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/NCT05969210</url>
    </required_header>
    <id_info>
      <org_study_id>REC/RCR &amp; AHS/23/0423 Aqsa</org_study_id>
      <nct_id>NCT05969210</nct_id>
    </id_info>
    <brief_title>Effects of Big Toe Strengthening on Agility, Jump and Speed Among Runners</brief_title>
    <official_title>Effects of Big Toe Strengthening on Agility, Jump and Speed Among Runners</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah International 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>
        Running form and technique have a direct influence on a runner's economy, and therefore small&#xD;
        changes in specific running mechanics could be useful to improving running performance. The&#xD;
        thumb plays an important role in the functionality of the foot. During standing, the big toe&#xD;
        is more loaded than the head of the five metatarsals and the heel.&#xD;
  &#xD;
        The study design will be a Randomized Controlled Trial. This study will be conducted in&#xD;
        Pakistan Sports Board (PSB) Lahore. The study will be completed within the time duration of&#xD;
        eight to ten months after the approval of the synopsis. The sample size will be 30 subjects.&#xD;
        Non-probability convenient sampling technique will be used to recruit the individuals for the&#xD;
        study. Then randomization will be done by lottery method to divide the individuals into 2&#xD;
        treatment groups. The experimental group is given big toe strengthening program for 3 weeks&#xD;
        along with running training on the other hand control group will do only their running&#xD;
        training and after that measure their pre-post values on spss.&#xD;
  &#xD;
        In this study, it will be aimed to examine the relationship of big toe strength with&#xD;
        parameters that affect anaerobic athletic performance in runners such as vertical jump,&#xD;
        horizontally jumping, strength, agility and speed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The objective of my study is to explore the effects of big toe strengthening on agility, jump&#xD;
        and speed among runners.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 22, 2022</start_date>
    <completion_date type="Actual">June 30, 2023</completion_date>
    <primary_completion_date type="Actual">May 30, 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>HIP AND TOE DYNAMOMETER</measure>
      <time_frame>3 weeks</time_frame>
      <description>Athletes will placed their feet on the ground prepared in accordance with the big toe and adjusted their big toes according to the location of the pinch meter. During the measurement, athletes will asked to apply maximum force with their big toe. Strength measurements were made on the athletes in the sitting position without any support(6).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dynamic balance Y TEST, Star excursion test (SEBT)</measure>
      <time_frame>3 weeks</time_frame>
      <description>Y test reliability (ICC = 0.88- 0.99 (14) The reliability of the SEBT as being moderate to good (ICC 0.67- 0.97 )(14).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Vertical jumping, Horizontal jumping</measure>
      <time_frame>3 weeks</time_frame>
      <description>puts chalk on their fingertips to mark the wall at the height of their jump. Then stands away from the wall, and jumps vertically as high as possible using both arms and legs to assist in projecting the body upwards. Attempt to touch the wall at the highest point of the jump(15)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>STRENGHT • Speed: 20m Sprint test • Agility---- T- Test</measure>
      <time_frame>3 weeks</time_frame>
      <description>Ask the player to put the thumb on dynamometer and press it and see the strength.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">24</enrollment>
    <condition>Sports Physical Therapy</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>12 participants will be in experimental group giving them Toe strengthening exercise protocol along with running training for three weeks, measure all values before giving them protocol and after protocol.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>12 participants will be in control group they will do only there running training.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Toe strengthening exercise</intervention_name>
      <description>12 participants will be in experimental group giving them Toe strengthening exercise protocol along with running training for three weeks, measure all values before giving them protocol and after protocol.</description>
      <arm_group_label>Group A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control Group</intervention_name>
      <description>12 participants will be in control group they will do only there running training.</description>
      <arm_group_label>Group B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age; 16-28yrs&#xD;
  &#xD;
