<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/NCT02188628</url>
  </required_header>
  <id_info>
    <org_study_id>2014/00122</org_study_id>
    <nct_id>NCT02188628</nct_id>
  </id_info>
  <brief_title>Refinement and Clinical Evaluation of the H-Man for Arm Rehabilitation After Stroke</brief_title>
  <official_title>Refinement and Clinical Evaluation of the H-Man: A Novel, Portable, Inexpensive Planar Robot for Arm Rehabilitation After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tan Tock Seng Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Medical Research Council (NMRC), Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tan Tock Seng Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Locally, stroke remains the 4th cause of death, causing 8.4% of deaths annually in Singapore,&#xD;
      and a leading cause of neurological disability worldwide. Nearly 40% of the stroke survivors&#xD;
      will require specialized rehabilitation. In recent years, robot-aided therapy has been&#xD;
      proposed as a means of complementing traditional therapy to alleviate the burden on&#xD;
      therapists and on the healthcare system. For shoulder/elbow rehabilitation, dozens of robots&#xD;
      have been proposed in the literature but only half a dozen have been commercialized and&#xD;
      typically none are seen in local clinics, due to exceedingly high costs. A novel, compact,&#xD;
      inexpensive robotic interface, named 'H-Man', was recently designed and developed at NTU for&#xD;
      experiments in motor control neuroscience. The H-man can generate computer-controlled force&#xD;
      fields to assist or resist a subject's motion and is potentially an optimal trade-off between&#xD;
      clinical efficacy and robotic complexity. A first prototype of the H-Man is available at&#xD;
      NTU.The primary aim of this proposed project is to assess to what extent the investigators&#xD;
      H-Man is suitable for rehabilitation purposes using a feasibility pilot clinical trial design&#xD;
      involving stroke survivors. The investigators believe that H-Man can be used for&#xD;
      neuro-rehabilitation of stroke patients with hemiparetic weakness, motor incoordination and&#xD;
      motor ataxia of the upper limbs.In close cooperation between clinicians at the TTSH and NTU&#xD;
      engineers, a portable version of the H-Man will be developed which will be tested in a 12&#xD;
      subject Pilot study, refined and then used in a 44 subject Randomized Controlled Trial (RCT)&#xD;
      study. At the same time, the feasibility of H-Man integration for a pared down home use model&#xD;
      will be assessed in 4 subjects.&#xD;
&#xD;
      The investigators primary hypothesis is that sub-acute/chronic patients will exhibit&#xD;
      clinically significant decreases of impairment when training with the H-Man combined with&#xD;
      standard arm therapy on robot-measured scales and standardized clinical scales, at the level&#xD;
      of elbow/shoulder after 18 sessions of training on the H-Man.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As above&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2014</start_date>
  <completion_date type="Actual">March 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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>
    <intervention_model_description>H-Man training + conventional therapy vs equal amount of conventional therapy 1:1 allocation</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Blinded therapist assessor to determine clinical outcomes at pre and post treatment and follow up.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Fugl Meyer Assessment of Motor Recovery</measure>
    <time_frame>0, 3, 6, 12 and 24 weeks after start of intervention</time_frame>
    <description>As above</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Action Research Arm Test</measure>
    <time_frame>0, 3, 6, 12 and 24 weeks after start of intervention</time_frame>
    <description>As above</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>H-Man</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>H-Man is a novel, portable, inexpensive end-effector upper limb robot.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Additional Conventional Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Repetitive goals based arm therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>H-Man</intervention_name>
    <description>H-man is a portable end-effector planar upper limb robot.</description>
    <arm_group_label>H-Man</arm_group_label>
    <other_name>No other names.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Additional Conventional Therapy</intervention_name>
    <description>Repetitive goals based arm therapy</description>
    <arm_group_label>Additional Conventional Therapy</arm_group_label>
    <other_name>No other names</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First ever clinical stroke (ischaemic or haemorrhagic) confirmed on brain imaging&#xD;
&#xD;
          -  Duration post stroke: 3 months to 24 months&#xD;
&#xD;
          -  Age 21 to 85 years&#xD;
&#xD;
          -  Hemiplegic pattern of arm motor impairment with Shoulder abduction MRC motor power &gt;/=&#xD;
             3/5 and elbow flexion MRC motor power &gt;/= 3/5&#xD;
&#xD;
          -  Affected upper limb Fugl Myer Motor Assessment (FMMA) scale 20-50&#xD;
&#xD;
          -  And / or associated motor incoordination or motor ataxia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non stroke related causes of arm motor impairment&#xD;
&#xD;
          -  Medical conditions incompatible with research participation: uncontrolled medical&#xD;
             illnesses (hypertension or diabetes, heart failure, asthma, depression, end stage&#xD;
