<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/NCT03799887</url>
  </required_header>
  <id_info>
    <org_study_id>2010-171</org_study_id>
    <nct_id>NCT03799887</nct_id>
  </id_info>
  <brief_title>Effects of Different Percentages Body Weight Supported Treadmill Training on Gait, Balance, Quality of Life and Fatigue in Parkinson's Disease</brief_title>
  <official_title>Effects of Different Percentages Body Weight Supported Treadmill Training on Gait, Balance, Quality of Life and Fatigue in Parkinson's Disease: A Double Blind Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hitit University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hitit 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>
      Body weight supported treadmill training (BWSTT) is an important rehabilitative choice for&#xD;
      neurologically impaired subjects such as Parkinson's disease (PD). The aim of the study is to&#xD;
      evaluate the effectiveness of different percentages BWSTT on gait, balance, quality of life&#xD;
      and fatigue in moderate to advanced PD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Body weight supported treadmill training (BWSTT) is an important rehabilitative choice for&#xD;
      neurologically impaired subjects such as Parkinson's disease (PD). The aim of the study is to&#xD;
      evaluate the effectiveness of different percentages BWSTT on gait, balance, quality of life&#xD;
      and fatigue in moderate to advanced PD. Thirty five patients were randomly assigned to one of&#xD;
      the three groups according to the percentage unweighed: 0% BWSTT, 10% BWSTT and 20% BWSTT.&#xD;
      All patients participated 30 minutes BWSTT sessions 5 days a week, for 6 weeks. Primary&#xD;
      outcomes were 6 minute walk test (6MWT), Berg balance scale (BBS), Unified Parkinson's&#xD;
      Disease Rating Scale (UPDRS); and secondary outcomes were Nottingham health profile (NHP),&#xD;
      Fatigue Impact Scale (FIS) and Fatigue Severity Scale (FSS) which were performed at the&#xD;
      beginning and end of the rehabilitation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 20, 2010</start_date>
  <completion_date type="Actual">November 20, 2012</completion_date>
  <primary_completion_date type="Actual">October 20, 2010</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>6 Minute Walk Test (6MWT)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Functional exercise capacity was assessed by distance walked in 6 minutes (6MWT). The patient was asked to walk as long as possible for 6 minutes on a 30 meters of marked and flat ground, at a self selected speed. 6MWT is a submaximal exercise test and can be used to assess treatment response .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Berg Balance Scale (BBS):</measure>
    <time_frame>6 weeks</time_frame>
    <description>It contains 14 instructions and 0 - 4 points is given for each instruction according to the performance of the patients. 0 points are given when the patient totally could not do the activity while 4 points are given when the patient completes the activity independently.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Unified Parkinson's Disease Rating Scale (UPDRS):</measure>
    <time_frame>6 weeks</time_frame>
    <description>It is used to follow the clinical status of PD. It consists of four main parts (totally 183 points): mentation, behavior and mood (UPDRS I: 16 points), activities of daily living (UPDRS II: 52 points), motor examination (UPDRS III: 92 points), treatment complications (UPDRS IV: 23 points).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nottingham Health Profile (NHP):</measure>
    <time_frame>6 weeks</time_frame>
    <description>It contains 38 items that address pain, physical mobility, emotional reactions, energy, social isolation, and sleep dimensions. Higher scores indicate worse quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue Impact Scale (FIS):</measure>
    <time_frame>6 weeks</time_frame>
    <description>This scale assesses the cognitive, physical and social effects of fatigue during the last one week in a total of 40 - item questionnaire (0 = no problem, 4 = maximum problem).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue Severity Scale (FSS):</measure>
    <time_frame>6 weeks</time_frame>
    <description>This scale assesses the severity of fatigue during the last one week in a total of 9 - item questionnaire (1 = strongly disagree, 7 = strongly agree). The total score ranges from 9 - 63, in which higher score means higher severity of fatigue .</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>0% unweighed BWSTT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0% unweighed Body Weight Supported Treadmill Training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>10% unweighed BWSTT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0% unweighed Body Weight Supported Treadmill Training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>20% unweighed BWSTT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20% unweighed Body Weight Supported Treadmill Training</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>0% unweighed BWSTT</intervention_name>
    <description>30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises.&#xD;
After CRP, participants were provided 30 minutes 0% unweighed BWSTT sessions including a 5 minutes warm - up and cool - down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions).</description>
    <arm_group_label>0% unweighed BWSTT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>10% unweighed BWSTT</intervention_name>
    <description>30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises.&#xD;
After CRP, participants were provided 30 minutes 10% unweighed BWSTT sessions including a 5 minutes warm - up and cool - down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions).</description>
    <arm_group_label>10% unweighed BWSTT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>20% unweighed BWSTT</intervention_name>
    <description>30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises.&#xD;
After CRP, participants were provided 30 minutes 20% unweighed BWSTT sessions including a 5 minutes warm - up and cool - down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions).</description>
    <arm_group_label>20% unweighed BWSTT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of Parkinson's disease according to the UK Brain Bank criteria.&#xD;
&#xD;
          -  Subjects had clinically moderate to advanced severity of disease (Hoehn and Yahr stage&#xD;
             2 - 4).&#xD;
&#xD;
          -  Subjects whose medical treatment had been on stable dosage of dopaminomimetics for at&#xD;
             least 4 weeks before the study.&#xD;
&#xD;
          -  Subjects ability to walk with or without assistive device.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects had cardiovascular, inflammatory or musculoskeletal problems that could&#xD;
             prevent them to participate in an exercise program.&#xD;
&#xD;
          -  Subjects whose mini mental status examination score was less than 26.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tuğba Atan</name>
      <address>
        <city>Çorum</city>
        <zip>19100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hitit University</investigator_affiliation>
    <investigator_full_name>Tuğba Atan</investigator_full_name>
    <investigator_title>Assoc. Prof.</investigator_title>
  </responsible_party>
  <keyword>Parkinson's disease</keyword>
  <keyword>gait</keyword>
  <keyword>balance</keyword>
  <keyword>treadmill training</keyword>
  <keyword>fatigue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Fatigue</mesh_term>
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03799887
org study id: 2010-171
nct id: NCT03799887
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Body weight supported treadmill training (BWSTT) is an important rehabilitative choice for
      neurologically impaired subjects such as Parkinson's disease (PD). The aim of the study is to
      evaluate the effectiveness of different percentages BWSTT on gait, balance, quality of life
      and fatigue in moderate to advanced PD.
