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/NCT05974020</url>
    </required_header>
    <id_info>
      <org_study_id>22-54</org_study_id>
      <nct_id>NCT05974020</nct_id>
    </id_info>
    <brief_title>Investigation of the Effect of Foot Intrinsic Muscle Training in Individuals With Diabetic Foot Syndrome</brief_title>
    <official_title>Investigation of the Effect of Foot Intrinsic Muscle Training on Foot Posture and Plantar Pressure Distribution in Individuals With Diabetic Foot Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Saglik Bilimleri Universitesi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Saglik Bilimleri Universitesi</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>
        The goal of this experimental randomized controlled study is to evaluate the effectiveness of&#xD;
        the exercise program to be applied to prevent foot wounds, which is one of the leading foot&#xD;
        problems that develop as a result of diabetes, based on foot posture and plantar pressure&#xD;
        distribution.&#xD;
  &#xD;
        Participants who meet the inclusion criteria and are between the ages of 18-65 will be&#xD;
        randomly assigned to one of the two experimental groups or the control group.Participants&#xD;
        will be assessed through surveys to evaluate their physical activity level, foot health and&#xD;
        functionality, and sensory status of the feet. Measurements related to foot position and&#xD;
        posture will be taken. The use of a pedobarography device will allow for the examination of&#xD;
        plantar pressure distribution. Following these assessments, participants will receive general&#xD;
        foot care instructions and information on appropriate footwear, along with the designated&#xD;
        exercise program.&#xD;
  &#xD;
        During routine check-ups and treatment procedures related to diabetes, blood glucose levels&#xD;
        and HbA1c values taken from participants will be analyzed by the physician before and after&#xD;
        the program to make comparisons. The study is planned to last for 12 weeks, and evaluations&#xD;
        will be conducted before and after the program.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        According to the literature, evaluations for preventing and treating diabetic foot ulcers&#xD;
        commonly include plantar pressure measurements, and it is emphasized that methods involving&#xD;
        plantar pressure technologies should be added to traditional evaluations to be more&#xD;
        successful in preventing diabetic foot ulcers, even in high-risk individuals.&#xD;
  &#xD;
        Based on the findings from previous research, it is believed that the reduced foot intrinsic&#xD;
        muscle strength, which has not been extensively examined in its relationship with other&#xD;
        factors, needs to be systematically investigated for its effects on foot related measurements&#xD;
        and plantar pressure. Furthermore, there seems to be insufficient information regarding&#xD;
        exercise interventions focusing on foot intrinsic muscle training for preventing ulcer&#xD;
        development in diabetic foot. Therefore, the aim of the study is to examine the effects of&#xD;
        foot intrinsic muscle training on foot posture and plantar pressure distribution in&#xD;
        individuals with diabetic foot syndrome. By elucidating these factors, it is hoped that the&#xD;
        exercise protocol focusing on foot intrinsic muscle training, implemented to prevent ulcer&#xD;
        formation, will contribute to the literature and reduce the burdens associated with the&#xD;
        disease.&#xD;
  &#xD;
        Hypotheses of the study:&#xD;
  &#xD;
        H0: Foot intrinsic muscle training has no effect on plantar pressure in individuals with&#xD;
        diabetic foot syndrome.&#xD;
  &#xD;
        H1: Foot intrinsic muscle training has an effect on plantar pressure in individuals with&#xD;
        diabetic foot syndrome.&#xD;
  &#xD;
        H2: Foot intrinsic muscle training has no effect on foot posture in individuals with diabetic&#xD;
        foot syndrome.&#xD;
  &#xD;
        H3: Foot intrinsic muscle training has an effect on foot posture in individuals with diabetic&#xD;
        foot syndrome.&#xD;
  &#xD;
        In this study, individuals with diabetic foot syndrome between the ages of 18-65 will be&#xD;
        included. The study is designed as a randomized controlled trial, and the participants will&#xD;
        be divided into three groups: one control group (Group 1) and two experimental groups (Group&#xD;
        2 and Group 3). The sample size was determined using the G-power program. According to the&#xD;
        results obtained, it was calculated that a total of 30 individuals should be included in the&#xD;
        study, with 10 participants in each group, considering a statistical power level of 82% and a&#xD;
        significance level of 5%.&#xD;
  &#xD;
        As part of the research, investigators will gain insights into participants' foot health&#xD;
        through questionnaire questions, complete observational analyses of foot and foot-related&#xD;
        measurements, evaluate participants' plantar pressure distribution using pedobarographic&#xD;
        analysis, and implement exercise protocols focusing on foot intrinsic muscle training.&#xD;
  &#xD;
        The study was designed with evaluation and treatment protocols. Demographic information and&#xD;
        physical activity levels of the participants to be included in the study will be recorded.&#xD;
