<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/NCT03235284</url>
  </required_header>
  <id_info>
    <org_study_id>NintendoWii x Exercises</org_study_id>
    <nct_id>NCT03235284</nct_id>
  </id_info>
  <brief_title>Nintendo WII and Exercises at Rehabilitation of Individuals With Parkinson's Disease</brief_title>
  <official_title>Efficacy of Nintendo WII and Exercises at Rehabilitation of Individuals With Parkinson's Disease: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Bahia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Bahia</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Patients with Parkinson's disease present motor dysfunctions such as stiffness, tremor,&#xD;
      postural instability and bradykinesia, which leads to alterations of balance, necessitating&#xD;
      specialized physiotherapeutic treatment. In this way this study aims to determine the&#xD;
      effectiveness of two tools used in physiotherapy, kinesiotherapy and the Nintendo Wii. 45&#xD;
      patients will be evaluated through the Berg Balance Scale, Dynamic Gait Index, Timed up and&#xD;
      go and PDQ-39, and will then be randomized to receive 16 sessions of Exercises or Nintendo&#xD;
      Wii alone or together. After this period the patients will be reassessed to verify the&#xD;
      effects of the techniques.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with Parkinson's disease present motor dysfunctions such as stiffness, tremor,&#xD;
      postural instability and bradykinesia, which leads to alterations of balance, necessitating&#xD;
      specialized physiotherapeutic treatment. In this way this study aims to determine the&#xD;
      effectiveness of two tools used in physiotherapy, kinesiotherapy and the Nintendo Wii. 45&#xD;
      patients will be evaluated through the Berg Equilibrium Scale, Evaluated by the Dynamic Gait&#xD;
      Index and the Timed up and go and PDQ-39. Later patients will be randomized to receive 16&#xD;
      sessions of Kinesiotherapy or Nintendo Wii alone or together, twice a week, for 50 minutes at&#xD;
      the Neurociencias Outpatient Clinic of Teacher Magalhães Neto - FUBA. After this period the&#xD;
      patients will be reassessed to verify the effects of the techniques.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2015</start_date>
  <completion_date type="Actual">August 31, 2017</completion_date>
  <primary_completion_date type="Actual">August 31, 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>
    <masking_description>Single Blind (Outcomes Assessor)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Berg Balance Scale</measure>
    <time_frame>8 weeks</time_frame>
    <description>It is a scale that allows a functional assessment of the balance of the performance. It is based on 14 common items of everyday life, graduated from 0 to 4 points, reaching 56 points maximum score.&#xD;
It presents test reliability and re-test of 98%, another particularity of the scale is the non-linear relationship between the score and the risk of corresponding falls. The scores range from 0 to 56, the higher the score, the better the assessed individual's balance. Each point less on the scale corresponds to an increased risk of falls; between scores 56 to 54, each minus point is associated with a 3 to 4% increase in the risk of falls; between 54 and 46 an increase of 6 to 8% of chances for each point, being that below 36 points the risk of falls is almost 100%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dynamic Gait Index - DGI</measure>
    <time_frame>8 weeks</time_frame>
    <description>It is a scale that allows a functional assessment of the balance of the performance. Comprising 8 tasks with a score ranging from 0 to 3 points, maximum score of 24 points and minimum score of 0 points It consists of eight tasks involving walking in different sensory contexts, which include flat surface, change in gait speed, horizontal and vertical head movements, overpassing and bypassing obstacles, turning over the body axis itself, going up and down stairs . The maximum score is 24 points, and a score of 19 points or less predicts risk of falls. The scale has no gaps, only cutoff points. The higher the value, the better the gait performance. For patients with Parkinson's disease, values below 19 points predict major gait problems and high risk of falls.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed Up and Go - TUG</measure>
    <time_frame>8 weeks</time_frame>
    <description>The TUG measures, in seconds, the time it takes an individual to lift from a standard armchair (height of approximately 46 cm), walk a distance of 3 meters, turn, walk back to the chair and sit again.&#xD;
The patient is asked to lift from a chair (seat height of 45 cm and arms from 65 cm) to walk 3 meters, return and sit again, while the time spent in performing this task is timed.&#xD;
