<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/NCT04440033</url>
  </required_header>
  <id_info>
    <org_study_id>B6702020000044</org_study_id>
    <nct_id>NCT04440033</nct_id>
  </id_info>
  <brief_title>Factors Associated With Falling in Parkinson's Disease</brief_title>
  <official_title>Factors Associated With Falling in Parkinson's Disease: a Multidisciplinary Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Ghent</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>
      The objective of this study will be to identify multidisciplinary fall risk factors in&#xD;
      persons with stage 3 idiopathic Parkinson's Disease compared to age and sex-matched healthy&#xD;
      adults. Both the relative contribution of each independent factor, as well as the interaction&#xD;
      between these factors, will be examined. The study will include multidisciplinary&#xD;
      assessments, including locomotor, speech, auditory, vestibular and opthalmologic assessments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 12, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Case-control</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fall events</measure>
    <time_frame>baseline to 6 months after baseline</time_frame>
    <description>Number of accidental falls documented using a daily fall diary with monthly telephone follow-ups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Walking speed</measure>
    <time_frame>baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment</time_frame>
    <description>Walking speed (meters/second) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking cadence</measure>
    <time_frame>baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment</time_frame>
    <description>Walking cadence (steps/minute) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Step length</measure>
    <time_frame>baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment</time_frame>
    <description>Step length (meters) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip, knee and ankle joint angle during walking</measure>
    <time_frame>baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment</time_frame>
    <description>Hip, knee and ankle joint angle during walking (°) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip, knee and ankle joint moment during walking</measure>
    <time_frame>baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment</time_frame>
    <description>Hip, knee and ankle joint moment during walking (Nm/kg) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip, knee and ankle joint power during walking</measure>
    <time_frame>baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment</time_frame>
    <description>Hip, knee and ankle joint moment during power (W/kg) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freezing of gait</measure>
    <time_frame>baseline during 6 min self-paced treadmill walking in a virtual environment</time_frame>
    <description>Number of freezing of gait events measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spontaneous speech production</measure>
    <time_frame>baseline; baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment</time_frame>
    <description>Audio recordings analyzed using PRAAT software to assess spontaneous speech production</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spontaneous speech production</measure>
    <time_frame>baseline; baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment</time_frame>
    <description>Audio recordings analyzed using Motor Speech Profile software to assess spontaneous speech production</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech Handicap Index</measure>
    <time_frame>baseline</time_frame>
    <description>A 15-item self-reported questionnaire based on the Parole Handicap Index to evaluate the physical, functional and psychosocial impact of dysarthria (0-60). Higher scores indicate a higher level of speech-related problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Otoscopy</measure>
    <time_frame>baseline</time_frame>
    <description>A otoscopic test to examine the external auditory canal and the tympanic membrane</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tympanometry</measure>
    <time_frame>baseline</time_frame>
    <description>An auditory test to assess the middle-ear function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pure tone audiometry</measure>
    <time_frame>baseline</time_frame>
    <description>An auditory test to assess hearing threshold levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Otoacoustic Emissions Test</measure>
    <time_frame>baseline</time_frame>
    <description>An auditory test to measure cochlear outer hair cell function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Video Head Impuls Test</measure>
    <time_frame>baseline</time_frame>
    <description>A vestibular function test to objectify high frequency function of the horizontal and vertical semicircular canals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cervical Vestibular Evoked Myogenic Potential Testing</measure>
    <time_frame>baseline</time_frame>
    <description>A vestibular function test to assess the saccular and inferior vestibular nerve function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular Vestibular Evoked Myogenic Potential Testing</measure>
    <time_frame>baseline</time_frame>
    <description>A vestibular function test to assess the utricular and superior vestibular nerve function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular Motor Testing</measure>
    <time_frame>baseline</time_frame>
    <description>A vestibular function test to evaluate oculomotor function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dix-Hallpike Test</measure>
    <time_frame>baseline</time_frame>
    <description>A diagnostic maneuver to identify benign paroxysmal positional vertigo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Roll Test</measure>
