<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/NCT03281421</url>
  </required_header>
  <id_info>
    <org_study_id>Mestrado_Bruno</org_study_id>
    <nct_id>NCT03281421</nct_id>
  </id_info>
  <brief_title>Immediate Effects of Ankle Mobilization on Dorsiflexion Range of Motion in Women With Patellofemoral Pain.</brief_title>
  <acronym>Mestrado</acronym>
  <official_title>Immediate Effects of Ankle Mobilization on Dorsiflexion Range of Motion in Closed Kinetic Chain in Women With Patellofemoral Pain: A Random Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Ceara</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Ceara</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>
      Anterior Knee Pain or Patellofemoral Pain (PFP) is one of the most common disorders that&#xD;
      affecting knee in the physically active population, being a condition that typically presents&#xD;
      as diffuse knee pain in the anterior region and retro- or peri-patellar area, mainly in&#xD;
      activities that increase compression force in patellofemoral joint, such as squatting,&#xD;
      running, stair ascent and descent. The overall prevalence of PFP has been reported as between&#xD;
      15-45% of the population, and its incidence is higher among women. The literature cites as&#xD;
      etiology of PFP the ocorrence of dysfunctions in the local (knee), proximal (trunk, pelvis&#xD;
      and hip complex) and distal (ankle and foot regions) factores. Actually, there is a lack of&#xD;
      studies that investigate the interventions influences on distal factors in outcomes clinical&#xD;
      in persons with PFP. Thus, the aim of this study is analyze the effect of ankle mobilization&#xD;
      techiniques in ankle dorsiflexion range of motion closed kinetic chain in women with&#xD;
      patellofemoral pain and with dorsoflexion restriction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The sample of this study will be formed by 117 lower limbs of women with PFP who have ankle&#xD;
      dorsoflexion restriction, divided into three groups. Each group will contain 39 lower limbs&#xD;
      and receive an ankle mobilization technique with a specific sense of mobilization. The group&#xD;
      nominated GAP will receive an mobilization technique with slip sense from anterior to&#xD;
      posterior. The group nominated GPA will receive an mobilization technique with slip sense&#xD;
      from posterior to anterior. The group nominated GPA-AP will receive an mobilization technique&#xD;
      with slip sense both from posterior to anterior and from anterior to posterior.&#xD;
&#xD;
      Each group will receive a single intervention, which will consist of four sets of five&#xD;
      repetitions of the ankle mobilization technique (according to the specific slip direction of&#xD;
      each group), with rest time between series of one minute. In the group GPA-AP, to&#xD;
      standardized the sequence of mobilization, the first two sets will be performed with slip&#xD;
      sense from anterior to posterior, and the last two sets will be performede with slip sense&#xD;
      from posterior to anterior. There will be randomisation allocation of individuals in the&#xD;
      groups and because of the nature of the interventions only the evaluator may be blind.&#xD;
&#xD;
      The Kolmogorov - Smirnov test is used to verify the data distribution normality. The&#xD;
      characterization of the participants is performed by means of descriptive statistical&#xD;
      analysis. Parametric or non-parametric tests will be used according to the data distribution&#xD;
      normality for comparison between groups at baseline. The evaluator blinding will be tested&#xD;
      using the chi -square test by comparing the randomization code with the evaluator opinion.&#xD;
      The difference between the groups and their respective confidence intervals will be&#xD;
      calculated by linear mixed models using interaction term of &quot;time versus group&quot;.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 14, 2017</start_date>
  <completion_date type="Actual">September 25, 2018</completion_date>
  <primary_completion_date type="Actual">March 31, 2018</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Range of motion of ankle dorsiflexion.</measure>
    <time_frame>Immediatly after intervention day.</time_frame>
    <description>Closed kinetic chain evaluation to find the greatest distance between the foot and the wall without compensations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Range of motion of ankle dorsiflexion.</measure>
    <time_frame>Two days after intervention day.</time_frame>
    <description>Closed kinetic chain evaluation to find the greatest distance between the foot and the wall without compensations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angle of projection in the frontal plane in the lower limb.</measure>
    <time_frame>Immediatly and two days after intervention day.</time_frame>
    <description>Will be measured during the conduct of the Forward Step-Down Test through captured footage using a digital camera that will be positioned within two meters of the participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric Pain Scale.</measure>
    <time_frame>Immediatly and two days after intervention day.</time_frame>
    <description>Pain was assessed by use of an Numeric Pain Scale of eleven point, where zero corresponded to no pain and ten corresponded to worst imaginable pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Effect Perception Scale for Treatment</measure>
    <time_frame>Immediatly and two days after intervention day.</time_frame>
    <description>Global Effect Perception Scale for Treatment was assessed by use f an numeric scale of eleven point, where the lowest score corresponds to the extremely worst condition and the highest score corresponds to the fully recovered condition.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">117</enrollment>
