<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/NCT02999997</url>
  </required_header>
  <id_info>
    <org_study_id>LUH-4865</org_study_id>
    <nct_id>NCT02999997</nct_id>
  </id_info>
  <brief_title>Evaluation of Ronnie Gardiner Method in Individuals With Parkinson's Disease</brief_title>
  <acronym>RGM/PD</acronym>
  <official_title>Randomized Controlled Trial to Evaluate the Rhythm and Music Based Rehabilitation Method the Ronnie Gardiner Method Regarding Dual-task in Individuals With Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Linkoeping</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Linkoeping</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Parkinson's disease (PD) is typically associated with cognitive and movement related&#xD;
      functional disabilities. One commonly described cognitive complaint is the ability to do&#xD;
      several things simultaneously, defined as dual or multiple tasking. The Ronnie Gardiner&#xD;
      Method (RGM) is a rhythm and music based rehabilitation intervention that includes components&#xD;
      that will train this ability specifically in addition to postural control, motor learning,&#xD;
      movement ability and general cognitive function. The aim with the present randomized&#xD;
      controlled single-blinded trial is to evaluate the RGM with main focus on dual-task&#xD;
      performance, compared to a control group, in individuals with PD. The control group will&#xD;
      continue with everyday activities, including ordinary exercise activities, with no additional&#xD;
      activity. Both groups will be evaluated pre-, post-, and after 3 months post intervention.&#xD;
      Following outcome measures will be analyzed:&#xD;
&#xD;
        1. dual task performance (motor-motor, and motor-cognitive)&#xD;
&#xD;
        2. level of physical activity, motor function and balance&#xD;
&#xD;
        3. cognitive function including memory and spatial function&#xD;
&#xD;
        4. health-related quality of life, fear of falling, and freezing of gait&#xD;
&#xD;
        5. qualitative interviews from focus group discussions&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with Parkinson's disease at the neurological department of University Hospital of&#xD;
      Linköping are included and randomized to either the rhythm and music based rehabilitation&#xD;
      method Ronnie Gardiner Method or to a control group with no other activity other than&#xD;
      everyday activities including habitual exercise. Timed Up and Go (TUG) cognitive and TUG&#xD;
      manual will be used to evaluate dual-task performance. The intervention will take place twice&#xD;
      weekly for twelve weeks in a neurological rehabilitation facility, and will be led by a&#xD;
      highly skilled physiotherapist with ten years of practice from the Ronnie Gardiner Method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">April 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Timed Up and Go Cognitive (TUGcog) (motor-cognitive dual task)</measure>
    <time_frame>Change from Baseline through study completion (at 12 weeks) and at 3 months</time_frame>
    <description>Time in seconds to complete the following sequence: stand up from a chair, walk 3 meters, turn, walk back to the chair and sit down with the addition of counting backwards with 7 from 100, 90, 80, 70, 60, or 50. Number of errors are noted. Higher speed indicated better function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed Up and Go manual (TUG manual) (motor-motor dual task)</measure>
    <time_frame>Change from Baseline through study completion (at 12 weeks) and at 3 months</time_frame>
    <description>Time in seconds to complete the following sequence: stand up from a chair, walk 3 meters, turn, walk back to the chair and sit down with the additional task to carry a tray with two glasses of water. Higher speed indicates better function.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dual-task cost (DTC)</measure>
    <time_frame>Change from Baseline through study completion (at 12 weeks) and at 3 months</time_frame>
    <description>Measuring the difference between Timed Up and Go (TUG) single task and TUG cognitive and manual respectively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini-BESTest (Balance Evaluation Systems Test)</measure>
    <time_frame>Change from Baseline through study completion (at 12 weeks) and at 3 months</time_frame>
    <description>A balance test focusing on dynamic balance and can be conducted in 10-15 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Four Step Square Test, FSST</measure>
    <time_frame>Change from Baseline through study completion (at 12 weeks) and at 3 months</time_frame>
    <description>Patient steps over four canes set-up like a cross on the floor with the tips of the canes facing together. At the start of the test, the patient stands on the upper left square (in Square 1, facing Square 2). The stepping sequence is (clockwise): Square 1, Square 2, Square 4, Square 3, return to Square 1 with the feet. Then (counterclockwise): Back to Square 3, Square 4, Square 2, and end in Square 1 with both feet.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Scale</measure>
    <time_frame>Change from Baseline through study completion (at 12 weeks) and at 3 months</time_frame>
