<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/NCT03804047</url>
  </required_header>
  <id_info>
    <org_study_id>HS18-0012</org_study_id>
    <nct_id>NCT03804047</nct_id>
  </id_info>
  <brief_title>KITAMS: Kinesio Tape and Physical Function in Persons With Multiples Sclerosis</brief_title>
  <acronym>KITAMS</acronym>
  <official_title>KITAMS: Kinesio Tape and Physical Function in Persons With Multiples Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northern Illinois University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northern Illinois University</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>
      Multiple sclerosis (MS) is a disease that causes damage within the central nervous system and&#xD;
      results in deficits of body functions. The investigators propose a pilot randomized&#xD;
      controlled trial examining the acute effect of kinesio tape application in various body&#xD;
      segments on balance, mobility, physical functioning, and pain in persons with MS (pwMS) aged&#xD;
      18 to 55 years old. The investigators will objectively assess balance using a force platform&#xD;
      and mobility and physical functioning will be assessed using standardized tests (i.e., Timed&#xD;
      Up and Go, Timed 25-foot Walk, 6-minute Step Test, Six Spot Step Test). The trial will&#xD;
      recruit 24 pwMS aged 18 to 55 years with mild-to-moderate MS-related disability who will be&#xD;
      randomized into intervention (Kinesio Tape) or control conditions (Sham/Inflexible Tape).&#xD;
      Participants will complete assessments before and after tape application. This pilot trial&#xD;
      will inform future research interventions aiming to use the approach in different situations&#xD;
      with pwMS (e.g., exercise).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research Plan&#xD;
&#xD;
      Participants The investigators will recruit and enroll 24 pwMS (12 per group) aged 18-55&#xD;
      years. This sample size is appropriate for pilot trials, and was not based on power analysis.&#xD;
      The number of 12 per group is justified based on feasibility, gains in the precision about&#xD;
      the mean and variance, and regulatory consideration. Related to gains in the precision, the&#xD;
      gains are less pronounced after 12 participants. Recruitment will occur though advertisements&#xD;
      in local newspapers (100-mile radius around Illinois campus) and posts on the Greater&#xD;
      Illinois chapter of the National Multiple Sclerosis Society (NMSS) website. The investigators&#xD;
      will further recruit using our participant's database that includes pwMS 40 years of age and&#xD;
      older. The 24 persons will be randomly assigned in equal ratios through concealed allocation&#xD;
      into either the intervention (i.e., Kinesio Tape - KTG; n=12) or control (i.e., Sham Tape -&#xD;
      STG; n=12) conditions. The inclusion criteria are: clinically definitive diagnosis of MS; age&#xD;
      between 18 and 55 years; relapse-free for the past 30 days and; ability to walk with or&#xD;
      without assistive device (i.e., cane, but not walker/rollator). Participants further must be&#xD;
      willing to complete in-person assessments in a university research setting. The investigators&#xD;
      will exclude those who use wheelchair, crutches and walker or who have moderate cognitive&#xD;
      impairment based on the modified Telephone Interview for Cognitive Status (i.e., moderate&#xD;
      cognitive impairment, ≤ 12 points).&#xD;
&#xD;
      Main Outcomes&#xD;
&#xD;
      Balance. Balance will be objectively measured using a force platform (AccuSway, AMTI, Newton,&#xD;
      MA, USA) which will be used to calculate the coordinates of the center of pressure (COP)&#xD;
      during the standing test using three orthogonal forces and moments. Signals from the force&#xD;
      plate will be sampled at 100HZ. Data analysis will then be performed using specific programs&#xD;
      developed in MATLAB (Mathworks, Natick, MA, USA). Four classical time domain posturographic&#xD;
      parameters will be calculated from the COP co-ordinates: mean deviation along the&#xD;
      anterior-posterior (X) and medio-lateral (Y) axes, mean COP velocity along the&#xD;
      anterior-posterior (VCOPX) and medio-lateral (VCOPY) axes. Participants will perform a total&#xD;
      of four trials (i.e., two with eyes open and two with eyes closed) where they will be asked&#xD;
      to stand on the force plate and maintain balance. The force plate will be set up 1.5 meters&#xD;
      away from the wall. In the eyes open condition participants will be asked to focus at a dark&#xD;
      disc (5cm in diameter) on the wall at the subject's eye level. Each trial will last one&#xD;
      minute and participants will be given two minutes rest between trials. The order of the trial&#xD;
      condition (eyes open or closed) will be randomized to prevent any order effect.&#xD;
&#xD;
      The Timed and up and Go test (TUG) will be used as a measure of functional mobility. The&#xD;
      primary outcome of the TUG test is the total time (in seconds) taken to complete the test.&#xD;
      The test will be set up on the basis of standardized descriptions that have been previously&#xD;
      reported. Participants will be instructed to complete the course as safely and quickly as&#xD;
      possible by standing up (without the help of hands), walking toward and around a cone/mark on&#xD;
      the floor (approx. 10 feet), walking back to the chair, and then sitting down. If needed,&#xD;
      participants will be allowed to use assistive devices while performing the task. Participants&#xD;
      will be given 2 trials to complete the TUG test, and the average time across the 2 trials&#xD;
      will be computed as the final score.&#xD;
&#xD;
      The Timed 25-foot Walk test (T25FW) will be used as a measure of walking speed. The primary&#xD;
      outcome of the T25FW test is the total time (in seconds) taken to complete the test.&#xD;
