<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/NCT02206542</url>
  </required_header>
  <id_info>
    <org_study_id>201311021DINB</org_study_id>
    <nct_id>NCT02206542</nct_id>
  </id_info>
  <brief_title>Scientifically Merged Acupuncture and Robot-assisted Technology (SMART) for Rehabilitation of Frozen Shoulder Syndrome: Second-year Project-Comparison of Robot and Conventional Physiotherapy (Including Preliminary Test on Healthy Volunteers)</brief_title>
  <official_title>Scientifically Merged Acupuncture and Robot-assisted Technology (SMART) for Rehabilitation of Frozen Shoulder Syndrome: Second-year Project-Comparison of Robot and Conventional Physiotherapy (Including Preliminary Test on Healthy Volunteers)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Disability of upper limbs due to neurologic and orthopedic disorder or injuries is commonly&#xD;
      seen clinically. For example paralysis or paresis of upper limb due to stroke is relatively&#xD;
      prevalent, and it may result in severe muscle weakness, pain, contracture, spasticity and&#xD;
      disability. These patients need early and regular rehabilitation to regain their function and&#xD;
      prevent unnecessary complications such as contracture and disuse atrophy. Proper&#xD;
      rehabilitation is important but the challenge is also great. However, rehabilitation training&#xD;
      is a very labor-intensive task in which one to one treatment is essential and that will&#xD;
      restrict the number of patients served. Moreover, patients receiving home programs are&#xD;
      difficult to supervise, resulting in reduced training effect and delayed functional recovery.&#xD;
      In order to reduce related cost (including time, personnel, facilities, and expense, etc.) of&#xD;
      rehabilitation in hospitals or clinics, this Robot research team had developed a prototype of&#xD;
      upper-limb exoskeleton rehabilitation robot and its related technology and human-robot&#xD;
      interaction. This robot is used to serve the rehabilitation need of those patients suffering&#xD;
      from upper extremities dysfunctions and also can provide careful designed therapeutic program&#xD;
      of upper limbs including shoulder and elbow joint exercises. Its control software also&#xD;
      provides a therapeutic management system with intelligence and ergonomic consideration. This&#xD;
      work was funded by National Taiwan University Hospital (NTUH) since 2008 and has applied for&#xD;
      both the U.S. and Taiwan (ROC) patents, where the latter has been approved in Nov. 2011. The&#xD;
      clinical trial was firstly approved by Research Ethics Committee B of NTUH in 2009 and&#xD;
      finally approved by Department of Health (DOH) in April 2011. This team had completed the&#xD;
      clinical trial for healthy subjects and pre-clinical trial for stroke patients. Based upon&#xD;
      this experience an innovative and intelligent SMART Robot Rehabilitation System for Frozen&#xD;
      Shoulder Syndrome is proposed to prove its safety, efficacy, and cost-effectiveness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disabilities of the Arm, Shoulder and Hand (DASH)</measure>
    <time_frame>One year</time_frame>
    <description>The DASH is a self-report questionnaire (30 items) that measures physical function and symptoms in people with musculoskeletal disorders of the upper limb. The questionnaire can be used to assess any or all joints in the upper limb. The questionnaire records symptoms as well as activity performance. The DASH includes two optional modules relating to Work or Sports/Performing Arts. A shorter version of the DASH, the QuickDASH is available. However, the DASH provides greater precision for monitoring individual arm pain and function and hence is recommended for use in the clinical setting.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder Pain And Disability Index (SPADI)</measure>
    <time_frame>One year</time_frame>
    <description>The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Passive and Active Range of Motion</measure>
    <time_frame>One year</time_frame>
    <description>The range of motion represents the distance (linear or angular)between the proximal and distal part of target joint.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Musculoskeletal Ultrasound</measure>
    <time_frame>One year</time_frame>
    <description>Ultrasonic evaluation of coracohumeral ligament thickness, integrity of supraspinatus tendon and subdeltoid bursa</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Adhesive Capsulitis</condition>
  <arm_group>
    <arm_group_label>Robot-assisted group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Electroacupuncture, physical therapy and upper limb rehabilitation robot</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Electroacupuncture and physical therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Upper limb rehabilitation robot</intervention_name>
    <description>Upper limb rehabilitation robot is to carry out passive shoulder joint movements including shoulder flexion, shoulder abduction, shoulder horizontal-abduction and shoulder rotation.</description>
    <arm_group_label>Robot-assisted group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical therapy</intervention_name>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Robot-assisted group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electroacupuncture</intervention_name>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Robot-assisted group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        [Healthy Volunteers]&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Age from 20 to 65 years old&#xD;
&#xD;
          2. Good physical condition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unconsciousness&#xD;
&#xD;
          2. History of stroke&#xD;
&#xD;
          3. Medical disease (Heart disease, cancer)&#xD;
&#xD;
          4. Shoulder lesions&#xD;
&#xD;
          5. Severe osteoporosis&#xD;
&#xD;
          6. Arrhythmia and with pacemaker device&#xD;
&#xD;
        [Subjects]&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Age from 20 to 65 years old&#xD;
&#xD;
          2. Diagnosis as adhesive capsulitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of humeral fracture or trauma event around shoulder girdle&#xD;
&#xD;
          2. Central nervous system disease&#xD;
