<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/NCT03278093</url>
  </required_header>
  <id_info>
    <org_study_id>16.0029</org_study_id>
    <nct_id>NCT03278093</nct_id>
  </id_info>
  <brief_title>Effect of Orthoses and Underfoot Vibration on Balance in Neuropathy</brief_title>
  <official_title>The Feasibility and Effect of Ankle Foot Orthoses and Underfoot Vibration on the Postural Stability of People With Inherited Neuropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St George's, University of London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University College London Hospitals</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St George's, University of London</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>
      A cross-sectional study which will look at the effects of AFO's and vibrating insoles on&#xD;
      balance performance in people with CMT disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Balance impairments and falls are more common in people who have Charcot Marie Tooth disease&#xD;
      (CMT) than in people without the condition. CMT is a condition which affects the nerves&#xD;
      causing a variety of symptoms including sensation impairments and weakness. The impairments&#xD;
      are usually most evident in the feet and hands, but they can progress very slowly moving&#xD;
      closer to the trunk. Ankle Foot Orthoses (AFO's) are often prescribed to help with walking&#xD;
      and daily function. So far the effects of AFO's on standing balance in people who have CMT&#xD;
      have not been looked at. Insoles are also often prescribed to realign foot deformity and&#xD;
      reduce pain. Insoles which give a vibratory input have had a positive impact on walking in&#xD;
      older people but have not been looked at in balance and in CMT. Insoles which give a&#xD;
      vibration feedback to the sole of the foot when worn have been designed. This study will look&#xD;
      at whether the use of AFO's and the vibratory insoles have an effect on standing balance in&#xD;
      people with CMT or related peripheral neuropathy. Balance measurements will be taken in a&#xD;
      single session comparing a variety of postures. Patients will be recruited from neurology&#xD;
      outpatient clinics at the National Hospital of Neurology and Neurosurgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 20, 2017</start_date>
  <completion_date type="Anticipated">February 20, 2019</completion_date>
  <primary_completion_date type="Anticipated">February 20, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Posturography</measure>
    <time_frame>30 second caputer in a variety of conditions</time_frame>
    <description>CODA motion movement analysis for postural sway Measures will be taken in all conditions with feet together and feet apart. Both conditions will also be looked at with eyes open and eyes closed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>force measures</measure>
    <time_frame>30 second caputer in a variety of conditions</time_frame>
    <description>AMTI forceplate for centre of pressure . Measures will be taken in all conditions with feet together and feet apart. Both conditions will also be looked at with eyes open and eyes closed.</description>
  </primary_outcome>
  <enrollment type="Anticipated">15</enrollment>
  <condition>CMT - Charcot-Marie-Tooth Disease</condition>
  <condition>Peripheral Neuropathy</condition>
  <condition>Hereditary Peripheral Neuropathy</condition>
  <condition>CMT1A</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Mobile adults who have CMT with both motor and sensory symptoms.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical or genetically confirmed diagnosis of CMT or related peripheral neuropathy&#xD;
&#xD;
          2. Mixed sensory and motor presentation&#xD;
&#xD;
          3. Over 18 years&#xD;
&#xD;
          4. Able to stand unsupported for five minutes&#xD;
&#xD;
          5. Able to walk for 50m with or without a walking stick or orthotic devices&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of other significant neurological disorders (such as multiple sclerosis,&#xD;
             cerebrovascular diseases, epilepsy, movement disorders), or major comorbidities (e.g.&#xD;
             vestibular dysfunction, use of medication which may affect balance, cognitive&#xD;
             impairment, presence of medical conditions in which exercise training may be&#xD;
             detrimental).&#xD;
&#xD;
          2. Presence of peripheral neuropathy caused by a condition other than CMT.&#xD;
&#xD;
          3. Limb surgery during the six months prior to screening (or planned before final&#xD;
             assessment).&#xD;
&#xD;
          4. Women of child-bearing age if they are pregnant, planning a pregnancy during their&#xD;
             time in the study or in the 12 weeks following giving birth. This is due to the&#xD;
             effects of pregnancy on balance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gita Ramdharry</last_name>
    <role>Principal Investigator</role>
    <affiliation>Senior Physiotherapist</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Magdalena Dudziec</last_name>
    <phone>020 3108 7520</phone>
    <email>m.dudziec@ucl.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gita Ramdharry</last_name>
    <phone>020 3108 7517</phone>
    <email>g.ramdharry@ucl.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Hopsital of Neurology and Neurosurgery</name>
      <address>
        <city>London</city>
        <zip>WC1N 3BG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Magdalena Dudziec</last_name>
      <phone>020 3108 7520</phone>
      <email>m.dudziec@ucl.ac.uk</email>
    </contact>
    <contact_backup>
      <last_name>Gita Ramdharry</last_name>
      <phone>020 3108 7517</phone>
      <email>g.ramdharry@ucl.ac.uk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>January 18, 2019</last_update_submitted>
  <last_update_submitted_qc>January 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Physiotherapy</keyword>
  <keyword>Physical therapy</keyword>
  <keyword>Balance</keyword>
  <keyword>Posturography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth Diseases</mesh_term>
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Charcot-Marie-Tooth Disease</mesh_term>
    <mesh_term>Nerve Compression Syndromes</mesh_term>
    <mesh_term>Hereditary Sensory and Motor Neuropathy</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/NCT03278093
org study id: 16.0029
nct id: NCT03278093
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A cross-sectional study which will look at the effects of AFO's and vibrating insoles on
      balance performance in people with CMT disease.
Balance impairments and falls are more common in people who have Charcot Marie Tooth disease
      (CMT) than in people without the condition. CMT is a condition which affects the nerves
      causing a variety of symptoms including sensation impairments and weakness. The impairments
      are usually most evident in the feet and hands, but they can progress very slowly moving
      closer to the trunk. Ankle Foot Orthoses (AFO's) are often prescribed to help with walking
      and daily function. So far the effects of AFO's on standing balance in people who have CMT
      have not been looked at. Insoles are also often prescribed to realign foot deformity and
      reduce pain. Insoles which give a vibratory input have had a positive impact on walking in
      older people but have not been looked at in balance and in CMT. Insoles which give a
      vibration feedback to the sole of the foot when worn have been designed. This study will look
      at whether the use of AFO's and the vibratory insoles have an effect on standing balance in
      people with CMT or related peripheral neuropathy. Balance measurements will be taken in a
      single session comparing a variety of postures. Patients will be recruited from neurology
      outpatient clinics at the National Hospital of Neurology and Neurosurgery.
observational model: Cohort
time perspective: Cross-Sectional
measure: Posturography
time frame: 30 second caputer in a variety of conditions
description: CODA motion movement analysis for postural sway Measures will be taken in all conditions with feet together and feet apart. Both conditions will also be looked at with eyes open and eyes closed.
measure: force measures
time frame: 30 second caputer in a variety of conditions
description: AMTI forceplate for centre of pressure . Measures will be taken in all conditions with feet together and feet apart. Both conditions will also be looked at with eyes open and eyes closed.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gita Ramdharry
role: Principal Investigator
affiliation: Senior Physiotherapist
last name: Magdalena Dudziec
phone: 020 3108 7520
email: m.dudziec@ucl.ac.uk
last name: Gita Ramdharry
phone: 020 3108 7517
email: g.ramdharry@ucl.ac.uk
facility: 
status: Recruiting
contact: 
contact backup: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Tooth Diseases
mesh term: Peripheral Nervous System Diseases
mesh term: Charcot-Marie-Tooth Disease
mesh term: Nerve Compression Syndromes
mesh term: Hereditary Sensory and Motor Neuropathy