    <description>Static and dynamic activities of varying difficulty are performed. Item-level scores range from 0-4, determined by ability to perform the assessed activity. Item scores are summed. Maximum score = 56</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chair stand 30 seconds</measure>
    <time_frame>Change from Baseline through study completion (at 12 weeks) and at 3 months</time_frame>
    <description>Standing up and sitting down, hands crossed over chest, as many times as possible for 30 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>Change from Baseline through study completion (at 12 weeks) and at 3 months</time_frame>
    <description>Screening of cognitive function. License has been approved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Auditory memory test, direct and delayed</measure>
    <time_frame>Change from Baseline through study completion (at 12 weeks) and at 3 months</time_frame>
    <description>A text is read to the patient. The patient is then required to reproduce the text as exactly as possible, and then again after appr. 10 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symbol Digit Modalities Test (SDMT)</measure>
    <time_frame>Change from Baseline through study completion (at 12 weeks) and at 3 months</time_frame>
    <description>A code key is presented to the patient where each code key represents a number between 1 and 9. The patient is then required to solve as many codes as possible in 90 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Victoria Stroop test</measure>
    <time_frame>Change from Baseline through study completion (at 12 weeks) and at 3 months</time_frame>
    <description>Colored words are presented to the patient but in a different color than the word says, eg. the word BLUE appears in the color red and the patient is required to say &quot;red&quot;, and not read the word &quot;blue&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grooved Pegboard</measure>
    <time_frame>Change from Baseline through study completion (at 12 weeks) and at 3 months</time_frame>
    <description>The patient is required to move a number of metal sticks from one side to another as fast as possible. A measure of fine motor control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trail Making Test A and B</measure>
    <time_frame>Change from Baseline through study completion (at 12 weeks) and at 3 months</time_frame>
    <description>The patient is required to draw a line between the numbers 1 to 25 (A), and between the numbers 1 to 13 and vary to the letters A to L, i.e. 1-A-2-B-3-C, etc, without lifting the pen from the paper.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rey complex figure</measure>
    <time_frame>Change from Baseline through study completion (at 12 weeks) and at 3 months</time_frame>
    <description>The patient is required to copy a figure twice: the first time from a model in front of him/her; the second time without the model by memory only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WHODAS 2.0</measure>
    <time_frame>Baseline</time_frame>
    <description>A questionnaire based on the International Classification of Functioning (ICF) for assessing impairments and function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freezing of gait questionnaire</measure>
    <time_frame>Change from Baseline through study completion (at 12 weeks) and at 3 months</time_frame>
    <description>A questionnaire with questions about freezing of gait</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parkinson's disease questionnaire 39 items (PDQ-39)</measure>
    <time_frame>Change from Baseline through study completion (at 12 weeks) and at 3 months</time_frame>
    <description>A questionnaire for quality of life in people with Parkinson's disease. License as been approved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Falls Efficacy Scale International (FES-I)</measure>
    <time_frame>Change from Baseline through study completion (at 12 weeks) and at 3 months</time_frame>
    <description>A questionnaire related to fear of falling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Actigraphy with GeneActiv Armband</measure>
    <time_frame>Change from Baseline through study completion (at 12 weeks) and at 3 months</time_frame>
    <description>Actigraphy is a method to evaluate physical activity in a research person´s normal life. GeneActiv is used to record number of steps daily but also time spent lying and standing which will give information about the activity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Ronnie Gardiner Method (RGM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercising two times/week according to the RGM program in groups of 15 participants (2 groups).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control group are instructed to live their ordinary life.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Ronnie Gardiner Method (RGM)</intervention_name>
    <description>RGM includes functional exercises consisting of cognitively challenging multi-task exercises. The exercises are performed sitting down or standing up with weight shifting exercises. The practitioner projects unique symbols shaped as red or blue hands and feet on the wall in specific 'choreoscores' of 2-8 bars. Red symbolizes left side of the body, blue the right side. Each symbol is accompanied with a certain movement and sound code. To the sound of rhythmical music the participants follow the symbols beat by beat, performing the movements and pronouncing the word. The exercises are progressed by increasing the tempo of the music, or by using more symbols. The practitioner uses a shirt with the color red on one side, and blue on the other side, in order to facilitate for the participants.</description>