        The measurements related to the foot will include evaluation of foot posture, goniometric&#xD;
        measurements, assessment of tactile sensation, plantar pressure distribution analysis, and&#xD;
        questionnaire evaluations. In addition to all these assessments, participants' blood values&#xD;
        will be examined by the doctor before and after treatment.&#xD;
  &#xD;
        The treatment protocols consist of general foot care instructions and information about&#xD;
        appropriate footwear selection, along with exercise protocols. Group 1 - Control Group&#xD;
        participants will receive only general foot care instructions and education on appropriate&#xD;
        footwear selection. Group 2 participants will receive general foot care instructions and&#xD;
        education on appropriate footwear selection, along with an exercise protocol focusing on foot&#xD;
        intrinsic muscle training. Group 3 participants will receive general foot care instructions&#xD;
        and education on appropriate footwear selection, foot intrinsic muscle training, and in&#xD;
        addition, an aerobic exercise protocol. The treatment protocols will be implemented for 12&#xD;
        weeks, and pre- and post-treatment evaluations will be repeated to compare the results.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 4, 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Actual">September 13, 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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Plantar Pressure Distribution</measure>
      <time_frame>3 months</time_frame>
      <description>Plantar pressure distribution analysis will be performed statically and dynamically with the Baropodometric Platforms Freemed™, 120 cm (Sensor Medica, Italia) pedobarography platform and software. In order to obtain the static plantar pressure distribution parameters of the people included in the study, on the surface with a pressure gauge sensor; As soon as the pressure falling on one foot reaches the value to be determined, it will be analyzed during standing static stance.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Foot Posture</measure>
      <time_frame>3 months</time_frame>
      <description>Foot Posture Index was used to evaluate the foot posture of the individuals to be included in the study. The assessment will be made by the therapist based on observation and palpation by asking individuals to stand still in a relaxed position where they feel comfortable. The talonavicular joint of the forefoot, medial longitudinal arch, and abduction/adduction of the forefoot relative to the hindfoot will be evaluated. In the hindfoot, eversion/inversion of the head of the talus, lateral malleolus, and calcaneus will be evaluated.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Diabetic Foot</condition>
    <arm_group>
      <arm_group_label>Group 1- Control</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group 1 - Control Group will receive only general foot care instructions and education on appropriate footwear selection.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2- Intrinsic Muscle Training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group 2 participants will receive general foot care instructions and education on appropriate footwear selection, along with an exercise protocol focusing on foot intrinsic muscle training.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 3- Aerobic Exercise</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group 3 participants will receive general foot care instructions and education on appropriate footwear selection, foot intrinsic muscle training, and in addition, an aerobic exercise protocol.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control</intervention_name>
      <description>No intervention will be applied to the control group, and information will be given on general foot care instructions and the use of appropriate shoes.</description>
      <arm_group_label>Group 1- Control</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Intrinsic Muscle Training</intervention_name>
      <description>In addition to general foot care instructions and briefings on the use of appropriate shoes, intrinsic muscle training including alternating toe movement, toes picking up sheets, opening and closing the toes, pinching the toe separators, toe transitions and short foot exercises will be implemented.&#xD;
  Additionaly, warm-up exercises, ankle exercises and functional exercises will be included in the program.</description>
      <arm_group_label>Group 2- Intrinsic Muscle Training</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Aerobic Exercise</intervention_name>
      <description>In addition to general foot care instructions and information on the use of appropriate shoes, warm-up exercises, ankle exercises, functional exercises and intrinsic muscle training, the participants will be given a walking program for aerobic exercise.</description>
      <arm_group_label>Group 3- Aerobic Exercise</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Agree to participate in the study voluntarily&#xD;
  &#xD;
            -  Be between the ages of 18-65&#xD;
  &#xD;
            -  Being diagnosed with type 1 or type 2 diabetes&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusing to participate in the study or wanting to leave the study&#xD;
  &#xD;
            -  Presence of severe deformity and/or orthopedic problem in the foot&#xD;
  &#xD;
            -  Presence of foot ulcer&#xD;
  &#xD;
            -  History of lower extremity surgery&#xD;
  &#xD;
            -  History of lower extremity amputation&#xD;
  &#xD;
