xml: <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/NCT06006533</url>
    </required_header>
    <id_info>
      <org_study_id>Uskudar61</org_study_id>
      <nct_id>NCT06006533</nct_id>
    </id_info>
    <brief_title>Fascia Release Techniques Applied to Plantar Flexor Muscles and Acute Efficacy of Kinesio Taping</brief_title>
    <official_title>Investigation of the Effects of Fascia Relaxation Techniques Applied to Plantar Flexor Muscles on Proprioception, Balance and Flexibility.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uskudar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uskudar University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study; The aim of this study is to examine the effects of kinesio taping&#xD;
        technique and percussive massage technique applied to plantar flexor muscles on&#xD;
        proprioception, balance and flexibility in healthy individuals.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The sample of the study will consist of healthy individuals who have not had any discomfort&#xD;
        or surgical operation related to the lower extremity in the last 6 months. The demographic&#xD;
        information of the individuals who agreed to participate in the study will be recorded and&#xD;
        their written consent will be obtained. Participants will be divided into 2 groups as kinesio&#xD;
        taping and Percussive Massage groups by randomization method. The dominant lower extremities&#xD;
        of both groups will be applied. The Percussive Massage group will be applied to the posterior&#xD;
        part of the sural fascia for 5 minutes, 3 times a week, including the plantar flexor muscles.&#xD;
        In the kinesio taping group, taping will be done in accordance with the fascia correction&#xD;
        technique, including the plantar flexor muscles, and it will be requested to stay for 3 days.&#xD;
        Both groups will be evaluated before and after the application. Joint position sense test&#xD;
        will be used to evaluate proprioception. In the evaluation of balance, the one-leg standing&#xD;
        test will be considered. In the evaluation of flexibility; The flexibility of the hamstring,&#xD;
        gastrocnemius, and plantar fascia will be examined. The Straight Leg Lift Test will be&#xD;
        performed to look at the flexibility of the hamstring muscle. Pre- and post-intervention data&#xD;
        were statistically analyzed and compared.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2023</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>kinesio taping and percussive massage techniques</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Joint Position Sense Test</measure>
      <time_frame>1 weeks</time_frame>
      <description>The joint to be evaluated is passively brought to a certain angle and it is waited for 10 seconds so that the person can learn the position of the joint. The person is asked to actively bring the evaluated extremity back to this angle with the eyes closed. When the person completes the movement, the error degrees between the predetermined angles are determined and averaged.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>One Leg Standing Test</measure>
      <time_frame>1weeks</time_frame>
      <description>Persons are positioned on one leg, with their hands on their waists, in front of a visually determined target. The foot to be tested is on the ground. The raised foot should not touch the leg on the ground. Time is kept from standing on one leg. The time taken until the foot held above touches the other leg or is lowered to the ground is recorded.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Evaluation of Gastrocnemius Elasticity</measure>
      <time_frame>1 weeks</time_frame>
      <description>The person to be evaluated is positioned by extending his legs so that the heel is in contact with the wall, without bending the knees. The person is asked to pull the ankle towards himself without removing the heel from the wall. The distance between the person's thumb and the wall is measured and recorded.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Evaluation of Plantar Fascia Flexibility</measure>
      <time_frame>1 weeks</time_frame>
      <description>The person to be evaluated is positioned by extending his legs so that the heel is in contact with the wall, without bending the knees. The person is asked to pull the fingers back without separating the heel and metatarsal heads from the wall. The distance between the person's thumb and the wall is measured and recorded.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Straight Leg Lift Test</measure>
      <time_frame>1 weeks</time_frame>
      <description>The person to be evaluated lies in the supine position without bending their knees. The person is asked to raise the leg to be evaluated to the point where he or she will feel a stretching sensation in the back of the thigh, keeping the knee straight. It is recorded by measuring with a goniometer or digital inclinometer.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Balance; Distorted</condition>
    <condition>Fascia; Anomaly</condition>
    <arm_group>