TUG up to ten seconds - individual without change of balance and with low risk of falls; (2) TUG between 11 and 20 seconds - individual with no significant alteration of balance, but presenting some fragility and medium risk of falls; (3) TUG greater than 20 seconds and less than 30 seconds - individual in need of intervention; (4) TUG greater than 30 seconds - individual at high risk for falls and with impaired mobility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parkinson's Disease Questionnaire (PDQ-39)</measure>
    <time_frame>8 weeks</time_frame>
    <description>39 items divided into 8 domains. The total score ranges from 0 to 100, in which a lower score denotes a better perception of the patient's.&#xD;
It is divided into eight categories: mobility (10 items), daily life activities (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (3 items) and body discomfort (3 items) .43 The score ranges from 0 (no problem) to 100 (maximum problem level), ie low score indicates the individual's perception of a better quality of life .. These items can be grouped into three domains: physical, mental and social. The score is made by rule of three and transformed into values from 0 to 100, and higher values refer to poorer quality of life.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Exercises</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A program of therapeutic exercises (GC) based on the PNF method for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GC treatment program consists of the following protocols: a) protocol 1: 20 minutes diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation),10 minutes diagonal exercise scapula (anterior and posterior elevation) and 10 minutes of exercise for trunk extension; b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nintendo Wii</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nintendo Wii program (GW) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes.&#xD;
The GW treatment program consists of the following protocols: a) protocol 1 games (Boxing and Soccer); b) protocol 2 games (Golf and running). 20 minutes for each game</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercises and Nintendo Wii</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In GCW program will be performed 20 minutes GC protocol (1 or 2, used alternately between sessions a week) and 20 minutes GW protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercises</intervention_name>
    <description>A program of therapeutic exercises (GC) based on the PNF method for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GC treatment program consists of the following protocols: a) protocol 1: 20 minutes diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation),10 minutes diagonal exercise scapula (anterior and posterior elevation) and 10 minutes of exercise for trunk extension; b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training</description>
    <arm_group_label>Exercises</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nintendo Wii</intervention_name>
    <description>Nintendo Wii program (GW) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes.&#xD;
The GW treatment program consists of the following protocols: a) protocol 1 games (Boxing and Soccer); b) protocol 2 games (Golf and running). 20 minutes for each game</description>
    <arm_group_label>Nintendo Wii</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercises and Nintendo Wii</intervention_name>
    <description>In GCW program will be performed 20 minutes GC protocol (1 or 2, used alternately between sessions a week) and 20 minutes GW protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols</description>
    <arm_group_label>Exercises and Nintendo Wii</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 40 and 80 years,&#xD;
&#xD;
          -  Stage 1 to 3 on the Hoehn and Yahr scale,&#xD;
&#xD;
          -  Absence of visual or auditory impairment,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of cognitive alterations according to MEEM: illiterate 19 points; 1 to 3&#xD;
             years of schooling 23 points; 4 to 7 years 24 points and above 7 years of 28 points&#xD;
&#xD;
          -  Presence of other neurodegenerative diseases,&#xD;
&#xD;
          -  Uncontrolled osteomioarticular or chronic diseases&#xD;
&#xD;
          -  Participation in other rehabilitation programs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Complex Hospital Professor Edgard Santos, Federal University of Bahia</name>
      <address>
        <city>Salvador</city>
        <state>Bahia</state>
        <zip>40.110-060</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>http://dx.doi.org/10.4236/apd.2013.24018</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <results_first_submitted>January 15, 2019</results_first_submitted>
  <results_first_submitted_qc>September 11, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 16, 2019</results_first_posted>
  <last_update_submitted>September 11, 2019</last_update_submitted>
  <last_update_submitted_qc>September 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Bahia</investigator_affiliation>