      Participants will be directed to one end of a clearly marked 25-foot course and will be&#xD;
      instructed to walk 25 feet as quickly as possible, but within the limits of their safety. The&#xD;
      time is calculated from the initiation of the instruction to start and ends when the&#xD;
      participant has reached the 25-foot mark. If needed, participants may use assistive devices&#xD;
      when performing the task. Participants will be given 2 trials to complete the T25FW test and&#xD;
      the final score will be the average of the 2 completed trials.&#xD;
&#xD;
      The Six-minute Walking test (6MW) will be used as a measure of walking endurance. The primary&#xD;
      outcome is the distance traveled at the end of 6 minutes with the use of a measuring wheel.&#xD;
      The course is set up in a straight and clean hallway with at least 100-feet. Participants&#xD;
      will be instructed to walk as quickly and safely as possible for 6 minutes making laps within&#xD;
      2 cones places 30 meters apart from each other. Participants will be allowed to use an&#xD;
      assistive device if necessary and to rest when necessary. During the test participants will&#xD;
      be followed by a second researcher who will walk to one side close enough for safety&#xD;
      purposes. Only one trial is deemed to be appropriate and also helps avoiding fatigue.&#xD;
&#xD;
      The Six-spot Step test (SSST) will be used as a measure of lower-body coordination. The&#xD;
      primary outcome of the SSST is the mean of the 4 trials in seconds. Participants complete the&#xD;
      course as quickly as possible, while kicking the cones off of their labeled position with one&#xD;
      foot, alternating between medial and lateral sides of the foot. Each participant completed&#xD;
      the SSST four times: twice using their dominant foot, and twice using their non-dominant foot&#xD;
      to kick the cones off of their demarcated position.&#xD;
&#xD;
      Experiment&#xD;
&#xD;
      Intervention Condition&#xD;
&#xD;
      Participants allocated into the Kinesio Tape Group (KTG) will receive a single time&#xD;
      application of the kinesio tape flexible tape (Kinesio® Tex, Albuquerque, NM, USA) in the&#xD;
      upper-body (i.e., back part of the trunk) and in the lower-body (i.e., legs and ankle)&#xD;
      according to standardized procedures regarding tape application and participant skin&#xD;
      preparation (https://kinesiotaping.com/how-to/). The tape is latex-free and wearable for&#xD;
      weeks without causing skin irritation (i.e., hypoallergenic); and safe for populations&#xD;
      ranging from pediatric to geriatric. The tape will be applied by a physical therapist with&#xD;
      experience in tape application. Tape application will be conducted in a private room with&#xD;
      complete structure for the procedure.&#xD;
&#xD;
      Control Condition&#xD;
&#xD;
      Participants allocated into the Sham Tape Group (STG) will receive a single time application&#xD;
      of an inflexible tape (i.e., sham tape) in the same body segments as the intervention&#xD;
      condition and applied by an experienced physical therapist. Tape application will be&#xD;
      conducted in a private room with complete structure for the procedure.&#xD;
&#xD;
      Procedure&#xD;
&#xD;
      Recruitment ads/flyers will be created and posted. The study will be described as a&#xD;
      non-invasive therapy approach to help improve balance, mobility and physical function.&#xD;
      Interested persons will be asked to contact the Principal and co-Investigator (PI and Co-I)&#xD;
      through telephone or email. Participant screening, contact, and enrollment will be undertaken&#xD;
      over the telephone by a student involved in the project with the supervision of the&#xD;
      Investigators. Those who are interested after the description will be screened for inclusion&#xD;
      criteria. Participants meeting eligibility criteria who are interested in participating will&#xD;
      be scheduled for a single test session for the provision of informed consent, demographic and&#xD;
      anthropometric characteristics, and assessments of balance, mobility and physical function&#xD;
      outcomes in the Department of Kinesiology and Physical Education. Participants will then be&#xD;
      randomly assigned into either the KTG or STG group using concealed allocation. Participants&#xD;
      will undertake the respective group-type tape application and will undergo the same&#xD;
      assessment protocol as done for baseline.&#xD;
&#xD;
      Data-analysis&#xD;
&#xD;
      Dr. Zhang and Dr. Sebastião will be responsible for data analysis using SPSS software 24&#xD;
      version (SPSS Inc. Armonk, NY: IBM Corp.). The effect of the intervention will be examined&#xD;
      using Condition × Time mixed-factor ANOVA with significance set a IP&lt;.05. The partial&#xD;
      eta-squared estimate for the interaction term from the ANOVA will inform power analyses for&#xD;
      future Phase II trials, and the intra-correlation coefficient for test-retest reliability for&#xD;
      the control group will inform the reliability estimate for the power analyses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 25, 2021</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>
    <intervention_model_description>Two arm randomized controlled trial (Pre; Post)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Randomization will done using concealed allocation with the use of opaque envelopes. Envelopes will be spread out over a table and participants will choose one to give it to the Physical Therapist (PT). The PT will open the envelope to check the type of tape (without showing or saying it to the participant) to be applied (kinesio or Sham tape). Participants are unaware about tape categorization &quot;treatment&quot; or &quot;placebo&quot; as the tapes are unlabeled.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Static Balance Performance</measure>
