<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/NCT04490655</url>
  </required_header>
  <id_info>
    <org_study_id>NTU-IRB-2019-10-022</org_study_id>
    <nct_id>NCT04490655</nct_id>
  </id_info>
  <brief_title>Active Somatosensory Exercise for Chronic Stroke</brief_title>
  <acronym>ActSens</acronym>
  <official_title>Effectiveness of Robotic-based ACTive somatoSENSory (Act.Sens) Retraining on Upper Limb Functions: Protocol for a Pilot Randomised Controlled Trial With Community-dwelling Stroke Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanyang Technological University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanyang Technological University</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 current work aims to examine whether the proposed rehabilitation training or exercise&#xD;
      will eventually yield improvements in both motor and somatosensory aspects at one goal. Here,&#xD;
      the word 'somatosensory' refers to bodily sensations associated with proprioception or&#xD;
      kinesthesia, not the sensation of touch, pain, and temperature. The study focuses on upper&#xD;
      limb retraining for community-dwelling stroke survivors using a robotic device. At the end of&#xD;
      training, both movement accuracy and somatosensory acuity in chronic stroke survivors are&#xD;
      presumed to improve, and such paradigm is expected to provide reliable benefits as compared&#xD;
      to conventional intervention alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Long-term disability is common sequela among people with stroke. On top of motor impairment,&#xD;
      many stroke survivors suffer from somatosensory impairment of their paretic arm, leading to&#xD;
      their inability to perform activities of daily living using upper limb. In this respect,&#xD;
      recent research on motor recovery following stroke has begun to place more emphasis on the&#xD;
      inclusion of somatosensory retraining in stroke rehabilitation program. Although evidence is&#xD;
      still scarce, training paradigms that simultaneously combine both somatosensory and motor&#xD;
      aspects are considered useful for motor recovery in stroke survivors. Principally, studies&#xD;
      focusing on such form of training paradigm sought to employ robotic technologies to assist in&#xD;
      the retraining of both motor and somatosensory function in stroke survivors. Robotic&#xD;
      technologies have gained popularity recently for assessing somatosensory function in clinical&#xD;
      setting due to its objective quantification of patients' performance and high inter-rater&#xD;
      reliability. Thus, with the purpose of improving both motor and somatosensory functions in&#xD;
      chronic stroke survivors, this proposed study will provide an intensive robotic-based&#xD;
      behavioral training intervention to chronic stroke survivors from the community. The&#xD;
      intervention will require active participation of the patients through an exploratory&#xD;
      strategy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2021</start_date>
  <completion_date type="Anticipated">March 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2023</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in motor behavioral scores</measure>
    <time_frame>Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).</time_frame>
    <description>A robotic-based assessment to evaluate the movement accuracy of patients' paretic arm. This will be analyzed through their ability to propel the robotic handle to a target location as straight and as fast as possible. Key kinematic parameters such as endpoint deviation (cm) and movement smoothness will be computed where larger numbers indicate worse performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in somatosensory acuity</measure>
    <time_frame>Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).</time_frame>
    <description>A robotic-based assessment to measure performance in proprioception/kinesthesia of patients' paretic arm. This will be analysed through their ability to first passively sense where the arm is being moved to and later on to reproduce the movement made by the robot. Key kinematic parameters such as endpoint deviation (cm) will be computed where a larger number indicate worse performance.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE)</measure>
    <time_frame>Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).</time_frame>
    <description>Patients' paretic arm movement ability will be evaluated across different categories of reflex, movement, and coordination. For each category, a larger number signifies better perforrmance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in streamlined Wolf Motor Function Test (WMFT)</measure>
    <time_frame>Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).</time_frame>
    <description>Patients' paretic arm performance will be measured by six timed tasks. For each category, a larger number signifies better performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Erasmus-MC version of the Nottingham Sensory Assessment (EmNSA)</measure>