&#xD;
          3. Shockwave or injection therapy at shoulder joint in past 6 months&#xD;
&#xD;
          4. History or planning for operation at shoulder girdle&#xD;
&#xD;
        Subject within our criteria will receive both examination with ultrasound and treatment,&#xD;
        however, there is some limitations for subjects who will be approved examination at&#xD;
        shoulder girdle with magnetic resonance imaging:&#xD;
&#xD;
          1. Claustrophobia&#xD;
&#xD;
          2. Metal implant (Pacemaker, artificial valve prosthesis, implantable cardioverter&#xD;
             defibrillator, nerve stimulator, in vivo drugs delivery system, intraocular implant,&#xD;
             cochlear implants, Swan-Ganz catheter, arterial clips, bullets or metal fragments)&#xD;
&#xD;
          3. Renal insufficiency (Estimated creatinine clearance &lt; 90 mL/min)&#xD;
&#xD;
          4. Pregnancy and breast milk feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin-Shin Lai, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Health Science and Wellness Center/Dept. of Physical Medicine &amp; Rehabilitation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jin-Shin Lai, Prof.</last_name>
    <phone>886-2-29251256</phone>
    <email>jslai@ntu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jin-Shin Lai, Prof.</last_name>
      <phone>886-2-29251256</phone>
      <email>jslai@ntu.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>March 3, 2015</last_update_submitted>
  <last_update_submitted_qc>March 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acupuncture,frozen shoulder,robot,sonography,MRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bursitis</mesh_term>
  </condition_browse>
  <!-- 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/NCT02206542
org study id: 201311021DINB
nct id: NCT02206542
lead sponsor: 
has dmc: No
Disability of upper limbs due to neurologic and orthopedic disorder or injuries is commonly
      seen clinically. For example paralysis or paresis of upper limb due to stroke is relatively
      prevalent, and it may result in severe muscle weakness, pain, contracture, spasticity and
      disability. These patients need early and regular rehabilitation to regain their function and
      prevent unnecessary complications such as contracture and disuse atrophy. Proper
      rehabilitation is important but the challenge is also great. However, rehabilitation training
      is a very labor-intensive task in which one to one treatment is essential and that will
      restrict the number of patients served. Moreover, patients receiving home programs are
      difficult to supervise, resulting in reduced training effect and delayed functional recovery.
      In order to reduce related cost (including time, personnel, facilities, and expense, etc.) of
      rehabilitation in hospitals or clinics, this Robot research team had developed a prototype of
      upper-limb exoskeleton rehabilitation robot and its related technology and human-robot
      interaction. This robot is used to serve the rehabilitation need of those patients suffering
      from upper extremities dysfunctions and also can provide careful designed therapeutic program
      of upper limbs including shoulder and elbow joint exercises. Its control software also
      provides a therapeutic management system with intelligence and ergonomic consideration. This
      work was funded by National Taiwan University Hospital (NTUH) since 2008 and has applied for
      both the U.S. and Taiwan (ROC) patents, where the latter has been approved in Nov. 2011. The
      clinical trial was firstly approved by Research Ethics Committee B of NTUH in 2009 and
      finally approved by Department of Health (DOH) in April 2011. This team had completed the
      clinical trial for healthy subjects and pre-clinical trial for stroke patients. Based upon
      this experience an innovative and intelligent SMART Robot Rehabilitation System for Frozen
      Shoulder Syndrome is proposed to prove its safety, efficacy, and cost-effectiveness.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
time frame: One year
description: The DASH is a self-report questionnaire (30 items) that measures physical function and symptoms in people with musculoskeletal disorders of the upper limb. The questionnaire can be used to assess any or all joints in the upper limb. The questionnaire records symptoms as well as activity performance. The DASH includes two optional modules relating to Work or Sports/Performing Arts. A shorter version of the DASH, the QuickDASH is available. However, the DASH provides greater precision for monitoring individual arm pain and function and hence is recommended for use in the clinical setting.
measure: Shoulder Pain And Disability Index (SPADI)
time frame: One year
description: The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.
measure: Passive and Active Range of Motion
time frame: One year
description: The range of motion represents the distance (linear or angular)between the proximal and distal part of target joint.
measure: Musculoskeletal Ultrasound
time frame: One year
description: Ultrasonic evaluation of coracohumeral ligament thickness, integrity of supraspinatus tendon and subdeltoid bursa
arm group label: Robot-assisted group
arm group type: Experimental
description: Electroacupuncture, physical therapy and upper limb rehabilitation robot
arm group label: Control group
arm group type: Active Comparator
description: Electroacupuncture and physical therapy
intervention type: Device
intervention name: Upper limb rehabilitation robot
description: Upper limb rehabilitation robot is to carry out passive shoulder joint movements including shoulder flexion, shoulder abduction, shoulder horizontal-abduction and shoulder rotation.
arm group label: Robot-assisted group
intervention type: Other
intervention name: Physical therapy
arm group label: Control group
arm group label: Robot-assisted group
intervention type: Device
intervention name: Electroacupuncture
arm group label: Control group
arm group label: Robot-assisted group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jin-Shin Lai, Prof.
role: Study Chair
affiliation: Health Science and Wellness Center/Dept. of Physical Medicine & Rehabilitation
last name: Jin-Shin Lai, Prof.
phone: 886-2-29251256
email: jslai@ntu.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Bursitis