xml: <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/NCT06005857</url>
    </required_header>
    <id_info>
      <org_study_id>PhysiAppHFR</org_study_id>
      <nct_id>NCT06005857</nct_id>
    </id_info>
    <brief_title>Smartphone Application to Help Rehabilitation After Palmar Plate Osteosynthesis of Distal Radius Fracture</brief_title>
    <official_title>Validation of a Smartphone Application to Enhance Hand Therapy Adherence of Patient After Palmar Plate Osteosynthesis of Distal Intra Articular Radius Fracture: A Multidisciplinary Prospective Randomized Simple-blind Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hôpital Fribourgeois</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hôpital Fribourgeois</source>
    <oversight_info>
      <has_dmc>Yes</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 aim of this study is to evaluate of the effectiveness of a Smartphone application in&#xD;
        aiding post-operative rehabilitation of an intra-articular distal radius (wrist) fracture.&#xD;
  &#xD;
        This study will focus on healthy patients operated on for isolated wrist fractures (intra&#xD;
        articular fracture of the distal radius with or without fracture of the distal ulna/cubitus)&#xD;
        using plate and screw.&#xD;
  &#xD;
        The PhysiApp application is a secure smartphone application that enables therapists to&#xD;
        transmit personalized rehabilitation exercises to patients. Its effectiveness in patients&#xD;
        undergoing surgery for intra-articular fractures of the distal radius fracture.&#xD;
  &#xD;
        The aim of our research project is to determine the effectiveness of this application for&#xD;
        patients undergoing intra-articular distal radius fracture surgery at the Cantonal Hospital&#xD;
        of Fribourg in Switzerland.&#xD;
  &#xD;
        The operation itself will be carried out in the usual way. However, rehabilitation will be&#xD;
        carried out with the help of the application, in addition to the usual follow-up by a hand&#xD;
        therapist.&#xD;
  &#xD;
        The aim is to improve wrist mobility and function.&#xD;
  &#xD;
        Once wrist surgery has been performed (plate and screw osteosynthesis), post-operative&#xD;
        rehabilitation will either take place in the company of a hand therapist, using the&#xD;
        smartphone application, or will consist solely of conventional rehabilitation by a hand&#xD;
        therapist only.&#xD;
  &#xD;
        Only the patient and the therapist will be aware of the use of the application. The follow-up&#xD;
        doctor will receive no information on the treatment methods (single-blind procedure), to&#xD;
        enhance the scientific quality of the results of this study.&#xD;
  &#xD;
        During the 3 months following the operation, wrist mobility will be measured and&#xD;
        questionnaires on wrist function will be completed by patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The smartphone application (PhysiApp) will be analyzed for patients undergoing intra&#xD;
        articular distal radius fracture treated by open reduction and internal fixation by palmar&#xD;
        plate.&#xD;
  &#xD;
        Primary endpoint: range of motion. Secondary endpoints: clinical scores (PRWE and Cooney&#xD;
        score), visual analogue scale (VAS), grip strength and patient's satisfaction.&#xD;
  &#xD;
        Inclusion criteria :&#xD;
  &#xD;
          -  Complete intra-articular DRF (classification AO 23 C1, C2 or C3)&#xD;
  &#xD;
          -  Simple palmar operative approach&#xD;
  &#xD;
          -  Simple palmar pate fixation&#xD;
  &#xD;
          -  DRUJ instability with ulnar styloid fixation needed&#xD;
  &#xD;
          -  Age 18-65 years&#xD;
  &#xD;
          -  French or German speaker&#xD;
  &#xD;
        Exclusion criteria :&#xD;
  &#xD;
          -  Extra-articular or partial-articular DRF&#xD;
  &#xD;
          -  Double/triple operative approaches needed&#xD;
  &#xD;
          -  Bilateral procedure&#xD;
  &#xD;
          -  Fracture aged than more of 2 weeks&#xD;
  &#xD;
          -  Patient refusal/no informed consent&#xD;
  &#xD;
          -  Inability to give informed consent&#xD;
  &#xD;
          -  Previous wrist injury or surgery&#xD;
  &#xD;
          -  Pregnant women&#xD;
  &#xD;
          -  Rheumatoid polyarthritis&#xD;
  &#xD;
          -  Body mass index &gt; 40kg/m2&#xD;
  &#xD;
          -  Refusal to be informed of an incidental finding that has a direct impact on health&#xD;
             status&#xD;
