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/NCT06033157</url>
    </required_header>
    <id_info>
      <org_study_id>ASIST-1</org_study_id>
      <nct_id>NCT06033157</nct_id>
    </id_info>
    <brief_title>Physiotherapist Supervised Training in Patients With Anterior Shoulder Instability</brief_title>
    <acronym>ASIST</acronym>
    <official_title>The Effect of Physiotherapist Supervised Training on Neuromuscular Control in Patients With Traumatic Anterior Shoulder Instability</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hvidovre University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hvidovre University Hospital</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 goal of this clinical trial is to investigate if physiotherapist supervised training&#xD;
        improves neuromuscular control in patients suffering from traumatic anterior shoulder&#xD;
        instability. The main question(s) it aims to answer are:&#xD;
  &#xD;
          -  Does physiotherapist supervised training improve shoulder neuromuscular control&#xD;
  &#xD;
          -  Does physiotherapist supervised training prevent recurring shoulder dislocations&#xD;
  &#xD;
          -  Is physiotherapist supervised training as good as surgery in improving shoulder&#xD;
             neuromuscular control Participants will be randomised to either a training group or a&#xD;
             no-training group.&#xD;
  &#xD;
        Participants in the training group will undergo a 12 week training-program supervised by a&#xD;
        physiotherapist.&#xD;
  &#xD;
        Participants in the no-training group will receive a consultation with a shoulder surgeon,&#xD;
        where information and general advice regarding the shoulder injury is provided.&#xD;
  &#xD;
        Researchers will compare the training group to the no-training group to see if&#xD;
        physiotherapist supervised training improves shoulder neuromuscular control in patients with&#xD;
        traumatic anterior shoulder instability. The training group will also be compared to a&#xD;
        historic group of patients with traumatic anterior shoulder instability, who underwent&#xD;
        arthroscopic surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        -  Aim: To investigate the effect of physiotherapist supervised training on shoulder&#xD;
             neuromuscular control, and increase understanding of traumatic anterior shoulder&#xD;
             instability.&#xD;
  &#xD;
          -  Main research questions:&#xD;
  &#xD;
        A: Is supervised training in patients with traumatic anterior shoulder instability better in&#xD;
        improving neuromuscular control, strength, apprehension and patient reported outcomes when&#xD;
        compared to no training.&#xD;
  &#xD;
        B: Is supervised training in patients with traumatic anterior shoulder instability better in&#xD;
        preventing re-dislocations and need for surgical stabilisation when compared to no training.&#xD;
  &#xD;
        C: Is supervised training in patients with traumatic anterior shoulder as good as Bankart&#xD;
        surgery in improving neuromuscular control and patient reported outcome when compared to no&#xD;
        training.&#xD;
  &#xD;
        • Objectives for research question A:&#xD;
  &#xD;
        To investigate if, in patients with traumatic anterior shoulder instability, a supervised&#xD;
        12-week training programme is better than no training in improving:&#xD;
  &#xD;
          1. Neuromuscular control&#xD;
  &#xD;
          2. Shoulder internal rotational strength&#xD;
  &#xD;
          3. Shoulder apprehension&#xD;
  &#xD;
          4. Patient reported outcomes&#xD;
  &#xD;
          5. Clinical shoulder instability Outcomes are measured at a) the end of the 12-weeks&#xD;
             intervention and b) 6 months after the beginning of the intervention. Furthermore,&#xD;
             patient reported outcomes is also measured at 1 and 2 years after the beginning of the&#xD;
             intervention.&#xD;
  &#xD;
               -  Objective for research question B:&#xD;
  &#xD;
        To investigate if, in traumatic anterior shoulder instability, a supervised 12-week training&#xD;
        programme is better than no training in preventing a) re-dislocations and b) need for&#xD;
        surgical stabilisation within the first 24 months.&#xD;
  &#xD;
        • Objectives for research question C:&#xD;
  &#xD;
        To investigate if, in patients with traumatic anterior shoulder instability, a specialised&#xD;
        12-week training programme is as good as arthroscopic Bankart surgery in improving:&#xD;
  &#xD;
          1. Neuromuscular control&#xD;
  &#xD;
          2. Shoulder internal rotational strength&#xD;
  &#xD;
          3. Shoulder apprehension&#xD;
  &#xD;
          4. Patient reported outcomes The training group is measured 6 months after the beginning of&#xD;
             the intervention and the historic Bankart surgery group is measured 6 months after the&#xD;
             surgery.&#xD;
  &#xD;
        For all objectives neuromuscular control is investigated by determining a) shoulder joint&#xD;
        position sense (JPS), b) shoulder reaction time, and c) shoulder sway length.&#xD;
  &#xD;
          -  Type of study: Pilot randomized controlled trial including 64 patients, which is&#xD;
             allocated to either training og no-training (32 patients in each group).&#xD;
  &#xD;
          -  Time schedule: Recruitment and inclusion is planned to begin September 1st 2023 and is&#xD;
             expected to last for 12-18 months. With a 2-year follow-up the complete study period is&#xD;
             expected to last 3-3,5 years.&#xD;
  &#xD;
          -  Set-up: Patients presenting with shoulder instability in the outpatient clinic at&#xD;
             Department of Orthopedic Surgery, Copenhagen University Hospital Hvidovre, will be&#xD;
             recruited for the study. Patients who have signed an informed consent form will be&#xD;
             randomised to either training- og no training-intervention and undergo examinations&#xD;
             prior to, as well as three and six months after beginning of the intervention. All&#xD;
             examinations will take place at the Copenhagen University Hospital Hvidovre. Patients in&#xD;
             the training-group will be refered to training supervised by a physiotherapist. The&#xD;
             training will take place at either Copenhagen University Hospital Hvidovre or a&#xD;
             municipal rehabilitation center in Copenhagen. All examinations will include&#xD;
             neuromuscular testing, accompanied by a clinical shoulder examination, strength measures&#xD;
             and a validated electronic questionnaires regarding shoulder-related function. A&#xD;
             pre-interventional 3D computed tomography scan will be performed to evaluate bone loss.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2027</completion_date>
    <primary_completion_date type="Anticipated">September 2025</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>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Neuromuscular control - Shouldersway</measure>
