<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/NCT03812978</url>
  </required_header>
  <id_info>
    <org_study_id>FlexortendonsSOS2018</org_study_id>
    <nct_id>NCT03812978</nct_id>
  </id_info>
  <brief_title>Mobile Application for Improving Rehabilitation After Flexor Tendon Repair</brief_title>
  <official_title>Mobile Application for Improving Rehabilitation After Flexor Tendon Repair - A Randomized Controlled Multicenter Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</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>
      Can a mobile application improve adherence, self-efficacy and range of motion after flexor&#xD;
      tendon repair? A randomized controlled multicenter trial.&#xD;
&#xD;
      Aim Evaluate how the use of a mobile application will affect exercise adherence, range of&#xD;
      motion and self-efficacy when compared to standard rehabilitation after flexor tendon repair.&#xD;
      Method Multicenter randomized controlled trial. Patients with flexor tendon repair in zone I&#xD;
      or II were included and rehabilitated with early active motion and followed 12 weeks&#xD;
      post-surgery. Randomization was performed by a computer-generated concealed block to control&#xD;
      (n=60) or intervention group (n=60). Both groups received standard rehabilitation according&#xD;
      to early active motion. Intervention group also received a smart phone app including;&#xD;
      exercise videos, push-notifications for exercise, exercise diary, written information on the&#xD;
      surgery, rehabilitation, questions and answers. Evaluation was made at baseline, 2, 6- and&#xD;
      12-weeks after surgery. Primary outcome was physiotherapist rated adherence on the Sport&#xD;
      Injury Adherence Scale (SIRAS). Secondary outcome was self-reported adherence, perceived&#xD;
      self-efficacy, total Active range of motion (TAM) in the Proximal Interphalangeal (PIP) joint&#xD;
      and Distal Interphalangeal (DIP) joint and perceived satisfaction with rehabilitation and&#xD;
      information.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">May 10, 2019</completion_date>
  <primary_completion_date type="Actual">May 10, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sport injury adherence scale (SIRAS)</measure>
    <time_frame>assessed at 2 weeks (totalt score range 3-15, higher value indicates better outcome)</time_frame>
    <description>Physiotherapist rated adherence questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sport injury adherence scale (SIRAS)</measure>
    <time_frame>assessed at 6 weeks (totalt score range 3-15, higher value indicates better outcome)</time_frame>
    <description>Physiotherapist rated adherence questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self reported adherence</measure>
    <time_frame>assessed at 2 and 6 weeks (total score range 0-100,higher value indicates better outcome )</time_frame>
    <description>Patient rated adherence questionnaire duration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self reported adherence</measure>
    <time_frame>assessed at 2 and 6 weeks (total score range 0-100,higher value indicates better outcome )</time_frame>
    <description>Patient rated adherence questionnaire frequency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self reported adherence</measure>
    <time_frame>assessed at 2 and 6 weeks (total score range 0-100, higher value indicates better outcome)</time_frame>
    <description>Patient rated adherence questionnaire quality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Athlet injury self efficacy questionnaire (AISEQ)</measure>
    <time_frame>baseline, 2 and 6 weeks (Change over time)</time_frame>
    <description>Patient reported self efficacy for rehabilitation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion</measure>
    <time_frame>assessed at 12 weeks (range 0-240,higher value indicates better outcome )</time_frame>
    <description>Total range of motion in the proximal interphalangeal and distal interphalangeal joints measured with a finger goniometer</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Perceived satisfaction with rehabilitation</measure>
    <time_frame>at 12 weeks (range 0-100, higher value indicates better outcome)</time_frame>
    <description>questions on a Likert scale regarding satisfaction of rehabilitation. &quot;how do you perceive the rehabilitation after the operation?&quot;</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived satisfaction with information</measure>
    <time_frame>at 12 weeks (range 0-100, higher value indicates better outcome)</time_frame>
    <description>questions on a Likert scale regarding satisfaction of information: &quot;how do you perceive the information after the operation?&quot;</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Flexor Digitorum Profundus Injury</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard treatment and intervention (Smart phone application)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Smart phone application</intervention_name>
    <description>Smart phone application including exercise videos, push notifications for exercise, questions and answers, exercise diary.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18 years old,&#xD;
&#xD;
          -  Own a mobile phone, fluent in Swedish,&#xD;
&#xD;
          -  Suited for early active motion rehabilitation&#xD;
&#xD;
          -  Injury to one or both of the flexor tendons in the a finger&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  concomitant fracture in the hand&#xD;
&#xD;
          -  tendon injury to flexor pollicis longus.&#xD;
&#xD;
          -  Extensor tendon injury in the same hand.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marianne Arner, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of hand surgery, Skåne university hospital</name>
      <address>
        <city>Malmö</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of hand surgery, Södersjukshuset</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of hand surgery, Uppsala university hospital</name>
      <address>
        <city>Uppsala</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of hand surgery, University hospital Örebro</name>
      <address>
        <city>Örebro</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>August 19, 2019</last_update_submitted>
  <last_update_submitted_qc>August 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Marianne Arner</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>&quot;Flexor tendon rehabilitation&quot;</keyword>
  <keyword>&quot;Smart-phone application&quot;</keyword>
  <keyword>&quot;adherence&quot;</keyword>
  <!-- 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/NCT03812978
org study id: FlexortendonsSOS2018
nct id: NCT03812978
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Can a mobile application improve adherence, self-efficacy and range of motion after flexor
      tendon repair? A randomized controlled multicenter trial.

