<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/NCT03788954</url>
  </required_header>
  <id_info>
    <org_study_id>18/066</org_study_id>
    <nct_id>NCT03788954</nct_id>
  </id_info>
  <brief_title>Effect of Kinesiotaping on Wrist Kinematics and Functional Performance</brief_title>
  <official_title>Effect of Kinesiotaping on Wrist Kinematics and Functional Performance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mehmet Gürhan KARAKAYA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Muğla Sıtkı Koçman University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Muğla Sıtkı Koçman 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>
      This study perform to investigate the immediate effects of kinesiotaping and plasebo&#xD;
      kinesiotaping on Dart Throwing Motion (DTM) angle and functional performance scores of wrist&#xD;
      in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Kinesiotape which created by Kenzo Kase in 1976, is a thin and elastic taping material&#xD;
      similar to the structural properties and flexibility of human skin without limiting joint&#xD;
      movements. In this study, kinesiotape will apply to the wrist extensor and flexor muscles&#xD;
      using the functional correction and muscle facilitation techniques. Also placebo taping will&#xD;
      apply on the same muscles with same kinesiotape without any stretching or positioning. A&#xD;
      total of 4 applications including kinesiotaping and placebo taping will perform randomly in 4&#xD;
      consecutive days.&#xD;
&#xD;
      For each subject; A total of 5 separate evaluations will perform on the first day (without&#xD;
      taping) and following 4 consecutive days (flexor carpi ulnaris muscle kinesiotaping, extensor&#xD;
      carpi radialis muscle kinesiotaping, flexor carpi ulnaris muscle placebo kinesiotaping,&#xD;
      extensor carpi radialis muscle placebo kinesiotaping). Between the taping and evaluation of&#xD;
      the subjects will wait for 30 minutes.&#xD;
&#xD;
      There are several studies evaluating wrist movements performed in one plane with different&#xD;
      methods. The Dart Throwing Motion (DTM) is the most commonly used wrist pattern in daily life&#xD;
      and includes the entire oblique movement from radial extension to ulnar flexion.&#xD;
&#xD;
      The aim of this study is to investigate the effects of kinesio taping on the kinematics and&#xD;
      functional performance of healthy wrist. This study will be prospective, double-blind,&#xD;
      randomized, placebo-controlled and crossover.&#xD;
&#xD;
      We did not find any study including fascia correction kinesiotaping for DTM pattern.&#xD;
&#xD;
      The therapists who works in this area will have an advantage in the rehabilitation programs&#xD;
      to know the effects of the muscle facilitation and fascia correction techniques kinesiotaping&#xD;
      on wrist kinematics via DTM and wrist functional performance.&#xD;
&#xD;
      Also, we believe that our study will guide different professional groups working on&#xD;
      technological rehabilitation with measurement techniques and evaluation methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 25, 2018</start_date>
  <completion_date type="Actual">January 27, 2019</completion_date>
  <primary_completion_date type="Actual">January 15, 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>Crossover Assignment</intervention_model>
    <intervention_model_description>Crossover Assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Double</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change of wrist range of motion.</measure>
    <time_frame>Change of wrist DTM from baseline at the end of 30 minutes of each kinesiotaping intervention.</time_frame>
    <description>Change of wrist dart throwing motion (DTM- radial extansion to ulnar flexion movement of wrist) angle.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of wrist functional performance.</measure>
    <time_frame>Change of MMDT scores from baseline at the end of 30 minutes of each kinesiotaping intervention.</time_frame>
    <description>Change of functional performance of wrist (The Minnesota Manual Dexterity Test - MMDT).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Wrist Injuries</condition>
  <condition>Kinematics</condition>
  <condition>Functional Performance</condition>
  <arm_group>
    <arm_group_label>Kinesiotaping on FCU</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Muscle fasilitation and Fascia Correction techniques of Kinesiotaping on m. flexor carpi ulnaris.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kinesiotaping on ECR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Muscle fasilitation and Fascia Correction techniques of Kinesiotaping on m. extensor carpi radialis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Plasebo Kinesiotaping on FCU</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Same kinesiotape used on m. flexor carpi ulnaris without any taping techniques.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Plasebo Kinesiotaping on ECR</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Same kinesiotape used on m. extensor carpi radialis without any taping techniques.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kinesiotaping</intervention_name>
    <description>Kinesio tape (KT) is the original elastic adhesive tape for injury prevention, rehabilitation, and performance enhancement. Kinesio Tape is latex-free, hypoallergenic and wearable for days at a time. It has been shown to be clinically effective in joint range of motion promotion,increasing muscle activity and functional performance.</description>
    <arm_group_label>Kinesiotaping on ECR</arm_group_label>
    <arm_group_label>Kinesiotaping on FCU</arm_group_label>
    <arm_group_label>Plasebo Kinesiotaping on ECR</arm_group_label>
    <arm_group_label>Plasebo Kinesiotaping on FCU</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent form and participated in all stages of the study&#xD;
&#xD;
          -  Being in the age range of 18-25&#xD;
&#xD;
          -  Being right-handed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having physical, mental disability (vision, hearing, etc.) which may affect&#xD;
             participation in the study&#xD;
&#xD;
          -  Presence of a history of congenital or acquired orthopedic, neurological, or rheumatic&#xD;
             disease that may impair joint range and / or function of the hand and wrist&#xD;
&#xD;
          -  Having a history of trauma requiring medical, conservative and surgical treatment for&#xD;
             the application area in the last 6 months&#xD;
&#xD;
          -  Presence of skin lesions (burns, cellulite, vesicles, bulla, pisoriasis, open / closed&#xD;
             wound, scar, active infection, malignancy, etc.) in the application area.&#xD;
&#xD;
          -  Excessive skin reaction to applications&#xD;
&#xD;
          -  The problem of hirsutism to the extent of preventing the kinesiotaping in the&#xD;
             application area.&#xD;
&#xD;
          -  Dart sports experience as amateur or professional&#xD;
&#xD;
          -  To have consumed alcohol, pharmaceutical substance until 24 hours before the&#xD;
             evaluation&#xD;
&#xD;
          -  Using anabolic substance&#xD;
&#xD;
          -  To have theoretical and practical experience in Kinesio taping&#xD;
&#xD;
          -  Being obese&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Muğla Sıtkı Koçman University</name>
      <address>
        <city>Muğla</city>
        <state>Menteşe</state>
        <zip>48000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mugla Sıtkı Koçman University</name>
      <address>
        <city>Muğla</city>
        <zip>48000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>June 13, 2019</last_update_submitted>
  <last_update_submitted_qc>June 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Muğla Sıtkı Koçman University</investigator_affiliation>
    <investigator_full_name>Mehmet Gürhan KARAKAYA</investigator_full_name>
    <investigator_title>Principal investigator, Head of Neurological Rehabilitation Department, Pt. PhD. Prof.</investigator_title>
  </responsible_party>
  <keyword>Range of motion</keyword>
  <keyword>Hand injuries</keyword>
  <keyword>Biomechanics</keyword>
  <keyword>Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wrist Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03788954
org study id: 18/066
nct id: NCT03788954
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study perform to investigate the immediate effects of kinesiotaping and plasebo
      kinesiotaping on Dart Throwing Motion (DTM) angle and functional performance scores of wrist
      in healthy subjects.
Kinesiotape which created by Kenzo Kase in 1976, is a thin and elastic taping material
      similar to the structural properties and flexibility of human skin without limiting joint
      movements. In this study, kinesiotape will apply to the wrist extensor and flexor muscles
      using the functional correction and muscle facilitation techniques. Also placebo taping will
      apply on the same muscles with same kinesiotape without any stretching or positioning. A
      total of 4 applications including kinesiotaping and placebo taping will perform randomly in 4
      consecutive days.

