<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/NCT04420910</url>
  </required_header>
  <id_info>
    <org_study_id>2019-71</org_study_id>
    <nct_id>NCT04420910</nct_id>
  </id_info>
  <brief_title>Non-motor Symptoms, Balance, Muscle Strength, and Functional Mobility in Patients With Parkinson's Disease</brief_title>
  <official_title>Investigation of Non-motor Symptoms, Balance, Muscle Strength, and Functional Mobility in Patients With Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara Yildirim Beyazıt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara Yildirim Beyazıt University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purposes of this study is to examine balance, muscle strength, and mobility in relation&#xD;
      with non-motor symptoms (NMSs) in patients with Parkinsosn's Disease (PD).&#xD;
&#xD;
      NMSs have been shown to be the key determinant of health-related quality of life (HRQoL) and&#xD;
      have a greater effect on HRQoL compared to motor symptoms.Despite a growing literature on&#xD;
      NMSs, there are few data on the association between NMSs and motor phenotypes of PD, and they&#xD;
      have usually focused only on specific domains of NMSs, such as cognition, mood/anxiety&#xD;
      issues, or sleep disorders.&#xD;
&#xD;
      When literature is examined, there is no study which examines balance, muscle strength, and&#xD;
      mobility in relation with NMSs in patients with PD.For all these reasons, we think that&#xD;
      balance, muscle strength, mobility, and NMSs in patients with PD are worse than those of the&#xD;
      healthy individuals and that there is a relationship between NMSs and motor symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2019</start_date>
  <completion_date type="Actual">September 15, 2019</completion_date>
  <primary_completion_date type="Actual">August 15, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Non-Motor Symptoms</measure>
    <time_frame>one hour</time_frame>
    <description>Non-motor symptoms of the participants were evaluated using the Non-Motor Symptoms Scale (NMSS).Each item of the scale is scored between 0 and 30, with &quot;yes&quot; 1 point and &quot;no&quot; 0 point. According to the scoring result, &quot;0&quot; indicates no NMSs, &quot;1-5&quot; indicates mild NMSs, &quot;6-9&quot; indicates medium NMSs, &quot;10-13&quot; indicates heavy NMSs, and &quot;≥14&quot; indicates very heavy NMSs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Balance</measure>
    <time_frame>one hour</time_frame>
    <description>To measure balance, the Biodex Balance System (Biodex Medical Systems, Shirley, NY, USA) was used.The test consisted of three 20 s trials, each separated by 10 s breaks. Measurements were conducted while their eyes were open and close, and the results were analyzed by calculating the average value of the measurements. As a result, overall stability and anteroposterior and mediolateral indexes were taken into account, and low values indicate high postural stability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lower limb strength</measure>
    <time_frame>one hour</time_frame>
    <description>A Biodex® System 4 Dynamometer device was used to evaluate muscle strength.Maximal concentric knee flexion and extension muscle strength was measured at 90 degrees/sec angular velocity with 5 repetition [19]. The flexion and extension peak torque (PT) values, peak torque/body weight (PT/BW) ratio, and hamstring/quadriceps (H/Q) ratio were recorded. Low values indicate decreased muscle strength.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional mobility</measure>
    <time_frame>one hour</time_frame>
    <description>The Timed Up and Go test (TUG) was used in the evaluation of functional mobility. Dual task performance was performed by adding cognitive and motor tasks into the TUG.. As the time increases, dual task performance decreases.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">44</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Balance</condition>
  <condition>Muscle Strength</condition>
  <condition>Mobility</condition>
  <condition>Non-motor Symptoms</condition>
  <arm_group>
    <arm_group_label>Parkinson's disease group</arm_group_label>
    <description>being diagnosed with PD by a neurologist, being in Hoehn &amp; Yahr Stage 1-3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy group</arm_group_label>
    <description>20 healthy volunteers with matching ages and genders.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-Motor Symptoms</intervention_name>