    <time_frame>Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).</time_frame>
    <description>Tactile sensations, sharp-blunt discrimination and proprioception of patients' paretic arm will be assessed. For each category, a larger number signifies better performance.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Active somatosensory training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chronic stroke patients will be randomized to receive 15 sessions of robotic-based training intervention that focuses on the retraining of both motor and somatosensory functions, for a maximum of one hour per session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Motor-based training group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Chronic stroke patients will be randomized to receive 15 sessions of robotic-based training intervention that is purely motor based, for a maximum of one hour per session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active somatosensory training</intervention_name>
    <description>Patients in the experimental group will be required to move the robotic handle using their paretic arm from the start position to a visual target shown on screen. However, patients' paretic arm will be occluded from vision throughout the training session. They will make the reaching movement by depending on their proprioception of the arm position in space, without relying too much on the vision of their arm. Haptic guidance will be provided as somatosensory cues while participants are actively moving. Positive reinforcement will also be given for each successful movement that reaches the target in the form of a pleasant audio tone, visual feedback, and a running score. Assessment will be performed before and after the completion of the whole 15 training sessions.</description>
    <arm_group_label>Active somatosensory training group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motor-based training</intervention_name>
    <description>Patients in the control group will also be required to propel the robotic handle using their paretic arm to a target location. This training covers the same centre-out reaching movements but without any emphasis on proprioception, where the view of the paretic arm will not be occluded. However, no haptic guidance will be provided during the reaching movement. Positive reinforcement will still be given to inform the participants of their trial outcomes. Assessment will be performed before and after the completion of the whole 15 training sessions.</description>
    <arm_group_label>Motor-based training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First-time ischemic or haemorrhagic stroke survivors;&#xD;
&#xD;
          -  Patients of at least 6-month post-stroke;&#xD;
&#xD;
          -  Patients with severe to moderate sensory impairment as assessed by Erasmus Nottingham&#xD;
             Sensory Assessment (≤ 6/8);&#xD;
&#xD;
          -  Patients with arm motor impairment, shoulder abduction and elbow extension Medical&#xD;
             Research Council (MRC) motor power grade 3-5;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with bilateral impairment;&#xD;
&#xD;
          -  Patients with high upper-limb spasticity (Ashworth scale &gt; 2);&#xD;
&#xD;
          -  Patients with unilateral neglect as assessed by Star Cancellation Test (score &lt; 44);&#xD;
&#xD;
          -  Patients with cognitive impairment as assessed by a 2-step instructions from the&#xD;
             modified Mini Mental State Examination;&#xD;
&#xD;
          -  Patients with a known history of mental disorders;&#xD;
&#xD;
          -  Patients with the inability to perform upper arm activity due to excessive pain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ananda Sidarta, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Fellow</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ananda Sidarta, PhD</last_name>
    <phone>+65 6904 1361</phone>
    <email>ananda.sidarta@ntu.edu.sg</email>
  </overall_contact>
  <location>
    <facility>
      <name>St Luke's Hospital</name>
      <address>
        <city>Bukit Batok New Town</city>
        <state>Bukit Batok</state>
        <zip>659674</zip>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Celis Zeng</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kwong Wai Shiu Hospital</name>
      <address>
        <city>Serangoon</city>
        <zip>328127</zip>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Margaret Goh</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <reference>
    <citation>Bernardi NF, Darainy M, Ostry DJ. Somatosensory Contribution to the Initial Stages of Human Motor Learning. J Neurosci. 2015 Oct 21;35(42):14316-26. doi: 10.1523/JNEUROSCI.1344-15.2015.</citation>
    <PMID>26490869</PMID>
  </reference>
  <reference>
    <citation>Sidarta A, Vahdat S, Bernardi NF, Ostry DJ. Somatic and Reinforcement-Based Plasticity in the Initial Stages of Human Motor Learning. J Neurosci. 2016 Nov 16;36(46):11682-11692. doi: 10.1523/JNEUROSCI.1767-16.2016.</citation>
