<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/NCT03798483</url>
  </required_header>
  <id_info>
    <org_study_id>MRes/18-19/04/2</org_study_id>
    <secondary_id>251913</secondary_id>
    <nct_id>NCT03798483</nct_id>
  </id_info>
  <brief_title>INDividualised EXercise for Kneecap Dislocations</brief_title>
  <acronym>INDEX-KD</acronym>
  <official_title>Individualised Exercise for Adults With an Acute Lateral Patellar Dislocation: a Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>City, University of London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oxford University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>City, University of London</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>
      This study is a feasibility study. It will assess areas of uncertainty relating to the&#xD;
      implementation of an individualised exercise programme for patients with a recent kneecap&#xD;
      dislocation. This will help determine if a future larger study is feasible, and inform the&#xD;
      design and conduct of future research that would aim to optimise outcomes after a kneecap&#xD;
      dislocation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators aim to recruit 15 adult participants with a recent, first-time or recurrent&#xD;
      kneecap dislocation, from an acute hospital. Participants will receive up to 6 physiotherapy&#xD;
      sessions over 3 months. The investigator's exercise programme aims to improve leg muscle&#xD;
      strength and facilitate a return to the participant's usual activities. This may include&#xD;
      activities such as hopping and changing direction which differentiates it from other&#xD;
      programmes. Participants will be required to perform the exercise programme 3 times a week&#xD;
      independently. Strategies to increase adherence to the exercise programme will also be used.&#xD;
      This study is part of a Masters in Clinical Research funded by the National Institute for&#xD;
      Health Research&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 24, 2019</start_date>
  <completion_date type="Actual">October 15, 2019</completion_date>
  <primary_completion_date type="Actual">October 8, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Eligibility Rate</measure>
    <time_frame>15 weeks</time_frame>
    <description>Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recruitment Rate</measure>
    <time_frame>15 weeks</time_frame>
    <description>Percentage of eligible participants who consented to participate in the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Attrition</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability [Participant Satisfaction]: Questionnaire</measure>
    <time_frame>12 weeks</time_frame>
    <description>Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percentage (0-100%) of scheduled physiotherapy sessions attended</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale]</measure>
    <time_frame>12 weeks</time_frame>
    <description>Participant response at follow-up to the question 'how often did you perform your exercises at least three times a week?' using a five-point Likert scale (0-4) anchored at 'always' (0) and 'never' (4)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability of Outcome Data Collection</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percentage (0-100%) of questions completed in the following patient-reported outcome measures: Lysholm Knee Scoring Scale, Tegner Activity Scale, EQ-5D-5L, completed at baseline and returned at 3-month follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Related Adverse Events Experienced by Participants</measure>
    <time_frame>Through 12 weeks after first physiotherapy session</time_frame>
    <description>The total number and type of treatment related adverse events experienced by participants will be recorded. This will be recorded from commencement of the intervention to 12 week follow-up. Treatment related adverse events will be recorded by physiotherapists at each physiotherapy session and by participant self report at 12 week follow up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria</measure>
    <time_frame>Baseline</time_frame>
    <description>Following diagnosis of a lateral patellar dislocation by an orthopaedic surgeon or physiotherapist, the clinician will be asked which of the following proposed assessment findings to include in the eligibility criteria for future studies, were present/absent during their clinical examination: positive patella apprehension test, visible knee joint effusion or haemarthrosis, medial patellofemoral ligament tenderness on palpation, and a convincing patient history of a visible deformity on the lateral aspect of the knee or a sensation of the patella 'popping' out of joint followed by spontaneous reduction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tegner Activity Scale Questionnaire</measure>
    <time_frame>12 weeks</time_frame>
    <description>This measures activity on a scale from 0-10, with higher scores indicating higher activity. It will be administered as a patient completed questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lyhsolm Knee Scoring Scale Questionnaire</measure>
    <time_frame>12 Weeks</time_frame>
    <description>It is scored from 0-100 with lower scores indicating higher pain and disability. It will be administered as a patient completed questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Using the EQ-5D-5L Questionnaire</measure>
    <time_frame>12 weeks</time_frame>
    <description>This assess quality of life using 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depress, each containing 5 options. These domains are combined to give a single score ranging from -0.594 to 1 for UK populations, with higher scores indicating higher quality of life. Participants rate their overall health on a visual analogue scale from 0 (worst health you can imagine) to 100 (the best help you can imagine). It will be administered as a patient completed questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy]</measure>
    <time_frame>From date of injury until date of the first physiotherapy session, assessed up to 6 weeks</time_frame>
    <description>Treatment logs will be analysed to record the duration (number of days) from injury to commencing the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess Delivery of the Intervention [Number of Physiotherapy Sessions Received by Participants]</measure>
    <time_frame>12 weeks</time_frame>
    <description>Treatment logs will be analysed to assess the number of physiotherapy sessions received by participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess Delivery of the Intervention [Duration of Intervention]</measure>