    <investigator_full_name>PIETRO ARAÚJO DOS SANTOS</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Parkinson's Disease ande Video Games</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 11, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT03235284/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 11, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT03235284/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Exercises</title>
          <description>The GC treatment program consists of the following protocols: a) protocol 1: 20 minutes diagonal exercise upper limb,10 minutes diagonal exercise scapula and 10 minutes of exercise for trunk extension; b) protocol 2: 20 minutes diagonal exercise lower limb ,10 minutes diagonal exercise pelvis, and 10 minutes gait cycle training;</description>
        </group>
        <group group_id="P2">
          <title>Nintendo Wii</title>
          <description>Nintendo Wii program (GNW) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes.&#xD;
The GNW treatment program consists of the following protocols: a) protocol 1 games (Boxing and Soccer); b) protocol 2 games (Golf and running). 20 minutes for each game</description>
        </group>
        <group group_id="P3">
          <title>Exercises and Nintendo Wii</title>
          <description>Exercises and Nintendo Wii: A program of therapeutic exercises (GC) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). The GC treatment program consists of the following protocols: a) protocol 1 : 30 minutes diagonal exercise upper limb, 10 minutes diagonal exercise scapula and 20 minutes 20 minutes of extension exercises for the trunk; b) protocol 2: 20 minutes diagonal exercise lower limb,10 minutes diagonal exercise pelvis, and 10 minutes gait cycle training. Nintendo Wii program (GW) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). Protocol 1 games (Boxing e Soccer); b) protocol 2 games (Golf and Running). In GCW program will be performed 20 minutes G0 protocol (1 or 2, used alternately between sessions a week) and 20 minutes G1 protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>patients with Parkinson's disease</population>
      <group_list>
        <group group_id="B1">
          <title>Exercises</title>
          <description>A program of therapeutic exercises (GC) based on the PNF method for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GC treatment program consists of the following protocols: a) protocol 1: 20 minutes diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation),10 minutes diagonal exercise scapula (anterior and posterior elevation) and 10 minutes of exercise for trunk extension; b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training;</description>
        </group>
        <group group_id="B2">
          <title>Nintendo Wii</title>
          <description>Nintendo Wii program (GW) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes.&#xD;
The GW treatment program consists of the following protocols: a) protocol 1 games (Boxing and Soccer); b) protocol 2 games (Golf and running). 20 minutes for each game</description>
        </group>
        <group group_id="B3">
          <title>Exercises and Nintendo Wii</title>
          <description>Exercises and Nintendo Wii: A program of therapeutic exercises (GC) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). The GC treatment program consists of the following protocols: a) protocol 1 : 30 minutes diagonal exercise upper limb, 10 minutes diagonal exercise scapula and 20 minutes 20 minutes of extension exercises for the trunk; b) protocol 2: 20 minutes diagonal exercise lower limb,10 minutes diagonal exercise pelvis, and 10 minutes gait cycle training. Nintendo Wii program (GW) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). Protocol 1 games (Boxing e Soccer); b) protocol 2 games (Golf and Running). In GCW program will be performed 20 minutes G0 protocol (1 or 2, used alternately between sessions a week) and 20 minutes G1 protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="14"/>
            <count group_id="B4" value="41"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.5" spread="9.8"/>
                    <measurement group_id="B2" value="61.7" spread="7.3"/>
                    <measurement group_id="B3" value="66.6" spread="8.2"/>
                    <measurement group_id="B4" value="64.2" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Berg Balance Scale</title>
        <description>It is a scale that allows a functional assessment of the balance of the performance. It is based on 14 common items of everyday life, graduated from 0 to 4 points, reaching 56 points maximum score.&#xD;
It presents test reliability and re-test of 98%, another particularity of the scale is the non-linear relationship between the score and the risk of corresponding falls. The scores range from 0 to 56, the higher the score, the better the assessed individual's balance. Each point less on the scale corresponds to an increased risk of falls; between scores 56 to 54, each minus point is associated with a 3 to 4% increase in the risk of falls; between 54 and 46 an increase of 6 to 8% of chances for each point, being that below 36 points the risk of falls is almost 100%</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exercises</title>
