<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/NCT03808454</url>
  </required_header>
  <id_info>
    <org_study_id>Tri-Service General Hospital</org_study_id>
    <nct_id>NCT03808454</nct_id>
  </id_info>
  <brief_title>The Effect of Proprioception of Platelet Rich Plasma for Patients With Ankle Sprain</brief_title>
  <official_title>The Effect of Proprioception of Platelet Rich Plasma for Patients With Ankle Sprain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Defense Medical Center, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tri-Service General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Defense Medical Center, Taiwan</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Ankle sprain is a fairly common sports medicine clinic. In Taiwan at least 150,000 to 200,000&#xD;
      people will suffer from ankle sprains every years. Clinicians have been looking for ways to&#xD;
      shorten treatment time and reduce discomfort. Platelet Rich Plasma(PRP) is an endogenous&#xD;
      therapeutic technology that involved in regenerative medicine due to its potential to&#xD;
      stimulate and accelerate tissue healing. PRP can release lots of growth factors like&#xD;
      platelet-derived growth factor (PDGF),transforming Growth Factor Beta(TGF-β), vascular&#xD;
      endothelial growth factor(VEGF),Epidermal growth factor(EGF) and insulin-like growth factor&#xD;
      (IGF). Its use had been based on the theory that increased autologous platelets, that then&#xD;
      yield high concentrations of growth factors and other proteins, will lead to increased&#xD;
      healing of tendon and soft tissue on a cellular level. In addition, there is no objective&#xD;
      evaluation after treatment, so that patients can not provide effective and accurate&#xD;
      quantitative feedback. In this study, the investigators divided patients into three groups,&#xD;
      respectively, general rehabilitation therapy, autologous PRP injection therapy, autologous&#xD;
      PRP injection combined with general rehabilitation therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators divided patients into three groups, respectively, general rehabilitation&#xD;
      therapy, autologous PRP injection therapy, autologous PRP injection combined with general&#xD;
      rehabilitation therapy randomly. The investigators also use the new ankle proprioception&#xD;
      evaluation system and evaluation of clinical function after treatment. It is expected to&#xD;
      establish another feasible and rapid treatment method for ankle sprain. Combined with high&#xD;
      accuracy ankle body defect evaluation method, it is helpful to design proper treatment and&#xD;
      rehabilitation strategy in the future so as to improve the rehabilitation of limbs&#xD;
      Coordination and control capabilities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 4</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>mean of the distance of ankle movement by the force plate system</measure>
    <time_frame>10 min</time_frame>
    <description>The proprioception could be evaluated by the parameter of mean of the distance of ankle movement by the force plate system</description>
  </primary_outcome>
  <primary_outcome>
    <measure>standard error</measure>
    <time_frame>10 min</time_frame>
    <description>evaluated by the parameter of standard error of the distance of ankle movement by the force plate system</description>
  </primary_outcome>
  <primary_outcome>
    <measure>coefficient of variance</measure>
    <time_frame>10 min</time_frame>
    <description>evaluated by the parameter of coefficient of variance of the distance of ankle movement by the force plate system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time Up and Go(TUG)</measure>
    <time_frame>15 sec</time_frame>
    <description>walking ability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analogues scale (VAS )</measure>
    <time_frame>5 sec</time_frame>
    <description>pain level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AOFAS Ankle-Hindfoot score</measure>
    <time_frame>10 min</time_frame>
    <description>function of ankle and foot</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Ankle Sprain 2Nd Degree</condition>
  <condition>Ankle Sprain 3Rd Degree</condition>
  <arm_group>
    <arm_group_label>Platelet rich plasma (PRP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PRP injection only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PRP+Rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PRP injection combined with rehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rehabilitation treatment only</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PRP</intervention_name>
    <description>The investigators draw 10cc of blood and concentrate the blood to get the platelet rich plasma</description>
    <arm_group_label>Platelet rich plasma (PRP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rehabilitation</intervention_name>
    <description>strengthening ex, posture training,...</description>
    <arm_group_label>Rehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>PRP+Rehabilitation</intervention_name>
    <description>combine PRP and Rehabilitation</description>
    <arm_group_label>PRP+Rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ankle sprain within one months&#xD;
&#xD;
          -  Gr II or Gr III ankle sprain (anterior talus fibular ligament)by sonogram proved&#xD;
&#xD;
          -  MMSE≥23&#xD;
&#xD;
          -  could cooperate the examination of the test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hemianopsia or hemineglect any brain lesion such as cerebrum of cerebellum involved&#xD;
             movement&#xD;
&#xD;
          -  cancer victim&#xD;
&#xD;
          -  pregnant If needed PRP treatment&#xD;
&#xD;
          -  Liver cirrhosis&#xD;
&#xD;
          -  Platelet &lt; 150000/UL&#xD;
&#xD;
          -  Sepsis, Leukemia&#xD;
&#xD;
          -  use anti-coagulation agents&#xD;
&#xD;
          -  under hemodialysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shang-Lin Chiang, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Department of rehabiliation,TSGH, Taipei, Taiwan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shang-Lin Chiang, PhD</last_name>