    <time_frame>12 weeks</time_frame>
    <description>Treatment logs will be analysed to assess the duration (days) of the study intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists]</measure>
    <time_frame>12 weeks</time_frame>
    <description>Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists]</measure>
    <time_frame>12 weeks</time_frame>
    <description>Treatment logs will be analysed to assess the dose of exercise prescribed by physiotherapists to participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess Delivery of the Intervention [Initial Injury Management]</measure>
    <time_frame>From date of review by trauma and orthopaedic team until date of the first physiotherapy session, assessed up to 6 weeks</time_frame>
    <description>Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Patella Dislocation</condition>
  <condition>Patella Dislocation Recurrent</condition>
  <arm_group>
    <arm_group_label>Individualized exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants after a lateral kneecap dislocation will be enrolled into an individualized exercise intervention supervised by a physiotherapist</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Individualised exercise</intervention_name>
    <description>The intervention will be comprised of up to 6, one-to-one physiotherapy sessions, over a maximum duration of 3 months. 1 or 2 extra sessions are allowed if deemed essential by the participant's physiotherapist. Less than 6 physiotherapy sessions can be agreed with the participant if they have achieved their goals. Throughout this time participants will be required to perform an exercise programme a minimum of 3 times per week. The exercise programme aims to increase leg muscle strength and facilitate a return to the participant's usual activities. It may include hopping and change of direction tasks if these are activities the participant would normally do. Behavioural change techniques to increase participant adherence to the exercise programme will also be used.</description>
    <arm_group_label>Individualized exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First time or recurrent lateral patella dislocation meeting the diagnostic criteria of&#xD;
             1) requiring reduction by paramedics or 2) diagnosed by a member of the trauma and&#xD;
             orthopaedic team.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent anterior cruciate ligament or posterior cruciate ligament injury confirmed&#xD;
             by negative Lachman's and posterior drawer test or confirmed by Magnetic Resonance&#xD;
             Imagery (MRI); medial collateral and lateral collateral ligament injury requiring&#xD;
             application of a hinged knee brace or surgical repair; concomitant injury that would&#xD;
             prohibit participation in the exercise intervention&#xD;
&#xD;
          -  &gt; 4 weeks from injury to presentation to acute care (ED or trauma services)&#xD;
&#xD;
          -  Unable to give written informed consent&#xD;
&#xD;
          -  Previous surgery on the affected knee&#xD;
&#xD;
          -  Presence of fracture on plain radiograph including osteochondral fractures&#xD;
&#xD;
          -  Medial patellar dislocation&#xD;
&#xD;
          -  Considered inappropriate for referral to physiotherapy (by member of trauma and&#xD;
             orthopaedic team assessing the patient)&#xD;
&#xD;
          -  History of severe neuromuscular or congenital disorders&#xD;
&#xD;
          -  Patients referred for orthopaedic opinion who are subsequently listed for surgery&#xD;
             prior to completion of the study intervention&#xD;
&#xD;
          -  Unable to understand written or spoken English&#xD;
&#xD;
          -  Unable to attend physiotherapy sessions at the John Radcliffe trauma outpatient&#xD;
             physiotherapy department&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Haddad, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>City, University of London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>John Radcliffe Hospital</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <results_first_submitted>November 9, 2020</results_first_submitted>
  <results_first_submitted_qc>January 12, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 1, 2021</results_first_posted>
  <last_update_submitted>January 12, 2021</last_update_submitted>
  <last_update_submitted_qc>January 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Dislocations</mesh_term>
    <mesh_term>Patellar Dislocation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT03798483/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Individualized Exercise</title>
          <description>Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist&#xD;
Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Returned All Follow-up Outcome Data</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Individualized Exercise</title>
          <description>Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist&#xD;
Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22" lower_limit="19" upper_limit="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ethnicity</title>
              <category_list>
                <category>
                  <title>White British</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>meters</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.75" lower_limit="1.62" upper_limit="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>Kilograms</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.9" lower_limit="64" upper_limit="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Secondary education</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Higher professional or University education</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Employment status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Employed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Student</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration from injury to eligibility assessment</title>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2" lower_limit="1" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Previous ipsilateral patellar dislocation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of previous ipsilateral patellar dislocations</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5-6</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Previous contralateral patellar dislocation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of previous contralateral patellar dislocations (number of participants)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;10</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Family history of patellar dislocation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Eligibility Rate</title>