  <condition>Patellofemoral Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>Group from posterior to anterior (GPA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in group GPA will receive a manual therapy intervention, through the technique of mobilization with movement in the ankle joint, with a slip sense from posterior to anterior. The physiotherapist will be positioned in front the participant's ankle, and a belt will be posicioned above the participant's malleolus and around physiotherapist's pelvis. The therapist applies with belt a anterior slip sustained in the tibia of the participant, while the talus are secured with the space between the thumb and the second finger of the hand of both hands on the physiotherapist´s. The participant will be instructed to perform a slow dorsiflexion movement at its maximum amplitude and hold five seconds in that position, returning to the initial position at the end of the five seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group from anterior to posterior (GAP)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in group GAP will receive a manual therapy intervention, through the technique of mobilization with movement in the ankle joint, with a slip sense from anterior to posterior. The physiotherapist will be positioned behind the participant's ankle. An belt will be posicioned above the participant's malleolus and around physiotherapist's trunk. The therapist applies with belt a posterior slip sustained in the tibia of the participant, while the heel and rearfoot are secured with the space between the thumb and the second finger of the hand of both hands on the physiotherapist´s. The participant will be instructed to perform a slow dorsiflexion movement at its maximum amplitude and hold five seconds in that position, returning to the initial position at the end of the five seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group GPA-AP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in group GAP will receive a manual therapy intervention, through the technique of mobilization with movement in the ankle joint, with a slip sense both from posterior to anterior and anterior to posterior. In the group GPA-AP, will be apllied both the procedure described for the group GPA as for the group GAP. To standardized the sequence of mobilization, the first two sets will be performed with slip sense from posterior to anterior, and the last two sets will be performede with slip sense from anterior to posterior.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual Therapy</intervention_name>
    <description>The manual therapy intervention, through the technique of mobilization with movement in the ankle joint (following the specific sense direction of the group), will be performed in a protocol that consists of four sets of five repetitions, with rest time between series of one minute.</description>
    <arm_group_label>Group GPA-AP</arm_group_label>
    <arm_group_label>Group from anterior to posterior (GAP)</arm_group_label>
    <arm_group_label>Group from posterior to anterior (GPA)</arm_group_label>
    <other_name>Manual Physical Therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of localized pain in the anterior region of the knee and / or around the&#xD;
             patella, reproduced with at least two of the following activities: climbing /&#xD;
             descending stairs, crouching, kneeling, long sitting, isometric contraction of the&#xD;
             quadriceps, running and jump.&#xD;
&#xD;
          -  Existence of a report of pain for at least three months, beginning incidental and&#xD;
             unrelated to some traumatic event in the knee.&#xD;
&#xD;
          -  Pain with intensity of at least three points in the Visual Analogue Scale (VAS) of&#xD;
             pain in the last week.&#xD;
&#xD;
          -  Limitation of the ankle dorsiflexion range of motion measured by the Lunge Test in the&#xD;
             lower limb with Patellofemoral Pain.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of surgery in the lumbar spine, hip, knee and / or ankle;&#xD;
&#xD;
          -  History of fractures in the lumbar spine, hip, knee and / or ankle;&#xD;
&#xD;
          -  History of patellar dislocation;&#xD;
&#xD;
          -  Presence of edema in the knee joint;&#xD;
&#xD;
          -  Presence of meniscal injury;&#xD;
&#xD;
          -  Injury of cruciate ligament and / or collateral ligaments;&#xD;
&#xD;
          -  Presence of tendonopathy in the patellar tendon, tendons of the goose and / or band&#xD;
             leg tibial ilium;&#xD;
&#xD;
          -  Presence of Osgood-Schlatter Syndrome or Sinding-Larsen-Johansson Syndromes.&#xD;
&#xD;
          -  Presence of pain in the lumbar spine and / or hip.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gabriel PL Almeida, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Ceará (UFC), Brazil.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal University of Ceara</name>
      <address>
        <city>Fortaleza</city>
        <state>Ceará</state>
        <zip>60430-160</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>February 21, 2019</last_update_submitted>
  <last_update_submitted_qc>February 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Ceara</investigator_affiliation>
    <investigator_full_name>Gabriel Peixoto Leão Almeida</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Patellofemoral Pain Syndrome</mesh_term>
  </condition_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/NCT03281421
org study id: Mestrado_Bruno
nct id: NCT03281421
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Anterior Knee Pain or Patellofemoral Pain (PFP) is one of the most common disorders that
      affecting knee in the physically active population, being a condition that typically presents
      as diffuse knee pain in the anterior region and retro- or peri-patellar area, mainly in
      activities that increase compression force in patellofemoral joint, such as squatting,
      running, stair ascent and descent. The overall prevalence of PFP has been reported as between
      15-45% of the population, and its incidence is higher among women. The literature cites as
      etiology of PFP the ocorrence of dysfunctions in the local (knee), proximal (trunk, pelvis
      and hip complex) and distal (ankle and foot regions) factores. Actually, there is a lack of
      studies that investigate the interventions influences on distal factors in outcomes clinical
      in persons with PFP. Thus, the aim of this study is analyze the effect of ankle mobilization
      techiniques in ankle dorsiflexion range of motion closed kinetic chain in women with
      patellofemoral pain and with dorsoflexion restriction.
