<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/NCT03020576</url>
  </required_header>
  <id_info>
    <org_study_id>AAAI0093</org_study_id>
    <nct_id>NCT03020576</nct_id>
  </id_info>
  <brief_title>Robotic and Conventional Hand Therapy After Stroke</brief_title>
  <official_title>Robot-assisted Hand Training (Amadeo) Compared With Conventional Physiotherapy Techniques in Chronic Ischemic Stroke Patients: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical University Innsbruck</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>New York University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Weakness is a major cause of disability in stroke survivors. Rehabilitation techniques are&#xD;
      often not effective in restoring full function of the upper limb. Specifically, many&#xD;
      individuals remain with weakness in the hand, preventing its return to full use.&#xD;
&#xD;
      Robotic therapies have been developed as exercise tools for stroke survivors. Devices, such&#xD;
      as the InMotion2, have been shown to be useful in restoring some motor function in the upper&#xD;
      limb. However, most existing devices designed to be used with the upper limb have primarily&#xD;
      been developed to treat the shoulder, elbow and wrist. They have not specifically addressed&#xD;
      hand function.&#xD;
&#xD;
      Tyromotion, Inc. has developed the Amadeo, which is primarily intended to provide&#xD;
      rehabilitation for patients with neurological or orthopedic deficits in hand function.&#xD;
      Initial clinical testing has demonstrated the practicality of using this device in a&#xD;
      population of stroke survivors, although further research is needed to better understand the&#xD;
      usefulness of the Amadeo device as compared with conventional rehabilitation methods. The&#xD;
      purpose of this study was to compare results of training with the Amadeo device or training&#xD;
      with conventional therapies.&#xD;
&#xD;
      A total of 28 subjects from two separate sites participated in the study and underwent&#xD;
      baseline testing of upper limb motor and sensory performance and function. Subjects were then&#xD;
      assigned to one of two treatment groups with a 50:50 chance of being in either group. One&#xD;
      group underwent training with the Amadeo device and the other group underwent training with&#xD;
      conventional therapy. All training sessions were 60 minutes in duration, three days/week for&#xD;
      eight weeks (24 total sessions). Subjects were reassessed on completion of the training&#xD;
      program.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2012</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>Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer</measure>
    <time_frame>Through study completion, an average of 8 weeks (at baseline and at the 8-week completion point)</time_frame>
    <description>quantitative performance measure (scale ranging from 0 (minimum) to 66 (maximum) points) of arm and hand impairment. A higher score represents more skilled movements of the arm and hand.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Range of Motion Measures</measure>
    <time_frame>Through study completion, an average of 8 weeks</time_frame>
    <description>quantitative assessment of the mobility of joints throughout the upper limb using standard goniometric measures. Measured in degrees (0-360 degrees)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hand and Pinch Strength</measure>
    <time_frame>Through study completion, an average of 8 weeks</time_frame>
    <description>quantitative assessment of hand strength using standard dynamometry measurements in units of kilograms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Motor Activity Log Amount</measure>
    <time_frame>Through study completion (taken at baseline and at 8-week study completion)</time_frame>
    <description>quantitative, self report scale measuring the 'Amount' and 'How Well' an individual performs a battery of motor tasks. Maximum score of 150 (raw score) for each 'Amount' and 'How Well' sections. Higher scores reflect better performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mobility and Activities of Daily Living</measure>
    <time_frame>Through study completion (taken at baseline and at 8 week study completion)</time_frame>
    <description>The Barthel Index is a quantitative scale measuring the need for assistance an individual has in performance of tasks of general mobility and activities of daily living. Maximum raw score is 100. Higher values represent better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hand Dexterity</measure>
    <time_frame>Through study completion, an average of 8 weeks</time_frame>
    <description>The 9 Hole Peg Test was used as a quantitative measure of hand dexterity. The participant is asked to remove the pegs and put them back into the slots in a period of 100 sec. The number of pegs moved is recorded as an overall score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Spasticity Measures</measure>
    <time_frame>Through study completion, an average of 8 weeks</time_frame>
    <description>The Modified Ashworth Scale is a standardized quantitative assessment of muscle tightness/spasticity during movements of the arm and wrist. It is scored on a scale of 1-5, with higher numbers reflecting a greater severity of spasticity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Motor Activity Log How Well</measure>
    <time_frame>Through study completion (taken at baseline and on 8 week study completion)</time_frame>
    <description>quantitative, self report scale measuring the 'Amount' and 'How Well' an individual performs a battery of motor tasks. Maximum score of 150 (raw score) for each 'Amount' and 'How Well' sections. Higher scores reflect better performance.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Conventional Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to this arm will receive conventional based therapy to their affected upper limb dose matched with the Robotic Therapy group. These interventions are aimed at increasing range of motion, strength and function at the shoulder, elbow, wrist and hand.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Robotic Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to this arm will receive robotic based therapy using the Amadeo Hand Robot device to improve range of motion, strength, and coordination to the wrist and hand.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Amadeo Hand Robot Device</intervention_name>