  &#xD;
        All patients will undergo the same operative procedure. Upon arrival to the operating room,&#xD;
        patients will be placed in supine position, the injured limb resting on a hand table.&#xD;
        Standard anesthetic axillary nerve will be applied. All the operation will do by an&#xD;
        experienced hand surgeon having minimum 5 years of post-specialization clinical experience. A&#xD;
        standard modified Henry approach will be done. The DRF will be reduced and fixed with a&#xD;
        palmar plate (Aptus Adaptive II, Medartis®). The stability of the distal radio ulnar joint&#xD;
        (DRUJ) will be tested after the radius fixation. If the DRUJ will be instable, the ulnar&#xD;
        styloid fracture will be fixed (osteo suture (PDS wire) or screw fixation (Aptus CCS 1.7/2.2,&#xD;
        Medartis®)).&#xD;
  &#xD;
        Patients will be recruited from the emergency department. After the operation, whether the&#xD;
        criteria are met and their consent obtained, patients will be announced to an independent&#xD;
        study coordinator who is responsible for allocation consignment.&#xD;
  &#xD;
        The investigator will explain to each participant the nature of the study, its purpose, the&#xD;
        procedures involved, the expected duration, the potential risks and benefits and any&#xD;
        discomfort it may entail. Each participant will be informed that the participation in the&#xD;
        study is voluntary and that he or she may withdraw from the study at any time, and that&#xD;
        withdrawal of consent will not affect his or her subsequent medical assistance and treatment.&#xD;
  &#xD;
        The participant will be informed that his or her medical records may be examined by&#xD;
        authorised individuals other than their treating physician. These medical records may also be&#xD;
        used for further research.&#xD;
  &#xD;
        All participants in the study will receive a participant information sheet and a consent form&#xD;
        describing the study and providing sufficient information for the participants to make an&#xD;
        informed decision about their participation in the study. They will have the opportunity to&#xD;
        ask questions.&#xD;
  &#xD;
        The formal consent of a participant, using the approved consent form, will be obtained before&#xD;
        the participant is submitted to any study procedure.&#xD;
  &#xD;
        The consent form will be signed and dated by the investigator or his designee at the same&#xD;
        time as the participant signs. A copy of the signed informed consent will be given to the&#xD;
        study participant. The consent form will be retained as part of the study records.&#xD;
  &#xD;
        Two to three days after surgery, participants will be addressed by the study hand therapist.&#xD;
        This therapist will randomly assign the participants by drawing lots from a sealed envelope&#xD;
        containing the study group.&#xD;
  &#xD;
        All patients will undergo the same postoperative splint immobilization (removable palmar&#xD;
        custom splint) for 6 weeks.&#xD;
  &#xD;
        Patients will be randomly assigned to receive either the test item (standard hand therapy&#xD;
        program + smartphone application) or a standard hand therapy program.&#xD;
  &#xD;
        The unblinded study hand therapist will realize the removable palmar custom splint and do the&#xD;
        rehabilitation of all patients of the 2 groups during 12 weeks. At 6, 9 and 12 weeks, the&#xD;
        hand therapist will apply the standard post operative hand rehabilitation protocol and will&#xD;
        measure ROM, clinical scores, and monitor possible adverse events.&#xD;
  &#xD;
        At 6, 9 and 12 post-operative weeks, the unblinded study hand therapist will realize photos&#xD;
        of the wrist (flexion, extension, pronation and supination). These photos will be analyzed&#xD;
        and ROM will be measure by a blinded investigator.&#xD;
  &#xD;
        At 45 and 90 days, the blinded surgeon (not aware of the therapy the patient is undergoing)&#xD;
        will research any clinical or radiological adverse events.&#xD;
  &#xD;
        The smartphone application used is &quot;PhysiApp&quot;. This application has been selected because it&#xD;
        ensures a high level of data protection. Professional videos demonstrating the required&#xD;
        exercises will be prepared by the communication department of the HFR Fribourg - Hôpital&#xD;
