<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/NCT03768583</url>
  </required_header>
  <id_info>
    <org_study_id>Sensory motor training</org_study_id>
    <nct_id>NCT03768583</nct_id>
  </id_info>
  <brief_title>Analysis of Sensory Motor Training in Chronic Ankle Instability</brief_title>
  <official_title>Effect of Sensory Motor Training With and Without Sports Shoes on the Dynamic Postural Control of Athletes With Chronic Ankle Instability</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Estadual de Londrina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Estadual de Londrina</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Introduction: Sensory motor training (STS) is part of rehabilitation and injury prevention in&#xD;
      individuals with chronic ankle instability (ICS). The use of footwear during SST may&#xD;
      interfere with neuromuscular responses, but little is known about the difference in motor&#xD;
      control response when training is applied with the use of shoes or bare feet. Objectives: To&#xD;
      establish the effect of sensory motor training with and without sports shoes on the dynamic&#xD;
      postural control of athletes with chronic ankle instability. Materials and Methods: The study&#xD;
      will be performed with athletes linked to the Athletics of the State University of Londrina,&#xD;
      aged between 18 and 30 years, both sexes, with chronic ankle instability assessed using the&#xD;
      Cumberland Ankle Instability Tool (CAIT) questionnaire. Dynamic postural control will be&#xD;
      evaluated in Force Platform and muscle recruitment through the electromyography of the&#xD;
      muscles: anterior tibial, lateral and medial gastrocnemius, long fibular, gluteus maximus and&#xD;
      gluteus medius. After the evaluation the volunteers will be randomized into two groups: 1)&#xD;
      barefoot sensory-motor training and 2) sensory motor training with sneakers. The two groups&#xD;
      will develop the same protocol of sensory motor training consisting of exercises, for five&#xD;
      weeks, twice a week. At the end of the training they will be re-evaluated and the data&#xD;
      analyzed. Expected Results: It is expected to find better postural control in the group that&#xD;
      will perform in barefoot sensory-motor training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The total sample was determined in 54 volunteers, distributed equally in two groups: Chronic&#xD;
      Ankle Instability and Control. Each group will be randomized for sensory-motor training with&#xD;
      sneakers and without sneakers.&#xD;
&#xD;
      Inclusion criteria: athletes of both sexes, aged between 18 and 30 years, with history of&#xD;
      ankle sprain in the last 12 months, sensation of instability or &quot;yielding&quot; of the ankle and&#xD;
      score determined by the CAIT &lt;24 questionnaire, did not perform sensory-motor training or&#xD;
      conventional physiotherapy in the last six months.&#xD;
&#xD;
      Exclusion criteria: presence of pain complaints at the time of evaluation, recurrence of&#xD;
      sprain with acute inflammatory signs, painful complaints in the lower limbs, lower limb&#xD;
      surgery with neurological, cardiovascular, rheumatologic, diabetes, altered plantar&#xD;
      sensitivity.&#xD;
&#xD;
      Participants with chronic ankle instability and controls will be randomly assigned to the two&#xD;
      treatment groups, through the program www.ramdom.com, in blocks in the two groups: Sensory&#xD;
      Motor Training Group with Tennis (TSMT) and Group Training Sensory Motor Barefoot ( TSMD).&#xD;
&#xD;
      Scratchs:&#xD;
&#xD;
      Since this is a study with intervention in participants with chronic ankle instability, there&#xD;
      is a risk of new sprain during sensorimotor training. In case it occurs, the participant will&#xD;
      receive all the support of the team coordinated by the professor Christiane Guerino de Souza&#xD;
      Macedo in the extension project: Physiotherapy from theory to practice.&#xD;
&#xD;
      Procedures:&#xD;
&#xD;
      Initially the participants will complete the demographic data sheet (age, weight, height,&#xD;
      BMI, level of physical activity and dominance in the lower limbs) and history of lower limb&#xD;
      injury. Will respond to the chronic ankle instability questionnaire CAIT-p. They will sign&#xD;
      the informed consent form (TCLE).&#xD;
&#xD;
      Following, the Lunge test will be performed to analyze ankle mobility. The same will be&#xD;
      developed with the participant in orthostatism in front of a wall, with a tape measure, the&#xD;
      participant will begin the test with a distance of 2cm from the wall and will be incremented&#xD;
      by 1cm each time until the greater distance is reached. You will perform maximum knee flexion&#xD;
      without the heel lifting from the floor or assuming a valgus position, with the goal of&#xD;
      bringing the knee up to the wall. The result will be established by means of the halux-wall&#xD;
      distance.&#xD;
&#xD;
      Postural control and muscle recruitment of a lower limb with the same direction should not be&#xD;
      assessed by force platform and electromyography, respectively. The evaluations are made for&#xD;
      the blind and according to the order of the instruments and the use or not of the shoe.&#xD;
&#xD;
      The anchoring of electromyographic analysis electrodes is performed on the anterior tibialis&#xD;
      muscle (TA), lateral gastrocnemius (GL), medial gastrocnemius (GM), long fibularis (FL),&#xD;
      gluteus maximus (GMe) and gluteus maximus (GMa). There will be a screening of electrotherapy&#xD;
      supplements and cleaning of the area with alcohol rubbing (Moraes et al., 2012). The&#xD;
      electrodes will be attached to the previous muscular points, according to the guide.&#xD;
&#xD;
      After placement of the electrodes the participant will be positioned with the lower limb to&#xD;
      be tested on one step (based on height of applied force platform) and perform a series of&#xD;
      assactions per second for thirty seconds controlled by metronome. This evaluation will be&#xD;
      done 3 times. With a rest period of one full day in each test.&#xD;
&#xD;
      For an evaluation of dynamic postural control (BIOMEC400, Sistema EMG do Brasil, SP Ltda.).&#xD;
      On the platform will be placed the member with chronic instability of the ankle and perform&#xD;
      squatting to 30 seconds. With a rest period of one morning between each sitting test. They&#xD;
      will be carried out 3 times with sneakers and 3 times with bare feet.&#xD;
&#xD;
      At this moment, the main parameters of COP-based postural control are: The area of COP&#xD;
      ellipse (A-COP in cm²) and the mean COP oscillation distance (VEL in cm / s) are the most&#xD;
      indicated in the directions: anteroposterior (A / P) and medium-lateral (M / L). Results were&#xD;
      calculated for an average of three trials.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 20, 2018</start_date>
  <completion_date type="Actual">July 30, 2019</completion_date>
  <primary_completion_date type="Actual">July 20, 2019</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>Postural control response after intervention</measure>
    <time_frame>twenty weeks</time_frame>