    <time_frame>baseline</time_frame>
    <description>A diagnostic maneuver to identify benign paroxysmal positional vertigo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Static visual acuity</measure>
    <time_frame>baseline</time_frame>
    <description>Static visual acuity measured using a Snellen chart (static logMAR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamic visual acuity</measure>
    <time_frame>baseline</time_frame>
    <description>Visual acuity during head movement measured using a Snellen chart relative to static visual acuity (static logMAR - dynamic logMAR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dizziness Handicap Inventory</measure>
    <time_frame>baseline</time_frame>
    <description>A 25-item self-assessment inventory to evaluate self-perceived handicapping effects of dizziness (0-100). Higher scores indicate a greater perceived handicap due to dizziness.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Age</measure>
    <time_frame>baseline</time_frame>
    <description>Years since birth</description>
  </other_outcome>
  <other_outcome>
    <measure>Sex</measure>
    <time_frame>baseline</time_frame>
    <description>Male or female</description>
  </other_outcome>
  <other_outcome>
    <measure>Montreal Cognitive Assessment</measure>
    <time_frame>baseline</time_frame>
    <description>A screening test to assess global cognition (0-30). Higher scores indicate better performance.</description>
  </other_outcome>
  <other_outcome>
    <measure>Shortened Iconographical Falls Efficacy Scale</measure>
    <time_frame>baseline</time_frame>
    <description>A 10-item scale to assess fear of falling. Each item is scored on a 4-point scale (1 = not at all concerned to 4 = very concerned).</description>
  </other_outcome>
  <other_outcome>
    <measure>Fall history</measure>
    <time_frame>baseline</time_frame>
    <description>Number of falls in the past month</description>
  </other_outcome>
  <other_outcome>
    <measure>Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I</measure>
    <time_frame>baseline</time_frame>
    <description>A 13-item rating scale to assess non-motor experiences of daily living (0-52). Higher scores indicate a worse outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III</measure>
    <time_frame>baseline</time_frame>
    <description>An 18-item motor examination to assess motor symptoms (0-132). Higher scores indicate a worse outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part IV</measure>
    <time_frame>baseline</time_frame>
    <description>A 6-item rating scale to assess motor complications. Higher scores indicate a worse outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hoehn and Yahr scale</measure>
    <time_frame>baseline</time_frame>
    <description>A scale to assess disease severity/progression (0-5). Higher scores indicate more severe symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>New Freezing of Gait Questionnaire</measure>
    <time_frame>baseline</time_frame>
    <description>A 9-item questionnaire to assess freezing of gait severity (0-28). Higher scores indicate more severe freezing of gait.</description>
  </other_outcome>
  <other_outcome>
    <measure>Time since diagnosis</measure>
    <time_frame>baseline</time_frame>
    <description>The number of days since the diagnosis of Parkinson's Disease</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood pressure</measure>
    <time_frame>baseline</time_frame>
    <description>The ratio of systolic over diastolic blood pressure (mm Hg)</description>
  </other_outcome>
  <other_outcome>
    <measure>Medication</measure>
    <time_frame>baseline</time_frame>
    <description>Number, type and dose (mg) of medication</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">144</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Parkinson's Disease group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with stage 3 idiopathic Parkinson's Disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Age and sex-matched healthy adults</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Baseline assessment of demographic, anthropometric and clinical characteristics</intervention_name>
    <description>Age&#xD;
Sex&#xD;
Height&#xD;
Body weight&#xD;
Handedness&#xD;
Medication use&#xD;
Blood pressure&#xD;
Global cognition (Montreal Cognitive Assessment)&#xD;
Fear of falling (Shortened Iconographical Falls Efficacy Scale)&#xD;
History of falls (number of falls in the past month)&#xD;
Time since diagnosis and symptom onset&#xD;
Disease severity (UPDRS part III, Hoehn and Yahr)&#xD;
Non-motor symptoms (UPDRS part I)&#xD;
Motor symptoms (UPDRS part III)&#xD;
Motor complications (UPDRS part IV)&#xD;
Disease-dominant side (UPDRS part III)&#xD;
Freezing of gait (New Freezing of Gait Questionnaire)</description>
    <arm_group_label>Parkinson's Disease group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Baseline assessment of demographic, anthropometric and clinical characteristics</intervention_name>
    <description>Age&#xD;
Sex&#xD;
Height&#xD;
Body weight&#xD;
Handedness&#xD;
Medication use&#xD;
Blood pressure&#xD;
Global cognition (Montreal Cognitive Assessment)&#xD;
Fear of falling (Shortened Iconographical Falls Efficacy Scale)&#xD;
History of falls (number of falls in the past month)</description>
    <arm_group_label>Healthy control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Locomotor assessments</intervention_name>
    <description>First, 9 anthropometric measurements will be taken, 39 reflective markers will be placed, and a 6-min practice walking session will be conducted to familiarize participants with self-paced treadmill walking (SPTW). Thereafter, participants will partake in 7 experimental conditions in a (semi-)randomized order:&#xD;
3 min standing&#xD;
3 min standing while answering semi-standardized questions&#xD;
3 min SPTW&#xD;
