<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/NCT02994719</url>
  </required_header>
  <id_info>
    <org_study_id>2015P000310</org_study_id>
    <nct_id>NCT02994719</nct_id>
  </id_info>
  <brief_title>Gait Analysis in Neurological Disease</brief_title>
  <official_title>Gait Pattern Analysis in Neurological Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate whether speed-dependent measures of gait can be&#xD;
      identified in patients with neurological conditions that affect gait, particularly in&#xD;
      subjects with parkinsonian disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to determine whether the gait patterns in these subjects differ in&#xD;
      predictable and quantifiable ways from those of age- and sex-matched healthy controls. This&#xD;
      will be conducted by asking 40 Parkinsonian disorder subjects and 40 age-matched healthy&#xD;
      control subjects to walk 9 trials over an 18 ft walkway embedded with pressure sensors at&#xD;
      baseline, self-selected slower and faster speeds. In addition, the protocol aims to&#xD;
      investigate whether clusters of gait patterns can be identified within subgroups of&#xD;
      individuals with parkinsonian disorders with varying co-morbidities or treatment conditions&#xD;
      as well as patients with ataxia syndromes. For this aim an additional 20 Parkinsonian&#xD;
      disorder subjects need to be recruited. Patients with parkinsonism as defined by UK PD Brain&#xD;
      Bank Criteria (n=60), subjects with acquired or inherited ataxic syndromes (n=10) and age-&#xD;
      and sex matched controls (n=40) will be recruited. There is an optional second visit in the&#xD;
      protocol during which approximately 20 subjects with Parkinsonian disorders, who are willing&#xD;
      to come off antiparkinson medication and if applicable, off both medication and deep brain&#xD;
      stimulation, are asked to walk an additional 9 trials.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 1, 2016</start_date>
  <completion_date type="Anticipated">June 20, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 20, 2024</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Gait speed</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Method of assessment: physiological parameter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Swing duration</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Method of assessment: physiological parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stance duration</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Method of assessment: physiological parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cadence</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Method of assessment: physiological parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stride length</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Method of assessment: physiological parameter</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Parkinson's Disease</condition>
  <condition>Parkinsonian Disorders</condition>
  <condition>Atypical Parkinson Disease</condition>
  <condition>Progressive Supranuclear Palsy</condition>
  <condition>Multiple System Atrophy</condition>
  <condition>Corticobasal Degeneration</condition>
  <condition>Gait, Frontal</condition>
  <condition>Huntington Disease</condition>
  <arm_group>
    <arm_group_label>Neurological Disease subjects</arm_group_label>
    <description>Parkinson's Disease and other Parkinsonian Disorders subjects. Other Parkinsonian Disorders include Atypical Parkinsonism such as Progressive Supranuclear Palsy, Multiple System Atrophy, Corticobasal Degeneration, Primary Gait Freezing Disorder, Indeterminate Parkinsonian Syndrome. During the first visit no intervention will take place. There is an optional second visit during which subjects with Parkinson's Disease are asked to come come off antiparkinson medication and if applicable, off both medication and deep brain stimulation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control subjects</arm_group_label>
    <description>The healthy control subjects will be age- and sex-matched to the Neurological Disease subjects.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ataxia Subjects</arm_group_label>
    <description>The ataxia subjects will participate in an additional cohort that will test and validate the gait model.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Huntington Disease Subjects</arm_group_label>
    <description>The Huntington Disease subjects will participate in an additional cohort that will test and validate the gait model.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anti-Parkinson medication</intervention_name>
    <description>During the optional second visit subjects with neurological disease and already on anti-parkinson medication are asked to come off their anti-parkinson medication.</description>
    <arm_group_label>Neurological Disease subjects</arm_group_label>
    <other_name>Carbidopa/levodopa</other_name>
    <other_name>pramipexole</other_name>
    <other_name>ropinirole</other_name>
    <other_name>amantadine</other_name>
    <other_name>tolcapone</other_name>