        <description>Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria</description>
        <time_frame>15 weeks</time_frame>
        <population>These were patients with a clinically diagnosed lateral patellar dislocation who underwent an eligibility assessment</population>
        <group_list>
          <group group_id="O1">
            <title>Patients With a Diagnosed Lateral Patellar Dislocation</title>
            <description>Patients with a clinically diagnosed lateral patellar dislocation</description>
          </group>
        </group_list>
        <measure>
          <title>Eligibility Rate</title>
          <description>Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria</description>
          <population>These were patients with a clinically diagnosed lateral patellar dislocation who underwent an eligibility assessment</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Recruitment Rate</title>
        <description>Percentage of eligible participants who consented to participate in the study</description>
        <time_frame>15 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Individualized Exercise</title>
            <description>Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist&#xD;
Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used.</description>
          </group>
        </group_list>
        <measure>
          <title>Recruitment Rate</title>
          <description>Percentage of eligible participants who consented to participate in the study</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Attrition</title>
        <description>Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Individualized Exercise</title>
            <description>Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist&#xD;
Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used.</description>
          </group>
        </group_list>
        <measure>
          <title>Attrition</title>
          <description>Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Acceptability [Participant Satisfaction]: Questionnaire</title>
        <description>Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Completed and Returned Follow-up Outcome Data</title>
            <description>11/15 participants completed and returned all follow-up data. The results represents outcome data from these eleven participants</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability [Participant Satisfaction]: Questionnaire</title>
          <description>Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>How satisfied are you with the effect of your physiotherapy treatment?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How satisfied are you with your involvement in decision making about your physiotherapy treatment?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How satisfied were you with up to six physiotherapy sessions over three months after your injury?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How satisfied were you with the written information you were given describing the study?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How satisfied were you with the written information you were given about your injury?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How satisfied are you overall with the physiotherapy care you received after your injury?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How confident are you that you can return to all your normal activities?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How did doing your exercises fit into your weekly routine?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How confident are you that you were doing your exercises the way your physiotherapist showed you?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How confident are you that you understood how tiring the muscle strengthening exercises should feel?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How likely are you to continue your exercises now your physiotherapy is finished?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Adherence</title>
        <description>Percentage (0-100%) of scheduled physiotherapy sessions attended</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Individualized Exercise</title>
            <description>Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist&#xD;
Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used.</description>
          </group>
        </group_list>
        <measure>
          <title>Adherence</title>
          <description>Percentage (0-100%) of scheduled physiotherapy sessions attended</description>
          <units>Scheduled physiotherapy sessions</units>
          <param>Count of Units</param>
          <units_analyzed>Scheduled physiotherapy sessions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Scheduled physiotherapy sessions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale]</title>
        <description>Participant response at follow-up to the question 'how often did you perform your exercises at least three times a week?' using a five-point Likert scale (0-4) anchored at 'always' (0) and 'never' (4)</description>
        <time_frame>12 weeks</time_frame>
        <population>11/15 participants completed and returned data for this outcome</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Completed and Returned Follow-up Outcome Data</title>
            <description>11/15 participants completed and returned all follow-up data. The results represents outcome data from these eleven participants</description>
          </group>
        </group_list>
        <measure>
          <title>Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale]</title>
          <description>Participant response at follow-up to the question 'how often did you perform your exercises at least three times a week?' using a five-point Likert scale (0-4) anchored at 'always' (0) and 'never' (4)</description>
          <population>11/15 participants completed and returned data for this outcome</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>'Always'</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>'Often'</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>'Sometimes'</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acceptability of Outcome Data Collection</title>
        <description>Percentage (0-100%) of questions completed in the following patient-reported outcome measures: Lysholm Knee Scoring Scale, Tegner Activity Scale, EQ-5D-5L, completed at baseline and returned at 3-month follow-up</description>
        <time_frame>12 weeks</time_frame>