3 min SPTW while answering semi-standardized questions (SPTW-Q)&#xD;
3 min SPTW while verbally describing a VR environment (SPTW-VR1)&#xD;
6 min SPTW in a VR environment containing freezing of gait provoking elements (SPTW-VR2)</description>
    <arm_group_label>Healthy control group</arm_group_label>
    <arm_group_label>Parkinson's Disease group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Speech assessments</intervention_name>
    <description>Acoustic analysis (including voice reports and formant analysis), video recording and motor speech profile (including analysis of diadochokinesis, voice, standard syllabic rate, intonation and second formant (F2)).&#xD;
Spontaneous speech production will be assessed by answering semi-standardized questions based on the Aachen Aphasia Test and by describing a VR environment projected on a 180-degree cylindrical screen&#xD;
The Speech Handicap Index (a 15-item self-reported questionnaire)</description>
    <arm_group_label>Healthy control group</arm_group_label>
    <arm_group_label>Parkinson's Disease group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Audiology assessments</intervention_name>
    <description>Otoscopy&#xD;
Tympanometry&#xD;
Pure tone audiometry&#xD;
Otoacoustic emissions&#xD;
Video Head Impuls Test&#xD;
Cervical Vestibular Evoked Myogenic Potentials&#xD;
Ocular Vestibular Evoked Myogenic Potentials&#xD;
Oculomotor function testing&#xD;
Positional testing&#xD;
Static visual acuity test&#xD;
Dynamic visual acuity test&#xD;
Dizziness Handicap Inventory (a 25-item self-assessment inventory)</description>
    <arm_group_label>Healthy control group</arm_group_label>
    <arm_group_label>Parkinson's Disease group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Parkinson's Disease group&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Persons with idiopathic PD diagnosed by a medical doctor according to the United&#xD;
             Kingdom PD Brain Bank Criteria&#xD;
&#xD;
          -  Aged between 18 and 75 years-old&#xD;
&#xD;
          -  Stage 3 on the Hoehn and Yahr scale in the on-medication state&#xD;
&#xD;
          -  On a stable dose of PD medication (at least one week)&#xD;
&#xD;
          -  Able to stand and walk on a treadmill without support for at least 3 minutes&#xD;
&#xD;
          -  Able to give consent&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Atypical parkinsonism&#xD;
&#xD;
          -  Unpredictable symptom fluctuations&#xD;
&#xD;
          -  Previous surgical management of PD (i.e., deep brain stimulation surgery; pallidotomy)&#xD;
&#xD;
          -  Duodopa pump therapy&#xD;
&#xD;
          -  Dementia (Montreal Cognitive Assessment (MoCA) &lt; 21)[1]&#xD;
&#xD;
          -  Symptomatic orthostatic hypotension (e.g. frequent syncope episodes)&#xD;
&#xD;
          -  Concurrent neurological disorders (e.g. stroke)&#xD;
&#xD;
          -  Comorbidities that affect gait or balance (e.g. peripheral neuropathy)&#xD;
&#xD;
          -  Acute illness&#xD;
&#xD;
          -  Epilepsy or history of seizures&#xD;
&#xD;
          -  Depression (MDS-UPDRS item 1.3 ≥ 2)&#xD;
&#xD;
          -  Body weight over 120 kilograms&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Participation in other ongoing experimental trials&#xD;
&#xD;
        Healthy control group&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Age and sex-matched healthy adults&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Symptomatic orthostatic hypotension (e.g. frequent syncope episodes)&#xD;
&#xD;
          -  Body weight over 120 kilograms&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Participation in other ongoing experimental trials&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katie Bouche, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Ghent</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Leen Maes, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Ghent</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anke Van Bladel, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Ghent</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nina Lefeber, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Ghent</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nina Lefeber, PhD</last_name>
    <phone>+32 9 332 46 57</phone>
    <email>Nina.Lefeber@UGent.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ghent University Hospital</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katie Bouche, PhD</last_name>
      <email>Katie.Bouche@uzgent.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ghent University</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nina Lefeber, PhD</last_name>
      <email>Nina.Lefeber@UGent.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>December 20, 2022</last_update_submitted>
  <last_update_submitted_qc>December 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson's Disease</keyword>
  <keyword>Accidental Falls</keyword>
  <keyword>Risk factor</keyword>
  <keyword>Gait</keyword>
  <keyword>Speech</keyword>
  <keyword>Audiology</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/NCT04440033
org study id: B6702020000044
nct id: NCT04440033
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study will be to identify multidisciplinary fall risk factors in
      persons with stage 3 idiopathic Parkinson's Disease compared to age and sex-matched healthy
      adults. Both the relative contribution of each independent factor, as well as the interaction
      between these factors, will be examined. The study will include multidisciplinary
      assessments, including locomotor, speech, auditory, vestibular and opthalmologic assessments.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Case-control
primary purpose: Screening
masking: None (Open Label)
measure: Fall events
time frame: baseline to 6 months after baseline
description: Number of accidental falls documented using a daily fall diary with monthly telephone follow-ups.
