<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/NCT02244008</url>
  </required_header>
  <id_info>
    <org_study_id>RDS3123</org_study_id>
    <nct_id>NCT02244008</nct_id>
  </id_info>
  <brief_title>Accumulative Effects of Talus Mobilization</brief_title>
  <official_title>Effects of Anteroposterior Talus Mobilization on Range of Motion, Pain, and Functional Capacity in Participants With Sub-acute and Chronic Ankle Injuries: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Minas Gerais</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Minas Gerais</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to verify the effect of anteroposterior talus mobilization on&#xD;
      range of motion, pain, and functional capacity in participants with sub-acute and chronic&#xD;
      ankle injuries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study was to verify the acute effect (one session) and chronic (six&#xD;
      sessions) and follow-up of the anteroposterior talus mobilization Maitland's grade III on&#xD;
      range of motion, pain, and functional capacity in participants with sub-acute and chronic&#xD;
      ankle injuries. Thirty eight volunteers subjects (male and female) participated of this study&#xD;
      with minimum 18 and maximum 59 years old. The volunteers were allocated in two groups:&#xD;
      experimental and control. The variables related to range of motion, pain and functional&#xD;
      capacity were measured by biplane goniometer, Visual Analog Scale and Foot and Ankle Ability&#xD;
      Measure respectively in four moments: 1- baseline; 2- after the first intervention; 3- after&#xD;
      the sixth intervention (two weeks); 4- follow-up (one month). The experimental group received&#xD;
      anteroposterior articular mobilization of the talus and the control group received manual&#xD;
      contact.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in dorsiflexion range of motion</measure>
    <time_frame>1 month</time_frame>
    <description>Dorsiflexion range of motion were measured by biplane goniometer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in pain intensity</measure>
    <time_frame>1 month</time_frame>
    <description>Pain were measured by Visual Analog Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in functional capacity</measure>
    <time_frame>1 month</time_frame>
    <description>Functional capacity were measured by Foot and Ankle Ability Measure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Ankle Sprains</condition>
  <condition>Ankle Fractures</condition>
  <condition>Ankle Dislocations</condition>
  <condition>Ankle Bruises</condition>
  <condition>Achilles Tendon Rupture</condition>
  <arm_group>
    <arm_group_label>joint mobilization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Anteroposterior mobilization of the talus (Maitland mobilization grade III)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>manual contact</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>joint mobilization</intervention_name>
    <description>The experimental group received joint mobilization (anteroposterior mobilization of the talus - Maitland grade III). During the mobilization cyclic movements were applied in an anteroposterior direction from the first tissue resistance barrier until the end of the accessory range of motion without any pain or discomfort. This mobilization maneuver was performed in 30-second duration sets with a 30-second interval between each set. The interventions lasted two weeks with three sessions each, completing six sessions.</description>
    <arm_group_label>joint mobilization</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>manual contact</intervention_name>
    <description>The placebo group received only manual contact. This maneuver was performed in 30-second duration sets with a 30-second interval between each set. The interventions lasted two weeks with three sessions each, completing six sessions.</description>
    <arm_group_label>manual contact</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  unilateral traumatic injury of the ankle with at least two weeks and maximum eight&#xD;
