<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/NCT01696162</url>
  </required_header>
  <id_info>
    <org_study_id>413</org_study_id>
    <nct_id>NCT01696162</nct_id>
  </id_info>
  <brief_title>Conventional Home Exercise Programs Versus Electronic Home Exercise Versus Artificial Intelligence &quot;Virtual Therapy&quot; for Anterior Knee Pain</brief_title>
  <official_title>Conventional Home Exercise Programs Versus Electronic Home Exercise Versus Artificial Intelligence &quot;Virtual Therapy&quot; for Anterior Knee Pain: a Prospective Randomized Comparative Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Simpletherapy</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Simpletherapy</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a clinical research trial to evaluate the efficacy of delivering exercise therapy for&#xD;
      knee pain via the Internet utilizing an algorithm designed to adjust a home exercise program&#xD;
      based on user input. The investigators hypothesize that exercise therapy can be delivered&#xD;
      safely and effectively with increased participant satisfaction compared to the current&#xD;
      standard.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The 3 and 6 week survey data evaluating efficacy of the algorithm</measure>
    <time_frame>6 months</time_frame>
    <description>Each participant will be asked at the 3, 6 and 12 week mark to fill out a survey questionnaire that evaluates their knee pain to determine if their knee pain has improved.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participant compliance</measure>
    <time_frame>6 months</time_frame>
    <description>We will ask the participant at the 3, 6 and 12 week mark questions concerning whether they enjoyed the video exercises and whether they would do them again.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>6 months</time_frame>
    <description>The screening questionnaires will be evaluated for their safety and efficacy. This will be evaluated by having followup at the 3, 6 and 12 week marks and asking if the participant had any adverse event either via phone calls or survey questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Patellofemoral Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>PDF exercise sheets</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this arm will receive a PDF sheet of 6 exercises that are commonly administered for the treatment of anterior knee pain. They will be asked to perform the exercises three times a week for 6 weeks. A questionnaire will be administered at the three, six and twelve week mark to evaluate efficacy, compliance and safety.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Limited Exercise Videos</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this arm will receive the same six exercises as provided in the PDF sheet in arm 1 in a video format. They will be asked to perform the exercises three times per week for 6 weeks.&#xD;
A questionnaire will be administered at the three, six and twelve week mark to evaluate efficacy, compliance and safety.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Algorithm based Exercise Videos</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will be provided a 6 week regimen of exercise videos for their anterior knee pain. Following each exercise session, the participant will be asked for their input concerning each exercise. The algorithm will adjust the exercise regimen for the next session based on the participants input. A questionnaire will be administered at the three, six and twelve week mark to evaluate efficacy, compliance and safety.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Algorithm based Exercise Videos</intervention_name>
    <description>The algorithm will adjust the exercises in each session based upon the participant's feedback.</description>
    <arm_group_label>Algorithm based Exercise Videos</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PDF Exercise Sheets</intervention_name>
    <description>A sheet of six exercises with descriptions on how to perform them properly</description>
    <arm_group_label>PDF exercise sheets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Limited Exercise Videos</intervention_name>
    <description>Video of 6 exercises that provide instruction on how to perform the exercises</description>
    <arm_group_label>Limited Exercise Videos</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-64 with anterior knee pain&#xD;
&#xD;
          -  Have computer access&#xD;
&#xD;
          -  Cleared for exercise by a medical professional, if not possible or a medical&#xD;
             professional on the study team over the phone and the PAR-Q (Physical Activity&#xD;
             Readiness Questionnaire)&#xD;
&#xD;
          -  Have consented to participate in the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 or &gt; 64&#xD;
&#xD;
          -  Screened as unsafe for exercise by a medical professional or the, study team and/ or&#xD;
             Screened out by the PAR-Q&#xD;
&#xD;
          -  Does not consent to the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan P Garino, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Simpletherapy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Simpletherapy</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19147</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Baker KR, Nelson ME, Felson DT, Layne JE, Sarno R, Roubenoff R. The efficacy of home based progressive strength training in older adults with knee osteoarthritis: a randomized controlled trial. J Rheumatol. 2001 Jul;28(7):1655-65.</citation>
    <PMID>11469475</PMID>
  </reference>
  <reference>
    <citation>Margolis SA, Paule RC, Ziegler RG. Ascorbic and dehydroascorbic acids measured in plasma preserved with dithiothreitol or metaphosphoric acid. Clin Chem. 1990 Oct;36(10):1750-5.</citation>
    <PMID>2208649</PMID>
  </reference>
  <reference>
    <citation>Bassett SF, Prapavessis H. Home-based physical therapy intervention with adherence-enhancing strategies versus clinic-based management for patients with ankle sprains. Phys Ther. 2007 Sep;87(9):1132-43. doi: 10.2522/ptj.20060260. Epub 2007 Jul 3.</citation>
    <PMID>17609331</PMID>
  </reference>
  <reference>
    <citation>Crossley K, Bennell K, Green S, Cowan S, McConnell J. Physical therapy for patellofemoral pain: a randomized, double-blinded, placebo-controlled trial. Am J Sports Med. 2002 Nov-Dec;30(6):857-65. doi: 10.1177/03635465020300061701.</citation>
    <PMID>12435653</PMID>
  </reference>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>September 15, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>June 15, 2014</last_update_submitted>
  <last_update_submitted_qc>June 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Knee pain</keyword>
  <keyword>Anterior knee pain</keyword>
  <keyword>Patellofemoral</keyword>
  <keyword>Patellofemoral syndrome</keyword>
  <keyword>Runners knee</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Patellofemoral Pain Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT01696162
org study id: 413
nct id: NCT01696162
lead sponsor: 
has dmc: Yes
This is a clinical research trial to evaluate the efficacy of delivering exercise therapy for
      knee pain via the Internet utilizing an algorithm designed to adjust a home exercise program
      based on user input. The investigators hypothesize that exercise therapy can be delivered
      safely and effectively with increased participant satisfaction compared to the current
      standard.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: The 3 and 6 week survey data evaluating efficacy of the algorithm
time frame: 6 months
description: Each participant will be asked at the 3, 6 and 12 week mark to fill out a survey questionnaire that evaluates their knee pain to determine if their knee pain has improved.