            -  Male runners&#xD;
  &#xD;
            -  Doing Running practice for 3 days in a week(40-60minutes per day)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants a will be excluded if they have any neurological signs.&#xD;
  &#xD;
            -  Any lower limb trauma and history of fracture past six month&#xD;
  &#xD;
            -  Systematic illness ; diabetic ,hypertension(6)&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>28 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Aamir Gul Memon, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Pakistan Sports Board</name>
        <address>
          <city>Lahore</city>
          <state>Punjab</state>
          <zip>5400</zip>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <reference>
      <citation>Denadai BS, Greco CC. Could middle- and long-distance running performance of well-trained athletes be best predicted by the same aerobic parameters? Curr Res Physiol. 2022 Jun 23;5:265-269. doi: 10.1016/j.crphys.2022.06.006. eCollection 2022.</citation>
      <PMID>35800136</PMID>
    </reference>
    <reference>
      <citation>Tufano JJ, Amonette WE. Assisted versus resisted training: which is better for increasing jumping and sprinting? Strength &amp; Conditioning Journal. 2018;40(1):106-10.</citation>
    </reference>
    <reference>
      <citation>Horicka P, Simonek J, Brodani J. Diagnostics of reactive and running agility in young football players. Physical Activity Review. 2018;6:29-36.</citation>
    </reference>
    <reference>
      <citation>Stoneham R, Barry G, Saxby L, Wilkinson M. The influence of great toe valgus on pronation and frontal plane knee motion during running. The Foot and Ankle Online Journal. 2020;13(1):7.</citation>
    </reference>
    <reference>
      <citation>Angin S, Demirbüken İ. Ankle and foot complex. Comparative Kinesiology of the Human Body: Elsevier; 2020. p. 411-39.</citation>
    </reference>
    <reference>
      <citation>Sarikaya F, Sahin M. The Effect of Big Toe Strength Development on Some Athletic Performance Parameter in Young Male Footballers. Pakistan Journal of Medical &amp; Health Sciences. 2022;16(02):997-.</citation>
    </reference>
    <reference>
      <citation>Kurihara T, Terada M, Numasawa S, Kusagawa Y, Maeo S, Kanehisa H, Isaka T. Effects of age and sex on association between toe muscular strength and vertical jump performance in adolescent populations. PLoS One. 2021 Dec 31;16(12):e0262100. doi: 10.1371/journal.pone.0262100. eCollection 2021.</citation>
      <PMID>34972181</PMID>
    </reference>
    <reference>
      <citation>Sutkowska E, Sutkowski K, Sokolowski M, Franek E, Dragan S Sr. Distribution of the Highest Plantar Pressure Regions in Patients with Diabetes and Its Association with Peripheral Neuropathy, Gender, Age, and BMI: One Centre Study. J Diabetes Res. 2019 Jul 9;2019:7395769. doi: 10.1155/2019/7395769. eCollection 2019.</citation>
      <PMID>31380446</PMID>
    </reference>
    <reference>
      <citation>Liang ZQ, Meng Y, Popik S, Chen FF, editors. Analysis of foot morphology in habitually barefoot group. Journal of Biomimetics, Biomaterials and Biomedical Engineering; 2019: Trans Tech Publ.</citation>
    </reference>
    <reference>
      <citation>Yamauchi J, Koyama K. The mechanical role of the metatarsophalangeal joint in human jumping. PLoS One. 2022 May 20;17(5):e0268634. doi: 10.1371/journal.pone.0268634. eCollection 2022.</citation>
      <PMID>35594285</PMID>
    </reference>
    <reference>
      <citation>Yamauchi J, Koyama K. Importance of toe flexor strength in vertical jump performance. J Biomech. 2020 May 7;104:109719. doi: 10.1016/j.jbiomech.2020.109719. Epub 2020 Feb 26.</citation>
      <PMID>32173032</PMID>
    </reference>
    <reference>
      <citation>Otsuka M, Yamauchi J, Kurihara T, Morita N, Isaka T. Toe flexor strength and lower-limb physical performance in adolescent. Gazzetta medica italiana. 2015;174(7-8):307-13.</citation>
    </reference>
    <reference>
      <citation>Shin H, Moon SW, Kim GS, Park JD, Kim JH, Jung MJ, Yoon CH, Lee ES, Oh MK. Reliability of the pinch strength with digitalized pinch dynamometer. Ann Rehabil Med. 2012 Jun;36(3):394-9. doi: 10.5535/arm.2012.36.3.394. Epub 2012 Jun 30.</citation>
      <PMID>22837976</PMID>
    </reference>
    <reference>
      <citation>Plisky PJ, Gorman PP, Butler RJ, Kiesel KB, Underwood FB, Elkins B. The reliability of an instrumented device for measuring components of the star excursion balance test. N Am J Sports Phys Ther. 2009 May;4(2):92-9.</citation>
      <PMID>21509114</PMID>
    </reference>
    <reference>
      <citation>Young W, Wilson G, Byrne C. Relationship between strength qualities and performance in standing and run-up vertical jumps. J Sports Med Phys Fitness. 1999 Dec;39(4):285-93.</citation>
      <PMID>10726428</PMID>
    </reference>
    <reference>
      <citation>Dobbs CW, Gill ND, Smart DJ, McGuigan MR. Relationship between vertical and horizontal jump variables and muscular performance in athletes. J Strength Cond Res. 2015 Mar;29(3):661-71. doi: 10.1519/JSC.0000000000000694.</citation>
