<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/NCT03777501</url>
  </required_header>
  <id_info>
    <org_study_id>201702010B0C603</org_study_id>
    <nct_id>NCT03777501</nct_id>
  </id_info>
  <brief_title>The Effect of Whole Body Vibration in Individuals With Parkinson's Disease</brief_title>
  <official_title>The Effect of Whole Body Vibration on Sensorimotor Function in Individuals With Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous studies reported that whole body vibration has the potential impact on balance and&#xD;
      walking abilities in individuals with Parkinson's disease; however, the inconsistent&#xD;
      treatment protocols and different experimental designs lead to inconclusive results.&#xD;
      Therefore, the purpose of this study is to investigate the short term and long term effect of&#xD;
      whole body vibration on sensorimotor function in individuals with Parkinson's disease. The&#xD;
      experimental design will be randomized double-blinded controlled trial. Sixty individuals&#xD;
      with idiopathic Parkinson's disease will be randomly assigned to two groups and they are&#xD;
      non-random whole body vibration group and conventional therapy group. Each participant will&#xD;
      receive the treatment about one hour after the administration of medicine. For non-random&#xD;
      whole body vibration group, participants will be required to maintain the erect standing&#xD;
      position on the vibratory platform and the frequency and amplitude of vibratory stimuli will&#xD;
      be 6Hz and 3mm respectively. Each treatment includes five sessions and each session is&#xD;
      composed of one minute whole body vibration and one minute rest. For the conventional therapy&#xD;
      group, participants will receive the occupational therapy including dynamic balance training&#xD;
      and functional ambulatory training. Each session is 10 minutes in both groups and all&#xD;
      participants will receive one and twelve treatment sessions for short-term and long-term&#xD;
      effect respectively. Outcome measures include proprioceptive sensitivity threshold of upper&#xD;
      limb, position sense test of the knee joint, Unified Parkinson's disease rating scale-motor&#xD;
      (UPDRS motor), functional reach, and time up and go test (TUG). Specifically, the&#xD;
      investigators want to answer the following four questions: 1) Is there any difference in&#xD;
      proprioceptive sensitivity, motor performance and balance before and after treatment in&#xD;
      individuals with Parkinson's disease? 2) Is there any difference in short-term and long term&#xD;
      effect of whole body vibration in individuals with Parkinson's disease? 3) Is there any&#xD;
      difference in treatment effect in individuals with Parkinson's disease in Taiwan?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 28, 2018</start_date>
  <completion_date type="Actual">June 28, 2019</completion_date>
  <primary_completion_date type="Actual">June 28, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>randomized double-blinded controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in just noticeable difference threshold of proprioceptive sensitivity</measure>
    <time_frame>baseline, 1 day and 4 weeks</time_frame>
    <description>This experiment will use psychophysical methods to assess subject perception, the psychophysical methods developed two thresholds: detection threshold/absolute threshold and difference threshold/just noticeable difference threshold (JNDT). Difference threshold represents the minimum difference between two different intensity stimulation. In this experiment, the investigator will test the difference threshold for position sense and passive motion sense</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of position sense of the knee joint</measure>
    <time_frame>baseline, 1 day and 4 weeks</time_frame>
    <description>In the beginning, each subject sits comfortably in an arm chair (knee flexion 90o). The subject's non-affected leg is passively moved at three target angles (knee flexion 15, 30 and 70 degrees), and maintained the testing angle for 15 seconds before being return to knee flexion 90 degree (initial position). Subjects will be required to move the knee joint of the ipsilateral leg to the target angle. The assessor will use a hand-held goniometer to measure the angle of knee flexion. Each target angle will be measured three times, and both knee joints will be tested.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Unified Parkinson's disease rating scale-motor (UPDRS motor)</measure>
    <time_frame>baseline, 1 day and 4 weeks</time_frame>
    <description>Unified Parkinson's disease rating scale is used to evaluate the disease progression for Parkinson's disease (PD). Higher scores represent the more advanced disease progression. It includes four subscales: mentation, behavior and mood, activities of daily living, motor examination, and complications of therapy. In this study, the investigator mainly use the motor examination subscale. There are 14 items in motor examination including speech, facial expression, tremor at test, action or postural tremor of hands, rigidity, finger taps, postural stability, gait, body bradykinesia and hypokinesia…etc. The purpose is to evaluate the motor performance for individuals with PD (Movement Disorder Society Task Force on Rating Scales for Parkinson's, 2003).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of balance function (measured by Functional Reach Test)</measure>
    <time_frame>baseline, 1 day and 4 weeks</time_frame>
    <description>The purpose of functional reach test is used to measure balance function. Participants can be in standing or sitting position (unable to stand). It measures the difference of distance in centimeters between arm's length with arms at 90° flexion and maximal forward reach with a fixed base of support.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of mobility function (measured by Time up and go test)</measure>
