<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/NCT03774225</url>
  </required_header>
  <id_info>
    <org_study_id>Pâmela e Amarílis</org_study_id>
    <nct_id>NCT03774225</nct_id>
  </id_info>
  <brief_title>The Influence of Manual and Verbal Guidance for Therapeutic Results in People With Parkinson's Disease</brief_title>
  <official_title>Effects Of Physiotherapy Intervention In A Motor Training With Virtual Reality On Motor, Cognitive, Balance And Gait Of Patients With Parkinson Disease: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</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>
      A prospective, single-blind, parallel-group, randomised trial was conducted in Sao Paulo,&#xD;
      Brazil. Thrid eight People with Parkinson's Disease were recruited and randomly allocated in&#xD;
      two groups: Experimental Group (EG), that performed the balance and gait training based on&#xD;
      games from Microsoft Xbox Kinect System ® (MXKS) supported by manual and verbal guidance&#xD;
      (MVG) provided by a PT and a control group (CG) that performed an identical training with no&#xD;
      MVG during the training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It were recruited PPD in the &quot;Brazil Parkinson Association&quot; (BPA), a no-government&#xD;
      association of PD care, where the assessments and intervention were performed from December&#xD;
      2017 to June 2018. The PPD were recruited by randomization from the BPA list of active&#xD;
      patients and waiting list for PT intervention.&#xD;
&#xD;
      Outcome measures were obtained at up to three time points: before intervention, after 1 week&#xD;
      and after 8 weeks of the end of intervention, the last time point was considered as a&#xD;
      follow-up assessment. This study is in agreement with CONSORT guidelines for developing&#xD;
      randomised trials . Primary measures was the functional balance evaluation by the Balance&#xD;
      Evaluation Systems Test (BESTest) and Rapid Turn Test (RT Test), and gait performance&#xD;
      assessed in the six-minute walk test and Gait test in 30 seconds. As secondary measures were&#xD;
      used: Unified Parkinson's Disease Rate Scale (UPDRS), 5-Step Standing Passing Test (ST-DP5),&#xD;
      International Falls Efficiency Scale (FES-I), Brazilian Version of the Freezing Scale March&#xD;
      (FOGQ), Parkinson's Disease Quality of Life Questionnaire (PDQ-39), Geriatric Depression&#xD;
      Scale (GDS-15).&#xD;
&#xD;
      All patients performed 8 individual training sessions, under the supervision of a&#xD;
      physiotherapist, twice a week for four weeks. Each session had 10 minutes of identical global&#xD;
      exercises for both groups, consisting of stretching, muscle strengthening and axial mobility&#xD;
      exercises, one serie per session. After these initial 10 minutes, both groups performed an&#xD;
      additional 40 minutes of balance training using four XBOX games, four per session, under&#xD;
      different conditions for MVG and NMVG.&#xD;
&#xD;
      While the Control Group will be trained by conventional Physical Therapy exercises.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Anticipated">July 20, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</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>Prospective, single-blind, parallel-group, randomised trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>The assessments where conducting by a blind examiner (investigator) in different days of the training. The examinator wasn't know which group the participant would be performing</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Functional balance and gait with Best Test</measure>
    <time_frame>1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)</time_frame>
    <description>A scale consisting of 36 items, the score having a variation in four levels, 0 being the worst performance and 3 the best, with a total score of 108. This scale evaluates the balance under six different domains: biomechanical changes, stability / verticality limits, anticipatory postural adjustments, postural responses, sensory orientation and gait stability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Gait with 6 minut walk test</measure>
    <time_frame>1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)</time_frame>
    <description>a gait assessment method that measures the maximum distance a person can walk and measures maximal cardiorespiratory functions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Functional balance with Rapid turn test</measure>
    <time_frame>1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)</time_frame>
    <description>Is a mesure of dynamic balance. The subject tested turns in a complete circle (360 degrees) as faster as it could while time to finshed the turn is recorded. The test is done for both sides (right and left).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Specific motor and non-motor aspects of Parkinson's disease with UPDRS scale</measure>
    <time_frame>1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)</time_frame>
    <description>It's a scale composed of four parts: Part I (non-motor aspects of daily life), Part II (motor aspects of daily life), Part III (motor evaluation) and Part IV (motor complications)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk of falls with FES-I scale</measure>
    <time_frame>1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)</time_frame>
    <description>presents questions about the concern with the possibility of falling when performing 16 activities, with respective scores from one to four. The total score can range from 16 (no concern) to 64 (extreme worry)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endurance with 6 minut walk test</measure>