      <arm_group_label>kinesio taping</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>kinesio taping Technique: It is used to provide support to the joint range of motion and tissues. It has a wide range of uses for purposes such as correcting functional disorders, healing, protecting, reducing pain and inflammation. There are differences in cutting shapes according to the applied area and the target to be achieved.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>percussive massage</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Percussive Massage Technique: It is one of the instrument-assisted soft tissue mobilization techniques that emerged as a result of combining the effects of traditional massage and vibration therapy. With the mechanical oscillation effect that occurs in the Percussive Massage Technique, the muscle fiber is stimulated and an increase in reflex activity is observed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>taping</intervention_name>
      <description>Kinesio taping will be applied in accordance with the fascia correction technique, including the plantar flexor muscles, and it will be requested to stay on the skin for 3 days.</description>
      <arm_group_label>kinesio taping</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>massage</intervention_name>
      <description>Percussive Massage will be applied to the posterior part of the sural fascia, including the plantar flexor muscles, 3 times a week for 5 minutes.</description>
      <arm_group_label>percussive massage</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Volunteering to participate in the study&#xD;
  &#xD;
            -  Being between the ages of 18 and 60&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Injury or surgery involving the lower extremity in the last 6 months&#xD;
  &#xD;
            -  having had an operation&#xD;
  &#xD;
            -  Malignancy, aneurysm, fever, infection, fracture, osteoporosis, rheumatoid arthritis,&#xD;
               diabetes,&#xD;
  &#xD;
            -  coagulation disorder etc. myofascial release techniques are contraindicated&#xD;
  &#xD;
            -  have ailments&#xD;
  &#xD;
            -  Having any disorder that will affect balance&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gamze MAMUR</last_name>
      <role>Study Chair</role>
      <affiliation>Uskudar University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ömer ŞEVGİN</last_name>
      <phone>+905069787535</phone>
      <email>omer.sevgin@uskudar.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Üsküdar Unıversıty</name>
        <address>
          <city>Umraniye</city>
          <state>İstanbul</state>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ömer ŞEVGİN</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Leabeater A, Clarke A, James L, Huynh M, Driller M. Under the Gun: The effect of percussive massage therapy on physical and perceptual recovery in active adults. J Athl Train. 2023 May 26. doi: 10.4085/1062-6050-0041.23. Online ahead of print.</citation>
      <PMID>37248364</PMID>
    </reference>
    <reference>
      <citation>Biz C, Nicoletti P, Tomasin M, Bragazzi NL, Di Rubbo G, Ruggieri P. Is Kinesio Taping Effective for Sport Performance and Ankle Function of Athletes with Chronic Ankle Instability (CAI)? A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2022 Apr 29;58(5):620. doi: 10.3390/medicina58050620.</citation>
      <PMID>35630037</PMID>
    </reference>
    <reference>
      <citation>Cain MS, Ban RJ, Chen YP, Geil MD, Goerger BM, Linens SW. Four-Week Ankle-Rehabilitation Programs in Adolescent Athletes With Chronic Ankle Instability. J Athl Train. 2020 Aug 1;55(8):801-810. doi: 10.4085/1062-6050-41-19.</citation>
      <PMID>32577737</PMID>
    </reference>
    <reference>
      <citation>Williams S, Whatman C, Hume PA, Sheerin K. Kinesio taping in treatment and prevention of sports injuries: a meta-analysis of the evidence for its effectiveness. Sports Med. 2012 Feb 1;42(2):153-64. doi: 10.2165/11594960-000000000-00000.</citation>
      <PMID>22124445</PMID>
    </reference>
    <reference>
      <citation>Helly KL, Bain KA, Gribble PA, Hoch MC. The Effect of Plantar Massage on Static Postural Control in Patients With Chronic Ankle Instability: A Critically Appraised Topic. J Sport Rehabil. 2020 Oct 7;30(3):507-511. doi: 10.1123/jsr.2020-0092.</citation>
      <PMID>33027760</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uskudar University</investigator_affiliation>
      <investigator_full_name>Dr. Öğr. Üyesi Ömer Şevgin</investigator_full_name>
      <investigator_title>Asst. Prof. Dr.</investigator_title>
    </responsible_party>
    <keyword>proprioception</keyword>
    <keyword>flexibility</keyword>
    <keyword>balance</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06006533
  org study id: Uskudar61
  nct id: NCT06006533
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study; The aim of this study is to examine the effects of kinesio taping
        technique and percussive massage technique applied to plantar flexor muscles on
        proprioception, balance and flexibility in healthy individuals.
  The sample of the study will consist of healthy individuals who have not had any discomfort
        or surgical operation related to the lower extremity in the last 6 months. The demographic
        information of the individuals who agreed to participate in the study will be recorded and
        their written consent will be obtained. Participants will be divided into 2 groups as kinesio
        taping and Percussive Massage groups by randomization method. The dominant lower extremities
        of both groups will be applied. The Percussive Massage group will be applied to the posterior
        part of the sural fascia for 5 minutes, 3 times a week, including the plantar flexor muscles.
        In the kinesio taping group, taping will be done in accordance with the fascia correction
        technique, including the plantar flexor muscles, and it will be requested to stay for 3 days.