        <population>15 participants completed baseline patient-reported outcome measures and 11 participants completed all patient-reported outcome measures at 3-month follow-up and returned by post. Analysed data refers only to these participants.&#xD;
Lysholm Knee Scoring Scale outcome data was obtained for 2 participants by phone at 3-month follow-up, so they are not included in analysed data</population>
        <group_list>
          <group group_id="O1">
            <title>Individualized Exercise</title>
            <description>Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist&#xD;
Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used.</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability of Outcome Data Collection</title>
          <description>Percentage (0-100%) of questions completed in the following patient-reported outcome measures: Lysholm Knee Scoring Scale, Tegner Activity Scale, EQ-5D-5L, completed at baseline and returned at 3-month follow-up</description>
          <population>15 participants completed baseline patient-reported outcome measures and 11 participants completed all patient-reported outcome measures at 3-month follow-up and returned by post. Analysed data refers only to these participants.&#xD;
Lysholm Knee Scoring Scale outcome data was obtained for 2 participants by phone at 3-month follow-up, so they are not included in analysed data</population>
          <units>percentage of questions</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Lysholm Knee Scoring Scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Tegner Activity Scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline EQ-5D-5L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up Lysholm Knee Scoring Scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up Tegner Activity Scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up EQ-5D-5L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment Related Adverse Events Experienced by Participants</title>
        <description>The total number and type of treatment related adverse events experienced by participants will be recorded. This will be recorded from commencement of the intervention to 12 week follow-up. Treatment related adverse events will be recorded by physiotherapists at each physiotherapy session and by participant self report at 12 week follow up.</description>
        <time_frame>Through 12 weeks after first physiotherapy session</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Individualized Exercise</title>
            <description>Participants after a lateral kneecap dislocation will be enrolled into an individualized exercise intervention supervised by a physiotherapist&#xD;
Individualised exercise: The intervention will be comprised of up to 6, one-to-one physiotherapy sessions, over a maximum duration of 3 months. 1 or 2 extra sessions are allowed if deemed essential by the participant's physiotherapist. Less than 6 physiotherapy sessions can be agreed with the participant if they have achieved their goals. Throughout this time participants will be required to perform an exercise programme a minimum of 3 times per week. The exercise programme aims to increase leg muscle strength and facilitate a return to the participant's usual activities. It may include hopping and change of direction tasks if these are activities the participant would normally do. Behavioural change techniques to increase participant adherence to the exercise programme will also be used.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Related Adverse Events Experienced by Participants</title>
          <description>The total number and type of treatment related adverse events experienced by participants will be recorded. This will be recorded from commencement of the intervention to 12 week follow-up. Treatment related adverse events will be recorded by physiotherapists at each physiotherapy session and by participant self report at 12 week follow up.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>knee pain or swelling after completing prescribed exercises that lasted &gt;1 week</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Recurrent patella dislocation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No treatment related adverse event</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria</title>
        <description>Following diagnosis of a lateral patellar dislocation by an orthopaedic surgeon or physiotherapist, the clinician will be asked which of the following proposed assessment findings to include in the eligibility criteria for future studies, were present/absent during their clinical examination: positive patella apprehension test, visible knee joint effusion or haemarthrosis, medial patellofemoral ligament tenderness on palpation, and a convincing patient history of a visible deformity on the lateral aspect of the knee or a sensation of the patella 'popping' out of joint followed by spontaneous reduction</description>
        <time_frame>Baseline</time_frame>
        <population>15 participants were assessed for all the clinical findings below, except for the patella apprehension test which was only assessed in 13 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Patients With a Diagnosed Lateral Patellar Dislocation</title>
            <description>Patients with a clinically diagnosed lateral patellar dislocation</description>
          </group>
        </group_list>
        <measure>
          <title>Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria</title>
          <description>Following diagnosis of a lateral patellar dislocation by an orthopaedic surgeon or physiotherapist, the clinician will be asked which of the following proposed assessment findings to include in the eligibility criteria for future studies, were present/absent during their clinical examination: positive patella apprehension test, visible knee joint effusion or haemarthrosis, medial patellofemoral ligament tenderness on palpation, and a convincing patient history of a visible deformity on the lateral aspect of the knee or a sensation of the patella 'popping' out of joint followed by spontaneous reduction</description>
          <population>15 participants were assessed for all the clinical findings below, except for the patella apprehension test which was only assessed in 13 participants.</population>
          <units>percentage</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Medial patellofemoral ligament tenderness</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>convincing history of a lateral patellar dislocation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>visible knee joint effusion or haemarthrosis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>positive patella apprehension test,</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tegner Activity Scale Questionnaire</title>