      <time_frame>Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention</time_frame>
      <description>- Shoulder sway. Measured as sway-length (in millimeter).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Clinical examination - Shoulder instability</measure>
      <time_frame>Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention</time_frame>
      <description>- Shoulder instability tests: Sulcus sign, load and shift, apprehension test, relocation test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical examination - Shoulder range of motion</measure>
      <time_frame>Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention</time_frame>
      <description>- Shoulder range of motion in flexion, extension, abduction, internal and external rotation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Strength measure</measure>
      <time_frame>Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention</time_frame>
      <description>Shoulder internal rotational strength, measured in Newton.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apprehension measure</measure>
      <time_frame>Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention</time_frame>
      <description>An assessment (in degree) of when during an external rotational movement, the patient feels apprehension.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-reported outcome measures</measure>
      <time_frame>Will be tested prior to intervention and 3, 6, 12 and 24 months after the beginning of the intervention</time_frame>
      <description>WOSI-score&#xD;
  Purpose-made questions about return to sport and work, and fear of reinjury.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Redislocations</measure>
      <time_frame>Will be tested 3, 6, 12 and 24 months after the beginning of the intervention</time_frame>
      <description>Patients will be asked on every visit, if they have sustained re-dislocation of their shoulder</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neuromuscular control - Joint Position Sense</measure>
      <time_frame>Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention</time_frame>
      <description>- Joint position sense for shoulder external rotation. Repositioning error is measured in degree.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neuromuscular control - Reaction Time</measure>
      <time_frame>Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention</time_frame>
      <description>- Reaction time. Measured as the time (in milliseconds) it takes the patient to respond to a sudden movement in the shoulder joint.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">64</enrollment>
    <condition>Shoulder Instability Subluxation Bilateral</condition>
    <arm_group>
      <arm_group_label>Training</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>A 12 week physiotherapist supervised training program</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No-training</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>A short consultation with a designated orthopedic surgeon and a folder with general advice on how to avoid further dislocations and to relieve pain from the shoulder.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Physiotherapist supervised training</intervention_name>
      <description>A 12 week physiotherapist supervised training program. The patient will receive supervision by a physiotherapist 6 times during the intervention period.&#xD;
  The patient is strongly encouraged to do the assigned training protocol at home 3 times a week. The supervised physiotherapy consists of introduction, review and progression of the assigned exercises. In addition, the patient will receive education and guidance in daily use of the arm and appropriate load on the shoulder.</description>
      <arm_group_label>Training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18-40 years.&#xD;
  &#xD;
            -  Unilateral traumatic anterior shoulder instability.&#xD;
  &#xD;
            -  Willingness to adhere to the study protocol, herein attend follow-up.&#xD;
  &#xD;
            -  Ability to speak, read, and understand Danish.&#xD;
  &#xD;
            -  Ability to give written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Instability in the opposite shoulder.&#xD;
  &#xD;
            -  Off-track lesion.&#xD;
  &#xD;
            -  For both shoulders: Former or planned surgery.&#xD;
  &#xD;
            -  For both shoulders: posterior, multi-directional or atraumatic instability.&#xD;
  &#xD;
            -  For both shoulders: traumatic rotator cuff or biceps tendon tear.&#xD;
  &#xD;
            -  For both shoulders: traumatic fracture of proximal humerus (other than Hill-Sachs&#xD;
               lesion), clavicula, scapula (other than glenoid) or dislocation of sternoclavicular or&#xD;
               acromioclavicular joints.&#xD;
  &#xD;
            -  For both shoulders: atraumatic shoulder pathologies (e.g. frozen shoulder, symptomatic&#xD;
               osteoarthritis of the shoulder or acromioclavicular joints, acute tendinitis&#xD;
               calcarean).&#xD;
  &#xD;
            -  Pregnancy.&#xD;
  &#xD;
            -  Terminal illness or severe medical illness: ASA score ≥3.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kristine R Andreasen, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Copenhagen University Hospital, Hvidovre</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Kristoffer W Barfod, MD, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Copenhagen University Hospital, Hvidovre</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Kristoffer W Barfod, MD, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Copenhagen University Hospital, Hvidovre</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kristine R Andreasen, MD</last_name>
      <phone>+45 30604373</phone>
      <email>kristine.rask.andreasen.01@regionh.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kristoffer W Barfod, MD, PhD</last_name>
      <email>kbarfod@dadlnet.dk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sports Orthopedic Research Center - Copenhagen (SORC-C), Department of Orthopedic Surgery, Copenhagen University Hospital Hvidovre</name>
        <address>
          <city>Hvidovre</city>
          <state>Capital Region</state>
          <zip>2650</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <contact>
        <last_name>Kristine R Andreasen, MD</last_name>
        <phone>+4530604373</phone>
        <email>kristine.rask.andreasen.01@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hvidovre University Hospital</investigator_affiliation>
      <investigator_full_name>Kristine Rask Andreasen</investigator_full_name>
      <investigator_title>MD</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Joint Instability</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06033157
  org study id: ASIST-1
  nct id: NCT06033157
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to investigate if physiotherapist supervised training
        improves neuromuscular control in patients suffering from traumatic anterior shoulder
        instability. The main question(s) it aims to answer are:
  