            -  Having serious comorbidities (renal failure, severe retinopathy, cardiac problems,&#xD;
               neurological problems)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dilara Akar</last_name>
      <role>Principal Investigator</role>
      <affiliation>Saglik Bilimleri University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Saglik Bilimleri University</name>
        <address>
          <city>Istanbul</city>
          <state>Üsküdar</state>
          <zip>34674</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <link>
      <url>https://academic.oup.com/ptj/article-abstract/70/6/356/3051938</url>
      <description>. Relationship of Foot Deformity to Ulcer Location in Patients with Diabetes Mellitus</description>
    </link>
    <link>
      <url>http://www.ptjournal.org</url>
      <description>Epidemiology of Diabetes and Diabetes-Related Complications Diabetes Special Issue</description>
    </link>
    <link>
      <url>https://doi.org/10.1038/s41598-021-91901-0</url>
      <description>Feasibility of a home-based foot-ankle exercise programme for musculoskeletal dysfunctions in people with diabetes: randomised controlled FOotCAre (FOCA) Trial II. Sci Rep</description>
    </link>
    <reference>
      <citation>Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.</citation>
      <PMID>15111519</PMID>
    </reference>
    <reference>
      <citation>Morrison T, Jones S, Causby RS, Thoirs K. Can ultrasound measures of intrinsic foot muscles and plantar soft tissues predict future diabetes-related foot disease? A systematic review. PLoS One. 2018 Jun 15;13(6):e0199055. doi: 10.1371/journal.pone.0199055. eCollection 2018.</citation>
      <PMID>29906277</PMID>
    </reference>
    <reference>
      <citation>MANN R, INMAN VT. PHASIC ACTIVITY OF INTRINSIC MUSCLES OF THE FOOT. J Bone Joint Surg Am. 1964 Apr;46:469-81. No abstract available.</citation>
      <PMID>14131426</PMID>
    </reference>
    <reference>
      <citation>McKeon PO, Hertel J, Bramble D, Davis I. The foot core system: a new paradigm for understanding intrinsic foot muscle function. Br J Sports Med. 2015 Mar;49(5):290. doi: 10.1136/bjsports-2013-092690. Epub 2014 Mar 21.</citation>
      <PMID>24659509</PMID>
    </reference>
    <reference>
      <citation>Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available.</citation>
      <PMID>28614678</PMID>
    </reference>
    <reference>
      <citation>Matos M, Mendes R, Silva AB, Sousa N. Physical activity and exercise on diabetic foot related outcomes: A systematic review. Diabetes Res Clin Pract. 2018 May;139:81-90. doi: 10.1016/j.diabres.2018.02.020. Epub 2018 Feb 23.</citation>
      <PMID>29477503</PMID>
    </reference>
    <reference>
      <citation>Lung CW, Wu FL, Liao F, Pu F, Fan Y, Jan YK. Emerging technologies for the prevention and management of diabetic foot ulcers. J Tissue Viability. 2020 May;29(2):61-68. doi: 10.1016/j.jtv.2020.03.003. Epub 2020 Mar 17.</citation>
      <PMID>32197948</PMID>
    </reference>
    <reference>
      <citation>Monteiro RL, Ferreira JSSP, Silva EQ, Donini A, Cruvinel-Junior RH, Verissimo JL, Bus SA, Sacco ICN. Feasibility and Preliminary Efficacy of a Foot-Ankle Exercise Program Aiming to Improve Foot-Ankle Functionality and Gait Biomechanics in People with Diabetic Neuropathy: A Randomized Controlled Trial. Sensors (Basel). 2020 Sep 9;20(18):5129. doi: 10.3390/s20185129.</citation>
      <PMID>32916792</PMID>
    </reference>
    <reference>
      <citation>Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.</citation>
      <PMID>19896746</PMID>
    </reference>
    <reference>
      <citation>Monteiro-Soares M, Russell D, Boyko EJ, Jeffcoate W, Mills JL, Morbach S, Game F; International Working Group on the Diabetic Foot (IWGDF). Guidelines on the classification of diabetic foot ulcers (IWGDF 2019). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3273. doi: 10.1002/dmrr.3273.</citation>
      <PMID>32176445</PMID>
    </reference>
    <reference>
      <citation>Boulton AJ, Armstrong DG, Albert SF, Frykberg RG, Hellman R, Kirkman MS, Lavery LA, LeMaster JW, Mills JL Sr, Mueller MJ, Sheehan P, Wukich DK. Comprehensive foot examination and risk assessment. A report of the Task Force of the Foot Care Interest Group of the American Diabetes Association, with endorsement by the American Association of Clinical Endocrinologists. Phys Ther. 2008 Nov;88(11):1436-43. doi: 10.1093/ptj/88.11.1436. No abstract available.</citation>
      <PMID>19137633</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Saglik Bilimleri Universitesi</investigator_affiliation>
      <investigator_full_name>Fatma Dilara Akar</investigator_full_name>
      <investigator_title>Research Assistant</investigator_title>
    </responsible_party>
    <keyword>diabetic foot</keyword>
    <keyword>exercise</keyword>
    <keyword>plantar pressure</keyword>
    <keyword>intrinsic mucle training</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetic Foot</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>We plan to share the method and results of our study.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>3 months</ipd_time_frame>
    </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/NCT05974020
  org study id: 22-54
  nct id: NCT05974020
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this experimental randomized controlled study is to evaluate the effectiveness of
        the exercise program to be applied to prevent foot wounds, which is one of the leading foot
        problems that develop as a result of diabetes, based on foot posture and plantar pressure
        distribution.
  