      <PMID>25226312</PMID>
    </reference>
    <reference>
      <citation>Pauole K, Madole K, Garhammer J, Lacourse M, Rozenek R. Reliability and validity of the T-test as a measure of agility, leg power, and leg speed in college-aged men and women. The Journal of Strength &amp; Conditioning Research. 2000;14(4):443-50.</citation>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 6, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Big toe</keyword>
    <keyword>Athlete</keyword>
    <keyword>Dynamometer</keyword>
    <keyword>Muscle Strength</keyword>
    <keyword>Agility</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/NCT05969210
  org study id: REC/RCR & AHS/23/0423 Aqsa
  nct id: NCT05969210
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Running form and technique have a direct influence on a runner's economy, and therefore small
        changes in specific running mechanics could be useful to improving running performance. The
        thumb plays an important role in the functionality of the foot. During standing, the big toe
        is more loaded than the head of the five metatarsals and the heel.
  
        The study design will be a Randomized Controlled Trial. This study will be conducted in
        Pakistan Sports Board (PSB) Lahore. The study will be completed within the time duration of
        eight to ten months after the approval of the synopsis. The sample size will be 30 subjects.
        Non-probability convenient sampling technique will be used to recruit the individuals for the
        study. Then randomization will be done by lottery method to divide the individuals into 2
        treatment groups. The experimental group is given big toe strengthening program for 3 weeks
        along with running training on the other hand control group will do only their running
        training and after that measure their pre-post values on spss.
  
        In this study, it will be aimed to examine the relationship of big toe strength with
        parameters that affect anaerobic athletic performance in runners such as vertical jump,
        horizontally jumping, strength, agility and speed.
  The objective of my study is to explore the effects of big toe strengthening on agility, jump
        and speed among runners.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: HIP AND TOE DYNAMOMETER
  time frame: 3 weeks
  description: Athletes will placed their feet on the ground prepared in accordance with the big toe and adjusted their big toes according to the location of the pinch meter. During the measurement, athletes will asked to apply maximum force with their big toe. Strength measurements were made on the athletes in the sitting position without any support(6).
  measure: Dynamic balance Y TEST, Star excursion test (SEBT)
  time frame: 3 weeks
  description: Y test reliability (ICC = 0.88- 0.99 (14) The reliability of the SEBT as being moderate to good (ICC 0.67- 0.97 )(14).
  measure: Vertical jumping, Horizontal jumping
  time frame: 3 weeks
  description: puts chalk on their fingertips to mark the wall at the height of their jump. Then stands away from the wall, and jumps vertically as high as possible using both arms and legs to assist in projecting the body upwards. Attempt to touch the wall at the highest point of the jump(15)
  measure: STRENGHT • Speed: 20m Sprint test • Agility---- T- Test
  time frame: 3 weeks
  description: Ask the player to put the thumb on dynamometer and press it and see the strength.
  arm group label: Group A
  arm group type: Experimental
  description: 12 participants will be in experimental group giving them Toe strengthening exercise protocol along with running training for three weeks, measure all values before giving them protocol and after protocol.
  arm group label: Group B
  arm group type: Experimental
  description: 12 participants will be in control group they will do only there running training.
  intervention type: Other
  intervention name: Toe strengthening exercise
  description: 12 participants will be in experimental group giving them Toe strengthening exercise protocol along with running training for three weeks, measure all values before giving them protocol and after protocol.
  arm group label: Group A
  intervention type: Other
  intervention name: Control Group
  description: 12 participants will be in control group they will do only there running training.
  arm group label: Group B
  criteria: 
  gender: Male
  gender based: Yes
  minimum age: 16 Years
  maximum age: 28 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Aamir Gul Memon, MS
  role: Principal Investigator
  affiliation: Riphah International University
  facility: 
  country: Pakistan
  citation: Denadai BS, Greco CC. Could middle- and long-distance running performance of well-trained athletes be best predicted by the same aerobic parameters? Curr Res Physiol. 2022 Jun 23;5:265-269. doi: 10.1016/j.crphys.2022.06.006. eCollection 2022.