        cantonal, under the supervision of the study hand therapist. Patients in the group using the&#xD;
        application will install the latter on their personal phone and thus have access to the&#xD;
        exercises program. Patients will be able to manage notification alarms themselves.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2024</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>Supportive Care</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Range of motion</measure>
      <time_frame>From enrollment to the end of treatment at 3 months</time_frame>
      <description>Measurement (in degrees) of joint mobility using a goniometer</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Clinical outcomes</measure>
      <time_frame>From enrollment to the end of treatment at 3 months</time_frame>
      <description>Clinical score (Patient-Rated Wrist Evaluation) at 6 , 9 and 12 weeks after surgery.&#xD;
  The Patient-Rated Wrist Evaluation score measure the pain score of all 5 items, measure the function score of all the 10 items. The total score the sum of pain and function scores. The best score is 0 and the worst score is 100.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Distal Radius Fracture</condition>
    <arm_group>
      <arm_group_label>Group standard hand therapy program + smartphone application</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A group receive either the test item (standard hand therapy program + smartphone application).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group intervention and group control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The control group will receive a standard hand therapy program.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Standard hand therapy program + smartphone application</intervention_name>
      <description>Standard post-operative hand rehabilitation and using the smartphone application</description>
      <arm_group_label>Group standard hand therapy program + smartphone application</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Standard hand therapy program</intervention_name>
      <description>Standard post-operative hand rehabilitation alone</description>
      <arm_group_label>Group intervention and group control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Complete intra-articular DRF (classification AO 23 C1, C2 or C3)&#xD;
  &#xD;
            -  Simple palmar operative approach&#xD;
  &#xD;
            -  Simple palmar pate fixation&#xD;
  &#xD;
            -  DRUJ instability with ulnar styloid fixation needed&#xD;
  &#xD;
            -  Age 18-65 years&#xD;
  &#xD;
            -  French or German speaker&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Extra-articular or partial-articular DRF&#xD;
  &#xD;
            -  Double/triple operative approaches needed&#xD;
  &#xD;
            -  Bilateral procedure&#xD;
  &#xD;
            -  Fracture aged than more of 2 weeks&#xD;
  &#xD;
            -  Patient refusal/no informed consent&#xD;
  &#xD;
            -  Inability to give informed consent&#xD;
  &#xD;
            -  Previous wrist injury or surgery&#xD;
  &#xD;
            -  Pregnant women&#xD;
  &#xD;
            -  Rheumatoid polyarthritis&#xD;
  &#xD;
            -  Body mass index &gt; 40kg/m2&#xD;
  &#xD;
            -  Refusal to be informed of an incidental finding that has a direct impact on health&#xD;
               status&#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>Thomas TM Mészaros, MD</last_name>
      <role>Study Director</role>
      <affiliation>HFR Fribourg, Hôpital Cantonal</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Daniel DE Estoppey</last_name>
      <phone>0041 79 472 62 57</phone>
      <email>daniel.estoppey@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Thomas TM Mészaros, MD</last_name>
      <phone>0041 26 306 27 90</phone>
      <email>thomas.meszaros@h-fr.ch</email>
    </overall_contact_backup>
    <reference>
      <citation>Lu C, Hu Y, Xie J, Fu Q, Leigh I, Governor S, Wang G. The Use of Mobile Health Applications to Improve Patient Experience: Cross-Sectional Study in Chinese Public Hospitals. JMIR Mhealth Uhealth. 2018 May 23;6(5):e126. doi: 10.2196/mhealth.9145.</citation>
      <PMID>29792290</PMID>
    </reference>
    <reference>
      <citation>Valdes K, Gendernalik E, Hauser J, Tipton M. Use of mobile applications in hand therapy. J Hand Ther. 2020 Apr-Jun;33(2):229-234. doi: 10.1016/j.jht.2019.10.003. Epub 2020 Apr 3.</citation>
      <PMID>32253058</PMID>
    </reference>
