<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/NCT03038815</url>
  </required_header>
  <id_info>
    <org_study_id>Stability Boots</org_study_id>
    <nct_id>NCT03038815</nct_id>
  </id_info>
  <brief_title>The Influence of Stability Boots on Gait Pattern in Healthy Adults</brief_title>
  <official_title>The Influence of Stability Boots on Gait Pattern in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute for Biomechanics, ETH Zürich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute for Biomechanics, ETH Zürich</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>
      After an ankle injury like distorsions, fractures or arthrodeses, or congenital defects ankle&#xD;
      support limit the range of motion in the joint, help pain relief, control loading of the&#xD;
      injured tissues and promote recovery of a normal gait pattern. Gait analysis is applied in&#xD;
      orthopedics, sport science and rehabilitation. Numerous measure systems and methods enable&#xD;
      accurate analysis of human movement.&#xD;
&#xD;
      The study is set to describe and compare the gait analysis of two modifiable stability boots&#xD;
      (Ortho® Tri-Phase and the VACOped®) on the standard walking parameters during two conditions&#xD;
      (level and ramp walking) in healthy adults and draw comparisons with a control indoor shoe.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participants are joining one session in the gait lab. Here the are measured during&#xD;
      walking with normal shoes and two modifiable stability boots. The duration of a session is&#xD;
      typically 3 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ROM Ankle Joint</measure>
    <time_frame>duration of a session is typically 3 hours</time_frame>
    <description>Ankle joint motion ROM Sagittal left, during gait</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symmetrie Index</measure>
    <time_frame>duration of a session is typically 3 hours</time_frame>
    <description>The symmetrie index, represents the % difference step length, index= 2*100*(step length left-step length right)/(step length left+step length right) This measure has no unit. 0 would represent a total symmetric gait.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Rehabilitation After Ankle Injuries</condition>
  <arm_group>
    <arm_group_label>Controll-VACOped-Ortho Tri</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed. For control, the participants are wearing Sport shoes.This group had the VACOped as the first intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controll-Ortho Tri-VACOped</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed. For control, the participants are wearing Sport shoes.This group had the Ortho Tri first intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VACOped</intervention_name>
    <description>restriction of ankle joint motion</description>
    <arm_group_label>Controll-Ortho Tri-VACOped</arm_group_label>
    <arm_group_label>Controll-VACOped-Ortho Tri</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ortho Tri</intervention_name>
    <description>restriction of ankle joint motion</description>
    <arm_group_label>Controll-Ortho Tri-VACOped</arm_group_label>
    <arm_group_label>Controll-VACOped-Ortho Tri</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy&#xD;
&#xD;
          -  18-45 years old&#xD;
&#xD;
          -  shoe size 5,6,9 or 10&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  injuries of the lower limbs&#xD;
&#xD;
          -  previous surgeries on the lower limbs&#xD;
&#xD;
          -  neuromuscular disorders&#xD;
&#xD;
          -  restriction in gait capabilities&#xD;
&#xD;
          -  current medical treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Silvio Lorenzetti, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute for Biomechanics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute for Biomechanics ETH Zürich</name>
      <address>
        <city>Zurich</city>
        <state>ZH</state>
        <zip>8093</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <results_first_submitted>June 27, 2019</results_first_submitted>
  <results_first_submitted_qc>October 14, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 1, 2019</results_first_posted>
  <last_update_submitted>November 1, 2019</last_update_submitted>
  <last_update_submitted_qc>November 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2019</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>Ankle Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03038815/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Controll-VACOped-Ortho Tri</title>
          <description>VACOped first</description>
        </group>
        <group group_id="P2">
          <title>Controll-Ortho Tri-VACOped</title>
          <description>Ortho Tri first</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Controll Condition, 1 Hour</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Intervention 1, 1 Hour</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Intervention 2, 1 Hour</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control Group-VACOped-Ortho Tri-Phase</title>
          <description>All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed. For control, the participants are wearing Sport shoes.&#xD;
This group had the VACUped as first intervention.</description>
        </group>
        <group group_id="B2">
          <title>Control Group-Ortho Tri-Phase-VACOped</title>
          <description>All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed. For control, the participants are wearing Sport shoes.&#xD;
This group had the Ortho Tri as first intervention.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24" spread="2"/>
                    <measurement group_id="B2" value="24" spread="2"/>
                    <measurement group_id="B3" value="24" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Switzerland</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>ROM Ankle Joint</title>
        <description>Ankle joint motion ROM Sagittal left, during gait</description>