    <description>This is a robotic device designed to offer rehabilitation to remediate weakness and limitations of range of motion of the hand and fingers.</description>
    <arm_group_label>Robotic Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional Therapy</intervention_name>
    <description>This arm involves treatment using conventional methods designed to promote range of motion, strength, coordination and function at the level of the shoulder, elbow, wrist and hand.</description>
    <arm_group_label>Conventional Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  history of stroke (&gt;3 months from time of ictus)&#xD;
&#xD;
          -  paresis or plegia of the upper extremity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe spasticity (defined on the Ashworth Scale with a score of 4-5)&#xD;
&#xD;
          -  severe pain despite conventional pain therapy of the paretic upper extremity&#xD;
&#xD;
          -  swelling, infection, fracture or ulcers of the paretic extremity&#xD;
&#xD;
          -  arthritis of the hand joints&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  botulinum toxin- therapy to the upper extremity within 3 months prior to study entry&#xD;
&#xD;
          -  severe contractions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joel Stein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Raimund Helbok, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Innsbruck Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innsbruck Medical University</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <results_first_submitted>January 17, 2017</results_first_submitted>
  <results_first_submitted_qc>January 23, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">January 25, 2018</results_first_posted>
  <last_update_submitted>January 23, 2018</last_update_submitted>
  <last_update_submitted_qc>January 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Joel Stein</investigator_full_name>
    <investigator_title>Department of Rehabilitation and Regenerative Medicine Chair</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Conventional Group</title>
          <description>The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.</description>
        </group>
        <group group_id="P2">
          <title>Robotic Group</title>
          <description>The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Conventional Group</title>
          <description>The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.</description>
        </group>
        <group group_id="B2">
          <title>Robotic Group</title>
          <description>The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="28"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.14" spread="17.9"/>
                    <measurement group_id="B2" value="54.57" spread="13.8"/>
                    <measurement group_id="B3" value="57.13" spread="15.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer</title>
        <description>quantitative performance measure (scale ranging from 0 (minimum) to 66 (maximum) points) of arm and hand impairment. A higher score represents more skilled movements of the arm and hand.</description>
        <time_frame>Through study completion, an average of 8 weeks (at baseline and at the 8-week completion point)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Conventional Group</title>
            <description>The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.</description>
          </group>
          <group group_id="O2">
            <title>Robotic Group</title>
            <description>The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.</description>
          </group>
        </group_list>
        <measure>
          <title>Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer</title>
          <description>quantitative performance measure (scale ranging from 0 (minimum) to 66 (maximum) points) of arm and hand impairment. A higher score represents more skilled movements of the arm and hand.</description>
          <units>change in units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" spread="13.7"/>
                    <measurement group_id="O2" value="2.1" spread="16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Range of Motion Measures</title>
        <description>quantitative assessment of the mobility of joints throughout the upper limb using standard goniometric measures. Measured in degrees (0-360 degrees)</description>
        <time_frame>Through study completion, an average of 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Conventional Group</title>
            <description>The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.</description>
          </group>
          <group group_id="O2">
            <title>Robotic Group</title>
            <description>The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Range of Motion Measures</title>
          <description>quantitative assessment of the mobility of joints throughout the upper limb using standard goniometric measures. Measured in degrees (0-360 degrees)</description>
          <units>change in units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.53" spread="0.45"/>
                    <measurement group_id="O2" value="3.33" spread="0.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Hand and Pinch Strength</title>
        <description>quantitative assessment of hand strength using standard dynamometry measurements in units of kilograms</description>
        <time_frame>Through study completion, an average of 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Conventional Group</title>
            <description>The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.</description>
          </group>
          <group group_id="O2">
            <title>Robotic Group</title>
            <description>The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Hand and Pinch Strength</title>
          <description>quantitative assessment of hand strength using standard dynamometry measurements in units of kilograms</description>
          <units>change in kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.63" spread="7.8"/>
                    <measurement group_id="O2" value="0.84" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Motor Activity Log Amount</title>
        <description>quantitative, self report scale measuring the 'Amount' and 'How Well' an individual performs a battery of motor tasks. Maximum score of 150 (raw score) for each 'Amount' and 'How Well' sections. Higher scores reflect better performance.</description>
        <time_frame>Through study completion (taken at baseline and at 8-week study completion)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Conventional Group</title>