    <time_frame>10minutes</time_frame>
    <description>Center of Pressure (CoP) related measures collected from force plate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed and Up and Go</measure>
    <time_frame>6minutes</time_frame>
    <description>a measure of functional mobility</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed 25-foot Walk</measure>
    <time_frame>6minutes</time_frame>
    <description>a measure of walking speed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Six-minute Walking Test</measure>
    <time_frame>10minutes</time_frame>
    <description>a measure of walking endurance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Six-spot Step Test</measure>
    <time_frame>6minutes</time_frame>
    <description>a measure of lower-body coordination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Short Physical Performance Battery</measure>
    <time_frame>6minutes</time_frame>
    <description>represent a recently validity measure of physical function in persons with MS</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Kinesio Tape (KTG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants allocated into the KTG will receive a single time application of the kinesio tape flexible tape (Kinesio® Tex, Albuquerque, NM, USA) in the upper-body (i.e., back part of the trunk) and in the lower-body (i.e., legs and ankle) according to standardized procedures (https://kinesiotaping.com/how-to/). The tape is latex-free and wearable for weeks without causing skin irritation (i.e., hypoallergenic); and safe for populations ranging from pediatric to geriatric. The tape will be applied by a Physical Therapist with experience in tape application. Tape application will be conducted in a private room with a complete structure for the procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Tape (STG)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants allocated into the STG will receive a single time application of an inflexible tape (i.e., sham tape) in the same body segments as the intervention condition. Tape application will be conducted in a private room with a complete structure for the procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>kinesio tape</intervention_name>
    <description>kinesio tape is a therapeutic method used in the treatment of various musculoskeletal and neuromuscular deficits to provide support for muscles and increase or inhibit muscle recruitment, to correct joint malalignment, decrease swelling, and pain relieve</description>
    <arm_group_label>Kinesio Tape (KTG)</arm_group_label>
    <arm_group_label>Sham Tape (STG)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinically definitive diagnosis of MS&#xD;
&#xD;
          -  aged 18 - 50 years&#xD;
&#xD;
          -  relapse-free for the past 30 days and&#xD;
&#xD;
          -  ability to walk with or without an assistive device (i.e., cane, but not&#xD;
             walker/rollator).&#xD;
&#xD;
          -  must be willing to complete in-person assessments at a university research setting&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  use wheelchair, crutches and walker&#xD;
&#xD;
          -  have moderate cognitive impairment based on the modified Telephone Interview for&#xD;
             Cognitive Status (i.e., moderate cognitive impairment, ≤ 12 points).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emerson Sebastiao, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Kinesiology and Physical Education - Northern Illinois University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shuqi Zhang, PhD</last_name>
    <phone>2254567821</phone>
    <email>szhang3@niu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Emerson Sebastiao, PhD</last_name>
    <phone>(815) 753-3656</phone>
    <email>esebastiao@niu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Kinesiology and Physical Education. Northern Illinois University</name>
      <address>
        <city>DeKalb</city>
        <state>Illinois</state>
        <zip>60115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emerson Sebastiao, PhD</last_name>
      <phone>815-753-3656</phone>
      <email>esebastiao@niu.edu</email>
    </contact>
    <contact_backup>
      <last_name>Shuqi Zhang, PhD</last_name>
      <phone>815-753-1418</phone>
      <email>szhang3@niu.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>March 2, 2021</last_update_submitted>
  <last_update_submitted_qc>March 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northern Illinois University</investigator_affiliation>
    <investigator_full_name>Emerson Sebastião</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Kinesio Tape</keyword>
  <keyword>Physical functioning</keyword>
  <keyword>Disability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 21, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03804047
org study id: HS18-0012
nct id: NCT03804047
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Multiple sclerosis (MS) is a disease that causes damage within the central nervous system and
      results in deficits of body functions. The investigators propose a pilot randomized
      controlled trial examining the acute effect of kinesio tape application in various body
      segments on balance, mobility, physical functioning, and pain in persons with MS (pwMS) aged
      18 to 55 years old. The investigators will objectively assess balance using a force platform
      and mobility and physical functioning will be assessed using standardized tests (i.e., Timed
      Up and Go, Timed 25-foot Walk, 6-minute Step Test, Six Spot Step Test). The trial will
      recruit 24 pwMS aged 18 to 55 years with mild-to-moderate MS-related disability who will be
      randomized into intervention (Kinesio Tape) or control conditions (Sham/Inflexible Tape).
      Participants will complete assessments before and after tape application. This pilot trial
      will inform future research interventions aiming to use the approach in different situations
      with pwMS (e.g., exercise).
Research Plan