      Aim Evaluate how the use of a mobile application will affect exercise adherence, range of
      motion and self-efficacy when compared to standard rehabilitation after flexor tendon repair.
      Method Multicenter randomized controlled trial. Patients with flexor tendon repair in zone I
      or II were included and rehabilitated with early active motion and followed 12 weeks
      post-surgery. Randomization was performed by a computer-generated concealed block to control
      (n=60) or intervention group (n=60). Both groups received standard rehabilitation according
      to early active motion. Intervention group also received a smart phone app including;
      exercise videos, push-notifications for exercise, exercise diary, written information on the
      surgery, rehabilitation, questions and answers. Evaluation was made at baseline, 2, 6- and
      12-weeks after surgery. Primary outcome was physiotherapist rated adherence on the Sport
      Injury Adherence Scale (SIRAS). Secondary outcome was self-reported adherence, perceived
      self-efficacy, total Active range of motion (TAM) in the Proximal Interphalangeal (PIP) joint
      and Distal Interphalangeal (DIP) joint and perceived satisfaction with rehabilitation and
      information.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Sport injury adherence scale (SIRAS)
time frame: assessed at 2 weeks (totalt score range 3-15, higher value indicates better outcome)
description: Physiotherapist rated adherence questionnaire
measure: Sport injury adherence scale (SIRAS)
time frame: assessed at 6 weeks (totalt score range 3-15, higher value indicates better outcome)
description: Physiotherapist rated adherence questionnaire
measure: Self reported adherence
time frame: assessed at 2 and 6 weeks (total score range 0-100,higher value indicates better outcome )
description: Patient rated adherence questionnaire duration
measure: Self reported adherence
time frame: assessed at 2 and 6 weeks (total score range 0-100,higher value indicates better outcome )
description: Patient rated adherence questionnaire frequency
measure: Self reported adherence
time frame: assessed at 2 and 6 weeks (total score range 0-100, higher value indicates better outcome)
description: Patient rated adherence questionnaire quality
measure: Athlet injury self efficacy questionnaire (AISEQ)
time frame: baseline, 2 and 6 weeks (Change over time)
description: Patient reported self efficacy for rehabilitation
measure: Range of motion
time frame: assessed at 12 weeks (range 0-240,higher value indicates better outcome )
description: Total range of motion in the proximal interphalangeal and distal interphalangeal joints measured with a finger goniometer
measure: Perceived satisfaction with rehabilitation
time frame: at 12 weeks (range 0-100, higher value indicates better outcome)
description: questions on a Likert scale regarding satisfaction of rehabilitation. "how do you perceive the rehabilitation after the operation?"
measure: Perceived satisfaction with information
time frame: at 12 weeks (range 0-100, higher value indicates better outcome)
description: questions on a Likert scale regarding satisfaction of information: "how do you perceive the information after the operation?"
arm group label: Control
arm group type: No Intervention
description: Standard treatment
arm group label: Intervention
arm group type: Experimental
description: Standard treatment and intervention (Smart phone application)
intervention type: Other
intervention name: Smart phone application
description: Smart phone application including exercise videos, push notifications for exercise, questions and answers, exercise diary.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marianne Arner, Phd
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
facility: 
facility: 
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Marianne Arner
investigator title: Principal Investigator