        <time_frame>duration of a session is typically 3 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed. For control, the participants are wearing Sport shoes.</description>
          </group>
          <group group_id="O2">
            <title>VACOped</title>
            <description>All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed.&#xD;
VACOped: restriction of ankle joint motion</description>
          </group>
          <group group_id="O3">
            <title>Ortho Tri-Phase</title>
            <description>All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed.&#xD;
Ortho Tri-Phase: restriction of ankle joint motion</description>
          </group>
        </group_list>
        <measure>
          <title>ROM Ankle Joint</title>
          <description>Ankle joint motion ROM Sagittal left, during gait</description>
          <units>degree</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.4" spread="5.7"/>
                    <measurement group_id="O2" value="18.4" spread="3.5"/>
                    <measurement group_id="O3" value="21.2" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Symmetrie Index</title>
        <description>The symmetrie index, represents the % difference step length, index= 2*100*(step length left-step length right)/(step length left+step length right) This measure has no unit. 0 would represent a total symmetric gait.</description>
        <time_frame>duration of a session is typically 3 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed. For control, the participants are wearing Sport shoes.</description>
          </group>
          <group group_id="O2">
            <title>VACOped</title>
            <description>All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed.&#xD;
VACOped: restriction of ankle joint motion</description>
          </group>
          <group group_id="O3">
            <title>Ortho Tri-Phase</title>
            <description>All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed.&#xD;
Ortho Tri-Phase: restriction of ankle joint motion</description>
          </group>
        </group_list>
        <measure>
          <title>Symmetrie Index</title>
          <description>The symmetrie index, represents the % difference step length, index= 2*100*(step length left-step length right)/(step length left+step length right) This measure has no unit. 0 would represent a total symmetric gait.</description>
          <units>percentage of step length</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.45" spread="0.05"/>
                    <measurement group_id="O2" value="7.62" spread="0.15"/>
                    <measurement group_id="O3" value="1.9" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>during the intervention, up to 3 hours</time_frame>
      <desc>Standard definitions</desc>
      <group_list>
        <group group_id="E1">
          <title>Controll-VACOped-Ortho Tri</title>
          <description>This group had first the control condition, than the VACUped intervention and last the Ortho Tri intervention.</description>
        </group>
        <group group_id="E2">
          <title>Controll-Ortho Tri-VACOped</title>
          <description>This group had first the control condition, than the Ortho Tri intervention and last the VACOped intervention.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Silvio Lorenzetti</name_or_title>
      <organization>Institute for Biomechanics ETH Zürich</organization>
      <phone>078 608 14 84</phone>
      <email>sl@ethz.ch</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03038815
org study id: Stability Boots
nct id: NCT03038815
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
After an ankle injury like distorsions, fractures or arthrodeses, or congenital defects ankle
      support limit the range of motion in the joint, help pain relief, control loading of the
      injured tissues and promote recovery of a normal gait pattern. Gait analysis is applied in
      orthopedics, sport science and rehabilitation. Numerous measure systems and methods enable
      accurate analysis of human movement.

      The study is set to describe and compare the gait analysis of two modifiable stability boots
      (Ortho® Tri-Phase and the VACOped®) on the standard walking parameters during two conditions
      (level and ramp walking) in healthy adults and draw comparisons with a control indoor shoe.
The participants are joining one session in the gait lab. Here the are measured during
      walking with normal shoes and two modifiable stability boots. The duration of a session is
      typically 3 hours.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: ROM Ankle Joint
time frame: duration of a session is typically 3 hours
description: Ankle joint motion ROM Sagittal left, during gait
measure: Symmetrie Index
time frame: duration of a session is typically 3 hours
description: The symmetrie index, represents the % difference step length, index= 2*100*(step length left-step length right)/(step length left+step length right) This measure has no unit. 0 would represent a total symmetric gait.
arm group label: Controll-VACOped-Ortho Tri
arm group type: Experimental
description: All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed. For control, the participants are wearing Sport shoes.This group had the VACOped as the first intervention.
arm group label: Controll-Ortho Tri-VACOped
arm group type: Experimental
description: All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed. For control, the participants are wearing Sport shoes.This group had the Ortho Tri first intervention
intervention type: Device
intervention name: VACOped
description: restriction of ankle joint motion
arm group label: Controll-Ortho Tri-VACOped
arm group label: Controll-VACOped-Ortho Tri
intervention type: Device
intervention name: Ortho Tri
description: restriction of ankle joint motion
arm group label: Controll-Ortho Tri-VACOped
arm group label: Controll-VACOped-Ortho Tri
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Silvio Lorenzetti, PhD
role: Principal Investigator
affiliation: Institute for Biomechanics
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Ankle Injuries
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 