    <description>Response of sensorial motor training in improving motor control in volunteers with chronic ankle instability or not. Will use force platform.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle recruitment response after intervention</measure>
    <time_frame>twenty weeks</time_frame>
    <description>Response of sensorial motor training in the muscular recruitment of volunteers with chronic ankle instability or not, and the difference in response when performed with sneakers or barefoot. Will use electromyography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>measurement ankle dorsiflexion</measure>
    <time_frame>twenty weeks</time_frame>
    <description>The dorsiflexion will be mensure with the Lunge test in centimeter</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Recruitment</condition>
  <arm_group>
    <arm_group_label>Group TSM ICT sneakers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ICT with sneaker&#xD;
five weeks&#xD;
twice a week&#xD;
half hour.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group TSM ICT barefoot</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ICT barefoot&#xD;
five weeks&#xD;
twice a week&#xD;
half hour.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group TSM health barefoot</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Health with sneaker&#xD;
five weeks&#xD;
twice a week&#xD;
half hour.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group TSM health sneakers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Health barefoot&#xD;
five weeks&#xD;
twice a week&#xD;
half hour.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group TSM ICT sneakers</intervention_name>
    <description>Sensory motor training with sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week.</description>
    <arm_group_label>Group TSM ICT sneakers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group TSM ICT barefoot</intervention_name>
    <description>Sensory motor training without sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week.</description>
    <arm_group_label>Group TSM ICT barefoot</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group TSM health sneaker</intervention_name>
    <description>Sensory motor training with sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week.</description>
    <arm_group_label>Group TSM health sneakers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group TSM health barefoot</intervention_name>
    <description>Sensory motor training without sneaker for volunteers with Chronic ankle instability, for five weeks, twice a week.</description>
    <arm_group_label>Group TSM health barefoot</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  athletes of both sexes&#xD;
&#xD;
          -  aged between 18 and 30 years,&#xD;
&#xD;
          -  with history of the first ankle sprain for at least 12 months,&#xD;
&#xD;
          -  feeling of instability or &quot;flaccidity&quot; of the ankle&#xD;
&#xD;
          -  score determined by the CAIT questionnaire of less than 24,&#xD;
&#xD;
          -  have not undergone sensory-motor or conventional physiotherapy training in the last&#xD;
             six months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Withdrawal at the time of the evaluation,&#xD;
&#xD;
          -  Recurrence of sprain accompanied by signs of inflammation, acute and painful&#xD;
             complaints in the lower group,&#xD;
&#xD;
          -  history of lower limb surgery, neurological, cardiovascular, rheumatologic, diabetes,&#xD;
             altered plantar sensitivity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christiane Macedo</last_name>
    <role>Principal Investigator</role>
    <affiliation>State University of Londrina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>university hospital of the State University of Londrina</name>
      <address>
        <city>Londrina</city>
        <state>Paraná</state>
        <zip>86038-350</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Hiller CE, Refshauge KM, Bundy AC, Herbert RD, Kilbreath SL. The Cumberland ankle instability tool: a report of validity and reliability testing. Arch Phys Med Rehabil. 2006 Sep;87(9):1235-41. doi: 10.1016/j.apmr.2006.05.022.</citation>
    <PMID>16935061</PMID>
  </reference>
  <reference>
    <citation>Konradsen L, Bech L, Ehrenbjerg M, Nickelsen T. Seven years follow-up after ankle inversion trauma. Scand J Med Sci Sports. 2002 Jun;12(3):129-35. doi: 10.1034/j.1600-0838.2002.02104.x.</citation>
    <PMID>12135444</PMID>
  </reference>
  <reference>
    <citation>Heleno LR, da Silva RA, Shigaki L, Araujo CG, Coelho Candido CR, Okazaki VH, Frisseli A, Macedo CS. Five-week sensory motor training program improves functional performance and postural control in young male soccer players - A blind randomized clinical trial. Phys Ther Sport. 2016 Nov;22:74-80. doi: 10.1016/j.ptsp.2016.05.004. Epub 2016 May 10.</citation>
    <PMID>27620862</PMID>
  </reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>July 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>August 15, 2019</last_update_submitted>
  <last_update_submitted_qc>August 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Postural Balace</keyword>
  <keyword>Physioteraphy</keyword>
  <keyword>Ankle Injuries</keyword>
  <keyword>Electromyography</keyword>
  <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/NCT03768583
org study id: Sensory motor training
nct id: NCT03768583
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Introduction: Sensory motor training (STS) is part of rehabilitation and injury prevention in
      individuals with chronic ankle instability (ICS). The use of footwear during SST may
      interfere with neuromuscular responses, but little is known about the difference in motor
      control response when training is applied with the use of shoes or bare feet. Objectives: To
      establish the effect of sensory motor training with and without sports shoes on the dynamic
      postural control of athletes with chronic ankle instability. Materials and Methods: The study
      will be performed with athletes linked to the Athletics of the State University of Londrina,
      aged between 18 and 30 years, both sexes, with chronic ankle instability assessed using the
      Cumberland Ankle Instability Tool (CAIT) questionnaire. Dynamic postural control will be
      evaluated in Force Platform and muscle recruitment through the electromyography of the
      muscles: anterior tibial, lateral and medial gastrocnemius, long fibular, gluteus maximus and
      gluteus medius. After the evaluation the volunteers will be randomized into two groups: 1)
      barefoot sensory-motor training and 2) sensory motor training with sneakers. The two groups
      will develop the same protocol of sensory motor training consisting of exercises, for five
      weeks, twice a week. At the end of the training they will be re-evaluated and the data
      analyzed. Expected Results: It is expected to find better postural control in the group that
      will perform in barefoot sensory-motor training.
The total sample was determined in 54 volunteers, distributed equally in two groups: Chronic
      Ankle Instability and Control. Each group will be randomized for sensory-motor training with
      sneakers and without sneakers.