            <description>The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.</description>
          </group>
          <group group_id="O2">
            <title>Robotic Group</title>
            <description>The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Motor Activity Log Amount</title>
          <description>quantitative, self report scale measuring the 'Amount' and 'How Well' an individual performs a battery of motor tasks. Maximum score of 150 (raw score) for each 'Amount' and 'How Well' sections. Higher scores reflect better performance.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.35" spread="35.1"/>
                    <measurement group_id="O2" value="2.53" spread="37.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mobility and Activities of Daily Living</title>
        <description>The Barthel Index is a quantitative scale measuring the need for assistance an individual has in performance of tasks of general mobility and activities of daily living. Maximum raw score is 100. Higher values represent better outcomes.</description>
        <time_frame>Through study completion (taken at baseline and at 8 week study completion)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Conventional Group</title>
            <description>The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.</description>
          </group>
          <group group_id="O2">
            <title>Robotic Group</title>
            <description>The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mobility and Activities of Daily Living</title>
          <description>The Barthel Index is a quantitative scale measuring the need for assistance an individual has in performance of tasks of general mobility and activities of daily living. Maximum raw score is 100. Higher values represent better outcomes.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.78" spread="19.1"/>
                    <measurement group_id="O2" value="-0.36" spread="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Hand Dexterity</title>
        <description>The 9 Hole Peg Test was used as a quantitative measure of hand dexterity. The participant is asked to remove the pegs and put them back into the slots in a period of 100 sec. The number of pegs moved is recorded as an overall score.</description>
        <time_frame>Through study completion, an average of 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Conventional Group</title>
            <description>The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.</description>
          </group>
          <group group_id="O2">
            <title>Robotic Group</title>
            <description>The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Hand Dexterity</title>
          <description>The 9 Hole Peg Test was used as a quantitative measure of hand dexterity. The participant is asked to remove the pegs and put them back into the slots in a period of 100 sec. The number of pegs moved is recorded as an overall score.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.67" spread="47.8"/>
                    <measurement group_id="O2" value="-1.12" spread="24.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Spasticity Measures</title>
        <description>The Modified Ashworth Scale is a standardized quantitative assessment of muscle tightness/spasticity during movements of the arm and wrist. It is scored on a scale of 1-5, with higher numbers reflecting a greater severity of spasticity.</description>
        <time_frame>Through study completion, an average of 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Conventional Group</title>
            <description>The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.</description>
          </group>
          <group group_id="O2">
            <title>Robotic Group</title>
            <description>The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Spasticity Measures</title>
          <description>The Modified Ashworth Scale is a standardized quantitative assessment of muscle tightness/spasticity during movements of the arm and wrist. It is scored on a scale of 1-5, with higher numbers reflecting a greater severity of spasticity.</description>
          <units>change in units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" spread="0.3"/>
                    <measurement group_id="O2" value="-0.10" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Motor Activity Log How Well</title>
        <description>quantitative, self report scale measuring the 'Amount' and 'How Well' an individual performs a battery of motor tasks. Maximum score of 150 (raw score) for each 'Amount' and 'How Well' sections. Higher scores reflect better performance.</description>
        <time_frame>Through study completion (taken at baseline and on 8 week study completion)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Conventional Group</title>
            <description>The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.</description>
          </group>
          <group group_id="O2">
            <title>Robotic Group</title>
            <description>The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Motor Activity Log How Well</title>
          <description>quantitative, self report scale measuring the 'Amount' and 'How Well' an individual performs a battery of motor tasks. Maximum score of 150 (raw score) for each 'Amount' and 'How Well' sections. Higher scores reflect better performance.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.79" spread="29.5"/>
                    <measurement group_id="O2" value="2.6" spread="35.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Conventional Group</title>
          <description>The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration.</description>
        </group>
        <group group_id="E2">
          <title>Robotic Group</title>
          <description>The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Lauri Bishop, PT, DPT Research Physical Therapist</name_or_title>
      <organization>Columbia University Medical Center/ Dept. of Rehabilitation &amp; Regenerative Medicine</organization>
      <phone>212-305-6095</phone>
      <email>LB2413@cumc.columbia.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03020576
org study id: AAAI0093
nct id: NCT03020576
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Weakness is a major cause of disability in stroke survivors. Rehabilitation techniques are
      often not effective in restoring full function of the upper limb. Specifically, many
      individuals remain with weakness in the hand, preventing its return to full use.