    <description>NMSs of the participants were evaluated using the Non-Motor Symptoms Scale (NMSS). The scale consists of 30 yes-no questions and is administered face to face with the therapist.</description>
    <arm_group_label>Healthy group</arm_group_label>
    <arm_group_label>Parkinson's disease group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Balance</intervention_name>
    <description>To measure balance, the Biodex Balance System (Biodex Medical Systems, Shirley, NY, USA) was used. The participants were asked to position themselves in a comfortable position on the platform, and their foot position coordinates were recorded. The participants focused on a characteristic dot on the monitor screen. Their task was to balance the body in such a way that the dot was in the center of a circle displayed on the monitor at the point of intersection of the coordinate axes. The test consisted of three 20 s trials, each separated by 10 s breaks. Measurements were conducted while their eyes were open and close, and the results were analyzed by calculating the average value of the measurements.</description>
    <arm_group_label>Healthy group</arm_group_label>
    <arm_group_label>Parkinson's disease group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lower Limb Strength</intervention_name>
    <description>A Biodex® System 4 Dynamometer device was used to evaluate muscle strength. The participants' dominant extremity was determined by asking them the foot with which they most often hit the ball.The dynamometer arm of the device was placed at the lateral condyle level of the knee, and the belt at the distal end of the dynamometer was attached to the lower leg on the malleolus. Knee flexion and extension movements were evaluated in sitting position between 90ᵒ flexion and 0ᵒ extension angles. The individual was asked to perform it with the maximum strength, while the therapist motivated the individual with verbal stimulation.</description>
    <arm_group_label>Healthy group</arm_group_label>
    <arm_group_label>Parkinson's disease group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Functional mobility</intervention_name>
    <description>The Timed Up and Go test (TUG) was used in the evaluation of functional mobility. . For this test, participants were seated on a standard armless chair and a cone was placed 3 meters away from the chair. Participants were instructed to stand up and (1) walk towards the cone, (2) turn around the cone, (3) walk back to the chair, and (4) sit back on the chair. It was stated that patients should walk without running but as fast as possible. Dual task performance was performed by adding cognitive and motor tasks into the TUG.</description>
    <arm_group_label>Healthy group</arm_group_label>
    <arm_group_label>Parkinson's disease group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        being diagnosed with PD by a neurologist, being in Hoehn &amp; Yahr Stage 1-3 and healthy&#xD;
        individuals of similar age and sex&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  being diagnosed with PD by a neurologist, being in Hoehn &amp; Yahr Stage 1-3, having no&#xD;
             musculoskeletal system problems in the previous 6 months, having a score of 24 or more&#xD;
             in the Mini-Mental State Examination (MMSE), and being volunteer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Healthy individuals of similar age and sex, without neurological problems, and who did&#xD;
             not experience any musculoskeletal system problems in the previous 6 months were&#xD;
             included in the control group.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation</name>
      <address>
        <city>Ankara</city>
        <state>Esenboğa</state>
        <zip>06970</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04420910
org study id: 2019-71
nct id: NCT04420910
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purposes of this study is to examine balance, muscle strength, and mobility in relation
      with non-motor symptoms (NMSs) in patients with Parkinsosn's Disease (PD).

      NMSs have been shown to be the key determinant of health-related quality of life (HRQoL) and
      have a greater effect on HRQoL compared to motor symptoms.Despite a growing literature on
      NMSs, there are few data on the association between NMSs and motor phenotypes of PD, and they
      have usually focused only on specific domains of NMSs, such as cognition, mood/anxiety
      issues, or sleep disorders.

