<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/NCT03779958</url>
  </required_header>
  <id_info>
    <org_study_id>47777</org_study_id>
    <nct_id>NCT03779958</nct_id>
  </id_info>
  <brief_title>Alternatives to Hand Therapy for Hand Surgery Patients</brief_title>
  <official_title>Alternatives to Hand Therapy for Hand Surgery Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</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>
      Patients will be asked to use a mobile phone app to conduct their hand therapy after having&#xD;
      hand surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who are undergoing the included procedures will be informed of the study &amp;&#xD;
      consented. They will be given information on how to download the app &amp; input their surgery&#xD;
      date. The app will guide the patient through various hand therapy exercises and ask them to&#xD;
      record their QuickDASH, PSFS and VAS Pain weekly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Logistics (Research Staffing)&#xD;
  </why_stopped>
  <start_date type="Actual">January 12, 2019</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>QuickDASH</measure>
    <time_frame>once a week for 6 weeks</time_frame>
    <description>The QD is a short form of the DASH, which measures disability of the arm, shoulder and hand. it is scored 0-100, with higher scores indicating higher disability</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Specific Functional Scale</measure>
    <time_frame>once a week for 6 weeks</time_frame>
    <description>the PSFS is a validated measure of disability, that is scored on a 0-10 scale with lower scored indicating higher disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS Pain</measure>
    <time_frame>once a week for 6 weeks</time_frame>
    <description>VAS pain is a validated measure of pain, scored 0-10, with higher scores indicating higher pain</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <condition>Trigger Finger</condition>
  <condition>Ganglion Cysts</condition>
  <condition>Distal Radius Fracture</condition>
  <condition>Finger Fracture</condition>
  <condition>De Quervain Syndrome</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <description>All patients will be given information about a mobile app to use during the recovery period to assist with hand therapy activities</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mobile App</intervention_name>
    <description>a mobile app that demonstrates hand therapy exercises</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients presenting to a single hand surgery clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing the following procedures: carpal tunnel release, trigger finger&#xD;
             release, distal radius fracture fixation, de quervains release, cyst excision, finger&#xD;
             fracture fixation&#xD;
&#xD;
          -  smart phone that is compatible with the app&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robin N Kamal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford Health Care</name>
      <address>
        <city>Redwood City</city>
        <state>California</state>
        <zip>94063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 17, 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>July 30, 2021</last_update_submitted>
  <last_update_submitted_qc>July 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Robin Kamal</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ganglion Cysts</mesh_term>
    <mesh_term>Trigger Finger Disorder</mesh_term>
    <mesh_term>Carpal Tunnel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Radius Fractures</mesh_term>
    <mesh_term>Wrist Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03779958
org study id: 47777
nct id: NCT03779958
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients will be asked to use a mobile phone app to conduct their hand therapy after having
      hand surgery.
Patients who are undergoing the included procedures will be informed of the study &
      consented. They will be given information on how to download the app & input their surgery
      date. The app will guide the patient through various hand therapy exercises and ask them to
      record their QuickDASH, PSFS and VAS Pain weekly.
observational model: Cohort
time perspective: Prospective
measure: QuickDASH
time frame: once a week for 6 weeks
description: The QD is a short form of the DASH, which measures disability of the arm, shoulder and hand. it is scored 0-100, with higher scores indicating higher disability
measure: Patient Specific Functional Scale
time frame: once a week for 6 weeks
description: the PSFS is a validated measure of disability, that is scored on a 0-10 scale with lower scored indicating higher disability.
measure: VAS Pain
time frame: once a week for 6 weeks
description: VAS pain is a validated measure of pain, scored 0-10, with higher scores indicating higher pain
arm group label: Study Group
description: All patients will be given information about a mobile app to use during the recovery period to assist with hand therapy activities
intervention type: Other
intervention name: Mobile App
description: a mobile app that demonstrates hand therapy exercises
arm group label: Study Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Robin N Kamal, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Robin Kamal
investigator title: Assistant Professor
mesh term: Ganglion Cysts
mesh term: Trigger Finger Disorder
mesh term: Carpal Tunnel Syndrome
mesh term: Syndrome
mesh term: Fractures, Bone
mesh term: Radius Fractures
mesh term: Wrist Fractures
sharing ipd: No