      Robotic therapies have been developed as exercise tools for stroke survivors. Devices, such
      as the InMotion2, have been shown to be useful in restoring some motor function in the upper
      limb. However, most existing devices designed to be used with the upper limb have primarily
      been developed to treat the shoulder, elbow and wrist. They have not specifically addressed
      hand function.

      Tyromotion, Inc. has developed the Amadeo, which is primarily intended to provide
      rehabilitation for patients with neurological or orthopedic deficits in hand function.
      Initial clinical testing has demonstrated the practicality of using this device in a
      population of stroke survivors, although further research is needed to better understand the
      usefulness of the Amadeo device as compared with conventional rehabilitation methods. The
      purpose of this study was to compare results of training with the Amadeo device or training
      with conventional therapies.

      A total of 28 subjects from two separate sites participated in the study and underwent
      baseline testing of upper limb motor and sensory performance and function. Subjects were then
      assigned to one of two treatment groups with a 50:50 chance of being in either group. One
      group underwent training with the Amadeo device and the other group underwent training with
      conventional therapy. All training sessions were 60 minutes in duration, three days/week for
      eight weeks (24 total sessions). Subjects were reassessed on completion of the training
      program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer
time frame: Through study completion, an average of 8 weeks (at baseline and at the 8-week completion point)
description: quantitative performance measure (scale ranging from 0 (minimum) to 66 (maximum) points) of arm and hand impairment. A higher score represents more skilled movements of the arm and hand.
measure: Change in Range of Motion Measures
time frame: Through study completion, an average of 8 weeks
description: quantitative assessment of the mobility of joints throughout the upper limb using standard goniometric measures. Measured in degrees (0-360 degrees)
measure: Change in Hand and Pinch Strength
time frame: Through study completion, an average of 8 weeks
description: quantitative assessment of hand strength using standard dynamometry measurements in units of kilograms
measure: Change in Motor Activity Log Amount
time frame: Through study completion (taken at baseline and at 8-week study completion)
description: quantitative, self report scale measuring the 'Amount' and 'How Well' an individual performs a battery of motor tasks. Maximum score of 150 (raw score) for each 'Amount' and 'How Well' sections. Higher scores reflect better performance.
measure: Change in Mobility and Activities of Daily Living
time frame: Through study completion (taken at baseline and at 8 week study completion)
description: The Barthel Index is a quantitative scale measuring the need for assistance an individual has in performance of tasks of general mobility and activities of daily living. Maximum raw score is 100. Higher values represent better outcomes.
measure: Change in Hand Dexterity
time frame: Through study completion, an average of 8 weeks
description: The 9 Hole Peg Test was used as a quantitative measure of hand dexterity. The participant is asked to remove the pegs and put them back into the slots in a period of 100 sec. The number of pegs moved is recorded as an overall score.
measure: Change in Spasticity Measures
time frame: Through study completion, an average of 8 weeks
description: The Modified Ashworth Scale is a standardized quantitative assessment of muscle tightness/spasticity during movements of the arm and wrist. It is scored on a scale of 1-5, with higher numbers reflecting a greater severity of spasticity.
measure: Change in Motor Activity Log How Well
time frame: Through study completion (taken at baseline and on 8 week study completion)
description: quantitative, self report scale measuring the 'Amount' and 'How Well' an individual performs a battery of motor tasks. Maximum score of 150 (raw score) for each 'Amount' and 'How Well' sections. Higher scores reflect better performance.
arm group label: Conventional Therapy
arm group type: Active Comparator
description: Participants randomized to this arm will receive conventional based therapy to their affected upper limb dose matched with the Robotic Therapy group. These interventions are aimed at increasing range of motion, strength and function at the shoulder, elbow, wrist and hand.
arm group label: Robotic Therapy
arm group type: Experimental
description: Participants randomized to this arm will receive robotic based therapy using the Amadeo Hand Robot device to improve range of motion, strength, and coordination to the wrist and hand.
intervention type: Device
intervention name: Amadeo Hand Robot Device
description: This is a robotic device designed to offer rehabilitation to remediate weakness and limitations of range of motion of the hand and fingers.
arm group label: Robotic Therapy
intervention type: Other
intervention name: Conventional Therapy
description: This arm involves treatment using conventional methods designed to promote range of motion, strength, coordination and function at the level of the shoulder, elbow, wrist and hand.
arm group label: Conventional Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Joel Stein, MD
role: Principal Investigator
affiliation: Columbia University
last name: Raimund Helbok, MD
role: Principal Investigator
affiliation: Innsbruck Medical University
facility: 
facility: 
country: Austria
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Joel Stein
investigator title: Department of Rehabilitation and Regenerative Medicine Chair
mesh term: Stroke
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 