  PMID: 35800136
  citation: Tufano JJ, Amonette WE. Assisted versus resisted training: which is better for increasing jumping and sprinting? Strength & Conditioning Journal. 2018;40(1):106-10.
  citation: Horicka P, Simonek J, Brodani J. Diagnostics of reactive and running agility in young football players. Physical Activity Review. 2018;6:29-36.
  citation: Stoneham R, Barry G, Saxby L, Wilkinson M. The influence of great toe valgus on pronation and frontal plane knee motion during running. The Foot and Ankle Online Journal. 2020;13(1):7.
  citation: Angin S, Demirbüken İ. Ankle and foot complex. Comparative Kinesiology of the Human Body: Elsevier; 2020. p. 411-39.
  citation: Sarikaya F, Sahin M. The Effect of Big Toe Strength Development on Some Athletic Performance Parameter in Young Male Footballers. Pakistan Journal of Medical & Health Sciences. 2022;16(02):997-.
  citation: Kurihara T, Terada M, Numasawa S, Kusagawa Y, Maeo S, Kanehisa H, Isaka T. Effects of age and sex on association between toe muscular strength and vertical jump performance in adolescent populations. PLoS One. 2021 Dec 31;16(12):e0262100. doi: 10.1371/journal.pone.0262100. eCollection 2021.
  PMID: 34972181
  citation: Sutkowska E, Sutkowski K, Sokolowski M, Franek E, Dragan S Sr. Distribution of the Highest Plantar Pressure Regions in Patients with Diabetes and Its Association with Peripheral Neuropathy, Gender, Age, and BMI: One Centre Study. J Diabetes Res. 2019 Jul 9;2019:7395769. doi: 10.1155/2019/7395769. eCollection 2019.
  PMID: 31380446
  citation: Liang ZQ, Meng Y, Popik S, Chen FF, editors. Analysis of foot morphology in habitually barefoot group. Journal of Biomimetics, Biomaterials and Biomedical Engineering; 2019: Trans Tech Publ.
  citation: Yamauchi J, Koyama K. The mechanical role of the metatarsophalangeal joint in human jumping. PLoS One. 2022 May 20;17(5):e0268634. doi: 10.1371/journal.pone.0268634. eCollection 2022.
  PMID: 35594285
  citation: Yamauchi J, Koyama K. Importance of toe flexor strength in vertical jump performance. J Biomech. 2020 May 7;104:109719. doi: 10.1016/j.jbiomech.2020.109719. Epub 2020 Feb 26.
  PMID: 32173032
  citation: Otsuka M, Yamauchi J, Kurihara T, Morita N, Isaka T. Toe flexor strength and lower-limb physical performance in adolescent. Gazzetta medica italiana. 2015;174(7-8):307-13.
  citation: Shin H, Moon SW, Kim GS, Park JD, Kim JH, Jung MJ, Yoon CH, Lee ES, Oh MK. Reliability of the pinch strength with digitalized pinch dynamometer. Ann Rehabil Med. 2012 Jun;36(3):394-9. doi: 10.5535/arm.2012.36.3.394. Epub 2012 Jun 30.
  PMID: 22837976
  citation: Plisky PJ, Gorman PP, Butler RJ, Kiesel KB, Underwood FB, Elkins B. The reliability of an instrumented device for measuring components of the star excursion balance test. N Am J Sports Phys Ther. 2009 May;4(2):92-9.
  PMID: 21509114
  citation: Young W, Wilson G, Byrne C. Relationship between strength qualities and performance in standing and run-up vertical jumps. J Sports Med Phys Fitness. 1999 Dec;39(4):285-93.
  PMID: 10726428
  citation: Dobbs CW, Gill ND, Smart DJ, McGuigan MR. Relationship between vertical and horizontal jump variables and muscular performance in athletes. J Strength Cond Res. 2015 Mar;29(3):661-71. doi: 10.1519/JSC.0000000000000694.
  PMID: 25226312
  citation: Pauole K, Madole K, Garhammer J, Lacourse M, Rozenek R. Reliability and validity of the T-test as a measure of agility, leg power, and leg speed in college-aged men and women. The Journal of Strength & Conditioning Research. 2000;14(4):443-50.
  responsible party type: Sponsor
  sharing ipd: No