    <arm_group_label>Ronnie Gardiner Method (RGM)</arm_group_label>
    <other_name>In Sweden and Israel known as RGRM</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parkinson's disease, stage 1,5 to 4 on the Hoehn &amp; Yahr scale, community dwelling,&#xD;
             stable medication, being able to walk at least 10 meters, being able to transport to&#xD;
             the intervention facility, being able to follow instructions in Swedish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  parkinsonism of other origin, color blindness, severely impaired vision or hearing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Petra Pohl, PhD, RPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Linkoeping</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Neurological clinic, Linkoeping Universityhospital</name>
      <address>
        <city>Linkoping</city>
        <state>Ostergotland</state>
        <zip>58185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>December 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>May 1, 2018</last_update_submitted>
  <last_update_submitted_qc>May 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Linkoeping</investigator_affiliation>
    <investigator_full_name>Petra Pohl</investigator_full_name>
    <investigator_title>PhD, Researcher</investigator_title>
  </responsible_party>
  <keyword>Physical therapy modalities</keyword>
  <keyword>Dual-task performance</keyword>
  <keyword>Parkinson's disease</keyword>
  <keyword>Active music therapy</keyword>
  <keyword>Physical activity</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/NCT02999997
org study id: LUH-4865
nct id: NCT02999997
lead sponsor: 
has dmc: No
Parkinson's disease (PD) is typically associated with cognitive and movement related
      functional disabilities. One commonly described cognitive complaint is the ability to do
      several things simultaneously, defined as dual or multiple tasking. The Ronnie Gardiner
      Method (RGM) is a rhythm and music based rehabilitation intervention that includes components
      that will train this ability specifically in addition to postural control, motor learning,
      movement ability and general cognitive function. The aim with the present randomized
      controlled single-blinded trial is to evaluate the RGM with main focus on dual-task
      performance, compared to a control group, in individuals with PD. The control group will
      continue with everyday activities, including ordinary exercise activities, with no additional
      activity. Both groups will be evaluated pre-, post-, and after 3 months post intervention.
      Following outcome measures will be analyzed:

        1. dual task performance (motor-motor, and motor-cognitive)

        2. level of physical activity, motor function and balance

        3. cognitive function including memory and spatial function

        4. health-related quality of life, fear of falling, and freezing of gait

        5. qualitative interviews from focus group discussions
Patients with Parkinson's disease at the neurological department of University Hospital of
      Linköping are included and randomized to either the rhythm and music based rehabilitation
      method Ronnie Gardiner Method or to a control group with no other activity other than
      everyday activities including habitual exercise. Timed Up and Go (TUG) cognitive and TUG
      manual will be used to evaluate dual-task performance. The intervention will take place twice
      weekly for twelve weeks in a neurological rehabilitation facility, and will be led by a
      highly skilled physiotherapist with ten years of practice from the Ronnie Gardiner Method.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Timed Up and Go Cognitive (TUGcog) (motor-cognitive dual task)
time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
description: Time in seconds to complete the following sequence: stand up from a chair, walk 3 meters, turn, walk back to the chair and sit down with the addition of counting backwards with 7 from 100, 90, 80, 70, 60, or 50. Number of errors are noted. Higher speed indicated better function.
measure: Timed Up and Go manual (TUG manual) (motor-motor dual task)
time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
description: Time in seconds to complete the following sequence: stand up from a chair, walk 3 meters, turn, walk back to the chair and sit down with the additional task to carry a tray with two glasses of water. Higher speed indicates better function.
measure: Dual-task cost (DTC)
time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
description: Measuring the difference between Timed Up and Go (TUG) single task and TUG cognitive and manual respectively
measure: Mini-BESTest (Balance Evaluation Systems Test)
time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
description: A balance test focusing on dynamic balance and can be conducted in 10-15 minutes.