    <reference>
      <citation>Murfin M. Know your apps: an evidence-based approach to evaluation of mobile clinical applications. J Physician Assist Educ. 2013;24(3):38-40. doi: 10.1097/01367895-201324030-00008.</citation>
      <PMID>24261171</PMID>
    </reference>
    <reference>
      <citation>Wallace S, Clark M, White J. 'It's on my iPhone': attitudes to the use of mobile computing devices in medical education, a mixed-methods study. BMJ Open. 2012 Aug 24;2(4):e001099. doi: 10.1136/bmjopen-2012-001099. Print 2012.</citation>
      <PMID>22923627</PMID>
    </reference>
    <reference>
      <citation>Lyngcoln A, Taylor N, Pizzari T, Baskus K. The relationship between adherence to hand therapy and short-term outcome after distal radius fracture. J Hand Ther. 2005 Jan-Mar;18(1):2-8; quiz 9. doi: 10.1197/j.jht.2004.10.008.</citation>
      <PMID>15674780</PMID>
    </reference>
    <reference>
      <citation>Wakefield AE, McQueen MM. The role of physiotherapy and clinical predictors of outcome after fracture of the distal radius. J Bone Joint Surg Br. 2000 Sep;82(7):972-6. doi: 10.1302/0301-620x.82b7.10377.</citation>
      <PMID>11041584</PMID>
    </reference>
    <reference>
      <citation>Brehmer JL, Husband JB. Accelerated rehabilitation compared with a standard protocol after distal radial fractures treated with volar open reduction and internal fixation: a prospective, randomized, controlled study. J Bone Joint Surg Am. 2014 Oct 1;96(19):1621-30. doi: 10.2106/JBJS.M.00860.</citation>
      <PMID>25274787</PMID>
    </reference>
    <reference>
      <citation>Kay S, McMahon M, Stiller K. An advice and exercise program has some benefits over natural recovery after distal radius fracture: a randomised trial. Aust J Physiother. 2008;54(4):253-9. doi: 10.1016/s0004-9514(08)70004-7.</citation>
      <PMID>19025505</PMID>
    </reference>
    <reference>
      <citation>Christensen OM, Kunov A, Hansen FF, Christiansen TC, Krasheninnikoff M. Occupational therapy and Colles' fractures. Int Orthop. 2001;25(1):43-5. doi: 10.1007/s002640000183.</citation>
      <PMID>11374267</PMID>
    </reference>
    <reference>
      <citation>Ezzat A, Baliga S, Carnegie C, Johnstone A. Volar locking plate fixation for distal radius fractures: Does age affect outcome? J Orthop. 2016 Feb 22;13(2):76-80. doi: 10.1016/j.jor.2016.01.001. eCollection 2016 Jun.</citation>
      <PMID>27053837</PMID>
    </reference>
    <reference>
      <citation>Mattila VM, Huttunen TT, Sillanpaa P, Niemi S, Pihlajamaki H, Kannus P. Significant change in the surgical treatment of distal radius fractures: a nationwide study between 1998 and 2008 in Finland. J Trauma. 2011 Oct;71(4):939-42; discussion 942-3. doi: 10.1097/TA.0b013e3182231af9.</citation>
      <PMID>21986738</PMID>
    </reference>
    <reference>
      <citation>Al Khudairy A, Hirpara KM, Kelly IP, Quinlan JF. Conservative treatment of the distal radius fracture using thermoplastic splint: pilot study results. Eur J Orthop Surg Traumatol. 2013 Aug;23(6):647-50. doi: 10.1007/s00590-012-1042-8. Epub 2012 Jul 14.</citation>
      <PMID>23412175</PMID>
    </reference>
    <reference>
      <citation>Jerrhag D, Englund M, Karlsson MK, Rosengren BE. Epidemiology and time trends of distal forearm fractures in adults - a study of 11.2 million person-years in Sweden. BMC Musculoskelet Disord. 2017 Jun 2;18(1):240. doi: 10.1186/s12891-017-1596-z.</citation>
      <PMID>28576135</PMID>
    </reference>
    <reference>
      <citation>Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.</citation>
      <PMID>16814787</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hôpital Fribourgeois</investigator_affiliation>
      <investigator_full_name>Estoppey Daniel</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>distal radius fracture</keyword>
    <keyword>smartphone application</keyword>
    <keyword>post-operative rehabilitation</keyword>
    <keyword>open reduction and internal fixation</keyword>
    <keyword>range of motion</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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>
      <ipd_description>Data will be secured and anonymized, and analyzed only by the principal investigator.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06005857
  org study id: PhysiAppHFR
  nct id: NCT06005857
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate of the effectiveness of a Smartphone application in
        aiding post-operative rehabilitation of an intra-articular distal radius (wrist) fracture.
  