    <other_name>entacapone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Deep Brain Stimulation</intervention_name>
    <description>During the optional second visit subjects with neurological disease already treated with deep brain stimulation are asked to come temporarily stop deep brain stimulation and resume stimulation, with walking trials done in each condition.</description>
    <arm_group_label>Neurological Disease subjects</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with Parkinsonism as defined by UK PD Brain Bank Criteria. The study population&#xD;
        includes subjects with Parkinson's Disease and may also include subjects who may have&#xD;
        indeterminate parkinsonism, when it is not clear whether they have idiopathic Parkinson's&#xD;
        Disease versus one of the Atypical Parkinsonisms, such as Vascular Parkinsonism, Multiple&#xD;
        System Atrophy, Progressive Supranuclear Palsy, Normal Pressure Hydrocephalus or&#xD;
        Corticobasal Degeneration.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-85 (for both healthy and affected subjects).&#xD;
&#xD;
          -  Presence of at least 2 of the following: bradykinesia, rest tremor, rigidity, postural&#xD;
             instability (UK PD Brain Bank Criteria) (Affected subjects only).&#xD;
&#xD;
          -  Montreal Cognitive Assessment will be employed to determine whether subjects will need&#xD;
             the assent of a legally authorized representative. Subjects with MOCA ≤ 21 will be&#xD;
             consented only with the assent of the subject and informed consent of the authorized&#xD;
             legal representative (Affected subjects only).&#xD;
&#xD;
          -  These may include subjects who may have indeterminate parkinsonism, when it is not&#xD;
             clear whether they have idiopathic Parkinson's Disease versus one of the Atypical&#xD;
             Parkinsonisms, such as Vascular Parkinsonism, Multiple System Atrophy, Progressive&#xD;
             Supranuclear Palsy, Normal Pressure Hydrocephalus or Corticobasal Degeneration&#xD;
             (Affected subjects only).&#xD;
&#xD;
          -  Subjects with assistive devices will be eligible for the study and may use them during&#xD;
             the study (Affected subjects only).&#xD;
&#xD;
          -  Absence of complaints regarding difficulty walking such as arthritic pain, fatigue&#xD;
             during walking or slowness of walking (Healthy subjects only).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of alternative explanation for parkinsonism such as head trauma, drug-induced&#xD;
             parkinsonism (affected subjects only).&#xD;
&#xD;
          -  Currently being treated for major medical illness requiring recent hospitalization&#xD;
             (&lt;14 days) (for both healthy and affected subjects).&#xD;
&#xD;
          -  Currently participating in another clinical study with an intervention arm (for both&#xD;
             healthy and affected subjects).&#xD;
&#xD;
          -  Inability to consent due to cognitive impairment and absence of legally authorized&#xD;
             representative (for both healthy and affected subjects).&#xD;
&#xD;
          -  Subjects with any cardiac, pulmonary conditions (congestive heart failure requiring&#xD;
             hospitalization within the past 90 days, recent myocardial infarction &lt; 90 days,&#xD;
             supplemental oxygen-requiring subjects due to cardiac or pulmonary conditions) that&#xD;
             limit their ability to safely participate in a walking trial (for both healthy and&#xD;
             affected subjects).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinical Research Center BIDMC</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 21, 2015</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>January 3, 2023</last_update_submitted>
  <last_update_submitted_qc>January 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Veronique Vanderhorst</investigator_full_name>
    <investigator_title>Associate Professor of Neurology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Huntington Disease</mesh_term>
    <mesh_term>Multiple System Atrophy</mesh_term>
    <mesh_term>Shy-Drager Syndrome</mesh_term>
    <mesh_term>Supranuclear Palsy, Progressive</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Parkinsonian Disorders</mesh_term>
    <mesh_term>Corticobasal Degeneration</mesh_term>
    <mesh_term>Gait Disorders, Neurologic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amantadine</mesh_term>
    <mesh_term>Levodopa</mesh_term>
    <mesh_term>Carbidopa</mesh_term>
    <mesh_term>Pramipexole</mesh_term>
    <mesh_term>Ropinirole</mesh_term>
    <mesh_term>Entacapone</mesh_term>
    <mesh_term>Carbidopa, levodopa drug combination</mesh_term>
    <mesh_term>Tolcapone</mesh_term>
  </intervention_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/NCT02994719
org study id: 2015P000310
nct id: NCT02994719
lead sponsor: 
has dmc: No
The purpose of this study is to investigate whether speed-dependent measures of gait can be
      identified in patients with neurological conditions that affect gait, particularly in
      subjects with parkinsonian disorders.