    <PMID>27852776</PMID>
  </reference>
  <reference>
    <citation>Goble DJ. Proprioceptive acuity assessment via joint position matching: from basic science to general practice. Phys Ther. 2010 Aug;90(8):1176-84. doi: 10.2522/ptj.20090399. Epub 2010 Jun 3.</citation>
    <PMID>20522675</PMID>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>September 27, 2022</last_update_submitted>
  <last_update_submitted_qc>September 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanyang Technological University</investigator_affiliation>
    <investigator_full_name>Ananda Sidarta</investigator_full_name>
    <investigator_title>Research Fellow</investigator_title>
  </responsible_party>
  <keyword>Somatosensory</keyword>
  <keyword>Proprioception</keyword>
  <keyword>Kinesthesia</keyword>
  <keyword>Rehabilitation robotics</keyword>
  <keyword>Positive reinforcement</keyword>
  <keyword>Upper limb retraining</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>Yes</sharing_ipd>
    <ipd_description>All patient-related information, and data generated by the robotic system will be maintained on a secure server owned by the university.&#xD;
Access to research records will be limited to primary research team members. Data monitoring will comply with the university policy, guidelines, and data management plan (DMP) approved for the study.</ipd_description>
    <ipd_time_frame>Estimated time will be by March 2022, for 10 years.</ipd_time_frame>
    <ipd_access_criteria>Written request to the Principal Investigator</ipd_access_criteria>
    <ipd_url>https://researchdata.ntu.edu.sg</ipd_url>
  </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/NCT04490655
org study id: NTU-IRB-2019-10-022
nct id: NCT04490655
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The current work aims to examine whether the proposed rehabilitation training or exercise
      will eventually yield improvements in both motor and somatosensory aspects at one goal. Here,
      the word 'somatosensory' refers to bodily sensations associated with proprioception or
      kinesthesia, not the sensation of touch, pain, and temperature. The study focuses on upper
      limb retraining for community-dwelling stroke survivors using a robotic device. At the end of
      training, both movement accuracy and somatosensory acuity in chronic stroke survivors are
      presumed to improve, and such paradigm is expected to provide reliable benefits as compared
      to conventional intervention alone.
Long-term disability is common sequela among people with stroke. On top of motor impairment,
      many stroke survivors suffer from somatosensory impairment of their paretic arm, leading to
      their inability to perform activities of daily living using upper limb. In this respect,
      recent research on motor recovery following stroke has begun to place more emphasis on the
      inclusion of somatosensory retraining in stroke rehabilitation program. Although evidence is
      still scarce, training paradigms that simultaneously combine both somatosensory and motor
      aspects are considered useful for motor recovery in stroke survivors. Principally, studies
      focusing on such form of training paradigm sought to employ robotic technologies to assist in
      the retraining of both motor and somatosensory function in stroke survivors. Robotic
      technologies have gained popularity recently for assessing somatosensory function in clinical
      setting due to its objective quantification of patients' performance and high inter-rater
      reliability. Thus, with the purpose of improving both motor and somatosensory functions in
      chronic stroke survivors, this proposed study will provide an intensive robotic-based
      behavioral training intervention to chronic stroke survivors from the community. The
      intervention will require active participation of the patients through an exploratory
      strategy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in motor behavioral scores
time frame: Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).
description: A robotic-based assessment to evaluate the movement accuracy of patients' paretic arm. This will be analyzed through their ability to propel the robotic handle to a target location as straight and as fast as possible. Key kinematic parameters such as endpoint deviation (cm) and movement smoothness will be computed where larger numbers indicate worse performance.
measure: Change in somatosensory acuity
time frame: Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).
description: A robotic-based assessment to measure performance in proprioception/kinesthesia of patients' paretic arm. This will be analysed through their ability to first passively sense where the arm is being moved to and later on to reproduce the movement made by the robot. Key kinematic parameters such as endpoint deviation (cm) will be computed where a larger number indicate worse performance.