        This study will focus on healthy patients operated on for isolated wrist fractures (intra
        articular fracture of the distal radius with or without fracture of the distal ulna/cubitus)
        using plate and screw.
  
        The PhysiApp application is a secure smartphone application that enables therapists to
        transmit personalized rehabilitation exercises to patients. Its effectiveness in patients
        undergoing surgery for intra-articular fractures of the distal radius fracture.
  
        The aim of our research project is to determine the effectiveness of this application for
        patients undergoing intra-articular distal radius fracture surgery at the Cantonal Hospital
        of Fribourg in Switzerland.
  
        The operation itself will be carried out in the usual way. However, rehabilitation will be
        carried out with the help of the application, in addition to the usual follow-up by a hand
        therapist.
  
        The aim is to improve wrist mobility and function.
  
        Once wrist surgery has been performed (plate and screw osteosynthesis), post-operative
        rehabilitation will either take place in the company of a hand therapist, using the
        smartphone application, or will consist solely of conventional rehabilitation by a hand
        therapist only.
  
        Only the patient and the therapist will be aware of the use of the application. The follow-up
        doctor will receive no information on the treatment methods (single-blind procedure), to
        enhance the scientific quality of the results of this study.
  
        During the 3 months following the operation, wrist mobility will be measured and
        questionnaires on wrist function will be completed by patients.
  The smartphone application (PhysiApp) will be analyzed for patients undergoing intra
        articular distal radius fracture treated by open reduction and internal fixation by palmar
        plate.
  
        Primary endpoint: range of motion. Secondary endpoints: clinical scores (PRWE and Cooney
        score), visual analogue scale (VAS), grip strength and patient's satisfaction.
  
        Inclusion criteria :
  
          -  Complete intra-articular DRF (classification AO 23 C1, C2 or C3)
  
          -  Simple palmar operative approach
  
          -  Simple palmar pate fixation
  
          -  DRUJ instability with ulnar styloid fixation needed
  
          -  Age 18-65 years
  
          -  French or German speaker
  
        Exclusion criteria :
  
          -  Extra-articular or partial-articular DRF
  
          -  Double/triple operative approaches needed
  
          -  Bilateral procedure
  
          -  Fracture aged than more of 2 weeks
  
          -  Patient refusal/no informed consent
  
          -  Inability to give informed consent
  
          -  Previous wrist injury or surgery
  
          -  Pregnant women
  
          -  Rheumatoid polyarthritis
  
          -  Body mass index > 40kg/m2
  
          -  Refusal to be informed of an incidental finding that has a direct impact on health
             status
  
        All patients will undergo the same operative procedure. Upon arrival to the operating room,
        patients will be placed in supine position, the injured limb resting on a hand table.
        Standard anesthetic axillary nerve will be applied. All the operation will do by an
        experienced hand surgeon having minimum 5 years of post-specialization clinical experience. A
        standard modified Henry approach will be done. The DRF will be reduced and fixed with a
        palmar plate (Aptus Adaptive II, Medartis®). The stability of the distal radio ulnar joint
        (DRUJ) will be tested after the radius fixation. If the DRUJ will be instable, the ulnar
        styloid fracture will be fixed (osteo suture (PDS wire) or screw fixation (Aptus CCS 1.7/2.2,
        Medartis®)).
  
        Patients will be recruited from the emergency department. After the operation, whether the
        criteria are met and their consent obtained, patients will be announced to an independent
        study coordinator who is responsible for allocation consignment.
  
        The investigator will explain to each participant the nature of the study, its purpose, the
        procedures involved, the expected duration, the potential risks and benefits and any
        discomfort it may entail. Each participant will be informed that the participation in the
        study is voluntary and that he or she may withdraw from the study at any time, and that
        withdrawal of consent will not affect his or her subsequent medical assistance and treatment.
  