This study aims to determine whether the gait patterns in these subjects differ in
      predictable and quantifiable ways from those of age- and sex-matched healthy controls. This
      will be conducted by asking 40 Parkinsonian disorder subjects and 40 age-matched healthy
      control subjects to walk 9 trials over an 18 ft walkway embedded with pressure sensors at
      baseline, self-selected slower and faster speeds. In addition, the protocol aims to
      investigate whether clusters of gait patterns can be identified within subgroups of
      individuals with parkinsonian disorders with varying co-morbidities or treatment conditions
      as well as patients with ataxia syndromes. For this aim an additional 20 Parkinsonian
      disorder subjects need to be recruited. Patients with parkinsonism as defined by UK PD Brain
      Bank Criteria (n=60), subjects with acquired or inherited ataxic syndromes (n=10) and age-
      and sex matched controls (n=40) will be recruited. There is an optional second visit in the
      protocol during which approximately 20 subjects with Parkinsonian disorders, who are willing
      to come off antiparkinson medication and if applicable, off both medication and deep brain
      stimulation, are asked to walk an additional 9 trials.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Gait speed
time frame: through study completion, an average of 1 year
description: Method of assessment: physiological parameter
measure: Swing duration
time frame: through study completion, an average of 1 year
description: Method of assessment: physiological parameter
measure: Stance duration
time frame: through study completion, an average of 1 year
description: Method of assessment: physiological parameter
measure: Cadence
time frame: through study completion, an average of 1 year
description: Method of assessment: physiological parameter
measure: Stride length
time frame: through study completion, an average of 1 year
description: Method of assessment: physiological parameter
arm group label: Neurological Disease subjects
description: Parkinson's Disease and other Parkinsonian Disorders subjects. Other Parkinsonian Disorders include Atypical Parkinsonism such as Progressive Supranuclear Palsy, Multiple System Atrophy, Corticobasal Degeneration, Primary Gait Freezing Disorder, Indeterminate Parkinsonian Syndrome. During the first visit no intervention will take place. There is an optional second visit during which subjects with Parkinson's Disease are asked to come come off antiparkinson medication and if applicable, off both medication and deep brain stimulation.
arm group label: Healthy control subjects
description: The healthy control subjects will be age- and sex-matched to the Neurological Disease subjects.
arm group label: Ataxia Subjects
description: The ataxia subjects will participate in an additional cohort that will test and validate the gait model.
arm group label: Huntington Disease Subjects
description: The Huntington Disease subjects will participate in an additional cohort that will test and validate the gait model.
intervention type: Drug
intervention name: Anti-Parkinson medication
description: During the optional second visit subjects with neurological disease and already on anti-parkinson medication are asked to come off their anti-parkinson medication.
arm group label: Neurological Disease subjects
other name: Carbidopa/levodopa
other name: pramipexole
other name: ropinirole
other name: amantadine
other name: tolcapone
other name: entacapone
intervention type: Device
intervention name: Deep Brain Stimulation
description: During the optional second visit subjects with neurological disease already treated with deep brain stimulation are asked to come temporarily stop deep brain stimulation and resume stimulation, with walking trials done in each condition.
arm group label: Neurological Disease subjects
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Veronique Vanderhorst
investigator title: Associate Professor of Neurology
mesh term: Parkinson Disease
mesh term: Huntington Disease
mesh term: Multiple System Atrophy
mesh term: Shy-Drager Syndrome
mesh term: Supranuclear Palsy, Progressive
mesh term: Nervous System Diseases
mesh term: Parkinsonian Disorders
mesh term: Corticobasal Degeneration
mesh term: Gait Disorders, Neurologic
mesh term: Amantadine
mesh term: Levodopa
mesh term: Carbidopa
mesh term: Pramipexole
mesh term: Ropinirole
mesh term: Entacapone
mesh term: Carbidopa, levodopa drug combination
mesh term: Tolcapone
sharing ipd: No