            <description>A program of therapeutic exercises (GC) based on the PNF method for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GC treatment program consists of the following protocols: a) protocol 1: 20 minutes diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation),10 minutes diagonal exercise scapula (anterior and posterior elevation) and 10 minutes of exercise for trunk extension; b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training;</description>
          </group>
          <group group_id="O2">
            <title>Nintendo Wii</title>
            <description>Nintendo Wii program (GW) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes.&#xD;
The GW treatment program consists of the following protocols: a) protocol 1 games (Boxing and Soccer); b) protocol 2 games (Golf and running). 20 minutes for each game</description>
          </group>
          <group group_id="O3">
            <title>Exercises and Nintendo Wii</title>
            <description>Exercises and Nintendo Wii: A program of therapeutic exercises (GC) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). The GC treatment program consists of the following protocols: a) protocol 1 : 30 minutes diagonal exercise upper limb, 10 minutes diagonal exercise scapula and 20 minutes 20 minutes of extension exercises for the trunk; b) protocol 2: 20 minutes diagonal exercise lower limb,10 minutes diagonal exercise pelvis, and 10 minutes gait cycle training. Nintendo Wii program (GW) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). Protocol 1 games (Boxing e Soccer); b) protocol 2 games (Golf and Running). In GCW program will be performed 20 minutes G0 protocol (1 or 2, used alternately between sessions a week) and 20 minutes G1 protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols.</description>
          </group>
        </group_list>
        <measure>
          <title>Berg Balance Scale</title>
          <description>It is a scale that allows a functional assessment of the balance of the performance. It is based on 14 common items of everyday life, graduated from 0 to 4 points, reaching 56 points maximum score.&#xD;
It presents test reliability and re-test of 98%, another particularity of the scale is the non-linear relationship between the score and the risk of corresponding falls. The scores range from 0 to 56, the higher the score, the better the assessed individual's balance. Each point less on the scale corresponds to an increased risk of falls; between scores 56 to 54, each minus point is associated with a 3 to 4% increase in the risk of falls; between 54 and 46 an increase of 6 to 8% of chances for each point, being that below 36 points the risk of falls is almost 100%</description>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.5" spread="5.6"/>
                    <measurement group_id="O2" value="43.9" spread="5.3"/>
                    <measurement group_id="O3" value="41.6" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.6" spread="5.4"/>
                    <measurement group_id="O2" value="49.2" spread="4.4"/>
                    <measurement group_id="O3" value="47.1" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dynamic Gait Index - DGI</title>
        <description>It is a scale that allows a functional assessment of the balance of the performance. Comprising 8 tasks with a score ranging from 0 to 3 points, maximum score of 24 points and minimum score of 0 points It consists of eight tasks involving walking in different sensory contexts, which include flat surface, change in gait speed, horizontal and vertical head movements, overpassing and bypassing obstacles, turning over the body axis itself, going up and down stairs . The maximum score is 24 points, and a score of 19 points or less predicts risk of falls. The scale has no gaps, only cutoff points. The higher the value, the better the gait performance. For patients with Parkinson's disease, values below 19 points predict major gait problems and high risk of falls.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exercises</title>
            <description>A program of therapeutic exercises (GC) based on the PNF method for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GC treatment program consists of the following protocols: a) protocol 1: 20 minutes diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation),10 minutes diagonal exercise scapula (anterior and posterior elevation) and 10 minutes of exercise for trunk extension; b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training;</description>
          </group>
          <group group_id="O2">
            <title>Nintendo Wii</title>
            <description>Nintendo Wii program (GW) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes.&#xD;
The GW treatment program consists of the following protocols: a) protocol 1 games (Boxing and Soccer); b) protocol 2 games (Golf and running). 20 minutes for each game</description>
