<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/NCT03236376</url>
  </required_header>
  <id_info>
    <org_study_id>s60278</org_study_id>
    <nct_id>NCT03236376</nct_id>
  </id_info>
  <brief_title>Brain-behavior Associations of Sensorimotor Therapy Post Stroke</brief_title>
  <official_title>Behavioral and Brain Connectivity Analysis of Upper Limb Sensorimotor Rehabilitation Post Stroke: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Research Foundation Flanders</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</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>
      Stroke survivors often encounter impairments in the upper limb after stroke. Sensorimotor&#xD;
      impairments are present in 67% of the stroke patients, resulting in problems with&#xD;
      independency and performance of activities of daily life. In addition, the pattern of&#xD;
      recovery in the brain is still a matter of ongoing debate. Although the importance of&#xD;
      somatosensory function on motor performance is well described, evidence for somatosensory or&#xD;
      sensorimotor therapy and brain-related changes is scares. Therefore, we aim to explore the&#xD;
      effect of a sensorimotor therapy compared to pure motor therapy on motor function of the&#xD;
      upper limb. A second objective is to investigate therapy-induced brain-behavior associations&#xD;
      using resting state functional Magnetic Resonance Imaging of the brain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke survivors often encounter impairments in the upper limb after stroke. Sensorimotor&#xD;
      impairments are present in 67% of the stroke patients, resulting in problems with&#xD;
      independency and performance of activities of daily life. In addition, the pattern of&#xD;
      recovery in the brain is still a matter of ongoing debate. Although the importance of&#xD;
      somatosensory function on motor performance is well described, evidence for somatosensory or&#xD;
      sensorimotor therapy and brain-related changes is scares. Therefore, will conduct a&#xD;
      Randomized Controlled Trial with three main objectives.&#xD;
&#xD;
      The first objective of this project is to investigate the effect of sensorimotor therapy on&#xD;
      motor function of the upper limb. To achieve this objective, a sensorimotor program will be&#xD;
      developed based on the SENSE therapy. Patients will be randomly allocated to either the&#xD;
      sensorimotor therapy group or the pure motor therapy group; and will receive 16 hours of&#xD;
      therapy. Motor and Somatosensory assessments will be performed at three time points:&#xD;
      baseline(admission to rehabilitation center), immediately after the 16 hours of therapy and&#xD;
      after 4 weeks of follow-up.&#xD;
&#xD;
      The second objective is to investigate therapy-induced brain-behavior associations with&#xD;
      resting state functional connectivity. In order to achieve insights in brain-behavior&#xD;
      associations, we will perform resting-state functional Magnetic Resonance Imaging (fMRI)&#xD;
      scans at the same time points as the clinical assessments: baseline, immediately after the 16&#xD;
      hours of therapy, and four weeks after the end of the therapy. Both measurements,&#xD;
      brain-imaging and clinical measurements will be combined to investigate the associations.&#xD;
&#xD;
      This project will lead to new insights in brain-behavior associations of sensorimotor&#xD;
      function of the upper limb after stroke and will provide evidence for a new therapy in upper&#xD;
      limb stroke rehabilitation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2017</start_date>
  <completion_date type="Actual">January 6, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 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>Randomized controlled Trial with two therapy groups ( experimental and control therapy) and one healthy control group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The assessor will be masked for treatment group</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Action Research Arm Test</measure>
    <time_frame>within 4 months post stroke</time_frame>
    <description>grasp, grip, pinch and gross movement of the affected arm and hand</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fugl-Meyer motor Assessment-upper Extremity</measure>
    <time_frame>within 4 months post stroke</time_frame>
    <description>overall motor impairment of the affected upper limb: shoulder, arm, wrist , hand and fingers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>composite standardized somatosensory deficit index</measure>
    <time_frame>within 4 months post stroke</time_frame>
    <description>composite standardized score consisting of fabric matching test, wrist position sense test and functional tactile object recognition test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Erasmus modified Nottingham Sensory Assessment</measure>
    <time_frame>within 4 months post stroke</time_frame>
    <description>light touch, pressure, sharp, sharp-dull discrimination, position sense of the arm and hand</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceptual Threshold of Touch</measure>
    <time_frame>within 4 months post stroke</time_frame>
    <description>threshold of light touch determined with Transcutaneous Electric Nerve Stimulation at the index finger.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nine Hole Peg test</measure>