measure: Participant compliance
time frame: 6 months
description: We will ask the participant at the 3, 6 and 12 week mark questions concerning whether they enjoyed the video exercises and whether they would do them again.
measure: Safety
time frame: 6 months
description: The screening questionnaires will be evaluated for their safety and efficacy. This will be evaluated by having followup at the 3, 6 and 12 week marks and asking if the participant had any adverse event either via phone calls or survey questionnaire.
arm group label: PDF exercise sheets
arm group type: Active Comparator
description: Participants in this arm will receive a PDF sheet of 6 exercises that are commonly administered for the treatment of anterior knee pain. They will be asked to perform the exercises three times a week for 6 weeks. A questionnaire will be administered at the three, six and twelve week mark to evaluate efficacy, compliance and safety.
arm group label: Limited Exercise Videos
arm group type: Active Comparator
description: Participants in this arm will receive the same six exercises as provided in the PDF sheet in arm 1 in a video format. They will be asked to perform the exercises three times per week for 6 weeks.
A questionnaire will be administered at the three, six and twelve week mark to evaluate efficacy, compliance and safety.
arm group label: Algorithm based Exercise Videos
arm group type: Experimental
description: Participants in this arm will be provided a 6 week regimen of exercise videos for their anterior knee pain. Following each exercise session, the participant will be asked for their input concerning each exercise. The algorithm will adjust the exercise regimen for the next session based on the participants input. A questionnaire will be administered at the three, six and twelve week mark to evaluate efficacy, compliance and safety.
intervention type: Other
intervention name: Algorithm based Exercise Videos
description: The algorithm will adjust the exercises in each session based upon the participant's feedback.
arm group label: Algorithm based Exercise Videos
intervention type: Other
intervention name: PDF Exercise Sheets
description: A sheet of six exercises with descriptions on how to perform them properly
arm group label: PDF exercise sheets
intervention type: Other
intervention name: Limited Exercise Videos
description: Video of 6 exercises that provide instruction on how to perform the exercises
arm group label: Limited Exercise Videos
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jonathan P Garino, MD
role: Principal Investigator
affiliation: Simpletherapy
facility: 
country: United States
citation: Baker KR, Nelson ME, Felson DT, Layne JE, Sarno R, Roubenoff R. The efficacy of home based progressive strength training in older adults with knee osteoarthritis: a randomized controlled trial. J Rheumatol. 2001 Jul;28(7):1655-65.
PMID: 11469475
citation: Margolis SA, Paule RC, Ziegler RG. Ascorbic and dehydroascorbic acids measured in plasma preserved with dithiothreitol or metaphosphoric acid. Clin Chem. 1990 Oct;36(10):1750-5.
PMID: 2208649
citation: Bassett SF, Prapavessis H. Home-based physical therapy intervention with adherence-enhancing strategies versus clinic-based management for patients with ankle sprains. Phys Ther. 2007 Sep;87(9):1132-43. doi: 10.2522/ptj.20060260. Epub 2007 Jul 3.
PMID: 17609331
citation: Crossley K, Bennell K, Green S, Cowan S, McConnell J. Physical therapy for patellofemoral pain: a randomized, double-blinded, placebo-controlled trial. Am J Sports Med. 2002 Nov-Dec;30(6):857-65. doi: 10.1177/03635465020300061701.
PMID: 12435653
responsible party type: Sponsor
mesh term: Patellofemoral Pain Syndrome