        The participant will be informed that his or her medical records may be examined by
        authorised individuals other than their treating physician. These medical records may also be
        used for further research.
  
        All participants in the study will receive a participant information sheet and a consent form
        describing the study and providing sufficient information for the participants to make an
        informed decision about their participation in the study. They will have the opportunity to
        ask questions.
  
        The formal consent of a participant, using the approved consent form, will be obtained before
        the participant is submitted to any study procedure.
  
        The consent form will be signed and dated by the investigator or his designee at the same
        time as the participant signs. A copy of the signed informed consent will be given to the
        study participant. The consent form will be retained as part of the study records.
  
        Two to three days after surgery, participants will be addressed by the study hand therapist.
        This therapist will randomly assign the participants by drawing lots from a sealed envelope
        containing the study group.
  
        All patients will undergo the same postoperative splint immobilization (removable palmar
        custom splint) for 6 weeks.
  
        Patients will be randomly assigned to receive either the test item (standard hand therapy
        program + smartphone application) or a standard hand therapy program.
  
        The unblinded study hand therapist will realize the removable palmar custom splint and do the
        rehabilitation of all patients of the 2 groups during 12 weeks. At 6, 9 and 12 weeks, the
        hand therapist will apply the standard post operative hand rehabilitation protocol and will
        measure ROM, clinical scores, and monitor possible adverse events.
  
        At 6, 9 and 12 post-operative weeks, the unblinded study hand therapist will realize photos
        of the wrist (flexion, extension, pronation and supination). These photos will be analyzed
        and ROM will be measure by a blinded investigator.
  
        At 45 and 90 days, the blinded surgeon (not aware of the therapy the patient is undergoing)
        will research any clinical or radiological adverse events.
  