        <description>This measures activity on a scale from 0-10, with higher scores indicating higher activity. It will be administered as a patient completed questionnaire.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Completed and Returned Follow-up Outcome Data</title>
            <description>11/15 participants completed and returned all follow-up data. The results represents outcome data from these eleven participants</description>
          </group>
        </group_list>
        <measure>
          <title>Tegner Activity Scale Questionnaire</title>
          <description>This measures activity on a scale from 0-10, with higher scores indicating higher activity. It will be administered as a patient completed questionnaire.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="3" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lyhsolm Knee Scoring Scale Questionnaire</title>
        <description>It is scored from 0-100 with lower scores indicating higher pain and disability. It will be administered as a patient completed questionnaire.</description>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Patients Who Returned Lysholm Knee Scoring Scale Outcome Data</title>
            <description>13 participants returned Lysholm Knee Scoring Scale data, for 2 of these participants outcome data was obtained by phone</description>
          </group>
        </group_list>
        <measure>
          <title>Lyhsolm Knee Scoring Scale Questionnaire</title>
          <description>It is scored from 0-100 with lower scores indicating higher pain and disability. It will be administered as a patient completed questionnaire.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90" lower_limit="76.5" upper_limit="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life Using the EQ-5D-5L Questionnaire</title>
        <description>This assess quality of life using 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depress, each containing 5 options. These domains are combined to give a single score ranging from -0.594 to 1 for UK populations, with higher scores indicating higher quality of life. Participants rate their overall health on a visual analogue scale from 0 (worst health you can imagine) to 100 (the best help you can imagine). It will be administered as a patient completed questionnaire.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Completed and Returned Follow-up Outcome Data</title>
            <description>11/15 participants completed and returned all follow-up data. The results represents outcome data from these eleven participants</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life Using the EQ-5D-5L Questionnaire</title>
          <description>This assess quality of life using 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depress, each containing 5 options. These domains are combined to give a single score ranging from -0.594 to 1 for UK populations, with higher scores indicating higher quality of life. Participants rate their overall health on a visual analogue scale from 0 (worst health you can imagine) to 100 (the best help you can imagine). It will be administered as a patient completed questionnaire.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Index score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.84" lower_limit="0.8" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Health on a Visual Analogue Scale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90" lower_limit="85" upper_limit="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy]</title>
        <description>Treatment logs will be analysed to record the duration (number of days) from injury to commencing the intervention</description>
        <time_frame>From date of injury until date of the first physiotherapy session, assessed up to 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Individualized Exercise</title>
            <description>Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist&#xD;
Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used.</description>
          </group>
        </group_list>
        <measure>
          <title>Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy]</title>
          <description>Treatment logs will be analysed to record the duration (number of days) from injury to commencing the intervention</description>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21" lower_limit="15" upper_limit="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assess Delivery of the Intervention [Number of Physiotherapy Sessions Received by Participants]</title>
        <description>Treatment logs will be analysed to assess the number of physiotherapy sessions received by participants</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Individualized Exercise</title>
            <description>Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist&#xD;
Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used.</description>
          </group>
        </group_list>
        <measure>
          <title>Assess Delivery of the Intervention [Number of Physiotherapy Sessions Received by Participants]</title>
          <description>Treatment logs will be analysed to assess the number of physiotherapy sessions received by participants</description>
          <units>physiotherapy sessions</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="3" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assess Delivery of the Intervention [Duration of Intervention]</title>
        <description>Treatment logs will be analysed to assess the duration (days) of the study intervention</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Individualized Exercise</title>
            <description>Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist&#xD;
Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used.</description>
          </group>
        </group_list>
        <measure>
          <title>Assess Delivery of the Intervention [Duration of Intervention]</title>
          <description>Treatment logs will be analysed to assess the duration (days) of the study intervention</description>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50" lower_limit="37" upper_limit="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists]</title>
        <description>Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Individualized Exercise</title>
            <description>Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist&#xD;
Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used.</description>
          </group>
