<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/NCT03779425</url>
  </required_header>
  <id_info>
    <org_study_id>D19021</org_study_id>
    <nct_id>NCT03779425</nct_id>
  </id_info>
  <brief_title>VR-Based Physical Therapy Pilot Study</brief_title>
  <acronym>VR-PT</acronym>
  <official_title>VR-Based Physical Therapy Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KairosXR</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AO North America</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the feasibility and acceptability of using the&#xD;
      virtual reality-based physical therapy platform in patients with extremity fracture.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 9, 2019</start_date>
  <completion_date type="Actual">December 20, 2019</completion_date>
  <primary_completion_date type="Actual">December 20, 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>Patient satisfaction</measure>
    <time_frame>Assessed directly after virtual reality physical therapy session</time_frame>
    <description>Patient satisfaction with the virtual reality based physical therapy platform. Patient satisfaction will be assessed using a questionnaire created for this study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Preference</measure>
    <time_frame>Assessed directly after virtual reality physical therapy session</time_frame>
    <description>Patient preference for virtual reality-based physical therapy when compared to standard supervised office based physical therapy. Patient preference will be assessed using a questionnaire created for this study.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Extremity Fracture Lower</condition>
  <arm_group>
    <arm_group_label>Virtual Reality Physical Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will undergo a non-weight bearing knee range of motion virtual reality physical therapy session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Virtual Reality Physical Therapy</intervention_name>
    <description>Participants will undergo a non-weight bearing knee range of motion virtual reality physical therapy session.</description>
    <arm_group_label>Virtual Reality Physical Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-65 years old&#xD;
&#xD;
          -  Diagnosed with an operative fracture of the femur and/or tibia&#xD;
&#xD;
          -  referred to physical therapy as standard of care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Injury Severity Score(ISS) &gt; 18&#xD;
&#xD;
          -  bilateral lower extremity injuries that preclude crutch ambulation&#xD;
&#xD;
          -  associated spine fractures&#xD;
&#xD;
          -  Glasgow Coma scale (GCS) &lt; 15 at time of discharge&#xD;
&#xD;
          -  major peripheral nerve injury&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ida L Gitajn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dartmouth-Hitchcock Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03766</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>January 27, 2020</last_update_submitted>
  <last_update_submitted_qc>January 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
    <investigator_full_name>Ida Leah Gitajn</investigator_full_name>
    <investigator_title>Staff Physician</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03779425
org study id: D19021
nct id: NCT03779425
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the feasibility and acceptability of using the
      virtual reality-based physical therapy platform in patients with extremity fracture.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patient satisfaction
time frame: Assessed directly after virtual reality physical therapy session
description: Patient satisfaction with the virtual reality based physical therapy platform. Patient satisfaction will be assessed using a questionnaire created for this study.
measure: Patient Preference
time frame: Assessed directly after virtual reality physical therapy session
description: Patient preference for virtual reality-based physical therapy when compared to standard supervised office based physical therapy. Patient preference will be assessed using a questionnaire created for this study.
arm group label: Virtual Reality Physical Therapy
arm group type: Experimental
description: Participants will undergo a non-weight bearing knee range of motion virtual reality physical therapy session.
intervention type: Other
intervention name: Virtual Reality Physical Therapy
description: Participants will undergo a non-weight bearing knee range of motion virtual reality physical therapy session.
arm group label: Virtual Reality Physical Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ida L Gitajn, MD
role: Principal Investigator
affiliation: Dartmouth-Hitchcock Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: Ida Leah Gitajn
investigator title: Staff Physician