<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/NCT03296865</url>
  </required_header>
  <id_info>
    <org_study_id>fapesc2012/10558-6</org_study_id>
    <nct_id>NCT03296865</nct_id>
  </id_info>
  <brief_title>Taping in Children With Cerebral Palsy</brief_title>
  <official_title>Effects of Kinesio Taping in Rectus Femoris Activity and Sit-to-stand Movement in Children With Unilateral Cerebral Palsy: Placebo-controlled, Repeated-measure Design</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Adriana Neves Dos Santos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade Federal de Santa Catarina</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>
      Kinesio taping (KT) has been commonly used in rehabilitation in children with Unilateral&#xD;
      Cerebral Palsy (UCP). However, there is a lack of studies that verified the effects of KT in&#xD;
      CP. We aimed to verify the effects of KT in the performance of sit to stand movement (STS) in&#xD;
      children with spastic UCP (USCP). A blinded, placebo and repeated-measure design was applied.&#xD;
      The setting was the rehabilitation clinic of the university and care facilities. Eleven&#xD;
      children, aged from 6 to 12 years old (10.5±-2.8 years), diagnosed with USCP, Gross Motor&#xD;
      Function Classification System levels I and II were evaluated. KT was applied over rectus&#xD;
      femoris (RF) muscle of the affected limb. We considered three taping conditions: KT, without&#xD;
      KT (with tension) and placebo (KT without tension). Mean root mean square (mRMS) of RF;&#xD;
      initial, final and peak angles, and range of motion of trunk, pelvis, hip, knee and ankles&#xD;
      joints; and total duration of STS were considered. STS was evaluated from three seat heights,&#xD;
      neutral (100%), lowered (80%) and elevated (120%). Mixed ANOVA test was applied for angular&#xD;
      variables of hip, knee and ankle, and mRMS of RF. Repeated ANOVA was applied for angular&#xD;
      variables of trunk and pelvis, total duration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We evaluated a non-probability convenience sample. Participants were recruited in the&#xD;
      rehabilitation clinic of the university and care facilities, between July of 2013 and July of&#xD;
      2014.&#xD;
&#xD;
      Body structures and functions and functionality component of the International Classification&#xD;
      of Functioning, Disability and Healthy, were evaluated. Muscle activity (electromyography)&#xD;
      and trunk and lower limbs alignment (kinematics) were evaluated as body structures and&#xD;
      functions measures. Time used to perform STS was used as functionality measure.&#xD;
&#xD;
      We evaluated sit to stand in three conditions: a) without taping; b) with KT, which was&#xD;
      characterized as the use of KT with tension; c) placebo.&#xD;
&#xD;
      Baseline measurement: STS without taping. The child was seated in a seat with adjustable&#xD;
      height, without shoes. Both feet were symmetrically positioned shoulder width apart and arms&#xD;
      were crossed over the chest. The participants could not use their arms to push up off the&#xD;
      chair. Also, the child should be seated with gluteal and the upper thighs regions supported&#xD;
      in seat. Children performed STS in a speed that simulated the one usually adopted in daily&#xD;
      routine.&#xD;
&#xD;
      Baseline measurement was evaluated in three seat heights: neutral, elevated and lowered.&#xD;
      Neutral corresponded to a seated position with 90° of hip, knee and ankle flexion. Lowered&#xD;
      and elevated were defined as, respectively, 80 and 120% of neutral height.The order of seat&#xD;
      heights was randomized by drawing lots. A interval of 5 minutes was allowed between each seat&#xD;
      height.&#xD;
&#xD;
      Evaluations were carried out in two testing episodes, with one-week interval between them. On&#xD;
      the first day, additional to baseline, the child performed STS with KT or placebo. The&#xD;
      determination of which tape condition would be applied was randomized by drawing lots. A&#xD;
      15-minute interval between baseline and tape condition was established. On the second day,&#xD;
      the tape condition that was not performed on the first day was evaluated. In all conditions,&#xD;
      the child performed STS in three seat heights.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2014</start_date>
  <completion_date type="Actual">March 1, 2016</completion_date>
  <primary_completion_date type="Actual">March 3, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>We used a blinded and repeated-measure design, with the application of a placebo condition</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Children and the person that performed the evaluation were blind only to KT and placebo conditions, since they did not know if KT was tensioned were not. The person that performed data analysis was blind to all conditions.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Rectus femoris muscle activity</measure>
    <time_frame>change measures (2 days, 3 measures)</time_frame>
    <description>A portable surface electromyography (Trigno™ Wireless EMG System, DelSys®, Boston, USA) was used to evaluate RF activity (sampling 2400Hz).&#xD;
Electrode was positioned at RF of both limbs while the child was lying in supine. Skin preparation and electrode placement were performed according to SENIAM guidelines.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trunk and lower limbs alignment (kinematics)</measure>
    <time_frame>change measures (2 days, 3 measures)</time_frame>