          -  Does physiotherapist supervised training improve shoulder neuromuscular control
  
          -  Does physiotherapist supervised training prevent recurring shoulder dislocations
  
          -  Is physiotherapist supervised training as good as surgery in improving shoulder
             neuromuscular control Participants will be randomised to either a training group or a
             no-training group.
  
        Participants in the training group will undergo a 12 week training-program supervised by a
        physiotherapist.
  
        Participants in the no-training group will receive a consultation with a shoulder surgeon,
        where information and general advice regarding the shoulder injury is provided.
  
        Researchers will compare the training group to the no-training group to see if
        physiotherapist supervised training improves shoulder neuromuscular control in patients with
        traumatic anterior shoulder instability. The training group will also be compared to a
        historic group of patients with traumatic anterior shoulder instability, who underwent
        arthroscopic surgery.
  -  Aim: To investigate the effect of physiotherapist supervised training on shoulder
             neuromuscular control, and increase understanding of traumatic anterior shoulder
             instability.
  
          -  Main research questions:
  
        A: Is supervised training in patients with traumatic anterior shoulder instability better in
        improving neuromuscular control, strength, apprehension and patient reported outcomes when
        compared to no training.
  
        B: Is supervised training in patients with traumatic anterior shoulder instability better in
        preventing re-dislocations and need for surgical stabilisation when compared to no training.
  
        C: Is supervised training in patients with traumatic anterior shoulder as good as Bankart
        surgery in improving neuromuscular control and patient reported outcome when compared to no
        training.
  
        • Objectives for research question A:
  
        To investigate if, in patients with traumatic anterior shoulder instability, a supervised
        12-week training programme is better than no training in improving:
  
          1. Neuromuscular control
  
          2. Shoulder internal rotational strength
  
          3. Shoulder apprehension
  
          4. Patient reported outcomes
  
          5. Clinical shoulder instability Outcomes are measured at a) the end of the 12-weeks
             intervention and b) 6 months after the beginning of the intervention. Furthermore,
             patient reported outcomes is also measured at 1 and 2 years after the beginning of the
             intervention.
  
               -  Objective for research question B:
  
        To investigate if, in traumatic anterior shoulder instability, a supervised 12-week training
        programme is better than no training in preventing a) re-dislocations and b) need for
        surgical stabilisation within the first 24 months.
  
        • Objectives for research question C:
  
        To investigate if, in patients with traumatic anterior shoulder instability, a specialised
        12-week training programme is as good as arthroscopic Bankart surgery in improving:
  
          1. Neuromuscular control
  
          2. Shoulder internal rotational strength
  
          3. Shoulder apprehension
  
          4. Patient reported outcomes The training group is measured 6 months after the beginning of
             the intervention and the historic Bankart surgery group is measured 6 months after the
             surgery.
  