The sample of this study will be formed by 117 lower limbs of women with PFP who have ankle
      dorsoflexion restriction, divided into three groups. Each group will contain 39 lower limbs
      and receive an ankle mobilization technique with a specific sense of mobilization. The group
      nominated GAP will receive an mobilization technique with slip sense from anterior to
      posterior. The group nominated GPA will receive an mobilization technique with slip sense
      from posterior to anterior. The group nominated GPA-AP will receive an mobilization technique
      with slip sense both from posterior to anterior and from anterior to posterior.

      Each group will receive a single intervention, which will consist of four sets of five
      repetitions of the ankle mobilization technique (according to the specific slip direction of
      each group), with rest time between series of one minute. In the group GPA-AP, to
      standardized the sequence of mobilization, the first two sets will be performed with slip
      sense from anterior to posterior, and the last two sets will be performede with slip sense
      from posterior to anterior. There will be randomisation allocation of individuals in the
      groups and because of the nature of the interventions only the evaluator may be blind.

      The Kolmogorov - Smirnov test is used to verify the data distribution normality. The
      characterization of the participants is performed by means of descriptive statistical
      analysis. Parametric or non-parametric tests will be used according to the data distribution
      normality for comparison between groups at baseline. The evaluator blinding will be tested
      using the chi -square test by comparing the randomization code with the evaluator opinion.
      The difference between the groups and their respective confidence intervals will be
      calculated by linear mixed models using interaction term of "time versus group".
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Range of motion of ankle dorsiflexion.
time frame: Immediatly after intervention day.
description: Closed kinetic chain evaluation to find the greatest distance between the foot and the wall without compensations.
measure: Range of motion of ankle dorsiflexion.
time frame: Two days after intervention day.
description: Closed kinetic chain evaluation to find the greatest distance between the foot and the wall without compensations.
measure: Angle of projection in the frontal plane in the lower limb.
time frame: Immediatly and two days after intervention day.
description: Will be measured during the conduct of the Forward Step-Down Test through captured footage using a digital camera that will be positioned within two meters of the participant.
measure: Numeric Pain Scale.
time frame: Immediatly and two days after intervention day.
description: Pain was assessed by use of an Numeric Pain Scale of eleven point, where zero corresponded to no pain and ten corresponded to worst imaginable pain
measure: Global Effect Perception Scale for Treatment
time frame: Immediatly and two days after intervention day.
description: Global Effect Perception Scale for Treatment was assessed by use f an numeric scale of eleven point, where the lowest score corresponds to the extremely worst condition and the highest score corresponds to the fully recovered condition.
arm group label: Group from posterior to anterior (GPA)
arm group type: Experimental
description: Participants in group GPA will receive a manual therapy intervention, through the technique of mobilization with movement in the ankle joint, with a slip sense from posterior to anterior. The physiotherapist will be positioned in front the participant's ankle, and a belt will be posicioned above the participant's malleolus and around physiotherapist's pelvis. The therapist applies with belt a anterior slip sustained in the tibia of the participant, while the talus are secured with the space between the thumb and the second finger of the hand of both hands on the physiotherapist´s. The participant will be instructed to perform a slow dorsiflexion movement at its maximum amplitude and hold five seconds in that position, returning to the initial position at the end of the five seconds.
arm group label: Group from anterior to posterior (GAP)
arm group type: Active Comparator
description: Participants in group GAP will receive a manual therapy intervention, through the technique of mobilization with movement in the ankle joint, with a slip sense from anterior to posterior. The physiotherapist will be positioned behind the participant's ankle. An belt will be posicioned above the participant's malleolus and around physiotherapist's trunk. The therapist applies with belt a posterior slip sustained in the tibia of the participant, while the heel and rearfoot are secured with the space between the thumb and the second finger of the hand of both hands on the physiotherapist´s. The participant will be instructed to perform a slow dorsiflexion movement at its maximum amplitude and hold five seconds in that position, returning to the initial position at the end of the five seconds.
arm group label: Group GPA-AP
arm group type: Active Comparator
description: Participants in group GAP will receive a manual therapy intervention, through the technique of mobilization with movement in the ankle joint, with a slip sense both from posterior to anterior and anterior to posterior. In the group GPA-AP, will be apllied both the procedure described for the group GPA as for the group GAP. To standardized the sequence of mobilization, the first two sets will be performed with slip sense from posterior to anterior, and the last two sets will be performede with slip sense from anterior to posterior.
intervention type: Other
intervention name: Manual Therapy
description: The manual therapy intervention, through the technique of mobilization with movement in the ankle joint (following the specific sense direction of the group), will be performed in a protocol that consists of four sets of five repetitions, with rest time between series of one minute.
arm group label: Group GPA-AP
arm group label: Group from anterior to posterior (GAP)
arm group label: Group from posterior to anterior (GPA)
other name: Manual Physical Therapy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Gabriel PL Almeida, MSc
role: Principal Investigator
affiliation: Federal University of Ceará (UFC), Brazil.
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Ceara
investigator full name: Gabriel Peixoto Leão Almeida
investigator title: Professor
mesh term: Patellofemoral Pain Syndrome
sharing ipd: No