        </group_list>
        <measure>
          <title>Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists]</title>
          <description>Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Knee flexibility exercise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trunk and leg control exercise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leg resistance exercise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Running exercise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bespoke exercise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists]</title>
        <description>Treatment logs will be analysed to assess the dose of exercise prescribed by physiotherapists to participants</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Individualized Exercise</title>
            <description>Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist&#xD;
Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used.</description>
          </group>
        </group_list>
        <measure>
          <title>Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists]</title>
          <description>Treatment logs will be analysed to assess the dose of exercise prescribed by physiotherapists to participants</description>
          <units>Prescribed leg resistance exercise</units>
          <param>Count of Units</param>
          <units_analyzed>Prescribed leg resistance exercise</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Prescribed leg resistance exercise</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Prescribed sets between 1-3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prescribed repetitions between 8-12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prescribed frequency 3 or more per week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assess Delivery of the Intervention [Initial Injury Management]</title>
        <description>Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team</description>
        <time_frame>From date of review by trauma and orthopaedic team until date of the first physiotherapy session, assessed up to 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Individualized Exercise</title>
            <description>Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist&#xD;
Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used.</description>
          </group>
        </group_list>
        <measure>
          <title>Assess Delivery of the Intervention [Initial Injury Management]</title>
          <description>Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lateral butress splint</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cricket pad splint</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hinged knee brace</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Full weight-bearing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Two elbow crutches</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No walking aids</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Knee range of movement exercises</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-weight bearing knee strengthening exercise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gait practice, balance exercises</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight-bearing knee strengthening, strengthening of unijured joints</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>through 3 months after the first physiotherapy session</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Individualized Exercise</title>
          <description>Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist&#xD;
Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Knee pain or swelling after completing prescribed exercise that last &gt;1 week</sub_title>
                <description>one participant reported knee pain or swelling after completing prescribed exercise that lasted more than 3 week on three separate occasions</description>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Recurrent patellar dislocation</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <description>One participant who was lost to follow-up was later found to have experienced a recurrent patellar dislocation after she finished the study intervention</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This study was conducted at one centre and the sample size was small. Therefore, further larger-scale feasibility testing is required to determine if a full-scale randomised controlled trial comparing physiotherapy treatments for patients after acute patellar dislocation is viable</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Colin Forde</name_or_title>
      <organization>Oxford University hospital foundation trust</organization>
      <phone>+441865221540</phone>
      <email>Colin.Forde@ouh.nhs.uk</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03798483
org study id: MRes/18-19/04/2
secondary id: 251913
nct id: NCT03798483
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a feasibility study. It will assess areas of uncertainty relating to the
      implementation of an individualised exercise programme for patients with a recent kneecap
      dislocation. This will help determine if a future larger study is feasible, and inform the
      design and conduct of future research that would aim to optimise outcomes after a kneecap
      dislocation.
The investigators aim to recruit 15 adult participants with a recent, first-time or recurrent
      kneecap dislocation, from an acute hospital. Participants will receive up to 6 physiotherapy
      sessions over 3 months. The investigator's exercise programme aims to improve leg muscle
      strength and facilitate a return to the participant's usual activities. This may include
      activities such as hopping and changing direction which differentiates it from other
      programmes. Participants will be required to perform the exercise programme 3 times a week
      independently. Strategies to increase adherence to the exercise programme will also be used.
      This study is part of a Masters in Clinical Research funded by the National Institute for
      Health Research
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Eligibility Rate
time frame: 15 weeks
description: Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria
measure: Recruitment Rate
time frame: 15 weeks
description: Percentage of eligible participants who consented to participate in the study
measure: Attrition
time frame: 12 weeks
description: Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data
measure: Acceptability [Participant Satisfaction]: Questionnaire
time frame: 12 weeks
description: Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually.