    <phone>8860287923311</phone>
    <phone_ext>12677</phone_ext>
    <email>andyyy520@yahoo.com.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Liang-Hsuan Lu, Ms</last_name>
    <phone>8860287923311</phone>
    <phone_ext>17070</phone_ext>
    <email>katelinana@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tri-service General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>115</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Department of Rehabilitation</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <results_reference>
    <citation>L. Laver, M. R. Carmont, M. O. McConkey, E. Palmanovich, E. Yaacobi, G. Mann, et al.,</citation>
  </results_reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>March 17, 2023</last_update_submitted>
  <last_update_submitted_qc>March 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Defense Medical Center, Taiwan</investigator_affiliation>
    <investigator_full_name>Shang-Lin Chiang</investigator_full_name>
    <investigator_title>Director, Department of Rehabilitation</investigator_title>
  </responsible_party>
  <keyword>Platelet rich plasma, proprioception, ankle sprain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sprains and Strains</mesh_term>
    <mesh_term>Ankle Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The investigators don't want to share IPD until the investigators publish it.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03808454
org study id: Tri-Service General Hospital
nct id: NCT03808454
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Ankle sprain is a fairly common sports medicine clinic. In Taiwan at least 150,000 to 200,000
      people will suffer from ankle sprains every years. Clinicians have been looking for ways to
      shorten treatment time and reduce discomfort. Platelet Rich Plasma(PRP) is an endogenous
      therapeutic technology that involved in regenerative medicine due to its potential to
      stimulate and accelerate tissue healing. PRP can release lots of growth factors like
      platelet-derived growth factor (PDGF),transforming Growth Factor Beta(TGF-β), vascular
      endothelial growth factor(VEGF),Epidermal growth factor(EGF) and insulin-like growth factor
      (IGF). Its use had been based on the theory that increased autologous platelets, that then
      yield high concentrations of growth factors and other proteins, will lead to increased
      healing of tendon and soft tissue on a cellular level. In addition, there is no objective
      evaluation after treatment, so that patients can not provide effective and accurate
      quantitative feedback. In this study, the investigators divided patients into three groups,
      respectively, general rehabilitation therapy, autologous PRP injection therapy, autologous
      PRP injection combined with general rehabilitation therapy.
The investigators divided patients into three groups, respectively, general rehabilitation
      therapy, autologous PRP injection therapy, autologous PRP injection combined with general
      rehabilitation therapy randomly. The investigators also use the new ankle proprioception
      evaluation system and evaluation of clinical function after treatment. It is expected to
      establish another feasible and rapid treatment method for ankle sprain. Combined with high
      accuracy ankle body defect evaluation method, it is helpful to design proper treatment and
      rehabilitation strategy in the future so as to improve the rehabilitation of limbs
      Coordination and control capabilities.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: mean of the distance of ankle movement by the force plate system
time frame: 10 min
description: The proprioception could be evaluated by the parameter of mean of the distance of ankle movement by the force plate system
measure: standard error
time frame: 10 min
description: evaluated by the parameter of standard error of the distance of ankle movement by the force plate system
measure: coefficient of variance
time frame: 10 min
description: evaluated by the parameter of coefficient of variance of the distance of ankle movement by the force plate system
measure: Time Up and Go(TUG)
time frame: 15 sec
description: walking ability
measure: Visual analogues scale (VAS )
time frame: 5 sec
description: pain level
measure: AOFAS Ankle-Hindfoot score
time frame: 10 min
description: function of ankle and foot
arm group label: Platelet rich plasma (PRP)
arm group type: Experimental
description: PRP injection only
arm group label: PRP+Rehabilitation
arm group type: Experimental
description: PRP injection combined with rehabilitation
arm group label: Rehabilitation
arm group type: Active Comparator
description: Rehabilitation treatment only
intervention type: Drug
intervention name: PRP
description: The investigators draw 10cc of blood and concentrate the blood to get the platelet rich plasma
arm group label: Platelet rich plasma (PRP)
intervention type: Other
intervention name: Rehabilitation
description: strengthening ex, posture training,...
arm group label: Rehabilitation
intervention type: Combination Product
intervention name: PRP+Rehabilitation
description: combine PRP and Rehabilitation
arm group label: PRP+Rehabilitation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Shang-Lin Chiang, PhD
role: Study Director
affiliation: Department of rehabiliation,TSGH, Taipei, Taiwan
last name: Shang-Lin Chiang, PhD
phone: 8860287923311
phone ext: 12677
email: andyyy520@yahoo.com.tw
last name: Liang-Hsuan Lu, Ms
phone: 8860287923311
phone ext: 17070
email: katelinana@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
citation: L. Laver, M. R. Carmont, M. O. McConkey, E. Palmanovich, E. Yaacobi, G. Mann, et al.,
responsible party type: Principal Investigator
investigator affiliation: National Defense Medical Center, Taiwan
investigator full name: Shang-Lin Chiang
investigator title: Director, Department of Rehabilitation
mesh term: Sprains and Strains
mesh term: Ankle Injuries
sharing ipd: No
ipd description: The investigators don't want to share IPD until the investigators publish it.