             months&#xD;
&#xD;
          -  at least a 5º limitation of passive dorsiflexion in comparison to the contralateral&#xD;
             side&#xD;
&#xD;
          -  do not be under another physical therapy treatment for the lesion&#xD;
&#xD;
          -  able to unload partial or total body weight&#xD;
&#xD;
          -  do not be in use of analgesic&#xD;
&#xD;
          -  provided informed consent after receiving and explanation of all procedures and&#xD;
             pertinent information regarding the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  joint blockage by surgical fixation or ankylosis&#xD;
&#xD;
          -  presence of vascular, rheumatic, neurological and neoplastic disease in the lower limb&#xD;
&#xD;
          -  open or contagious lesion in the ankle region&#xD;
&#xD;
          -  pain during palpation in the region anterior of the ankle&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Minas Gerais College of Medical Sciences</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <zip>30130-110</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <results_reference>
    <citation>Hoch MC, Andreatta RD, Mullineaux DR, English RA, Medina McKeon JM, Mattacola CG, McKeon PO. Two-week joint mobilization intervention improves self-reported function, range of motion, and dynamic balance in those with chronic ankle instability. J Orthop Res. 2012 Nov;30(11):1798-804. doi: 10.1002/jor.22150. Epub 2012 May 18.</citation>
    <PMID>22610971</PMID>
  </results_reference>
  <results_reference>
    <citation>Landrum EL, Kelln CB, Parente WR, Ingersoll CD, Hertel J. Immediate Effects of Anterior-to-Posterior Talocrural Joint Mobilization after Prolonged Ankle Immobilization: A Preliminary Study. J Man Manip Ther. 2008;16(2):100-5. doi: 10.1179/106698108790818413.</citation>
    <PMID>19119395</PMID>
  </results_reference>
  <results_reference>
    <citation>Teixeira LM, Pires T, Silva RD, de Resende MA. Immediate effect of a single anteroposterior talus mobilization on dorsiflexion range of motion in participants with orthopedic dysfunction of the ankle and foot. J Manipulative Physiol Ther. 2013 Jul-Aug;36(6):369-75. doi: 10.1016/j.jmpt.2013.06.003. Epub 2013 Jul 11.</citation>
    <PMID>23850371</PMID>
  </results_reference>
  <results_reference>
    <citation>Hoch MC, McKeon PO. Joint mobilization improves spatiotemporal postural control and range of motion in those with chronic ankle instability. J Orthop Res. 2011 Mar;29(3):326-32. doi: 10.1002/jor.21256. Epub 2010 Sep 30.</citation>
    <PMID>20886654</PMID>
  </results_reference>
  <results_reference>
    <citation>Harkey M, McLeod M, Van Scoit A, Terada M, Tevald M, Gribble P, Pietrosimone B. The immediate effects of an anterior-to-posterior talar mobilization on neural excitability, dorsiflexion range of motion, and dynamic balance in patients with chronic ankle instability. J Sport Rehabil. 2014 Nov;23(4):351-9. doi: 10.1123/jsr.2013-0085. Epub 2014 Apr 3. Erratum In: J Sport Rehabil. 2015 May;24(2):197.</citation>
    <PMID>24700526</PMID>
  </results_reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>September 16, 2014</last_update_submitted>
  <last_update_submitted_qc>September 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Minas Gerais</investigator_affiliation>
    <investigator_full_name>RAFAEL DUARTE SILVA</investigator_full_name>
    <investigator_title>Master</investigator_title>
  </responsible_party>
  <keyword>Mobilization</keyword>
  <keyword>Joint Range of Motion</keyword>
  <keyword>Ankle</keyword>
  <keyword>Manual Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rupture</mesh_term>
    <mesh_term>Ankle Injuries</mesh_term>
    <mesh_term>Ankle Fractures</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/NCT02244008
org study id: RDS3123
nct id: NCT02244008
lead sponsor: 
has dmc: Yes
The purpose of this study is to verify the effect of anteroposterior talus mobilization on
      range of motion, pain, and functional capacity in participants with sub-acute and chronic
      ankle injuries.