    <description>A six-camera motion analysis system Qualisys ProReflex MCU (QUALISYS-MEDICAL AB®, Gothenburg, Sweden) recorded body kinematics (sampling 240Hz). 27 non co-linear passive markers (15mm) were placed.&#xD;
Angular variation of trunk, pelvis, hip, knee and ankle were assessed using the Visual 3D software. We considered initial, final and peak angles. We also evaluated range of motion defined as the difference between final and initial angles.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time used to perform sit to stand movement</measure>
    <time_frame>change measures (2 days, 3 measures)</time_frame>
    <description>Time in seconds from kinematics evaluation</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Without taping</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Evaluations without taping</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kinesio taping</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Kinesio taping was apllied only one time. It was removed after intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo was apllied only one time. It was removed after intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Kinesio taping</intervention_name>
    <description>We applied a hypoallergenic, porous and adhesive tape of cotton (Kinesio Tex Gold) placed over Rectus Femoris muscle of the affected limb. Children were taped in accordance to Kenzo Kase's Kinesio manual. We used a facilitation technique, from muscle origin to insertion, in a Y shape. For KT condition: base of the KT strip 3cm below the anterior iliac spine, over the RF muscle until the upper edge of the patella and stretchered with 100% tension. For placebo condition: same technique without tension in the entire tape.&#xD;
We verified the immediate effect of KT/placebo. After the evaluation, KT/placebo was removed.</description>
    <arm_group_label>Kinesio taping</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>taping</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children diagnosed with unilateral spastic Cerebral Palsy&#xD;
&#xD;
          -  Aged from 6 and 12 years&#xD;
&#xD;
          -  Ability to perform sit to stand movement without support in three seat heights&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ability to understand simple commands&#xD;
&#xD;
          -  Muscle shortening in hamstrings, gastrocnemius and hip flexors&#xD;
&#xD;
          -  Deformity in the lower limbs, such as fixed hip and knee flexion, that could&#xD;
             compromise STS&#xD;
&#xD;
          -  Surgical procedures in lower limbs and trunk in previous 12 months&#xD;
&#xD;
          -  Botulinum toxin injection in lower limbs in the previous 6 months&#xD;
&#xD;
          -  Not attending physical therapy at least 2 times a week during the last 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nelci Adriana Cicuto Ferreira Rocha, Phd</last_name>
    <role>Study Director</role>
    <affiliation>Universidade de São Carlos</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade Federal de São Carlos</name>
      <address>
        <city>São Carlos</city>
        <state>São Paulo</state>
        <zip>13565-905</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>September 28, 2017</last_update_submitted>
  <last_update_submitted_qc>September 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal de Santa Catarina</investigator_affiliation>
    <investigator_full_name>Adriana Neves Dos Santos</investigator_full_name>
    <investigator_title>Professor, Reseacher</investigator_title>
  </responsible_party>
  <keyword>taping</keyword>
  <keyword>functionality</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>muscle activity</keyword>
  <keyword>electromyography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data for all primary outcomes will be made available</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>One year after study completion</ipd_time_frame>
  </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/NCT03296865
org study id: fapesc2012/10558-6
nct id: NCT03296865
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Kinesio taping (KT) has been commonly used in rehabilitation in children with Unilateral
      Cerebral Palsy (UCP). However, there is a lack of studies that verified the effects of KT in
      CP. We aimed to verify the effects of KT in the performance of sit to stand movement (STS) in
      children with spastic UCP (USCP). A blinded, placebo and repeated-measure design was applied.
      The setting was the rehabilitation clinic of the university and care facilities. Eleven
      children, aged from 6 to 12 years old (10.5±-2.8 years), diagnosed with USCP, Gross Motor
      Function Classification System levels I and II were evaluated. KT was applied over rectus
      femoris (RF) muscle of the affected limb. We considered three taping conditions: KT, without
      KT (with tension) and placebo (KT without tension). Mean root mean square (mRMS) of RF;
      initial, final and peak angles, and range of motion of trunk, pelvis, hip, knee and ankles
      joints; and total duration of STS were considered. STS was evaluated from three seat heights,
      neutral (100%), lowered (80%) and elevated (120%). Mixed ANOVA test was applied for angular
      variables of hip, knee and ankle, and mRMS of RF. Repeated ANOVA was applied for angular
      variables of trunk and pelvis, total duration.
We evaluated a non-probability convenience sample. Participants were recruited in the
      rehabilitation clinic of the university and care facilities, between July of 2013 and July of
      2014.

