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/NCT05982431</url>
    </required_header>
    <id_info>
      <org_study_id>RHPT/0021/0063</org_study_id>
      <nct_id>NCT05982431</nct_id>
    </id_info>
    <brief_title>Metatarsophalangeal Joint Sprain Kinesiotaping</brief_title>
    <official_title>Kinesiology Taping Helps Patients With First Metatarsophalangeal Joint Sprain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Qassim University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Prince Sattam Bin Abdulaziz University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Qassim 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>
        kinesio taping would reduce pain, improve gait performance, and enhance the functional&#xD;
        capacity of turf toe patients undergoing physical therapy&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Health practitioners have recently become interested in using kinesiology taping in clinical&#xD;
        practice as an alternative to traditional taping and bracing procedures for treating a&#xD;
        variety of diseases, including sprain of metatarsophalangeal joint of the big toe. Patients&#xD;
        with turf toe can benefit from kinesiology tape because it offers therapeutic support and&#xD;
        stability while preserving a normal range of motion.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 10, 2021</start_date>
    <completion_date type="Actual">January 15, 2023</completion_date>
    <primary_completion_date type="Actual">August 22, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pain visual analog scale</measure>
      <time_frame>at first week</time_frame>
      <description>The degree of the pain was assessed using a 10-cm visual analog scale (VAS), with 0 denoting no pain and 10 denoting the most painful event.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain visual analog scale</measure>
      <time_frame>after 12 weeks</time_frame>
      <description>The degree of the pain was assessed using a 10-cm visual analog scale (VAS), with 0 denoting no pain and 10 denoting the most painful event.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gait parameters (step length by centimeter).</measure>
      <time_frame>at first week</time_frame>
      <description>The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gait parameters (step length by centimeter).</measure>
      <time_frame>after 12 weeks</time_frame>
      <description>The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gait parameters (stride length by meter).</measure>
      <time_frame>at first week</time_frame>
      <description>The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gait parameters (stride length by meter).</measure>
      <time_frame>after 12 weeks</time_frame>
      <description>The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gait parameters (cadence by steps per minute).</measure>
      <time_frame>at first week</time_frame>
      <description>The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gait parameters (cadence by steps per minute).</measure>
      <time_frame>after 12 weeks</time_frame>
      <description>The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gait parameters (velocity by centimeter per second).</measure>
      <time_frame>at first week</time_frame>
      <description>The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gait parameters (velocity by centimeter per second).</measure>
      <time_frame>after 12 weeks</time_frame>
      <description>The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Functional ability assessment</measure>
      <time_frame>at first week</time_frame>
      <description>Functional ability was assessed using the 6-minute walk test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional ability assessment</measure>
      <time_frame>after 12 weeks</time_frame>
      <description>Functional ability was assessed using the 6-minute walk test.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Turf Toe</condition>
    <condition>Metatarsophalangeal (Joint) Sprain</condition>
    <arm_group>
      <arm_group_label>exercise group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>60-minutes exercise program, three times a week on alternate days for 12 successive weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>placebo kinesiology taping plus exercise group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Kinesiology taping was used, however the strain was zero. Before each exercise session, the tape was changed every two days while the patients were present.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>kinesiology taping plus exercise group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>putting no stress on the opposite end and a 50% stretch from the top of the big toe to the heel along the back of the heel. After applying a 50% stretch from the top of the big toe to the second horizontal little strip between the big toe and second toe, place the ends below the toe diagonally with no stress.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Traditional physical therapy program</intervention_name>
      <description>60-minutes exercise program, three times a week on alternate days for 12 successive weeks</description>
      <arm_group_label>exercise group</arm_group_label>