    <time_frame>1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)</time_frame>
    <description>a gait assessment method that measures the maximum distance a person can walk and measures maximal cardiorespiratory functions</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Manual and verbal guidance (MVG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The MVG Group will be done by experimental group with the manual and verbal guidance of a physiotherapist using four games of X-Box Kinect system®</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No manual and verbal guidance (NMVG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The NMVG Group will be done by experimental group using four games of X-Box Kinect system® in the presence of a physiotherapist that will care about the safety of the participants without interfere in their moviment pattern.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Control Group will be trained by conventional Physical Therapy exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Virtual Reality with Manual and Verbal Guidance</intervention_name>
    <description>Participants will perform 4 balance games during 8 sessions with a manually and verbally assisted by a experient physiotherapist.</description>
    <arm_group_label>Manual and verbal guidance (MVG)</arm_group_label>
    <arm_group_label>No manual and verbal guidance (NMVG)</arm_group_label>
    <arm_group_label>Physical Therapy</arm_group_label>
    <other_name>Experimental Group with Manual and Verbal Guidance (MVG)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Virtual Reality with No Manual and Verbal Guidance</intervention_name>
    <description>Participants will perform 4 balance games during 8 sessions in the presence of a experient physiotherapist that will ensure patient safety, providing motivational verbal stimuli, and replicating the feedback provided by the game.</description>
    <arm_group_label>Manual and verbal guidance (MVG)</arm_group_label>
    <arm_group_label>No manual and verbal guidance (NMVG)</arm_group_label>
    <arm_group_label>Physical Therapy</arm_group_label>
    <other_name>Experimental Group with No Manual and Verbal Guidance (NMVG)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical Therapy</intervention_name>
    <description>Patients of the control group will be trained with balance exercises by a experient physiotherapist.</description>
    <arm_group_label>Manual and verbal guidance (MVG)</arm_group_label>
    <arm_group_label>No manual and verbal guidance (NMVG)</arm_group_label>
    <arm_group_label>Physical Therapy</arm_group_label>
    <other_name>Control Group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parkinson's disease diagnosis according to Parkinson's Disease Society Brain Bank of&#xD;
             London criteria&#xD;
&#xD;
          -  Active treatment with levodopa&#xD;
&#xD;
          -  Classification in stages 1, 2 and 3 according to Hoehn and Yahr Classification&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cognitive impairment defined as ≤ 20 in Montreal Cognitive Assessment&#xD;
&#xD;
          -  Severe respiratory and / or cardiovascular conditions&#xD;
&#xD;
          -  Visual and / or auditory deficit that can not be corrected with orthotics;&#xD;
&#xD;
          -  Other previously detected orthopedic or neurological diseases, other than Parkinson's&#xD;
             Disease, that may interfere with the individual's performance;&#xD;
&#xD;
          -  Previous experience with Microsoft XBOX Kinect® games;&#xD;
&#xD;
          -  Be in rehab at another location concomitant with study training.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Elisa P Piemonte</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brazil Parkinson Association</name>
      <address>
        <city>São Paulo</city>
        <zip>04142-092</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Physiotherapy, Communication Science &amp; Disorders, Occupational Therapy, School of Medicine, University of São Paulo</name>
      <address>
        <city>São Paulo</city>
        <zip>05360-160</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>September 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>February 14, 2019</last_update_submitted>
  <last_update_submitted_qc>February 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Virtual Reality</keyword>
  <keyword>International Classification of Functioning</keyword>
  <keyword>Disability and Health</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Gait</keyword>
  <keyword>Balance</keyword>
  <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/NCT03774225
org study id: Pâmela e Amarílis
nct id: NCT03774225
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A prospective, single-blind, parallel-group, randomised trial was conducted in Sao Paulo,
      Brazil. Thrid eight People with Parkinson's Disease were recruited and randomly allocated in
      two groups: Experimental Group (EG), that performed the balance and gait training based on
      games from Microsoft Xbox Kinect System ® (MXKS) supported by manual and verbal guidance
      (MVG) provided by a PT and a control group (CG) that performed an identical training with no
      MVG during the training.
It were recruited PPD in the "Brazil Parkinson Association" (BPA), a no-government
      association of PD care, where the assessments and intervention were performed from December
      2017 to June 2018. The PPD were recruited by randomization from the BPA list of active
      patients and waiting list for PT intervention.