        The smartphone application used is "PhysiApp". This application has been selected because it
        ensures a high level of data protection. Professional videos demonstrating the required
        exercises will be prepared by the communication department of the HFR Fribourg - Hôpital
        cantonal, under the supervision of the study hand therapist. Patients in the group using the
        application will install the latter on their personal phone and thus have access to the
        exercises program. Patients will be able to manage notification alarms themselves.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  measure: Range of motion
  time frame: From enrollment to the end of treatment at 3 months
  description: Measurement (in degrees) of joint mobility using a goniometer
  measure: Clinical outcomes
  time frame: From enrollment to the end of treatment at 3 months
  description: Clinical score (Patient-Rated Wrist Evaluation) at 6 , 9 and 12 weeks after surgery.
  The Patient-Rated Wrist Evaluation score measure the pain score of all 5 items, measure the function score of all the 10 items. The total score the sum of pain and function scores. The best score is 0 and the worst score is 100.
  arm group label: Group standard hand therapy program + smartphone application
  arm group type: Experimental
  description: A group receive either the test item (standard hand therapy program + smartphone application).
  arm group label: Group intervention and group control
  arm group type: Active Comparator
  description: The control group will receive a standard hand therapy program.
  intervention type: Other
  intervention name: Standard hand therapy program + smartphone application
  description: Standard post-operative hand rehabilitation and using the smartphone application
  arm group label: Group standard hand therapy program + smartphone application
  intervention type: Other
  intervention name: Standard hand therapy program
  description: Standard post-operative hand rehabilitation alone
  arm group label: Group intervention and group control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Thomas TM Mészaros, MD
  role: Study Director
  affiliation: HFR Fribourg, Hôpital Cantonal
  last name: Daniel DE Estoppey
  phone: 0041 79 472 62 57
  email: daniel.estoppey@gmail.com
  last name: Thomas TM Mészaros, MD
  phone: 0041 26 306 27 90
  email: thomas.meszaros@h-fr.ch
  citation: Lu C, Hu Y, Xie J, Fu Q, Leigh I, Governor S, Wang G. The Use of Mobile Health Applications to Improve Patient Experience: Cross-Sectional Study in Chinese Public Hospitals. JMIR Mhealth Uhealth. 2018 May 23;6(5):e126. doi: 10.2196/mhealth.9145.
  PMID: 29792290
  citation: Valdes K, Gendernalik E, Hauser J, Tipton M. Use of mobile applications in hand therapy. J Hand Ther. 2020 Apr-Jun;33(2):229-234. doi: 10.1016/j.jht.2019.10.003. Epub 2020 Apr 3.
  PMID: 32253058
  citation: Murfin M. Know your apps: an evidence-based approach to evaluation of mobile clinical applications. J Physician Assist Educ. 2013;24(3):38-40. doi: 10.1097/01367895-201324030-00008.
  PMID: 24261171
  citation: Wallace S, Clark M, White J. 'It's on my iPhone': attitudes to the use of mobile computing devices in medical education, a mixed-methods study. BMJ Open. 2012 Aug 24;2(4):e001099. doi: 10.1136/bmjopen-2012-001099. Print 2012.
  PMID: 22923627
  citation: Lyngcoln A, Taylor N, Pizzari T, Baskus K. The relationship between adherence to hand therapy and short-term outcome after distal radius fracture. J Hand Ther. 2005 Jan-Mar;18(1):2-8; quiz 9. doi: 10.1197/j.jht.2004.10.008.
  PMID: 15674780
  citation: Wakefield AE, McQueen MM. The role of physiotherapy and clinical predictors of outcome after fracture of the distal radius. J Bone Joint Surg Br. 2000 Sep;82(7):972-6. doi: 10.1302/0301-620x.82b7.10377.
  PMID: 11041584
  citation: Brehmer JL, Husband JB. Accelerated rehabilitation compared with a standard protocol after distal radial fractures treated with volar open reduction and internal fixation: a prospective, randomized, controlled study. J Bone Joint Surg Am. 2014 Oct 1;96(19):1621-30. doi: 10.2106/JBJS.M.00860.
  PMID: 25274787
  citation: Kay S, McMahon M, Stiller K. An advice and exercise program has some benefits over natural recovery after distal radius fracture: a randomised trial. Aust J Physiother. 2008;54(4):253-9. doi: 10.1016/s0004-9514(08)70004-7.
  PMID: 19025505
  citation: Christensen OM, Kunov A, Hansen FF, Christiansen TC, Krasheninnikoff M. Occupational therapy and Colles' fractures. Int Orthop. 2001;25(1):43-5. doi: 10.1007/s002640000183.
  PMID: 11374267
  citation: Ezzat A, Baliga S, Carnegie C, Johnstone A. Volar locking plate fixation for distal radius fractures: Does age affect outcome? J Orthop. 2016 Feb 22;13(2):76-80. doi: 10.1016/j.jor.2016.01.001. eCollection 2016 Jun.
  PMID: 27053837
  citation: Mattila VM, Huttunen TT, Sillanpaa P, Niemi S, Pihlajamaki H, Kannus P. Significant change in the surgical treatment of distal radius fractures: a nationwide study between 1998 and 2008 in Finland. J Trauma. 2011 Oct;71(4):939-42; discussion 942-3. doi: 10.1097/TA.0b013e3182231af9.
  PMID: 21986738
  citation: Al Khudairy A, Hirpara KM, Kelly IP, Quinlan JF. Conservative treatment of the distal radius fracture using thermoplastic splint: pilot study results. Eur J Orthop Surg Traumatol. 2013 Aug;23(6):647-50. doi: 10.1007/s00590-012-1042-8. Epub 2012 Jul 14.
  PMID: 23412175
  citation: Jerrhag D, Englund M, Karlsson MK, Rosengren BE. Epidemiology and time trends of distal forearm fractures in adults - a study of 11.2 million person-years in Sweden. BMC Musculoskelet Disord. 2017 Jun 2;18(1):240. doi: 10.1186/s12891-017-1596-z.
  PMID: 28576135
  citation: Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.
  PMID: 16814787
  responsible party type: Principal Investigator
  investigator affiliation: Hôpital Fribourgeois
  investigator full name: Estoppey Daniel
  investigator title: Principal Investigator
  mesh term: Fractures, Bone
  mesh term: Radius Fractures
  mesh term: Wrist Fractures
  sharing ipd: No
  ipd description: Data will be secured and anonymized, and analyzed only by the principal investigator.