      For each subject; A total of 5 separate evaluations will perform on the first day (without
      taping) and following 4 consecutive days (flexor carpi ulnaris muscle kinesiotaping, extensor
      carpi radialis muscle kinesiotaping, flexor carpi ulnaris muscle placebo kinesiotaping,
      extensor carpi radialis muscle placebo kinesiotaping). Between the taping and evaluation of
      the subjects will wait for 30 minutes.

      There are several studies evaluating wrist movements performed in one plane with different
      methods. The Dart Throwing Motion (DTM) is the most commonly used wrist pattern in daily life
      and includes the entire oblique movement from radial extension to ulnar flexion.

      The aim of this study is to investigate the effects of kinesio taping on the kinematics and
      functional performance of healthy wrist. This study will be prospective, double-blind,
      randomized, placebo-controlled and crossover.

      We did not find any study including fascia correction kinesiotaping for DTM pattern.

      The therapists who works in this area will have an advantage in the rehabilitation programs
      to know the effects of the muscle facilitation and fascia correction techniques kinesiotaping
      on wrist kinematics via DTM and wrist functional performance.

      Also, we believe that our study will guide different professional groups working on
      technological rehabilitation with measurement techniques and evaluation methods.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Double
measure: Change of wrist range of motion.
time frame: Change of wrist DTM from baseline at the end of 30 minutes of each kinesiotaping intervention.
description: Change of wrist dart throwing motion (DTM- radial extansion to ulnar flexion movement of wrist) angle.
measure: Change of wrist functional performance.
time frame: Change of MMDT scores from baseline at the end of 30 minutes of each kinesiotaping intervention.
description: Change of functional performance of wrist (The Minnesota Manual Dexterity Test - MMDT).
arm group label: Kinesiotaping on FCU
arm group type: Active Comparator
description: Muscle fasilitation and Fascia Correction techniques of Kinesiotaping on m. flexor carpi ulnaris.
arm group label: Kinesiotaping on ECR
arm group type: Active Comparator
description: Muscle fasilitation and Fascia Correction techniques of Kinesiotaping on m. extensor carpi radialis.
arm group label: Plasebo Kinesiotaping on FCU
arm group type: Placebo Comparator
description: Same kinesiotape used on m. flexor carpi ulnaris without any taping techniques.
arm group label: Plasebo Kinesiotaping on ECR
arm group type: Placebo Comparator
description: Same kinesiotape used on m. extensor carpi radialis without any taping techniques.
intervention type: Other
intervention name: Kinesiotaping
description: Kinesio tape (KT) is the original elastic adhesive tape for injury prevention, rehabilitation, and performance enhancement. Kinesio Tape is latex-free, hypoallergenic and wearable for days at a time. It has been shown to be clinically effective in joint range of motion promotion,increasing muscle activity and functional performance.
arm group label: Kinesiotaping on ECR
arm group label: Kinesiotaping on FCU
arm group label: Plasebo Kinesiotaping on ECR
arm group label: Plasebo Kinesiotaping on FCU
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Muğla Sıtkı Koçman University
investigator full name: Mehmet Gürhan KARAKAYA
investigator title: Principal investigator, Head of Neurological Rehabilitation Department, Pt. PhD. Prof.
mesh term: Wrist Injuries
sharing ipd: Undecided