          </group>
          <group group_id="O3">
            <title>Exercises and Nintendo Wii</title>
            <description>Exercises and Nintendo Wii: A program of therapeutic exercises (GC) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). The GC treatment program consists of the following protocols: a) protocol 1 : 30 minutes diagonal exercise upper limb, 10 minutes diagonal exercise scapula and 20 minutes 20 minutes of extension exercises for the trunk; b) protocol 2: 20 minutes diagonal exercise lower limb,10 minutes diagonal exercise pelvis, and 10 minutes gait cycle training. Nintendo Wii program (GW) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). Protocol 1 games (Boxing e Soccer); b) protocol 2 games (Golf and Running). In GCW program will be performed 20 minutes G0 protocol (1 or 2, used alternately between sessions a week) and 20 minutes G1 protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols.</description>
          </group>
        </group_list>
        <measure>
          <title>Dynamic Gait Index - DGI</title>
          <description>It is a scale that allows a functional assessment of the balance of the performance. Comprising 8 tasks with a score ranging from 0 to 3 points, maximum score of 24 points and minimum score of 0 points It consists of eight tasks involving walking in different sensory contexts, which include flat surface, change in gait speed, horizontal and vertical head movements, overpassing and bypassing obstacles, turning over the body axis itself, going up and down stairs . The maximum score is 24 points, and a score of 19 points or less predicts risk of falls. The scale has no gaps, only cutoff points. The higher the value, the better the gait performance. For patients with Parkinson's disease, values below 19 points predict major gait problems and high risk of falls.</description>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.6" spread="4.7"/>
                    <measurement group_id="O2" value="15.7" spread="2.9"/>
                    <measurement group_id="O3" value="15.8" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.6" spread="3.6"/>
                    <measurement group_id="O2" value="19" spread="3.1"/>
                    <measurement group_id="O3" value="19.5" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Timed Up and Go - TUG</title>
        <description>The TUG measures, in seconds, the time it takes an individual to lift from a standard armchair (height of approximately 46 cm), walk a distance of 3 meters, turn, walk back to the chair and sit again.&#xD;
The patient is asked to lift from a chair (seat height of 45 cm and arms from 65 cm) to walk 3 meters, return and sit again, while the time spent in performing this task is timed.&#xD;
TUG up to ten seconds - individual without change of balance and with low risk of falls; (2) TUG between 11 and 20 seconds - individual with no significant alteration of balance, but presenting some fragility and medium risk of falls; (3) TUG greater than 20 seconds and less than 30 seconds - individual in need of intervention; (4) TUG greater than 30 seconds - individual at high risk for falls and with impaired mobility</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exercises</title>
            <description>A program of therapeutic exercises (GC) based on the PNF method for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GC treatment program consists of the following protocols: a) protocol 1: 20 minutes diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation),10 minutes diagonal exercise scapula (anterior and posterior elevation) and 10 minutes of exercise for trunk extension; b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training;</description>
          </group>
          <group group_id="O2">
            <title>Nintendo Wii</title>
            <description>Nintendo Wii program (GW) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes.&#xD;
The GW treatment program consists of the following protocols: a) protocol 1 games (Boxing and Soccer); b) protocol 2 games (Golf and running). 20 minutes for each game</description>
          </group>
          <group group_id="O3">
            <title>Exercises and Nintendo Wii</title>
            <description>Exercises and Nintendo Wii: A program of therapeutic exercises (GC) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). The GC treatment program consists of the following protocols: a) protocol 1 : 30 minutes diagonal exercise upper limb, 10 minutes diagonal exercise scapula and 20 minutes 20 minutes of extension exercises for the trunk; b) protocol 2: 20 minutes diagonal exercise lower limb,10 minutes diagonal exercise pelvis, and 10 minutes gait cycle training. Nintendo Wii program (GW) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). Protocol 1 games (Boxing e Soccer); b) protocol 2 games (Golf and Running). In GCW program will be performed 20 minutes G0 protocol (1 or 2, used alternately between sessions a week) and 20 minutes G1 protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols.</description>