      Body structures and functions and functionality component of the International Classification
      of Functioning, Disability and Healthy, were evaluated. Muscle activity (electromyography)
      and trunk and lower limbs alignment (kinematics) were evaluated as body structures and
      functions measures. Time used to perform STS was used as functionality measure.

      We evaluated sit to stand in three conditions: a) without taping; b) with KT, which was
      characterized as the use of KT with tension; c) placebo.

      Baseline measurement: STS without taping. The child was seated in a seat with adjustable
      height, without shoes. Both feet were symmetrically positioned shoulder width apart and arms
      were crossed over the chest. The participants could not use their arms to push up off the
      chair. Also, the child should be seated with gluteal and the upper thighs regions supported
      in seat. Children performed STS in a speed that simulated the one usually adopted in daily
      routine.

      Baseline measurement was evaluated in three seat heights: neutral, elevated and lowered.
      Neutral corresponded to a seated position with 90° of hip, knee and ankle flexion. Lowered
      and elevated were defined as, respectively, 80 and 120% of neutral height.The order of seat
      heights was randomized by drawing lots. A interval of 5 minutes was allowed between each seat
      height.

      Evaluations were carried out in two testing episodes, with one-week interval between them. On
      the first day, additional to baseline, the child performed STS with KT or placebo. The
      determination of which tape condition would be applied was randomized by drawing lots. A
      15-minute interval between baseline and tape condition was established. On the second day,
      the tape condition that was not performed on the first day was evaluated. In all conditions,
      the child performed STS in three seat heights.
allocation: Non-Randomized
intervention model: Crossover Assignment
intervention model description: We used a blinded and repeated-measure design, with the application of a placebo condition
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Children and the person that performed the evaluation were blind only to KT and placebo conditions, since they did not know if KT was tensioned were not. The person that performed data analysis was blind to all conditions.
measure: Rectus femoris muscle activity
time frame: change measures (2 days, 3 measures)
description: A portable surface electromyography (Trigno™ Wireless EMG System, DelSys®, Boston, USA) was used to evaluate RF activity (sampling 2400Hz).
Electrode was positioned at RF of both limbs while the child was lying in supine. Skin preparation and electrode placement were performed according to SENIAM guidelines.
measure: Trunk and lower limbs alignment (kinematics)
time frame: change measures (2 days, 3 measures)
description: A six-camera motion analysis system Qualisys ProReflex MCU (QUALISYS-MEDICAL AB®, Gothenburg, Sweden) recorded body kinematics (sampling 240Hz). 27 non co-linear passive markers (15mm) were placed.
Angular variation of trunk, pelvis, hip, knee and ankle were assessed using the Visual 3D software. We considered initial, final and peak angles. We also evaluated range of motion defined as the difference between final and initial angles.
measure: Time used to perform sit to stand movement
time frame: change measures (2 days, 3 measures)
description: Time in seconds from kinematics evaluation
arm group label: Without taping
arm group type: No Intervention
description: Evaluations without taping
arm group label: Kinesio taping
arm group type: Experimental
description: Kinesio taping was apllied only one time. It was removed after intervention.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo was apllied only one time. It was removed after intervention.
intervention type: Device
intervention name: Kinesio taping
description: We applied a hypoallergenic, porous and adhesive tape of cotton (Kinesio Tex Gold) placed over Rectus Femoris muscle of the affected limb. Children were taped in accordance to Kenzo Kase's Kinesio manual. We used a facilitation technique, from muscle origin to insertion, in a Y shape. For KT condition: base of the KT strip 3cm below the anterior iliac spine, over the RF muscle until the upper edge of the patella and stretchered with 100% tension. For placebo condition: same technique without tension in the entire tape.
We verified the immediate effect of KT/placebo. After the evaluation, KT/placebo was removed.
arm group label: Kinesio taping
arm group label: Placebo
other name: taping
criteria: 
gender: All
minimum age: 6 Years
maximum age: 16 Years
healthy volunteers: No
last name: Nelci Adriana Cicuto Ferreira Rocha, Phd
role: Study Director
affiliation: Universidade de São Carlos
facility: 
country: Brazil
responsible party type: Sponsor-Investigator
investigator affiliation: Universidade Federal de Santa Catarina
investigator full name: Adriana Neves Dos Santos
investigator title: Professor, Reseacher
mesh term: Cerebral Palsy
sharing ipd: Yes
ipd description: De-identified individual participant data for all primary outcomes will be made available
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: One year after study completion