      Participants The investigators will recruit and enroll 24 pwMS (12 per group) aged 18-55
      years. This sample size is appropriate for pilot trials, and was not based on power analysis.
      The number of 12 per group is justified based on feasibility, gains in the precision about
      the mean and variance, and regulatory consideration. Related to gains in the precision, the
      gains are less pronounced after 12 participants. Recruitment will occur though advertisements
      in local newspapers (100-mile radius around Illinois campus) and posts on the Greater
      Illinois chapter of the National Multiple Sclerosis Society (NMSS) website. The investigators
      will further recruit using our participant's database that includes pwMS 40 years of age and
      older. The 24 persons will be randomly assigned in equal ratios through concealed allocation
      into either the intervention (i.e., Kinesio Tape - KTG; n=12) or control (i.e., Sham Tape -
      STG; n=12) conditions. The inclusion criteria are: clinically definitive diagnosis of MS; age
      between 18 and 55 years; relapse-free for the past 30 days and; ability to walk with or
      without assistive device (i.e., cane, but not walker/rollator). Participants further must be
      willing to complete in-person assessments in a university research setting. The investigators
      will exclude those who use wheelchair, crutches and walker or who have moderate cognitive
      impairment based on the modified Telephone Interview for Cognitive Status (i.e., moderate
      cognitive impairment, ≤ 12 points).