          </group>
        </group_list>
        <measure>
          <title>Timed Up and Go - TUG</title>
          <description>The TUG measures, in seconds, the time it takes an individual to lift from a standard armchair (height of approximately 46 cm), walk a distance of 3 meters, turn, walk back to the chair and sit again.&#xD;
The patient is asked to lift from a chair (seat height of 45 cm and arms from 65 cm) to walk 3 meters, return and sit again, while the time spent in performing this task is timed.&#xD;
TUG up to ten seconds - individual without change of balance and with low risk of falls; (2) TUG between 11 and 20 seconds - individual with no significant alteration of balance, but presenting some fragility and medium risk of falls; (3) TUG greater than 20 seconds and less than 30 seconds - individual in need of intervention; (4) TUG greater than 30 seconds - individual at high risk for falls and with impaired mobility</description>
          <units>Seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7" spread="3.6"/>
                    <measurement group_id="O2" value="11.5" spread="5.1"/>
                    <measurement group_id="O3" value="13.9" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2" spread="2.5"/>
                    <measurement group_id="O2" value="8.5" spread="2.1"/>
                    <measurement group_id="O3" value="10.6" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parkinson's Disease Questionnaire (PDQ-39)</title>
        <description>39 items divided into 8 domains. The total score ranges from 0 to 100, in which a lower score denotes a better perception of the patient's.&#xD;
It is divided into eight categories: mobility (10 items), daily life activities (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (3 items) and body discomfort (3 items) .43 The score ranges from 0 (no problem) to 100 (maximum problem level), ie low score indicates the individual's perception of a better quality of life .. These items can be grouped into three domains: physical, mental and social. The score is made by rule of three and transformed into values from 0 to 100, and higher values refer to poorer quality of life.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exercises</title>
            <description>A program of therapeutic exercises (GC) based on the PNF method for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GC treatment program consists of the following protocols: a) protocol 1: 20 minutes diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation),10 minutes diagonal exercise scapula (anterior and posterior elevation) and 10 minutes of exercise for trunk extension; b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training;</description>
          </group>
          <group group_id="O2">
            <title>Nintendo Wii</title>
            <description>Nintendo Wii program (GW) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes.&#xD;
The GW treatment program consists of the following protocols: a) protocol 1 games (Boxing and Soccer); b) protocol 2 games (Golf and running). 20 minutes for each game</description>
          </group>
          <group group_id="O3">
            <title>Exercises and Nintendo Wii</title>
            <description>Exercises and Nintendo Wii: A program of therapeutic exercises (GC) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). The GC treatment program consists of the following protocols: a) protocol 1 : 30 minutes diagonal exercise upper limb, 10 minutes diagonal exercise scapula and 20 minutes 20 minutes of extension exercises for the trunk; b) protocol 2: 20 minutes diagonal exercise lower limb,10 minutes diagonal exercise pelvis, and 10 minutes gait cycle training. Nintendo Wii program (GW) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). Protocol 1 games (Boxing e Soccer); b) protocol 2 games (Golf and Running). In GCW program will be performed 20 minutes G0 protocol (1 or 2, used alternately between sessions a week) and 20 minutes G1 protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols.</description>
          </group>
        </group_list>
        <measure>
          <title>Parkinson's Disease Questionnaire (PDQ-39)</title>
          <description>39 items divided into 8 domains. The total score ranges from 0 to 100, in which a lower score denotes a better perception of the patient's.&#xD;
It is divided into eight categories: mobility (10 items), daily life activities (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (3 items) and body discomfort (3 items) .43 The score ranges from 0 (no problem) to 100 (maximum problem level), ie low score indicates the individual's perception of a better quality of life .. These items can be grouped into three domains: physical, mental and social. The score is made by rule of three and transformed into values from 0 to 100, and higher values refer to poorer quality of life.</description>
          <units>Score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.7" lower_limit="26.7" upper_limit="54"/>