        Participants who meet the inclusion criteria and are between the ages of 18-65 will be
        randomly assigned to one of the two experimental groups or the control group.Participants
        will be assessed through surveys to evaluate their physical activity level, foot health and
        functionality, and sensory status of the feet. Measurements related to foot position and
        posture will be taken. The use of a pedobarography device will allow for the examination of
        plantar pressure distribution. Following these assessments, participants will receive general
        foot care instructions and information on appropriate footwear, along with the designated
        exercise program.
  
        During routine check-ups and treatment procedures related to diabetes, blood glucose levels
        and HbA1c values taken from participants will be analyzed by the physician before and after
        the program to make comparisons. The study is planned to last for 12 weeks, and evaluations
        will be conducted before and after the program.
  According to the literature, evaluations for preventing and treating diabetic foot ulcers
        commonly include plantar pressure measurements, and it is emphasized that methods involving
        plantar pressure technologies should be added to traditional evaluations to be more
        successful in preventing diabetic foot ulcers, even in high-risk individuals.
  
        Based on the findings from previous research, it is believed that the reduced foot intrinsic
        muscle strength, which has not been extensively examined in its relationship with other
        factors, needs to be systematically investigated for its effects on foot related measurements
        and plantar pressure. Furthermore, there seems to be insufficient information regarding
        exercise interventions focusing on foot intrinsic muscle training for preventing ulcer
        development in diabetic foot. Therefore, the aim of the study is to examine the effects of
        foot intrinsic muscle training on foot posture and plantar pressure distribution in
        individuals with diabetic foot syndrome. By elucidating these factors, it is hoped that the
        exercise protocol focusing on foot intrinsic muscle training, implemented to prevent ulcer
        formation, will contribute to the literature and reduce the burdens associated with the
        disease.
  