             renal failure, terminal malignancy), life expectancy &lt;6 months, unhealed fractures or&#xD;
             severe arm pain (visual analogue scale VAS &gt; 5/10, pregnancy&#xD;
&#xD;
          -  Inability to tolerate sitting for 90 minutes.&#xD;
&#xD;
          -  Local factors which preclude robotic interfacing or may be worsened by intensive arm&#xD;
             therapy: spasticity of Modified Ashworth Scale grades 3-4, skin wounds, shoulder pain&#xD;
             VAS &gt;5/10, active fractures or arthritis or fixed flexion contractures of shoulder,&#xD;
             elbow, wrist or fingers incompatible with interface with the H-man robot.&#xD;
&#xD;
          -  Severe sensory impairment of affected limb&#xD;
&#xD;
          -  Severe visual impairment, hemispatial neglect or homonymous hemianopia&#xD;
&#xD;
          -  Cognitive impairments or uncontrolled behaviour. (Folstein mini mental state exam MMSE&#xD;
             &lt;26/28)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chua SG Sui Geok, MBBS,FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tan Tock Seng Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tan Tock Seng Rehabilitation Centre</name>
      <address>
        <city>Singapore</city>
        <zip>569766</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>September 11, 2019</last_update_submitted>
  <last_update_submitted_qc>September 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tan Tock Seng Hospital</investigator_affiliation>
    <investigator_full_name>Chua Sui Geok, Karen</investigator_full_name>
    <investigator_title>Senior Consultant</investigator_title>
  </responsible_party>
  <keyword>Motor recovery, robotics, stroke rehabilitation</keyword>
  <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>
  <!-- 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/NCT02188628
org study id: 2014/00122
nct id: NCT02188628
lead sponsor: 
collaborator: 
has dmc: No
Locally, stroke remains the 4th cause of death, causing 8.4% of deaths annually in Singapore,
      and a leading cause of neurological disability worldwide. Nearly 40% of the stroke survivors
      will require specialized rehabilitation. In recent years, robot-aided therapy has been
      proposed as a means of complementing traditional therapy to alleviate the burden on
      therapists and on the healthcare system. For shoulder/elbow rehabilitation, dozens of robots
      have been proposed in the literature but only half a dozen have been commercialized and
      typically none are seen in local clinics, due to exceedingly high costs. A novel, compact,
      inexpensive robotic interface, named 'H-Man', was recently designed and developed at NTU for
      experiments in motor control neuroscience. The H-man can generate computer-controlled force
      fields to assist or resist a subject's motion and is potentially an optimal trade-off between
      clinical efficacy and robotic complexity. A first prototype of the H-Man is available at
      NTU.The primary aim of this proposed project is to assess to what extent the investigators
      H-Man is suitable for rehabilitation purposes using a feasibility pilot clinical trial design
      involving stroke survivors. The investigators believe that H-Man can be used for
      neuro-rehabilitation of stroke patients with hemiparetic weakness, motor incoordination and
      motor ataxia of the upper limbs.In close cooperation between clinicians at the TTSH and NTU
      engineers, a portable version of the H-Man will be developed which will be tested in a 12
      subject Pilot study, refined and then used in a 44 subject Randomized Controlled Trial (RCT)
      study. At the same time, the feasibility of H-Man integration for a pared down home use model
      will be assessed in 4 subjects.

      The investigators primary hypothesis is that sub-acute/chronic patients will exhibit
      clinically significant decreases of impairment when training with the H-Man combined with
      standard arm therapy on robot-measured scales and standardized clinical scales, at the level
      of elbow/shoulder after 18 sessions of training on the H-Man.
As above
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: H-Man training + conventional therapy vs equal amount of conventional therapy 1:1 allocation
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: Blinded therapist assessor to determine clinical outcomes at pre and post treatment and follow up.
measure: Change from Baseline in Fugl Meyer Assessment of Motor Recovery
time frame: 0, 3, 6, 12 and 24 weeks after start of intervention
description: As above
measure: Change from Baseline in Action Research Arm Test
time frame: 0, 3, 6, 12 and 24 weeks after start of intervention
description: As above
arm group label: H-Man
arm group type: Experimental
description: H-Man is a novel, portable, inexpensive end-effector upper limb robot.
arm group label: Additional Conventional Therapy
arm group type: Active Comparator
description: Repetitive goals based arm therapy
intervention type: Device
intervention name: H-Man
description: H-man is a portable end-effector planar upper limb robot.
arm group label: H-Man
other name: No other names.
intervention type: Other
intervention name: Additional Conventional Therapy
description: Repetitive goals based arm therapy
arm group label: Additional Conventional Therapy
other name: No other names
criteria: 
gender: All
minimum age: 21 Years
maximum age: 85 Years
healthy volunteers: No
last name: Chua SG Sui Geok, MBBS,FRCP
role: Principal Investigator
affiliation: Tan Tock Seng Hospital
facility: 
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: Tan Tock Seng Hospital
investigator full name: Chua Sui Geok, Karen
investigator title: Senior Consultant
mesh term: Stroke
sharing ipd: No