilitative treatment (T5), and 3 months after the end of the treatment, namely 17 weeks after the first assessment (T17).
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Walking speed
time frame: 5 weeks
description: Walking speed calculated on a 10 m path using motion-capture system
measure: Hip Flexion-extension
time frame: 5 weeks
description: Angle of flexion-extension of hip joint during a gait cycle
measure: Knee Flexion-extension
time frame: 5 weeks
description: Angle of flexion-extension of knee joint during a gait cycle
measure: Ankle Dorsi- Plantar-flexion
time frame: 5 weeks
description: Angle of dorsi- plantar-flexion of ankle joint during a gait cycle
measure: GPS
time frame: 5 weeks
description: Gait Profile Score (synthetic index of deviation from a physiologic gait pattern)
arm group label: Artificial Sounds
arm group type: Experimental
description: Participants were provided headphones and a portable MP3 device which played a metronome tick at specified rhythm calculated as follows: a) if a patient's cadence was below the normality, the BPM of the stimulus was set at a value of 10% higher than one's own cadence; b) if a patient's cadence was below, but close to normality (less than 10% difference), the BPM of the stimulus was set at normality values; c) if a patient's cadence was above the normality, the BPM of the stimulus was set at a value equal to one's own cadence.
Participants performed daily 30 minutes of walking assisted by the rhythmic acoustic stimuli.
arm group label: Ecological Sounds
arm group type: Experimental
description: Participants were provided headphones and a portable MP3 device which played an ecological rhythmic sound obtained by actual footsteps of human at specified rhythm calculated as follows: a) if a patient's cadence was below the normality, the BPM of the stimulus was set at a value of 10% higher than one's own cadence; b) if a patient's cadence was below, but close to normality (less than 10% difference), the BPM of the stimulus was set at normality values; c) if a patient's cadence was above the normality, the BPM of the stimulus was set at a value equal to one's own cadence.
Participants performed daily 30 minutes of walking assisted by the rhythmic acoustic stimuli.
intervention type: Other
intervention name: Administration of rhytmic acoustic stimuli for gait training
description: The intervention consist in 5 weeks, 20 min/day gait training assisted by rhythmic acoustic stimuli administered using a portable MP3 player
arm group label: Artificial Sounds
arm group label: Ecological Sounds
criteria: 
gender: All
minimum age: 50 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Cagliari
investigator full name: Massimiliano Pau
investigator title: Associate Professor
mesh term: Parkinson Disease
sharing ipd: No