                    <measurement group_id="O2" value="37.1" lower_limit="24.5" upper_limit="45.3"/>
                    <measurement group_id="O3" value="32.9" lower_limit="22.4" upper_limit="36.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.7" lower_limit="12.6" upper_limit="36.2"/>
                    <measurement group_id="O2" value="29.7" lower_limit="22.4" upper_limit="35.1"/>
                    <measurement group_id="O3" value="23.5" lower_limit="17.9" upper_limit="32.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Two years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Exercises</title>
          <description>A program of therapeutic exercises (GC) based on the PNF method for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GC treatment program consists of the following protocols: a) protocol 1: 20 minutes diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation),10 minutes diagonal exercise scapula (anterior and posterior elevation) and 10 minutes of exercise for trunk extension; b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training. Fatigue, fainting, or changes in blood pressure may occur.</description>
        </group>
        <group group_id="E2">
          <title>Nintendo Wii</title>
          <description>Nintendo Wii program (GW) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes.&#xD;
The GW treatment program consists of the following protocols: a) protocol 1 games (Boxing and Soccer); b) protocol 2 games (Golf and running). 20 minutes for each game. Fatigue, fainting, or changes in blood pressure may occur.</description>
        </group>
        <group group_id="E3">
          <title>Exercises and Nintendo Wii</title>
          <description>A program of therapeutic exercises (GC) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). The GC treatment program consists of the following protocols: a) protocol 1 : 30 minutes diagonal exercise upper limb, 10 minutes diagonal exercise scapula and 20 minutes 20 minutes of extension exercises for the trunk; b) protocol 2: 20 minutes diagonal exercise lower limb,10 minutes diagonal exercise pelvis, and 10 minutes gait cycle training. Nintendo Wii program (GW) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). Protocol 1 games (Boxing e Soccer); b) protocol 2 games (Golf and Running). In GCW program will be performed 20 minutes G0 protocol (1 or 2, used alternately between sessions a week) and 20 minutes G1 protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols. Fatigue, fainting, or changes in blood pressure</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The absence of an instrument to verify the presence of depression, which is a clinical condition present in some patients with PD and may have influenced the absence of more significant results.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr.Pietro Araújo</name_or_title>
      <organization>Federal University of Bahia - FUBA</organization>
      <phone>71992520519</phone>
      <email>pietro.araujo@ufba.br</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03235284
org study id: NintendoWii x Exercises
nct id: NCT03235284
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients with Parkinson's disease present motor dysfunctions such as stiffness, tremor,
      postural instability and bradykinesia, which leads to alterations of balance, necessitating
      specialized physiotherapeutic treatment. In this way this study aims to determine the
      effectiveness of two tools used in physiotherapy, kinesiotherapy and the Nintendo Wii. 45
      patients will be evaluated through the Berg Balance Scale, Dynamic Gait Index, Timed up and
      go and PDQ-39, and will then be randomized to receive 16 sessions of Exercises or Nintendo
      Wii alone or together. After this period the patients will be reassessed to verify the
      effects of the techniques.
Patients with Parkinson's disease present motor dysfunctions such as stiffness, tremor,
      postural instability and bradykinesia, which leads to alterations of balance, necessitating
      specialized physiotherapeutic treatment. In this way this study aims to determine the
      effectiveness of two tools used in physiotherapy, kinesiotherapy and the Nintendo Wii. 45
      patients will be evaluated through the Berg Equilibrium Scale, Evaluated by the Dynamic Gait
      Index and the Timed up and go and PDQ-39. Later patients will be randomized to receive 16
      sessions of Kinesiotherapy or Nintendo Wii alone or together, twice a week, for 50 minutes at
      the Neurociencias Outpatient Clinic of Teacher Magalhães Neto - FUBA. After this period the
      patients will be reassessed to verify the effects of the techniques.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Single Blind (Outcomes Assessor)
measure: Berg Balance Scale
time frame: 8 weeks
description: It is a scale that allows a functional assessment of the balance of the performance. It is based on 14 common items of everyday life, graduated from 0 to 4 points, reaching 56 points maximum score.