      <arm_group_label>kinesiology taping plus exercise group</arm_group_label>
      <arm_group_label>placebo kinesiology taping plus exercise group</arm_group_label>
      <other_name>exercise program</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Kinsio taping</intervention_name>
      <description>One full strip of kinesiology taping tape and one half-length strip were needed for the kinesiology taping application</description>
      <arm_group_label>kinesiology taping plus exercise group</arm_group_label>
      <other_name>kinesiology taping</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>placebo Kinsio taping</intervention_name>
      <description>One full strip of kinesiology taping tape and one half-length strip were needed for the placebo kinesiology taping application</description>
      <arm_group_label>placebo kinesiology taping plus exercise group</arm_group_label>
      <other_name>placebo kinesiology taping</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  comprised athletes with 2nd grade turf toe.&#xD;
  &#xD;
            -  medically stable.&#xD;
  &#xD;
            -  had foot pain for more than a month prior to enrollment.&#xD;
  &#xD;
            -  didn't have persistent, incapacitating pain.&#xD;
  &#xD;
            -  had a doctor's note approving their decision to stop taking painkillers during the&#xD;
               research.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  if they had any surgical intervention before.&#xD;
  &#xD;
            -  range of motion limitation in the ankle joint.&#xD;
  &#xD;
            -  inability to exercise.&#xD;
  &#xD;
            -  systemic disease.&#xD;
  &#xD;
            -  any other orthopedic problem at ankle joints.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alshimaa Azab, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University</name>
        <address>
          <city>Al-Kharj</city>
          <state>Riyadh</state>
          <zip>11432</zip>
          <country>Saudi Arabia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>King Khalid Hospital</name>
        <address>
          <city>Al-Kharj</city>
          <state>Riyadh</state>
          <country>Saudi Arabia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Saudi Arabia</country>
    </location_countries>
    <reference>
      <citation>Mostafavifar M, Wertz J, Borchers J. A systematic review of the effectiveness of kinesio taping for musculoskeletal injury. Phys Sportsmed. 2012 Nov;40(4):33-40. doi: 10.3810/psm.2012.11.1986.</citation>
      <PMID>23306413</PMID>
    </reference>
    <reference>
      <citation>Burr JF, Bredin SS, Faktor MD, Warburton DE. The 6-minute walk test as a predictor of objectively measured aerobic fitness in healthy working-aged adults. Phys Sportsmed. 2011 May;39(2):133-9. doi: 10.3810/psm.2011.05.1904.</citation>
      <PMID>21673494</PMID>
    </reference>
    <reference>
      <citation>Kim MK, Shin YJ. Immediate Effects of Ankle Balance Taping with Kinesiology Tape for Amateur Soccer Players with Lateral Ankle Sprain: A Randomized Cross-Over Design. Med Sci Monit. 2017 Nov 21;23:5534-5541. doi: 10.12659/msm.905385.</citation>
      <PMID>29158472</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 5, 2023</last_update_submitted>
    <last_update_submitted_qc>August 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Qassim University</investigator_affiliation>
      <investigator_full_name>Maged Basha</investigator_full_name>
      <investigator_title>Assistant Professor, College of Medical Rehabilitation, Qassim University</investigator_title>
    </responsible_party>
    <keyword>turf toe</keyword>
    <keyword>Metatarsophalangeal Sprain</keyword>
    <keyword>functional ability</keyword>
    <keyword>gait parameters</keyword>
    <keyword>kinesiology taping</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sprains and Strains</mesh_term>
      <mesh_term>Foot Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>6 months after publication</ipd_time_frame>
      <ipd_access_criteria>relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.</ipd_access_criteria>
    </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/NCT05982431
  org study id: RHPT/0021/0063
  nct id: NCT05982431
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  kinesio taping would reduce pain, improve gait performance, and enhance the functional
        capacity of turf toe patients undergoing physical therapy
  Health practitioners have recently become interested in using kinesiology taping in clinical
        practice as an alternative to traditional taping and bracing procedures for treating a
        variety of diseases, including sprain of metatarsophalangeal joint of the big toe. Patients
        with turf toe can benefit from kinesiology tape because it offers therapeutic support and
        stability while preserving a normal range of motion.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Pain visual analog scale
  time frame: at first week
  description: The degree of the pain was assessed using a 10-cm visual analog scale (VAS), with 0 denoting no pain and 10 denoting the most painful event.
  measure: Pain visual analog scale
  time frame: after 12 weeks
  description: The degree of the pain was assessed using a 10-cm visual analog scale (VAS), with 0 denoting no pain and 10 denoting the most painful event.