measure: Adherence
time frame: 12 weeks
description: Percentage (0-100%) of scheduled physiotherapy sessions attended
measure: Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale]
time frame: 12 weeks
description: Participant response at follow-up to the question 'how often did you perform your exercises at least three times a week?' using a five-point Likert scale (0-4) anchored at 'always' (0) and 'never' (4)
measure: Acceptability of Outcome Data Collection
time frame: 12 weeks
description: Percentage (0-100%) of questions completed in the following patient-reported outcome measures: Lysholm Knee Scoring Scale, Tegner Activity Scale, EQ-5D-5L, completed at baseline and returned at 3-month follow-up
measure: Number of Treatment Related Adverse Events Experienced by Participants
time frame: Through 12 weeks after first physiotherapy session
description: The total number and type of treatment related adverse events experienced by participants will be recorded. This will be recorded from commencement of the intervention to 12 week follow-up. Treatment related adverse events will be recorded by physiotherapists at each physiotherapy session and by participant self report at 12 week follow up.
measure: Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria
time frame: Baseline
description: Following diagnosis of a lateral patellar dislocation by an orthopaedic surgeon or physiotherapist, the clinician will be asked which of the following proposed assessment findings to include in the eligibility criteria for future studies, were present/absent during their clinical examination: positive patella apprehension test, visible knee joint effusion or haemarthrosis, medial patellofemoral ligament tenderness on palpation, and a convincing patient history of a visible deformity on the lateral aspect of the knee or a sensation of the patella 'popping' out of joint followed by spontaneous reduction
measure: Tegner Activity Scale Questionnaire
time frame: 12 weeks
description: This measures activity on a scale from 0-10, with higher scores indicating higher activity. It will be administered as a patient completed questionnaire.
measure: Lyhsolm Knee Scoring Scale Questionnaire
time frame: 12 Weeks
description: It is scored from 0-100 with lower scores indicating higher pain and disability. It will be administered as a patient completed questionnaire.
measure: Quality of Life Using the EQ-5D-5L Questionnaire
time frame: 12 weeks
description: This assess quality of life using 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depress, each containing 5 options. These domains are combined to give a single score ranging from -0.594 to 1 for UK populations, with higher scores indicating higher quality of life. Participants rate their overall health on a visual analogue scale from 0 (worst health you can imagine) to 100 (the best help you can imagine). It will be administered as a patient completed questionnaire.
measure: Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy]
time frame: From date of injury until date of the first physiotherapy session, assessed up to 6 weeks
description: Treatment logs will be analysed to record the duration (number of days) from injury to commencing the intervention
measure: Assess Delivery of the Intervention [Number of Physiotherapy Sessions Received by Participants]
time frame: 12 weeks
description: Treatment logs will be analysed to assess the number of physiotherapy sessions received by participants
measure: Assess Delivery of the Intervention [Duration of Intervention]
time frame: 12 weeks
description: Treatment logs will be analysed to assess the duration (days) of the study intervention
measure: Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists]
time frame: 12 weeks
description: Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants
measure: Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists]
time frame: 12 weeks
description: Treatment logs will be analysed to assess the dose of exercise prescribed by physiotherapists to participants
measure: Assess Delivery of the Intervention [Initial Injury Management]
time frame: From date of review by trauma and orthopaedic team until date of the first physiotherapy session, assessed up to 6 weeks
description: Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team
arm group label: Individualized exercise
arm group type: Experimental
description: Participants after a lateral kneecap dislocation will be enrolled into an individualized exercise intervention supervised by a physiotherapist
intervention type: Other
intervention name: Individualised exercise
description: The intervention will be comprised of up to 6, one-to-one physiotherapy sessions, over a maximum duration of 3 months. 1 or 2 extra sessions are allowed if deemed essential by the participant's physiotherapist. Less than 6 physiotherapy sessions can be agreed with the participant if they have achieved their goals. Throughout this time participants will be required to perform an exercise programme a minimum of 3 times per week. The exercise programme aims to increase leg muscle strength and facilitate a return to the participant's usual activities. It may include hopping and change of direction tasks if these are activities the participant would normally do. Behavioural change techniques to increase participant adherence to the exercise programme will also be used.
arm group label: Individualized exercise
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Mark Haddad, PhD
role: Principal Investigator
affiliation: City, University of London
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Joint Dislocations
mesh term: Patellar Dislocation
sharing ipd: Yes
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study was conducted at one centre and the sample size was small. Therefore, further larger-scale feasibility testing is required to determine if a full-scale randomised controlled trial comparing physiotherapy treatments for patients after acute patellar dislocation is viable
point of contact: 