measure: Walking speed
time frame: baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment
description: Walking speed (meters/second) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
measure: Walking cadence
time frame: baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment
description: Walking cadence (steps/minute) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
measure: Step length
time frame: baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment
description: Step length (meters) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
measure: Hip, knee and ankle joint angle during walking
time frame: baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment
description: Hip, knee and ankle joint angle during walking (°) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
measure: Hip, knee and ankle joint moment during walking
time frame: baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment
description: Hip, knee and ankle joint moment during walking (Nm/kg) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
measure: Hip, knee and ankle joint power during walking
time frame: baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment
description: Hip, knee and ankle joint moment during power (W/kg) measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
measure: Freezing of gait
time frame: baseline during 6 min self-paced treadmill walking in a virtual environment
description: Number of freezing of gait events measured using the Gait Real-time Interactive Lab (GRAIL) system (Motekforce Link, The Netherlands).
measure: Spontaneous speech production
time frame: baseline; baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment
description: Audio recordings analyzed using PRAAT software to assess spontaneous speech production
measure: Spontaneous speech production
time frame: baseline; baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment
description: Audio recordings analyzed using Motor Speech Profile software to assess spontaneous speech production
measure: Speech Handicap Index
time frame: baseline
description: A 15-item self-reported questionnaire based on the Parole Handicap Index to evaluate the physical, functional and psychosocial impact of dysarthria (0-60). Higher scores indicate a higher level of speech-related problems.
measure: Otoscopy
time frame: baseline
description: A otoscopic test to examine the external auditory canal and the tympanic membrane
measure: Tympanometry
time frame: baseline
description: An auditory test to assess the middle-ear function
measure: Pure tone audiometry
time frame: baseline
description: An auditory test to assess hearing threshold levels
measure: Otoacoustic Emissions Test
time frame: baseline
description: An auditory test to measure cochlear outer hair cell function
measure: Video Head Impuls Test
time frame: baseline
description: A vestibular function test to objectify high frequency function of the horizontal and vertical semicircular canals
measure: Cervical Vestibular Evoked Myogenic Potential Testing
time frame: baseline
description: A vestibular function test to assess the saccular and inferior vestibular nerve function
measure: Ocular Vestibular Evoked Myogenic Potential Testing
time frame: baseline
description: A vestibular function test to assess the utricular and superior vestibular nerve function
measure: Ocular Motor Testing
time frame: baseline
description: A vestibular function test to evaluate oculomotor function
measure: Dix-Hallpike Test
time frame: baseline
description: A diagnostic maneuver to identify benign paroxysmal positional vertigo
measure: Roll Test
time frame: baseline
description: A diagnostic maneuver to identify benign paroxysmal positional vertigo
measure: Static visual acuity
time frame: baseline
description: Static visual acuity measured using a Snellen chart (static logMAR)
measure: Dynamic visual acuity
time frame: baseline
description: Visual acuity during head movement measured using a Snellen chart relative to static visual acuity (static logMAR - dynamic logMAR)
measure: Dizziness Handicap Inventory
time frame: baseline
description: A 25-item self-assessment inventory to evaluate self-perceived handicapping effects of dizziness (0-100). Higher scores indicate a greater perceived handicap due to dizziness.
measure: Age
time frame: baseline
description: Years since birth
measure: Sex
time frame: baseline
description: Male or female
measure: Montreal Cognitive Assessment
time frame: baseline
description: A screening test to assess global cognition (0-30). Higher scores indicate better performance.
measure: Shortened Iconographical Falls Efficacy Scale
time frame: baseline
description: A 10-item scale to assess fear of falling. Each item is scored on a 4-point scale (1 = not at all concerned to 4 = very concerned).
measure: Fall history
time frame: baseline
description: Number of falls in the past month
measure: Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I
time frame: baseline
description: A 13-item rating scale to assess non-motor experiences of daily living (0-52). Higher scores indicate a worse outcome.