measure: Four Step Square Test, FSST
time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
description: Patient steps over four canes set-up like a cross on the floor with the tips of the canes facing together. At the start of the test, the patient stands on the upper left square (in Square 1, facing Square 2). The stepping sequence is (clockwise): Square 1, Square 2, Square 4, Square 3, return to Square 1 with the feet. Then (counterclockwise): Back to Square 3, Square 4, Square 2, and end in Square 1 with both feet.
measure: Berg Balance Scale
time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
description: Static and dynamic activities of varying difficulty are performed. Item-level scores range from 0-4, determined by ability to perform the assessed activity. Item scores are summed. Maximum score = 56
measure: Chair stand 30 seconds
time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
description: Standing up and sitting down, hands crossed over chest, as many times as possible for 30 seconds.
measure: Montreal Cognitive Assessment (MoCA)
time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
description: Screening of cognitive function. License has been approved.
measure: Auditory memory test, direct and delayed
time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
description: A text is read to the patient. The patient is then required to reproduce the text as exactly as possible, and then again after appr. 10 minutes.
measure: Symbol Digit Modalities Test (SDMT)
time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
description: A code key is presented to the patient where each code key represents a number between 1 and 9. The patient is then required to solve as many codes as possible in 90 seconds.
measure: Victoria Stroop test
time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
description: Colored words are presented to the patient but in a different color than the word says, eg. the word BLUE appears in the color red and the patient is required to say "red", and not read the word "blue".
measure: Grooved Pegboard
time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
description: The patient is required to move a number of metal sticks from one side to another as fast as possible. A measure of fine motor control.
measure: Trail Making Test A and B
time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
description: The patient is required to draw a line between the numbers 1 to 25 (A), and between the numbers 1 to 13 and vary to the letters A to L, i.e. 1-A-2-B-3-C, etc, without lifting the pen from the paper.
measure: Rey complex figure
time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
description: The patient is required to copy a figure twice: the first time from a model in front of him/her; the second time without the model by memory only.
measure: WHODAS 2.0
time frame: Baseline
description: A questionnaire based on the International Classification of Functioning (ICF) for assessing impairments and function.
measure: Freezing of gait questionnaire
time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
description: A questionnaire with questions about freezing of gait
measure: Parkinson's disease questionnaire 39 items (PDQ-39)
time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
description: A questionnaire for quality of life in people with Parkinson's disease. License as been approved.
measure: Falls Efficacy Scale International (FES-I)
time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
description: A questionnaire related to fear of falling.
measure: Actigraphy with GeneActiv Armband
time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
description: Actigraphy is a method to evaluate physical activity in a research person´s normal life. GeneActiv is used to record number of steps daily but also time spent lying and standing which will give information about the activity.
arm group label: Ronnie Gardiner Method (RGM)
arm group type: Experimental
description: Exercising two times/week according to the RGM program in groups of 15 participants (2 groups).
arm group label: Control group
arm group type: No Intervention
description: Participants in the control group are instructed to live their ordinary life.
intervention type: Behavioral
intervention name: Ronnie Gardiner Method (RGM)
description: RGM includes functional exercises consisting of cognitively challenging multi-task exercises. The exercises are performed sitting down or standing up with weight shifting exercises. The practitioner projects unique symbols shaped as red or blue hands and feet on the wall in specific 'choreoscores' of 2-8 bars. Red symbolizes left side of the body, blue the right side. Each symbol is accompanied with a certain movement and sound code. To the sound of rhythmical music the participants follow the symbols beat by beat, performing the movements and pronouncing the word. The exercises are progressed by increasing the tempo of the music, or by using more symbols. The practitioner uses a shirt with the color red on one side, and blue on the other side, in order to facilitate for the participants.
arm group label: Ronnie Gardiner Method (RGM)
other name: In Sweden and Israel known as RGRM
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Petra Pohl, PhD, RPT
role: Principal Investigator
affiliation: University Hospital, Linkoeping
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Linkoeping
investigator full name: Petra Pohl
investigator title: PhD, Researcher
mesh term: Parkinson Disease