<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/NCT01702597</url>
  </required_header>
  <id_info>
    <org_study_id>315-12</org_study_id>
    <secondary_id>MMW-Stiftung</secondary_id>
    <nct_id>NCT01702597</nct_id>
  </id_info>
  <brief_title>WBV and Acute Lateral Ankle Sprain</brief_title>
  <acronym>WBV and ALAS</acronym>
  <official_title>The Effect of Whole Body Vibration and Acute Unilateral Unstable Lateral Ankle Sprain - A Biphasic Randomized Controlled Trial -</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ludwig-Maximilians - University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical University Innsbruck</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ludwig-Maximilians - University of Munich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this bicentric, biphasic, randomized, controlled study is to compare of the&#xD;
      current gold standard functional treatment to functional treatment plus WBV in patients with&#xD;
      acute unilateral unstable inversion ankle sprains over a period of 12 months&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Ankle sprains often result in ankle instability, which is most likely caused by damage to&#xD;
      passive and neurological structures. Whole body vibration (WBV) is a neuromuscular training&#xD;
      method improving those neurologic parameters impaired. The aim of this study is to compare&#xD;
      the current gold standard functional treatment to functional treatment plus WBV in patients&#xD;
      with acute unilateral unstable inversion ankle sprains.&#xD;
&#xD;
      Methods/Design:&#xD;
&#xD;
      60 patients, aged 18-40 years, presenting with an isolated, unilateral, acute unstable&#xD;
      inversion ankle sprain will be included in this bicentric, biphasic, randomized controlled&#xD;
      trial. Patients will be randomized by envelope drawing. All patients will be allowed early&#xD;
      mobilization and pain-depending weight bearing, limited functional immobilization by&#xD;
      orthesis, PRICE, NSARDs as well as home and supervised physiotherapy. Supervised physical&#xD;
      therapy will take place twice a week, 30 minutes per session, for 6 weeks, following a&#xD;
      standardized intervention protocol. During supervised physical therapy, the intervention&#xD;
      group will perform similar exercises on a side-alternating sinusoidal vibration platform as&#xD;
      the control group. Two time dependent primary outcome parameters will be assessed. Short-term&#xD;
      outcome after six weeks will be postural control quantified by the sway index. Mid-term&#xD;
      outcome after one year will be assessed by subjective instability, defined by the presence of&#xD;
      giving-way attacks. Secondary outcome parameters include return to pre-injury level of&#xD;
      activities, residual pain, recurrence, objective instability, energy / coordination, Foot and&#xD;
      Ankle Disability Index and EQ 5D.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">April 2014</completion_date>
  <primary_completion_date type="Anticipated">April 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postural control</measure>
    <time_frame>6 weeks</time_frame>
    <description>Sway Index measured via the Leonardo Mechanograph GRFP (16 bit, 800 Hz; NOVOTEC Medical GmbH, Germany)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective instability</measure>
    <time_frame>1 year</time_frame>
    <description>Patient recorded giving-way symptoms or recurrence</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Postural Control</condition>
  <condition>Subjective Instablity</condition>
  <arm_group>
    <arm_group_label>WBV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive supervised physical therapy using a whole body vibration device (Galileo® Med M Plus, Novotec, Pforzheim, Germany) twice a week, 30 minutes per session, for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient will receive the current gold standard treatment protocol: supervised physical therapy, twice a week, 30 minutes per session, for 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Whole body vibration (Galileo® Med M Plus, Novotec, Pforzheim, Germany)</intervention_name>
    <description>Patients will train on a WBV platform, following a standardized protocol, aiming at improving strength, endurance and proprioception of both legs.</description>
    <arm_group_label>WBV</arm_group_label>
    <other_name>WBV</other_name>
    <other_name>Galileo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physiotherapy</intervention_name>
    <description>Patients will receive a standardized physical therapy.</description>
    <arm_group_label>Physiotherapy</arm_group_label>
    <other_name>Physical Therapy, Training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute, unilateral, unstable, inversion ankle sprain (Grade II, III)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Conditions affecting the neuromuscular- or musculoskeletal System&#xD;
&#xD;
          -  Previous surgical interventions to the foot, ankle, knee or hip; known FAI, CAI&#xD;
&#xD;
          -  Conditions possibly affecting balance&#xD;
&#xD;
          -  Cardiovascular disease including thrombosis&#xD;
&#xD;
          -  Respiratory diseases&#xD;
&#xD;
          -  Abdominal diseases (including gallstones)&#xD;
&#xD;
          -  Urological diseases (including kidney- and bladder stones)&#xD;
&#xD;
          -  Gynaecological diseases and + intrauterine devices&#xD;
&#xD;
          -  Neurological diseases including epilepsia within the last 2 years&#xD;
&#xD;
          -  Acute injuries to the head&#xD;
&#xD;
          -  Patient is not available for follow up visits&#xD;
&#xD;
          -  Patient unable to give informed consent&#xD;
&#xD;
          -  Patient suspected to be non-compliant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthias Schieker, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ludwig-Maximilians - University of Munich</affiliation>
  </overall_official>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <last_update_submitted>October 4, 2012</last_update_submitted>
  <last_update_submitted_qc>October 4, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 8, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ludwig-Maximilians - University of Munich</investigator_affiliation>
    <investigator_full_name>Sebastian. F. Baumbach</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ankle Injuries</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/NCT01702597
org study id: 315-12
secondary id: MMW-Stiftung
nct id: NCT01702597
lead sponsor: 
collaborator: 
has dmc: No
The aim of this bicentric, biphasic, randomized, controlled study is to compare of the
      current gold standard functional treatment to functional treatment plus WBV in patients with
      acute unilateral unstable inversion ankle sprains over a period of 12 months
Background:

      Ankle sprains often result in ankle instability, which is most likely caused by damage to
      passive and neurological structures. Whole body vibration (WBV) is a neuromuscular training
      method improving those neurologic parameters impaired. The aim of this study is to compare
      the current gold standard functional treatment to functional treatment plus WBV in patients
      with acute unilateral unstable inversion ankle sprains.

      Methods/Design:

      60 patients, aged 18-40 years, presenting with an isolated, unilateral, acute unstable
      inversion ankle sprain will be included in this bicentric, biphasic, randomized controlled
      trial. Patients will be randomized by envelope drawing. All patients will be allowed early
      mobilization and pain-depending weight bearing, limited functional immobilization by
      orthesis, PRICE, NSARDs as well as home and supervised physiotherapy. Supervised physical
      therapy will take place twice a week, 30 minutes per session, for 6 weeks, following a
      standardized intervention protocol. During supervised physical therapy, the intervention
      group will perform similar exercises on a side-alternating sinusoidal vibration platform as
      the control group. Two time dependent primary outcome parameters will be assessed. Short-term
      outcome after six weeks will be postural control quantified by the sway index. Mid-term
      outcome after one year will be assessed by subjective instability, defined by the presence of
      giving-way attacks. Secondary outcome parameters include return to pre-injury level of
      activities, residual pain, recurrence, objective instability, energy / coordination, Foot and
      Ankle Disability Index and EQ 5D.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Postural control
time frame: 6 weeks
description: Sway Index measured via the Leonardo Mechanograph GRFP (16 bit, 800 Hz; NOVOTEC Medical GmbH, Germany)
measure: Subjective instability
time frame: 1 year
description: Patient recorded giving-way symptoms or recurrence
arm group label: WBV
arm group type: Experimental
description: Patients will receive supervised physical therapy using a whole body vibration device (Galileo® Med M Plus, Novotec, Pforzheim, Germany) twice a week, 30 minutes per session, for 6 weeks.
arm group label: Physiotherapy
arm group type: Active Comparator
description: Patient will receive the current gold standard treatment protocol: supervised physical therapy, twice a week, 30 minutes per session, for 6 weeks.
intervention type: Device
intervention name: Whole body vibration (Galileo® Med M Plus, Novotec, Pforzheim, Germany)
description: Patients will train on a WBV platform, following a standardized protocol, aiming at improving strength, endurance and proprioception of both legs.
arm group label: WBV
other name: WBV
other name: Galileo
intervention type: Other
intervention name: Physiotherapy
description: Patients will receive a standardized physical therapy.
arm group label: Physiotherapy
other name: Physical Therapy, Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Matthias Schieker, Prof.
role: Principal Investigator
affiliation: Ludwig-Maximilians - University of Munich
responsible party type: Principal Investigator
investigator affiliation: Ludwig-Maximilians - University of Munich
investigator full name: Sebastian. F. Baumbach
investigator title: Principle Investigator
mesh term: Ankle Injuries