Body weight supported treadmill training (BWSTT) is an important rehabilitative choice for
      neurologically impaired subjects such as Parkinson's disease (PD). The aim of the study is to
      evaluate the effectiveness of different percentages BWSTT on gait, balance, quality of life
      and fatigue in moderate to advanced PD. Thirty five patients were randomly assigned to one of
      the three groups according to the percentage unweighed: 0% BWSTT, 10% BWSTT and 20% BWSTT.
      All patients participated 30 minutes BWSTT sessions 5 days a week, for 6 weeks. Primary
      outcomes were 6 minute walk test (6MWT), Berg balance scale (BBS), Unified Parkinson's
      Disease Rating Scale (UPDRS); and secondary outcomes were Nottingham health profile (NHP),
      Fatigue Impact Scale (FIS) and Fatigue Severity Scale (FSS) which were performed at the
      beginning and end of the rehabilitation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: 6 Minute Walk Test (6MWT)
time frame: 6 weeks
description: Functional exercise capacity was assessed by distance walked in 6 minutes (6MWT). The patient was asked to walk as long as possible for 6 minutes on a 30 meters of marked and flat ground, at a self selected speed. 6MWT is a submaximal exercise test and can be used to assess treatment response .
measure: Berg Balance Scale (BBS):
time frame: 6 weeks
description: It contains 14 instructions and 0 - 4 points is given for each instruction according to the performance of the patients. 0 points are given when the patient totally could not do the activity while 4 points are given when the patient completes the activity independently.
measure: Unified Parkinson's Disease Rating Scale (UPDRS):
time frame: 6 weeks
description: It is used to follow the clinical status of PD. It consists of four main parts (totally 183 points): mentation, behavior and mood (UPDRS I: 16 points), activities of daily living (UPDRS II: 52 points), motor examination (UPDRS III: 92 points), treatment complications (UPDRS IV: 23 points).
measure: Nottingham Health Profile (NHP):
time frame: 6 weeks
description: It contains 38 items that address pain, physical mobility, emotional reactions, energy, social isolation, and sleep dimensions. Higher scores indicate worse quality of life.
measure: Fatigue Impact Scale (FIS):
time frame: 6 weeks
description: This scale assesses the cognitive, physical and social effects of fatigue during the last one week in a total of 40 - item questionnaire (0 = no problem, 4 = maximum problem).
measure: Fatigue Severity Scale (FSS):
time frame: 6 weeks
description: This scale assesses the severity of fatigue during the last one week in a total of 9 - item questionnaire (1 = strongly disagree, 7 = strongly agree). The total score ranges from 9 - 63, in which higher score means higher severity of fatigue .
arm group label: 0% unweighed BWSTT
arm group type: Active Comparator
description: 0% unweighed Body Weight Supported Treadmill Training
arm group label: 10% unweighed BWSTT
arm group type: Experimental
description: 0% unweighed Body Weight Supported Treadmill Training
arm group label: 20% unweighed BWSTT
arm group type: Experimental
description: 20% unweighed Body Weight Supported Treadmill Training
intervention type: Behavioral
intervention name: 0% unweighed BWSTT
description: 30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises.
After CRP, participants were provided 30 minutes 0% unweighed BWSTT sessions including a 5 minutes warm - up and cool - down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions).
arm group label: 0% unweighed BWSTT
intervention type: Behavioral
intervention name: 10% unweighed BWSTT
description: 30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises.
After CRP, participants were provided 30 minutes 10% unweighed BWSTT sessions including a 5 minutes warm - up and cool - down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions).
arm group label: 10% unweighed BWSTT
intervention type: Behavioral
intervention name: 20% unweighed BWSTT
description: 30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises.
After CRP, participants were provided 30 minutes 20% unweighed BWSTT sessions including a 5 minutes warm - up and cool - down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions).
arm group label: 20% unweighed BWSTT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hitit University
investigator full name: Tuğba Atan
investigator title: Assoc. Prof.
mesh term: Parkinson Disease
mesh term: Fatigue
mesh term: Body Weight
sharing ipd: Yes