    <time_frame>baseline, 1 day and 4 weeks</time_frame>
    <description>The purpose of time up and go test (TUG) is to evaluate the mobility function including both static and dynamic balance. The experimenter uses a stopwatch to measure the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. Participants can walk independently or with walking devices. It is easy to administer and can applied to elderly population.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>non-random whole body vibration group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each participant will receive the non-random type whole body vibration treatment about one hour after the administration of medicine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional therapy group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For the conventional therapy group, participants will receive the occupational therapy including dynamic balance training and functional ambulatory training. Each session is 10 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>non-random whole body vibration</intervention_name>
    <description>Each participant will receive the treatment about one hour after the administration of medicine. For non-random whole body vibration group, participants will be required to maintain the erect standing position on the vibratory platform and the frequency and amplitude of vibratory stimuli will be 6Hz and 3mm respectively. Each treatment includes five sessions and each session is composed of one minute whole body vibration and one minute rest.</description>
    <arm_group_label>non-random whole body vibration group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>occupational therapy</intervention_name>
    <description>Participants will receive the occupational therapy including dynamic balance training and functional ambulatory training.</description>
    <arm_group_label>conventional therapy group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  agree to sign the informed consent form.&#xD;
&#xD;
          -  diagnosed with idiopathic Parkinson's disease with Hoehn and Yahr stage 2~3&#xD;
&#xD;
          -  cognitive impairment (Mini-Mental State Examination [MMSE] score greater than 24&#xD;
             points&#xD;
&#xD;
          -  no depression as evaluated by the Beck Depression Inventory&#xD;
&#xD;
          -  no severe arm injuries or shoulder dislocation which might interfere with&#xD;
             proprioceptive function&#xD;
&#xD;
          -  can perform reaching movement&#xD;
&#xD;
          -  no diagnosed peripheral nerve disorders or other neurologic conditions&#xD;
&#xD;
          -  no severe tremor which might interfere with the measurement proprioceptive function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diagnosed with other central nervous system diseases, ex: stroke&#xD;
&#xD;
          -  had surgeries in head or arms&#xD;
&#xD;
          -  unable to sit for assessment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital</name>
      <address>
        <city>Linkou</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>January 22, 2020</last_update_submitted>
  <last_update_submitted_qc>January 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung University</investigator_affiliation>
    <investigator_full_name>Kuan-yi Li</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>proprioception</keyword>
  <keyword>vibration</keyword>
  <keyword>balance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03777501
org study id: 201702010B0C603
nct id: NCT03777501
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Previous studies reported that whole body vibration has the potential impact on balance and
      walking abilities in individuals with Parkinson's disease; however, the inconsistent
      treatment protocols and different experimental designs lead to inconclusive results.
      Therefore, the purpose of this study is to investigate the short term and long term effect of
      whole body vibration on sensorimotor function in individuals with Parkinson's disease. The
      experimental design will be randomized double-blinded controlled trial. Sixty individuals
      with idiopathic Parkinson's disease will be randomly assigned to two groups and they are
      non-random whole body vibration group and conventional therapy group. Each participant will
      receive the treatment about one hour after the administration of medicine. For non-random
      whole body vibration group, participants will be required to maintain the erect standing
      position on the vibratory platform and the frequency and amplitude of vibratory stimuli will
      be 6Hz and 3mm respectively. Each treatment includes five sessions and each session is
      composed of one minute whole body vibration and one minute rest. For the conventional therapy
      group, participants will receive the occupational therapy including dynamic balance training
      and functional ambulatory training. Each session is 10 minutes in both groups and all
      participants will receive one and twelve treatment sessions for short-term and long-term
      effect respectively. Outcome measures include proprioceptive sensitivity threshold of upper
      limb, position sense test of the knee joint, Unified Parkinson's disease rating scale-motor
      (UPDRS motor), functional reach, and time up and go test (TUG). Specifically, the
      investigators want to answer the following four questions: 1) Is there any difference in
      proprioceptive sensitivity, motor performance and balance before and after treatment in
      individuals with Parkinson's disease? 2) Is there any difference in short-term and long term
      effect of whole body vibration in individuals with Parkinson's disease? 3) Is there any
      difference in treatment effect in individuals with Parkinson's disease in Taiwan?