      When literature is examined, there is no study which examines balance, muscle strength, and
      mobility in relation with NMSs in patients with PD.For all these reasons, we think that
      balance, muscle strength, mobility, and NMSs in patients with PD are worse than those of the
      healthy individuals and that there is a relationship between NMSs and motor symptoms.
observational model: Case-Control
time perspective: Prospective
measure: Non-Motor Symptoms
time frame: one hour
description: Non-motor symptoms of the participants were evaluated using the Non-Motor Symptoms Scale (NMSS).Each item of the scale is scored between 0 and 30, with "yes" 1 point and "no" 0 point. According to the scoring result, "0" indicates no NMSs, "1-5" indicates mild NMSs, "6-9" indicates medium NMSs, "10-13" indicates heavy NMSs, and "≥14" indicates very heavy NMSs.
measure: Balance
time frame: one hour
description: To measure balance, the Biodex Balance System (Biodex Medical Systems, Shirley, NY, USA) was used.The test consisted of three 20 s trials, each separated by 10 s breaks. Measurements were conducted while their eyes were open and close, and the results were analyzed by calculating the average value of the measurements. As a result, overall stability and anteroposterior and mediolateral indexes were taken into account, and low values indicate high postural stability.
measure: Lower limb strength
time frame: one hour
description: A Biodex® System 4 Dynamometer device was used to evaluate muscle strength.Maximal concentric knee flexion and extension muscle strength was measured at 90 degrees/sec angular velocity with 5 repetition [19]. The flexion and extension peak torque (PT) values, peak torque/body weight (PT/BW) ratio, and hamstring/quadriceps (H/Q) ratio were recorded. Low values indicate decreased muscle strength.
measure: Functional mobility
time frame: one hour
description: The Timed Up and Go test (TUG) was used in the evaluation of functional mobility. Dual task performance was performed by adding cognitive and motor tasks into the TUG.. As the time increases, dual task performance decreases.
arm group label: Parkinson's disease group
description: being diagnosed with PD by a neurologist, being in Hoehn & Yahr Stage 1-3
arm group label: Healthy group
description: 20 healthy volunteers with matching ages and genders.
intervention type: Other
intervention name: Non-Motor Symptoms
description: NMSs of the participants were evaluated using the Non-Motor Symptoms Scale (NMSS). The scale consists of 30 yes-no questions and is administered face to face with the therapist.
arm group label: Healthy group
arm group label: Parkinson's disease group
intervention type: Other
intervention name: Balance
description: To measure balance, the Biodex Balance System (Biodex Medical Systems, Shirley, NY, USA) was used. The participants were asked to position themselves in a comfortable position on the platform, and their foot position coordinates were recorded. The participants focused on a characteristic dot on the monitor screen. Their task was to balance the body in such a way that the dot was in the center of a circle displayed on the monitor at the point of intersection of the coordinate axes. The test consisted of three 20 s trials, each separated by 10 s breaks. Measurements were conducted while their eyes were open and close, and the results were analyzed by calculating the average value of the measurements.
arm group label: Healthy group
arm group label: Parkinson's disease group
intervention type: Other
intervention name: Lower Limb Strength
description: A Biodex® System 4 Dynamometer device was used to evaluate muscle strength. The participants' dominant extremity was determined by asking them the foot with which they most often hit the ball.The dynamometer arm of the device was placed at the lateral condyle level of the knee, and the belt at the distal end of the dynamometer was attached to the lower leg on the malleolus. Knee flexion and extension movements were evaluated in sitting position between 90ᵒ flexion and 0ᵒ extension angles. The individual was asked to perform it with the maximum strength, while the therapist motivated the individual with verbal stimulation.
arm group label: Healthy group
arm group label: Parkinson's disease group
intervention type: Other
intervention name: Functional mobility
description: The Timed Up and Go test (TUG) was used in the evaluation of functional mobility. . For this test, participants were seated on a standard armless chair and a cone was placed 3 meters away from the chair. Participants were instructed to stand up and (1) walk towards the cone, (2) turn around the cone, (3) walk back to the chair, and (4) sit back on the chair. It was stated that patients should walk without running but as fast as possible. Dual task performance was performed by adding cognitive and motor tasks into the TUG.
arm group label: Healthy group
arm group label: Parkinson's disease group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Parkinson Disease