        Hypotheses of the study:
  
        H0: Foot intrinsic muscle training has no effect on plantar pressure in individuals with
        diabetic foot syndrome.
  
        H1: Foot intrinsic muscle training has an effect on plantar pressure in individuals with
        diabetic foot syndrome.
  
        H2: Foot intrinsic muscle training has no effect on foot posture in individuals with diabetic
        foot syndrome.
  
        H3: Foot intrinsic muscle training has an effect on foot posture in individuals with diabetic
        foot syndrome.
  
        In this study, individuals with diabetic foot syndrome between the ages of 18-65 will be
        included. The study is designed as a randomized controlled trial, and the participants will
        be divided into three groups: one control group (Group 1) and two experimental groups (Group
        2 and Group 3). The sample size was determined using the G-power program. According to the
        results obtained, it was calculated that a total of 30 individuals should be included in the
        study, with 10 participants in each group, considering a statistical power level of 82% and a
        significance level of 5%.
  
        As part of the research, investigators will gain insights into participants' foot health
        through questionnaire questions, complete observational analyses of foot and foot-related
        measurements, evaluate participants' plantar pressure distribution using pedobarographic
        analysis, and implement exercise protocols focusing on foot intrinsic muscle training.
  
        The study was designed with evaluation and treatment protocols. Demographic information and
        physical activity levels of the participants to be included in the study will be recorded.
        The measurements related to the foot will include evaluation of foot posture, goniometric
        measurements, assessment of tactile sensation, plantar pressure distribution analysis, and
        questionnaire evaluations. In addition to all these assessments, participants' blood values
        will be examined by the doctor before and after treatment.
  