      Inclusion criteria: athletes of both sexes, aged between 18 and 30 years, with history of
      ankle sprain in the last 12 months, sensation of instability or "yielding" of the ankle and
      score determined by the CAIT <24 questionnaire, did not perform sensory-motor training or
      conventional physiotherapy in the last six months.

      Exclusion criteria: presence of pain complaints at the time of evaluation, recurrence of
      sprain with acute inflammatory signs, painful complaints in the lower limbs, lower limb
      surgery with neurological, cardiovascular, rheumatologic, diabetes, altered plantar
      sensitivity.

      Participants with chronic ankle instability and controls will be randomly assigned to the two
      treatment groups, through the program www.ramdom.com, in blocks in the two groups: Sensory
      Motor Training Group with Tennis (TSMT) and Group Training Sensory Motor Barefoot ( TSMD).

      Scratchs:

      Since this is a study with intervention in participants with chronic ankle instability, there
      is a risk of new sprain during sensorimotor training. In case it occurs, the participant will
      receive all the support of the team coordinated by the professor Christiane Guerino de Souza
      Macedo in the extension project: Physiotherapy from theory to practice.

      Procedures:

      Initially the participants will complete the demographic data sheet (age, weight, height,
      BMI, level of physical activity and dominance in the lower limbs) and history of lower limb
      injury. Will respond to the chronic ankle instability questionnaire CAIT-p. They will sign
      the informed consent form (TCLE).