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized double-blinded controlled trial
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change in just noticeable difference threshold of proprioceptive sensitivity
time frame: baseline, 1 day and 4 weeks
description: This experiment will use psychophysical methods to assess subject perception, the psychophysical methods developed two thresholds: detection threshold/absolute threshold and difference threshold/just noticeable difference threshold (JNDT). Difference threshold represents the minimum difference between two different intensity stimulation. In this experiment, the investigator will test the difference threshold for position sense and passive motion sense
measure: Change of position sense of the knee joint
time frame: baseline, 1 day and 4 weeks
description: In the beginning, each subject sits comfortably in an arm chair (knee flexion 90o). The subject's non-affected leg is passively moved at three target angles (knee flexion 15, 30 and 70 degrees), and maintained the testing angle for 15 seconds before being return to knee flexion 90 degree (initial position). Subjects will be required to move the knee joint of the ipsilateral leg to the target angle. The assessor will use a hand-held goniometer to measure the angle of knee flexion. Each target angle will be measured three times, and both knee joints will be tested.
measure: Change of Unified Parkinson's disease rating scale-motor (UPDRS motor)
time frame: baseline, 1 day and 4 weeks
description: Unified Parkinson's disease rating scale is used to evaluate the disease progression for Parkinson's disease (PD). Higher scores represent the more advanced disease progression. It includes four subscales: mentation, behavior and mood, activities of daily living, motor examination, and complications of therapy. In this study, the investigator mainly use the motor examination subscale. There are 14 items in motor examination including speech, facial expression, tremor at test, action or postural tremor of hands, rigidity, finger taps, postural stability, gait, body bradykinesia and hypokinesia…etc. The purpose is to evaluate the motor performance for individuals with PD (Movement Disorder Society Task Force on Rating Scales for Parkinson's, 2003).
measure: Change of balance function (measured by Functional Reach Test)
time frame: baseline, 1 day and 4 weeks
description: The purpose of functional reach test is used to measure balance function. Participants can be in standing or sitting position (unable to stand). It measures the difference of distance in centimeters between arm's length with arms at 90° flexion and maximal forward reach with a fixed base of support.
measure: Change of mobility function (measured by Time up and go test)
time frame: baseline, 1 day and 4 weeks
description: The purpose of time up and go test (TUG) is to evaluate the mobility function including both static and dynamic balance. The experimenter uses a stopwatch to measure the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. Participants can walk independently or with walking devices. It is easy to administer and can applied to elderly population.
arm group label: non-random whole body vibration group
arm group type: Experimental
description: Each participant will receive the non-random type whole body vibration treatment about one hour after the administration of medicine.
arm group label: conventional therapy group
arm group type: Active Comparator
description: For the conventional therapy group, participants will receive the occupational therapy including dynamic balance training and functional ambulatory training. Each session is 10 minutes.
intervention type: Behavioral
intervention name: non-random whole body vibration
description: Each participant will receive the treatment about one hour after the administration of medicine. For non-random whole body vibration group, participants will be required to maintain the erect standing position on the vibratory platform and the frequency and amplitude of vibratory stimuli will be 6Hz and 3mm respectively. Each treatment includes five sessions and each session is composed of one minute whole body vibration and one minute rest.
arm group label: non-random whole body vibration group
intervention type: Behavioral
intervention name: occupational therapy
description: Participants will receive the occupational therapy including dynamic balance training and functional ambulatory training.
arm group label: conventional therapy group
criteria: 
gender: All
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Gung University
investigator full name: Kuan-yi Li
investigator title: Associate professor
mesh term: Parkinson Disease
sharing ipd: No