      Outcome measures were obtained at up to three time points: before intervention, after 1 week
      and after 8 weeks of the end of intervention, the last time point was considered as a
      follow-up assessment. This study is in agreement with CONSORT guidelines for developing
      randomised trials . Primary measures was the functional balance evaluation by the Balance
      Evaluation Systems Test (BESTest) and Rapid Turn Test (RT Test), and gait performance
      assessed in the six-minute walk test and Gait test in 30 seconds. As secondary measures were
      used: Unified Parkinson's Disease Rate Scale (UPDRS), 5-Step Standing Passing Test (ST-DP5),
      International Falls Efficiency Scale (FES-I), Brazilian Version of the Freezing Scale March
      (FOGQ), Parkinson's Disease Quality of Life Questionnaire (PDQ-39), Geriatric Depression
      Scale (GDS-15).

      All patients performed 8 individual training sessions, under the supervision of a
      physiotherapist, twice a week for four weeks. Each session had 10 minutes of identical global
      exercises for both groups, consisting of stretching, muscle strengthening and axial mobility
      exercises, one serie per session. After these initial 10 minutes, both groups performed an
      additional 40 minutes of balance training using four XBOX games, four per session, under
      different conditions for MVG and NMVG.

      While the Control Group will be trained by conventional Physical Therapy exercises.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, single-blind, parallel-group, randomised trial
primary purpose: Treatment
masking: Single (Investigator)
masking description: The assessments where conducting by a blind examiner (investigator) in different days of the training. The examinator wasn't know which group the participant would be performing
measure: Change in Functional balance and gait with Best Test
time frame: 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
description: A scale consisting of 36 items, the score having a variation in four levels, 0 being the worst performance and 3 the best, with a total score of 108. This scale evaluates the balance under six different domains: biomechanical changes, stability / verticality limits, anticipatory postural adjustments, postural responses, sensory orientation and gait stability
measure: Change in Gait with 6 minut walk test
time frame: 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
description: a gait assessment method that measures the maximum distance a person can walk and measures maximal cardiorespiratory functions
measure: Change in Functional balance with Rapid turn test
time frame: 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
description: Is a mesure of dynamic balance. The subject tested turns in a complete circle (360 degrees) as faster as it could while time to finshed the turn is recorded. The test is done for both sides (right and left).
measure: Specific motor and non-motor aspects of Parkinson's disease with UPDRS scale
time frame: 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
description: It's a scale composed of four parts: Part I (non-motor aspects of daily life), Part II (motor aspects of daily life), Part III (motor evaluation) and Part IV (motor complications)
measure: Risk of falls with FES-I scale
time frame: 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
description: presents questions about the concern with the possibility of falling when performing 16 activities, with respective scores from one to four. The total score can range from 16 (no concern) to 64 (extreme worry)
measure: Endurance with 6 minut walk test
time frame: 1 week before beginning the training; after 1 week of the end of training; and after 8 weeks of the ending the training (follow up)
description: a gait assessment method that measures the maximum distance a person can walk and measures maximal cardiorespiratory functions
arm group label: Manual and verbal guidance (MVG)
arm group type: Experimental
description: The MVG Group will be done by experimental group with the manual and verbal guidance of a physiotherapist using four games of X-Box Kinect system®
arm group label: No manual and verbal guidance (NMVG)
arm group type: Experimental
description: The NMVG Group will be done by experimental group using four games of X-Box Kinect system® in the presence of a physiotherapist that will care about the safety of the participants without interfere in their moviment pattern.
arm group label: Physical Therapy
arm group type: Active Comparator
description: The Control Group will be trained by conventional Physical Therapy exercises.
intervention type: Other
intervention name: Virtual Reality with Manual and Verbal Guidance
description: Participants will perform 4 balance games during 8 sessions with a manually and verbally assisted by a experient physiotherapist.
arm group label: Manual and verbal guidance (MVG)
arm group label: No manual and verbal guidance (NMVG)
arm group label: Physical Therapy
other name: Experimental Group with Manual and Verbal Guidance (MVG)
intervention type: Other
intervention name: Virtual Reality with No Manual and Verbal Guidance
description: Participants will perform 4 balance games during 8 sessions in the presence of a experient physiotherapist that will ensure patient safety, providing motivational verbal stimuli, and replicating the feedback provided by the game.
arm group label: Manual and verbal guidance (MVG)
arm group label: No manual and verbal guidance (NMVG)
arm group label: Physical Therapy
other name: Experimental Group with No Manual and Verbal Guidance (NMVG)
intervention type: Other
intervention name: Physical Therapy
description: Patients of the control group will be trained with balance exercises by a experient physiotherapist.
arm group label: Manual and verbal guidance (MVG)
arm group label: No manual and verbal guidance (NMVG)
arm group label: Physical Therapy
other name: Control Group
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: No
last name: Maria Elisa P Piemonte
role: Principal Investigator
affiliation: University of São Paulo
facility: 
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Parkinson Disease