      Following, the Lunge test will be performed to analyze ankle mobility. The same will be
      developed with the participant in orthostatism in front of a wall, with a tape measure, the
      participant will begin the test with a distance of 2cm from the wall and will be incremented
      by 1cm each time until the greater distance is reached. You will perform maximum knee flexion
      without the heel lifting from the floor or assuming a valgus position, with the goal of
      bringing the knee up to the wall. The result will be established by means of the halux-wall
      distance.

      Postural control and muscle recruitment of a lower limb with the same direction should not be
      assessed by force platform and electromyography, respectively. The evaluations are made for
      the blind and according to the order of the instruments and the use or not of the shoe.

      The anchoring of electromyographic analysis electrodes is performed on the anterior tibialis
      muscle (TA), lateral gastrocnemius (GL), medial gastrocnemius (GM), long fibularis (FL),
      gluteus maximus (GMe) and gluteus maximus (GMa). There will be a screening of electrotherapy
      supplements and cleaning of the area with alcohol rubbing (Moraes et al., 2012). The
      electrodes will be attached to the previous muscular points, according to the guide.

      After placement of the electrodes the participant will be positioned with the lower limb to
      be tested on one step (based on height of applied force platform) and perform a series of
      assactions per second for thirty seconds controlled by metronome. This evaluation will be
      done 3 times. With a rest period of one full day in each test.

      For an evaluation of dynamic postural control (BIOMEC400, Sistema EMG do Brasil, SP Ltda.).
      On the platform will be placed the member with chronic instability of the ankle and perform
      squatting to 30 seconds. With a rest period of one morning between each sitting test. They
      will be carried out 3 times with sneakers and 3 times with bare feet.

      At this moment, the main parameters of COP-based postural control are: The area of COP
      ellipse (A-COP in cm²) and the mean COP oscillation distance (VEL in cm / s) are the most
      indicated in the directions: anteroposterior (A / P) and medium-lateral (M / L). Results were
      calculated for an average of three trials.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Postural control response after intervention
time frame: twenty weeks
description: Response of sensorial motor training in improving motor control in volunteers with chronic ankle instability or not. Will use force platform.
measure: Muscle recruitment response after intervention
time frame: twenty weeks
description: Response of sensorial motor training in the muscular recruitment of volunteers with chronic ankle instability or not, and the difference in response when performed with sneakers or barefoot. Will use electromyography.
measure: measurement ankle dorsiflexion
time frame: twenty weeks
description: The dorsiflexion will be mensure with the Lunge test in centimeter
arm group label: Group TSM ICT sneakers
arm group type: Experimental
description: ICT with sneaker
five weeks
twice a week
half hour.
arm group label: Group TSM ICT barefoot
arm group type: Experimental
description: ICT barefoot
five weeks
twice a week
half hour.
arm group label: Group TSM health barefoot
arm group type: Experimental
description: Health with sneaker
five weeks
twice a week
half hour.
arm group label: Group TSM health sneakers
arm group type: Experimental
description: Health barefoot
five weeks
twice a week
half hour.
intervention type: Other
intervention name: Group TSM ICT sneakers
description: Sensory motor training with sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week.
arm group label: Group TSM ICT sneakers
intervention type: Other
intervention name: Group TSM ICT barefoot
description: Sensory motor training without sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week.
arm group label: Group TSM ICT barefoot
intervention type: Other
intervention name: Group TSM health sneaker
description: Sensory motor training with sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week.
arm group label: Group TSM health sneakers
intervention type: Other
intervention name: Group TSM health barefoot
description: Sensory motor training without sneaker for volunteers with Chronic ankle instability, for five weeks, twice a week.
arm group label: Group TSM health barefoot
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christiane Macedo
role: Principal Investigator
affiliation: State University of Londrina
facility: 
country: Brazil
citation: Hiller CE, Refshauge KM, Bundy AC, Herbert RD, Kilbreath SL. The Cumberland ankle instability tool: a report of validity and reliability testing. Arch Phys Med Rehabil. 2006 Sep;87(9):1235-41. doi: 10.1016/j.apmr.2006.05.022.
PMID: 16935061
citation: Konradsen L, Bech L, Ehrenbjerg M, Nickelsen T. Seven years follow-up after ankle inversion trauma. Scand J Med Sci Sports. 2002 Jun;12(3):129-35. doi: 10.1034/j.1600-0838.2002.02104.x.
PMID: 12135444
citation: Heleno LR, da Silva RA, Shigaki L, Araujo CG, Coelho Candido CR, Okazaki VH, Frisseli A, Macedo CS. Five-week sensory motor training program improves functional performance and postural control in young male soccer players - A blind randomized clinical trial. Phys Ther Sport. 2016 Nov;22:74-80. doi: 10.1016/j.ptsp.2016.05.004. Epub 2016 May 10.
PMID: 27620862
responsible party type: Sponsor
sharing ipd: No