measure: Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
time frame: Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).
description: Patients' paretic arm movement ability will be evaluated across different categories of reflex, movement, and coordination. For each category, a larger number signifies better perforrmance.
measure: Change in streamlined Wolf Motor Function Test (WMFT)
time frame: Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).
description: Patients' paretic arm performance will be measured by six timed tasks. For each category, a larger number signifies better performance.
measure: Change in Erasmus-MC version of the Nottingham Sensory Assessment (EmNSA)
time frame: Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).
description: Tactile sensations, sharp-blunt discrimination and proprioception of patients' paretic arm will be assessed. For each category, a larger number signifies better performance.
arm group label: Active somatosensory training group
arm group type: Experimental
description: Chronic stroke patients will be randomized to receive 15 sessions of robotic-based training intervention that focuses on the retraining of both motor and somatosensory functions, for a maximum of one hour per session.
arm group label: Motor-based training group
arm group type: Active Comparator
description: Chronic stroke patients will be randomized to receive 15 sessions of robotic-based training intervention that is purely motor based, for a maximum of one hour per session.
intervention type: Behavioral
intervention name: Active somatosensory training
description: Patients in the experimental group will be required to move the robotic handle using their paretic arm from the start position to a visual target shown on screen. However, patients' paretic arm will be occluded from vision throughout the training session. They will make the reaching movement by depending on their proprioception of the arm position in space, without relying too much on the vision of their arm. Haptic guidance will be provided as somatosensory cues while participants are actively moving. Positive reinforcement will also be given for each successful movement that reaches the target in the form of a pleasant audio tone, visual feedback, and a running score. Assessment will be performed before and after the completion of the whole 15 training sessions.
arm group label: Active somatosensory training group
intervention type: Behavioral
intervention name: Motor-based training
description: Patients in the control group will also be required to propel the robotic handle using their paretic arm to a target location. This training covers the same centre-out reaching movements but without any emphasis on proprioception, where the view of the paretic arm will not be occluded. However, no haptic guidance will be provided during the reaching movement. Positive reinforcement will still be given to inform the participants of their trial outcomes. Assessment will be performed before and after the completion of the whole 15 training sessions.
arm group label: Motor-based training group
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ananda Sidarta, PhD
role: Principal Investigator
affiliation: Research Fellow
last name: Ananda Sidarta, PhD
phone: +65 6904 1361
email: ananda.sidarta@ntu.edu.sg
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: Singapore
citation: Bernardi NF, Darainy M, Ostry DJ. Somatosensory Contribution to the Initial Stages of Human Motor Learning. J Neurosci. 2015 Oct 21;35(42):14316-26. doi: 10.1523/JNEUROSCI.1344-15.2015.
PMID: 26490869
citation: Sidarta A, Vahdat S, Bernardi NF, Ostry DJ. Somatic and Reinforcement-Based Plasticity in the Initial Stages of Human Motor Learning. J Neurosci. 2016 Nov 16;36(46):11682-11692. doi: 10.1523/JNEUROSCI.1767-16.2016.
PMID: 27852776
citation: Goble DJ. Proprioceptive acuity assessment via joint position matching: from basic science to general practice. Phys Ther. 2010 Aug;90(8):1176-84. doi: 10.2522/ptj.20090399. Epub 2010 Jun 3.
PMID: 20522675
responsible party type: Principal Investigator
investigator affiliation: Nanyang Technological University
investigator full name: Ananda Sidarta
investigator title: Research Fellow
mesh term: Stroke
sharing ipd: Yes
ipd description: All patient-related information, and data generated by the robotic system will be maintained on a secure server owned by the university.
Access to research records will be limited to primary research team members. Data monitoring will comply with the university policy, guidelines, and data management plan (DMP) approved for the study.
ipd time frame: Estimated time will be by March 2022, for 10 years.
ipd access criteria: Written request to the Principal Investigator
ipd url: https://researchdata.ntu.edu.sg