      Main Outcomes

      Balance. Balance will be objectively measured using a force platform (AccuSway, AMTI, Newton,
      MA, USA) which will be used to calculate the coordinates of the center of pressure (COP)
      during the standing test using three orthogonal forces and moments. Signals from the force
      plate will be sampled at 100HZ. Data analysis will then be performed using specific programs
      developed in MATLAB (Mathworks, Natick, MA, USA). Four classical time domain posturographic
      parameters will be calculated from the COP co-ordinates: mean deviation along the
      anterior-posterior (X) and medio-lateral (Y) axes, mean COP velocity along the
      anterior-posterior (VCOPX) and medio-lateral (VCOPY) axes. Participants will perform a total
      of four trials (i.e., two with eyes open and two with eyes closed) where they will be asked
      to stand on the force plate and maintain balance. The force plate will be set up 1.5 meters
      away from the wall. In the eyes open condition participants will be asked to focus at a dark
      disc (5cm in diameter) on the wall at the subject's eye level. Each trial will last one
      minute and participants will be given two minutes rest between trials. The order of the trial
      condition (eyes open or closed) will be randomized to prevent any order effect.

      The Timed and up and Go test (TUG) will be used as a measure of functional mobility. The
      primary outcome of the TUG test is the total time (in seconds) taken to complete the test.
      The test will be set up on the basis of standardized descriptions that have been previously
      reported. Participants will be instructed to complete the course as safely and quickly as
      possible by standing up (without the help of hands), walking toward and around a cone/mark on
      the floor (approx. 10 feet), walking back to the chair, and then sitting down. If needed,
      participants will be allowed to use assistive devices while performing the task. Participants
      will be given 2 trials to complete the TUG test, and the average time across the 2 trials
      will be computed as the final score.

      The Timed 25-foot Walk test (T25FW) will be used as a measure of walking speed. The primary
      outcome of the T25FW test is the total time (in seconds) taken to complete the test.
      Participants will be directed to one end of a clearly marked 25-foot course and will be
      instructed to walk 25 feet as quickly as possible, but within the limits of their safety. The
      time is calculated from the initiation of the instruction to start and ends when the
      participant has reached the 25-foot mark. If needed, participants may use assistive devices
      when performing the task. Participants will be given 2 trials to complete the T25FW test and
      the final score will be the average of the 2 completed trials.

      The Six-minute Walking test (6MW) will be used as a measure of walking endurance. The primary
      outcome is the distance traveled at the end of 6 minutes with the use of a measuring wheel.
      The course is set up in a straight and clean hallway with at least 100-feet. Participants
      will be instructed to walk as quickly and safely as possible for 6 minutes making laps within
      2 cones places 30 meters apart from each other. Participants will be allowed to use an
      assistive device if necessary and to rest when necessary. During the test participants will
      be followed by a second researcher who will walk to one side close enough for safety
      purposes. Only one trial is deemed to be appropriate and also helps avoiding fatigue.

      The Six-spot Step test (SSST) will be used as a measure of lower-body coordination. The
      primary outcome of the SSST is the mean of the 4 trials in seconds. Participants complete the
      course as quickly as possible, while kicking the cones off of their labeled position with one
      foot, alternating between medial and lateral sides of the foot. Each participant completed
      the SSST four times: twice using their dominant foot, and twice using their non-dominant foot
      to kick the cones off of their demarcated position.

      Experiment

      Intervention Condition

      Participants allocated into the Kinesio Tape Group (KTG) will receive a single time
      application of the kinesio tape flexible tape (Kinesio® Tex, Albuquerque, NM, USA) in the
      upper-body (i.e., back part of the trunk) and in the lower-body (i.e., legs and ankle)
      according to standardized procedures regarding tape application and participant skin
      preparation (https://kinesiotaping.com/how-to/). The tape is latex-free and wearable for
      weeks without causing skin irritation (i.e., hypoallergenic); and safe for populations
      ranging from pediatric to geriatric. The tape will be applied by a physical therapist with
      experience in tape application. Tape application will be conducted in a private room with
      complete structure for the procedure.

      Control Condition

      Participants allocated into the Sham Tape Group (STG) will receive a single time application
      of an inflexible tape (i.e., sham tape) in the same body segments as the intervention
      condition and applied by an experienced physical therapist. Tape application will be
      conducted in a private room with complete structure for the procedure.