It presents test reliability and re-test of 98%, another particularity of the scale is the non-linear relationship between the score and the risk of corresponding falls. The scores range from 0 to 56, the higher the score, the better the assessed individual's balance. Each point less on the scale corresponds to an increased risk of falls; between scores 56 to 54, each minus point is associated with a 3 to 4% increase in the risk of falls; between 54 and 46 an increase of 6 to 8% of chances for each point, being that below 36 points the risk of falls is almost 100%
measure: Dynamic Gait Index - DGI
time frame: 8 weeks
description: It is a scale that allows a functional assessment of the balance of the performance. Comprising 8 tasks with a score ranging from 0 to 3 points, maximum score of 24 points and minimum score of 0 points It consists of eight tasks involving walking in different sensory contexts, which include flat surface, change in gait speed, horizontal and vertical head movements, overpassing and bypassing obstacles, turning over the body axis itself, going up and down stairs . The maximum score is 24 points, and a score of 19 points or less predicts risk of falls. The scale has no gaps, only cutoff points. The higher the value, the better the gait performance. For patients with Parkinson's disease, values below 19 points predict major gait problems and high risk of falls.
measure: Timed Up and Go - TUG
time frame: 8 weeks
description: The TUG measures, in seconds, the time it takes an individual to lift from a standard armchair (height of approximately 46 cm), walk a distance of 3 meters, turn, walk back to the chair and sit again.
The patient is asked to lift from a chair (seat height of 45 cm and arms from 65 cm) to walk 3 meters, return and sit again, while the time spent in performing this task is timed.
TUG up to ten seconds - individual without change of balance and with low risk of falls; (2) TUG between 11 and 20 seconds - individual with no significant alteration of balance, but presenting some fragility and medium risk of falls; (3) TUG greater than 20 seconds and less than 30 seconds - individual in need of intervention; (4) TUG greater than 30 seconds - individual at high risk for falls and with impaired mobility
measure: Parkinson's Disease Questionnaire (PDQ-39)
time frame: 8 weeks
description: 39 items divided into 8 domains. The total score ranges from 0 to 100, in which a lower score denotes a better perception of the patient's.
It is divided into eight categories: mobility (10 items), daily life activities (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (3 items) and body discomfort (3 items) .43 The score ranges from 0 (no problem) to 100 (maximum problem level), ie low score indicates the individual's perception of a better quality of life .. These items can be grouped into three domains: physical, mental and social. The score is made by rule of three and transformed into values from 0 to 100, and higher values refer to poorer quality of life.
arm group label: Exercises
arm group type: Active Comparator
description: A program of therapeutic exercises (GC) based on the PNF method for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GC treatment program consists of the following protocols: a) protocol 1: 20 minutes diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation),10 minutes diagonal exercise scapula (anterior and posterior elevation) and 10 minutes of exercise for trunk extension; b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training;
arm group label: Nintendo Wii
arm group type: Active Comparator
description: Nintendo Wii program (GW) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes.
The GW treatment program consists of the following protocols: a) protocol 1 games (Boxing and Soccer); b) protocol 2 games (Golf and running). 20 minutes for each game
arm group label: Exercises and Nintendo Wii
arm group type: Experimental
description: In GCW program will be performed 20 minutes GC protocol (1 or 2, used alternately between sessions a week) and 20 minutes GW protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols
intervention type: Other
intervention name: Exercises
description: A program of therapeutic exercises (GC) based on the PNF method for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GC treatment program consists of the following protocols: a) protocol 1: 20 minutes diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation),10 minutes diagonal exercise scapula (anterior and posterior elevation) and 10 minutes of exercise for trunk extension; b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training
arm group label: Exercises
intervention type: Other
intervention name: Nintendo Wii
description: Nintendo Wii program (GW) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes.
The GW treatment program consists of the following protocols: a) protocol 1 games (Boxing and Soccer); b) protocol 2 games (Golf and running). 20 minutes for each game
arm group label: Nintendo Wii
intervention type: Other
intervention name: Exercises and Nintendo Wii
description: In GCW program will be performed 20 minutes GC protocol (1 or 2, used alternately between sessions a week) and 20 minutes GW protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols
arm group label: Exercises and Nintendo Wii
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Brazil
url: http://dx.doi.org/10.4236/apd.2013.24018
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Federal University of Bahia
investigator full name: PIETRO ARAÚJO DOS SANTOS
investigator title: Principal Investigator
mesh term: Parkinson Disease
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The absence of an instrument to verify the presence of depression, which is a clinical condition present in some patients with PD and may have influenced the absence of more significant results.
point of contact: 