        The treatment protocols consist of general foot care instructions and information about
        appropriate footwear selection, along with exercise protocols. Group 1 - Control Group
        participants will receive only general foot care instructions and education on appropriate
        footwear selection. Group 2 participants will receive general foot care instructions and
        education on appropriate footwear selection, along with an exercise protocol focusing on foot
        intrinsic muscle training. Group 3 participants will receive general foot care instructions
        and education on appropriate footwear selection, foot intrinsic muscle training, and in
        addition, an aerobic exercise protocol. The treatment protocols will be implemented for 12
        weeks, and pre- and post-treatment evaluations will be repeated to compare the results.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Plantar Pressure Distribution
  time frame: 3 months
  description: Plantar pressure distribution analysis will be performed statically and dynamically with the Baropodometric Platforms Freemed™, 120 cm (Sensor Medica, Italia) pedobarography platform and software. In order to obtain the static plantar pressure distribution parameters of the people included in the study, on the surface with a pressure gauge sensor; As soon as the pressure falling on one foot reaches the value to be determined, it will be analyzed during standing static stance.
  measure: Foot Posture
  time frame: 3 months
  description: Foot Posture Index was used to evaluate the foot posture of the individuals to be included in the study. The assessment will be made by the therapist based on observation and palpation by asking individuals to stand still in a relaxed position where they feel comfortable. The talonavicular joint of the forefoot, medial longitudinal arch, and abduction/adduction of the forefoot relative to the hindfoot will be evaluated. In the hindfoot, eversion/inversion of the head of the talus, lateral malleolus, and calcaneus will be evaluated.
  arm group label: Group 1- Control
  arm group type: Experimental
  description: Group 1 - Control Group will receive only general foot care instructions and education on appropriate footwear selection.
  arm group label: Group 2- Intrinsic Muscle Training
  arm group type: Experimental
  description: Group 2 participants will receive general foot care instructions and education on appropriate footwear selection, along with an exercise protocol focusing on foot intrinsic muscle training.
  arm group label: Group 3- Aerobic Exercise
  arm group type: Experimental
  description: Group 3 participants will receive general foot care instructions and education on appropriate footwear selection, foot intrinsic muscle training, and in addition, an aerobic exercise protocol.
  intervention type: Other
  intervention name: Control
  description: No intervention will be applied to the control group, and information will be given on general foot care instructions and the use of appropriate shoes.
  arm group label: Group 1- Control
  intervention type: Other
  intervention name: Intrinsic Muscle Training
  description: In addition to general foot care instructions and briefings on the use of appropriate shoes, intrinsic muscle training including alternating toe movement, toes picking up sheets, opening and closing the toes, pinching the toe separators, toe transitions and short foot exercises will be implemented.
  Additionaly, warm-up exercises, ankle exercises and functional exercises will be included in the program.
  arm group label: Group 2- Intrinsic Muscle Training
  intervention type: Other
  intervention name: Aerobic Exercise
  description: In addition to general foot care instructions and information on the use of appropriate shoes, warm-up exercises, ankle exercises, functional exercises and intrinsic muscle training, the participants will be given a walking program for aerobic exercise.
  arm group label: Group 3- Aerobic Exercise
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Dilara Akar
  role: Principal Investigator
  affiliation: Saglik Bilimleri University
  facility: 
  country: Turkey
  url: https://academic.oup.com/ptj/article-abstract/70/6/356/3051938
  description: . Relationship of Foot Deformity to Ulcer Location in Patients with Diabetes Mellitus
  url: http://www.ptjournal.org
  description: Epidemiology of Diabetes and Diabetes-Related Complications Diabetes Special Issue
  url: https://doi.org/10.1038/s41598-021-91901-0
  description: Feasibility of a home-based foot-ankle exercise programme for musculoskeletal dysfunctions in people with diabetes: randomised controlled FOotCAre (FOCA) Trial II. Sci Rep
  citation: Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.
  PMID: 15111519
  citation: Morrison T, Jones S, Causby RS, Thoirs K. Can ultrasound measures of intrinsic foot muscles and plantar soft tissues predict future diabetes-related foot disease? A systematic review. PLoS One. 2018 Jun 15;13(6):e0199055. doi: 10.1371/journal.pone.0199055. eCollection 2018.
  PMID: 29906277
  citation: MANN R, INMAN VT. PHASIC ACTIVITY OF INTRINSIC MUSCLES OF THE FOOT. J Bone Joint Surg Am. 1964 Apr;46:469-81. No abstract available.
  PMID: 14131426
  citation: McKeon PO, Hertel J, Bramble D, Davis I. The foot core system: a new paradigm for understanding intrinsic foot muscle function. Br J Sports Med. 2015 Mar;49(5):290. doi: 10.1136/bjsports-2013-092690. Epub 2014 Mar 21.
  PMID: 24659509
  citation: Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available.
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  PMID: 19137633
  responsible party type: Principal Investigator
  investigator affiliation: Saglik Bilimleri Universitesi
  investigator full name: Fatma Dilara Akar
  investigator title: Research Assistant
  mesh term: Diabetic Foot
  sharing ipd: Yes
  ipd description: We plan to share the method and results of our study.
  ipd info type: Study Protocol
  ipd time frame: 3 months