  measure: Gait parameters (step length by centimeter).
  time frame: at first week
  description: The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
  measure: Gait parameters (step length by centimeter).
  time frame: after 12 weeks
  description: The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
  measure: Gait parameters (stride length by meter).
  time frame: at first week
  description: The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
  measure: Gait parameters (stride length by meter).
  time frame: after 12 weeks
  description: The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
  measure: Gait parameters (cadence by steps per minute).
  time frame: at first week
  description: The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
  measure: Gait parameters (cadence by steps per minute).
  time frame: after 12 weeks
  description: The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
  measure: Gait parameters (velocity by centimeter per second).
  time frame: at first week
  description: The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
  measure: Gait parameters (velocity by centimeter per second).
  time frame: after 12 weeks
  description: The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
  measure: Functional ability assessment
  time frame: at first week
  description: Functional ability was assessed using the 6-minute walk test.
  measure: Functional ability assessment
  time frame: after 12 weeks
  description: Functional ability was assessed using the 6-minute walk test.
  arm group label: exercise group
  arm group type: Experimental
  description: 60-minutes exercise program, three times a week on alternate days for 12 successive weeks.
  arm group label: placebo kinesiology taping plus exercise group
  arm group type: Experimental
  description: Kinesiology taping was used, however the strain was zero. Before each exercise session, the tape was changed every two days while the patients were present.
  arm group label: kinesiology taping plus exercise group
  arm group type: Experimental
  description: putting no stress on the opposite end and a 50% stretch from the top of the big toe to the heel along the back of the heel. After applying a 50% stretch from the top of the big toe to the second horizontal little strip between the big toe and second toe, place the ends below the toe diagonally with no stress.
  intervention type: Other
  intervention name: Traditional physical therapy program
  description: 60-minutes exercise program, three times a week on alternate days for 12 successive weeks
  arm group label: exercise group
  arm group label: kinesiology taping plus exercise group
  arm group label: placebo kinesiology taping plus exercise group
  other name: exercise program
  intervention type: Other
  intervention name: Kinsio taping
  description: One full strip of kinesiology taping tape and one half-length strip were needed for the kinesiology taping application
  arm group label: kinesiology taping plus exercise group
  other name: kinesiology taping
  intervention type: Other
  intervention name: placebo Kinsio taping
  description: One full strip of kinesiology taping tape and one half-length strip were needed for the placebo kinesiology taping application
  arm group label: placebo kinesiology taping plus exercise group
  other name: placebo kinesiology taping
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 30 Years
  healthy volunteers: No
  last name: Alshimaa Azab, PhD
  role: Principal Investigator
  affiliation: Cairo University
  facility: 
  facility: 
  country: Saudi Arabia
  citation: Mostafavifar M, Wertz J, Borchers J. A systematic review of the effectiveness of kinesio taping for musculoskeletal injury. Phys Sportsmed. 2012 Nov;40(4):33-40. doi: 10.3810/psm.2012.11.1986.
  PMID: 23306413
  citation: Burr JF, Bredin SS, Faktor MD, Warburton DE. The 6-minute walk test as a predictor of objectively measured aerobic fitness in healthy working-aged adults. Phys Sportsmed. 2011 May;39(2):133-9. doi: 10.3810/psm.2011.05.1904.
  PMID: 21673494
  citation: Kim MK, Shin YJ. Immediate Effects of Ankle Balance Taping with Kinesiology Tape for Amateur Soccer Players with Lateral Ankle Sprain: A Randomized Cross-Over Design. Med Sci Monit. 2017 Nov 21;23:5534-5541. doi: 10.12659/msm.905385.
  PMID: 29158472
  responsible party type: Principal Investigator
  investigator affiliation: Qassim University
  investigator full name: Maged Basha
  investigator title: Assistant Professor, College of Medical Rehabilitation, Qassim University
  mesh term: Sprains and Strains
  mesh term: Foot Injuries
  sharing ipd: Yes
  ipd description: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
  ipd info type: Study Protocol
  ipd time frame: 6 months after publication
  ipd access criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.