      Procedure

      Recruitment ads/flyers will be created and posted. The study will be described as a
      non-invasive therapy approach to help improve balance, mobility and physical function.
      Interested persons will be asked to contact the Principal and co-Investigator (PI and Co-I)
      through telephone or email. Participant screening, contact, and enrollment will be undertaken
      over the telephone by a student involved in the project with the supervision of the
      Investigators. Those who are interested after the description will be screened for inclusion
      criteria. Participants meeting eligibility criteria who are interested in participating will
      be scheduled for a single test session for the provision of informed consent, demographic and
      anthropometric characteristics, and assessments of balance, mobility and physical function
      outcomes in the Department of Kinesiology and Physical Education. Participants will then be
      randomly assigned into either the KTG or STG group using concealed allocation. Participants
      will undertake the respective group-type tape application and will undergo the same
      assessment protocol as done for baseline.

      Data-analysis

      Dr. Zhang and Dr. Sebastião will be responsible for data analysis using SPSS software 24
      version (SPSS Inc. Armonk, NY: IBM Corp.). The effect of the intervention will be examined
      using Condition × Time mixed-factor ANOVA with significance set a IP<.05. The partial
      eta-squared estimate for the interaction term from the ANOVA will inform power analyses for
      future Phase II trials, and the intra-correlation coefficient for test-retest reliability for
      the control group will inform the reliability estimate for the power analyses.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two arm randomized controlled trial (Pre; Post)
primary purpose: Treatment
masking: Single (Participant)
masking description: Randomization will done using concealed allocation with the use of opaque envelopes. Envelopes will be spread out over a table and participants will choose one to give it to the Physical Therapist (PT). The PT will open the envelope to check the type of tape (without showing or saying it to the participant) to be applied (kinesio or Sham tape). Participants are unaware about tape categorization "treatment" or "placebo" as the tapes are unlabeled.
measure: Static Balance Performance
time frame: 10minutes
description: Center of Pressure (CoP) related measures collected from force plate
measure: Timed and Up and Go
time frame: 6minutes
description: a measure of functional mobility
measure: Timed 25-foot Walk
time frame: 6minutes
description: a measure of walking speed
measure: Six-minute Walking Test
time frame: 10minutes
description: a measure of walking endurance
measure: Six-spot Step Test
time frame: 6minutes
description: a measure of lower-body coordination
measure: The Short Physical Performance Battery
time frame: 6minutes
description: represent a recently validity measure of physical function in persons with MS
arm group label: Kinesio Tape (KTG)
arm group type: Experimental
description: Participants allocated into the KTG will receive a single time application of the kinesio tape flexible tape (Kinesio® Tex, Albuquerque, NM, USA) in the upper-body (i.e., back part of the trunk) and in the lower-body (i.e., legs and ankle) according to standardized procedures (https://kinesiotaping.com/how-to/). The tape is latex-free and wearable for weeks without causing skin irritation (i.e., hypoallergenic); and safe for populations ranging from pediatric to geriatric. The tape will be applied by a Physical Therapist with experience in tape application. Tape application will be conducted in a private room with a complete structure for the procedure.
arm group label: Sham Tape (STG)
arm group type: Sham Comparator
description: Participants allocated into the STG will receive a single time application of an inflexible tape (i.e., sham tape) in the same body segments as the intervention condition. Tape application will be conducted in a private room with a complete structure for the procedure.
intervention type: Other
intervention name: kinesio tape
description: kinesio tape is a therapeutic method used in the treatment of various musculoskeletal and neuromuscular deficits to provide support for muscles and increase or inhibit muscle recruitment, to correct joint malalignment, decrease swelling, and pain relieve
arm group label: Kinesio Tape (KTG)
arm group label: Sham Tape (STG)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Emerson Sebastiao, PhD
role: Principal Investigator
affiliation: Department of Kinesiology and Physical Education - Northern Illinois University
last name: Shuqi Zhang, PhD
phone: 2254567821
email: szhang3@niu.edu
last name: Emerson Sebastiao, PhD
phone: (815) 753-3656
email: esebastiao@niu.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
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PMID: 18970977
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PMID: 12857582
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PMID: 14763636
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PMID: 19432053
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PMID: 14534060
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PMID: 23776516
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PMID: 23941225
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PMID: 25922836
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PMID: 26321149
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PMID: 26504310
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PMID: 18591761
responsible party type: Principal Investigator
investigator affiliation: Northern Illinois University
investigator full name: Emerson Sebastião
investigator title: Assistant Professor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: No
submitted: March 21, 2023