measure: Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III
time frame: baseline
description: An 18-item motor examination to assess motor symptoms (0-132). Higher scores indicate a worse outcome.
measure: Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part IV
time frame: baseline
description: A 6-item rating scale to assess motor complications. Higher scores indicate a worse outcome.
measure: Hoehn and Yahr scale
time frame: baseline
description: A scale to assess disease severity/progression (0-5). Higher scores indicate more severe symptoms.
measure: New Freezing of Gait Questionnaire
time frame: baseline
description: A 9-item questionnaire to assess freezing of gait severity (0-28). Higher scores indicate more severe freezing of gait.
measure: Time since diagnosis
time frame: baseline
description: The number of days since the diagnosis of Parkinson's Disease
measure: Blood pressure
time frame: baseline
description: The ratio of systolic over diastolic blood pressure (mm Hg)
measure: Medication
time frame: baseline
description: Number, type and dose (mg) of medication
arm group label: Parkinson's Disease group
arm group type: Experimental
description: Patients with stage 3 idiopathic Parkinson's Disease
arm group label: Healthy control group
arm group type: Active Comparator
description: Age and sex-matched healthy adults
intervention type: Other
intervention name: Baseline assessment of demographic, anthropometric and clinical characteristics
description: Age
Sex
Height
Body weight
Handedness
Medication use
Blood pressure
Global cognition (Montreal Cognitive Assessment)
Fear of falling (Shortened Iconographical Falls Efficacy Scale)
History of falls (number of falls in the past month)
Time since diagnosis and symptom onset
Disease severity (UPDRS part III, Hoehn and Yahr)
Non-motor symptoms (UPDRS part I)
Motor symptoms (UPDRS part III)
Motor complications (UPDRS part IV)
Disease-dominant side (UPDRS part III)
Freezing of gait (New Freezing of Gait Questionnaire)
arm group label: Parkinson's Disease group
intervention type: Other
intervention name: Baseline assessment of demographic, anthropometric and clinical characteristics
description: Age
Sex
Height
Body weight
Handedness
Medication use
Blood pressure
Global cognition (Montreal Cognitive Assessment)
Fear of falling (Shortened Iconographical Falls Efficacy Scale)
History of falls (number of falls in the past month)
arm group label: Healthy control group
intervention type: Other
intervention name: Locomotor assessments
description: First, 9 anthropometric measurements will be taken, 39 reflective markers will be placed, and a 6-min practice walking session will be conducted to familiarize participants with self-paced treadmill walking (SPTW). Thereafter, participants will partake in 7 experimental conditions in a (semi-)randomized order:
3 min standing
3 min standing while answering semi-standardized questions
3 min SPTW
3 min SPTW while answering semi-standardized questions (SPTW-Q)
3 min SPTW while verbally describing a VR environment (SPTW-VR1)
6 min SPTW in a VR environment containing freezing of gait provoking elements (SPTW-VR2)
arm group label: Healthy control group
arm group label: Parkinson's Disease group
intervention type: Other
intervention name: Speech assessments
description: Acoustic analysis (including voice reports and formant analysis), video recording and motor speech profile (including analysis of diadochokinesis, voice, standard syllabic rate, intonation and second formant (F2)).
Spontaneous speech production will be assessed by answering semi-standardized questions based on the Aachen Aphasia Test and by describing a VR environment projected on a 180-degree cylindrical screen
The Speech Handicap Index (a 15-item self-reported questionnaire)
arm group label: Healthy control group
arm group label: Parkinson's Disease group
intervention type: Other
intervention name: Audiology assessments
description: Otoscopy
Tympanometry
Pure tone audiometry
Otoacoustic emissions
Video Head Impuls Test
Cervical Vestibular Evoked Myogenic Potentials
Ocular Vestibular Evoked Myogenic Potentials
Oculomotor function testing
Positional testing
Static visual acuity test
Dynamic visual acuity test
Dizziness Handicap Inventory (a 25-item self-assessment inventory)
arm group label: Healthy control group
arm group label: Parkinson's Disease group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Katie Bouche, PhD
role: Principal Investigator
affiliation: University Hospital, Ghent
last name: Leen Maes, PhD
role: Principal Investigator
affiliation: University Ghent
last name: Anke Van Bladel, PhD
role: Principal Investigator
affiliation: University Ghent
last name: Nina Lefeber, PhD
role: Principal Investigator
affiliation: University Ghent
last name: Nina Lefeber, PhD
phone: +32 9 332 46 57
email: Nina.Lefeber@UGent.be
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Sponsor
mesh term: Parkinson Disease