The purpose of this study was to verify the acute effect (one session) and chronic (six
      sessions) and follow-up of the anteroposterior talus mobilization Maitland's grade III on
      range of motion, pain, and functional capacity in participants with sub-acute and chronic
      ankle injuries. Thirty eight volunteers subjects (male and female) participated of this study
      with minimum 18 and maximum 59 years old. The volunteers were allocated in two groups:
      experimental and control. The variables related to range of motion, pain and functional
      capacity were measured by biplane goniometer, Visual Analog Scale and Foot and Ankle Ability
      Measure respectively in four moments: 1- baseline; 2- after the first intervention; 3- after
      the sixth intervention (two weeks); 4- follow-up (one month). The experimental group received
      anteroposterior articular mobilization of the talus and the control group received manual
      contact.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Changes in dorsiflexion range of motion
time frame: 1 month
description: Dorsiflexion range of motion were measured by biplane goniometer.
measure: Changes in pain intensity
time frame: 1 month
description: Pain were measured by Visual Analog Scale.
measure: Changes in functional capacity
time frame: 1 month
description: Functional capacity were measured by Foot and Ankle Ability Measure.
arm group label: joint mobilization
arm group type: Experimental
description: Anteroposterior mobilization of the talus (Maitland mobilization grade III)
arm group label: manual contact
arm group type: Placebo Comparator
intervention type: Other
intervention name: joint mobilization
description: The experimental group received joint mobilization (anteroposterior mobilization of the talus - Maitland grade III). During the mobilization cyclic movements were applied in an anteroposterior direction from the first tissue resistance barrier until the end of the accessory range of motion without any pain or discomfort. This mobilization maneuver was performed in 30-second duration sets with a 30-second interval between each set. The interventions lasted two weeks with three sessions each, completing six sessions.
arm group label: joint mobilization
intervention type: Other
intervention name: manual contact
description: The placebo group received only manual contact. This maneuver was performed in 30-second duration sets with a 30-second interval between each set. The interventions lasted two weeks with three sessions each, completing six sessions.
arm group label: manual contact
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: No
facility: 
country: Brazil
citation: Hoch MC, Andreatta RD, Mullineaux DR, English RA, Medina McKeon JM, Mattacola CG, McKeon PO. Two-week joint mobilization intervention improves self-reported function, range of motion, and dynamic balance in those with chronic ankle instability. J Orthop Res. 2012 Nov;30(11):1798-804. doi: 10.1002/jor.22150. Epub 2012 May 18.
PMID: 22610971
citation: Landrum EL, Kelln CB, Parente WR, Ingersoll CD, Hertel J. Immediate Effects of Anterior-to-Posterior Talocrural Joint Mobilization after Prolonged Ankle Immobilization: A Preliminary Study. J Man Manip Ther. 2008;16(2):100-5. doi: 10.1179/106698108790818413.
PMID: 19119395
citation: Teixeira LM, Pires T, Silva RD, de Resende MA. Immediate effect of a single anteroposterior talus mobilization on dorsiflexion range of motion in participants with orthopedic dysfunction of the ankle and foot. J Manipulative Physiol Ther. 2013 Jul-Aug;36(6):369-75. doi: 10.1016/j.jmpt.2013.06.003. Epub 2013 Jul 11.
PMID: 23850371
citation: Hoch MC, McKeon PO. Joint mobilization improves spatiotemporal postural control and range of motion in those with chronic ankle instability. J Orthop Res. 2011 Mar;29(3):326-32. doi: 10.1002/jor.21256. Epub 2010 Sep 30.
PMID: 20886654
citation: Harkey M, McLeod M, Van Scoit A, Terada M, Tevald M, Gribble P, Pietrosimone B. The immediate effects of an anterior-to-posterior talar mobilization on neural excitability, dorsiflexion range of motion, and dynamic balance in patients with chronic ankle instability. J Sport Rehabil. 2014 Nov;23(4):351-9. doi: 10.1123/jsr.2013-0085. Epub 2014 Apr 3. Erratum In: J Sport Rehabil. 2015 May;24(2):197.
PMID: 24700526
responsible party type: Principal Investigator
investigator affiliation: Federal University of Minas Gerais
investigator full name: RAFAEL DUARTE SILVA
investigator title: Master
mesh term: Rupture
mesh term: Ankle Injuries
mesh term: Ankle Fractures