        Both groups will be evaluated before and after the application. Joint position sense test
        will be used to evaluate proprioception. In the evaluation of balance, the one-leg standing
        test will be considered. In the evaluation of flexibility; The flexibility of the hamstring,
        gastrocnemius, and plantar fascia will be examined. The Straight Leg Lift Test will be
        performed to look at the flexibility of the hamstring muscle. Pre- and post-intervention data
        were statistically analyzed and compared.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: kinesio taping and percussive massage techniques
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Joint Position Sense Test
  time frame: 1 weeks
  description: The joint to be evaluated is passively brought to a certain angle and it is waited for 10 seconds so that the person can learn the position of the joint. The person is asked to actively bring the evaluated extremity back to this angle with the eyes closed. When the person completes the movement, the error degrees between the predetermined angles are determined and averaged.
  measure: One Leg Standing Test
  time frame: 1weeks
  description: Persons are positioned on one leg, with their hands on their waists, in front of a visually determined target. The foot to be tested is on the ground. The raised foot should not touch the leg on the ground. Time is kept from standing on one leg. The time taken until the foot held above touches the other leg or is lowered to the ground is recorded.
  measure: Evaluation of Gastrocnemius Elasticity
  time frame: 1 weeks
  description: The person to be evaluated is positioned by extending his legs so that the heel is in contact with the wall, without bending the knees. The person is asked to pull the ankle towards himself without removing the heel from the wall. The distance between the person's thumb and the wall is measured and recorded.
  measure: Evaluation of Plantar Fascia Flexibility
  time frame: 1 weeks
  description: The person to be evaluated is positioned by extending his legs so that the heel is in contact with the wall, without bending the knees. The person is asked to pull the fingers back without separating the heel and metatarsal heads from the wall. The distance between the person's thumb and the wall is measured and recorded.
  measure: Straight Leg Lift Test
  time frame: 1 weeks
  description: The person to be evaluated lies in the supine position without bending their knees. The person is asked to raise the leg to be evaluated to the point where he or she will feel a stretching sensation in the back of the thigh, keeping the knee straight. It is recorded by measuring with a goniometer or digital inclinometer.
  arm group label: kinesio taping
  arm group type: Experimental
  description: kinesio taping Technique: It is used to provide support to the joint range of motion and tissues. It has a wide range of uses for purposes such as correcting functional disorders, healing, protecting, reducing pain and inflammation. There are differences in cutting shapes according to the applied area and the target to be achieved.
  arm group label: percussive massage
  arm group type: Experimental
  description: Percussive Massage Technique: It is one of the instrument-assisted soft tissue mobilization techniques that emerged as a result of combining the effects of traditional massage and vibration therapy. With the mechanical oscillation effect that occurs in the Percussive Massage Technique, the muscle fiber is stimulated and an increase in reflex activity is observed.
  intervention type: Other
  intervention name: taping
  description: Kinesio taping will be applied in accordance with the fascia correction technique, including the plantar flexor muscles, and it will be requested to stay on the skin for 3 days.
  arm group label: kinesio taping
  intervention type: Other
  intervention name: massage
  description: Percussive Massage will be applied to the posterior part of the sural fascia, including the plantar flexor muscles, 3 times a week for 5 minutes.
  arm group label: percussive massage
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gamze MAMUR
  role: Study Chair
  affiliation: Uskudar University
  last name: Ömer ŞEVGİN
  phone: +905069787535
  email: omer.sevgin@uskudar.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Leabeater A, Clarke A, James L, Huynh M, Driller M. Under the Gun: The effect of percussive massage therapy on physical and perceptual recovery in active adults. J Athl Train. 2023 May 26. doi: 10.4085/1062-6050-0041.23. Online ahead of print.
  PMID: 37248364
  citation: Biz C, Nicoletti P, Tomasin M, Bragazzi NL, Di Rubbo G, Ruggieri P. Is Kinesio Taping Effective for Sport Performance and Ankle Function of Athletes with Chronic Ankle Instability (CAI)? A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2022 Apr 29;58(5):620. doi: 10.3390/medicina58050620.
  PMID: 35630037
  citation: Cain MS, Ban RJ, Chen YP, Geil MD, Goerger BM, Linens SW. Four-Week Ankle-Rehabilitation Programs in Adolescent Athletes With Chronic Ankle Instability. J Athl Train. 2020 Aug 1;55(8):801-810. doi: 10.4085/1062-6050-41-19.
  PMID: 32577737
  citation: Williams S, Whatman C, Hume PA, Sheerin K. Kinesio taping in treatment and prevention of sports injuries: a meta-analysis of the evidence for its effectiveness. Sports Med. 2012 Feb 1;42(2):153-64. doi: 10.2165/11594960-000000000-00000.
  PMID: 22124445
  citation: Helly KL, Bain KA, Gribble PA, Hoch MC. The Effect of Plantar Massage on Static Postural Control in Patients With Chronic Ankle Instability: A Critically Appraised Topic. J Sport Rehabil. 2020 Oct 7;30(3):507-511. doi: 10.1123/jsr.2020-0092.
  PMID: 33027760
  responsible party type: Principal Investigator
  investigator affiliation: Uskudar University
  investigator full name: Dr. Öğr. Üyesi Ömer Şevgin
  investigator title: Asst. Prof. Dr.
  sharing ipd: No