        For all objectives neuromuscular control is investigated by determining a) shoulder joint
        position sense (JPS), b) shoulder reaction time, and c) shoulder sway length.
  
          -  Type of study: Pilot randomized controlled trial including 64 patients, which is
             allocated to either training og no-training (32 patients in each group).
  
          -  Time schedule: Recruitment and inclusion is planned to begin September 1st 2023 and is
             expected to last for 12-18 months. With a 2-year follow-up the complete study period is
             expected to last 3-3,5 years.
  
          -  Set-up: Patients presenting with shoulder instability in the outpatient clinic at
             Department of Orthopedic Surgery, Copenhagen University Hospital Hvidovre, will be
             recruited for the study. Patients who have signed an informed consent form will be
             randomised to either training- og no training-intervention and undergo examinations
             prior to, as well as three and six months after beginning of the intervention. All
             examinations will take place at the Copenhagen University Hospital Hvidovre. Patients in
             the training-group will be refered to training supervised by a physiotherapist. The
             training will take place at either Copenhagen University Hospital Hvidovre or a
             municipal rehabilitation center in Copenhagen. All examinations will include
             neuromuscular testing, accompanied by a clinical shoulder examination, strength measures
             and a validated electronic questionnaires regarding shoulder-related function. A
             pre-interventional 3D computed tomography scan will be performed to evaluate bone loss.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: Neuromuscular control - Shouldersway
  time frame: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention
  description: - Shoulder sway. Measured as sway-length (in millimeter).
  measure: Clinical examination - Shoulder instability
  time frame: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention
  description: - Shoulder instability tests: Sulcus sign, load and shift, apprehension test, relocation test.
  measure: Clinical examination - Shoulder range of motion
  time frame: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention
  description: - Shoulder range of motion in flexion, extension, abduction, internal and external rotation
  measure: Strength measure
  time frame: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention
  description: Shoulder internal rotational strength, measured in Newton.
  measure: Apprehension measure
  time frame: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention
  description: An assessment (in degree) of when during an external rotational movement, the patient feels apprehension.
  measure: Patient-reported outcome measures
  time frame: Will be tested prior to intervention and 3, 6, 12 and 24 months after the beginning of the intervention
  description: WOSI-score
  Purpose-made questions about return to sport and work, and fear of reinjury.
  measure: Redislocations
  time frame: Will be tested 3, 6, 12 and 24 months after the beginning of the intervention
  description: Patients will be asked on every visit, if they have sustained re-dislocation of their shoulder
  measure: Neuromuscular control - Joint Position Sense
  time frame: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention
  description: - Joint position sense for shoulder external rotation. Repositioning error is measured in degree.
  measure: Neuromuscular control - Reaction Time
  time frame: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention
  description: - Reaction time. Measured as the time (in milliseconds) it takes the patient to respond to a sudden movement in the shoulder joint.
  arm group label: Training
  arm group type: Active Comparator
  description: A 12 week physiotherapist supervised training program
  arm group label: No-training
  arm group type: No Intervention
  description: A short consultation with a designated orthopedic surgeon and a folder with general advice on how to avoid further dislocations and to relieve pain from the shoulder.
  intervention type: Behavioral
  intervention name: Physiotherapist supervised training
  description: A 12 week physiotherapist supervised training program. The patient will receive supervision by a physiotherapist 6 times during the intervention period.
  The patient is strongly encouraged to do the assigned training protocol at home 3 times a week. The supervised physiotherapy consists of introduction, review and progression of the assigned exercises. In addition, the patient will receive education and guidance in daily use of the arm and appropriate load on the shoulder.
  arm group label: Training
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Kristine R Andreasen, MD
  role: Principal Investigator
  affiliation: Copenhagen University Hospital, Hvidovre
  last name: Kristoffer W Barfod, MD, PhD
  role: Study Chair
  affiliation: Copenhagen University Hospital, Hvidovre
  last name: Kristoffer W Barfod, MD, PhD
  role: Study Director
  affiliation: Copenhagen University Hospital, Hvidovre
  last name: Kristine R Andreasen, MD
  phone: +45 30604373
  email: kristine.rask.andreasen.01@regionh.dk
  last name: Kristoffer W Barfod, MD, PhD
  email: kbarfod@dadlnet.dk
  facility: 
  contact: 
  country: Denmark
  responsible party type: Principal Investigator
  investigator affiliation: Hvidovre University Hospital
  investigator full name: Kristine Rask Andreasen
  investigator title: MD
  mesh term: Joint Instability
  sharing ipd: No