    <time_frame>within 4 months post stroke</time_frame>
    <description>manual dexterity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Upper Limb Capacity Scale</measure>
    <time_frame>within 4 months post stroke</time_frame>
    <description>upper limb capacity by the means of ten functional and meaningful tasks related to daily live activities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>functional connectivity</measure>
    <time_frame>within 4 months post stroke</time_frame>
    <description>resting-state fMRI functional connectivity between Regions of Interest of the sensorimotor network</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>sensorimotor therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>sensorimotor therapy will consist of 30minutes of sensory discrimination training and 30 minutes of sensorimotor training per session. The sensory discrimination training is based on on the SENSe training of Carey et all. The sensorimotor training is the same individually tailored motor therapy as described below, but with integration of sensory discrimination training aspects.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>motor therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The motor therapy consists of 30 minutes of cognitive and attention-based table top games and 30 minutes of motor training per session. The cognitive-attention-based therapy consists of table top games such as chess, rush hour, or other smart games. Individually tailored motor therapy consists of a unilateral motor exercise program for the upper limb, while seated at a table, under supervision of a therapist to match the therapy and intensity provided in the other sensorimotor therapy group. This 30 minutes of motor arm training is based on a set of standardized exercises which comprise task-related practice for gross movements and dexterity including different grips and selective finger movements, and training in daily life activities, however without any attention to sensory discrimination training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>additional sensorimotor therapy for the upper limb</intervention_name>
    <description>The intervention will consist of additional physiotherapy for the upper limb after stroke consisting of sensory discrimination training and sensorimotor training.</description>
    <arm_group_label>sensorimotor therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>additional motor therapy for the upper limb after stroke</intervention_name>
    <description>The intervention will consist of additional physiotherapy for the upper limb after stroke consisting of cognitive-attention based training and motor training</description>
    <arm_group_label>motor therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first ever stroke as defined by the WHO (world health organisation) criteria&#xD;
&#xD;
          -  assessed and included within 8 weeks after stroke onset&#xD;
&#xD;
          -  unilateral motor impairment in the upper limb (ARAT &lt;52/56)&#xD;
&#xD;
          -  unilateral somatosensory impairment in the upper limb (SSD &lt;0.00)&#xD;
&#xD;
          -  minimally 18 years old&#xD;
&#xD;
          -  substantially cooperation to perform the assessments and therapy&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  musculoskeletal and/or other neurological disorders such as previous stroke, head&#xD;
             injuries, multiple sclerosis of Parkinson's disease&#xD;
&#xD;
          -  a subdural hematoma, tumor, encephalitis or trauma that lead to similar symptoms as a&#xD;
             stroke&#xD;
&#xD;
          -  severe communication deficits&#xD;
&#xD;
          -  severe cognitive deficits&#xD;
&#xD;
          -  the presence of contra-indications for proceeding an MRI scan such as defibrillator,&#xD;
             pacemaker or metal prosthesis ( as defined in the MRI checklist of Radiology UZ&#xD;
             Leuven)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Geert Verheyden</last_name>
    <role>Principal Investigator</role>
    <affiliation>KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KU Leuven</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <results_reference>
    <citation>Carey L, Macdonell R, Matyas TA. SENSe: Study of the Effectiveness of Neurorehabilitation on Sensation: a randomized controlled trial. Neurorehabil Neural Repair. 2011 May;25(4):304-13. doi: 10.1177/1545968310397705. Epub 2011 Feb 24.</citation>
    <PMID>21350049</PMID>
  </results_reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>June 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>January 16, 2020</last_update_submitted>
  <last_update_submitted_qc>January 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitaire Ziekenhuizen KU Leuven</investigator_affiliation>
    <investigator_full_name>Geert Verheyden</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>upper limb</keyword>
  <keyword>somatosensory impairments</keyword>
  <keyword>motor impairments</keyword>
  <keyword>brain imaging</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>Undecided</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/NCT03236376
org study id: s60278
nct id: NCT03236376
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Stroke survivors often encounter impairments in the upper limb after stroke. Sensorimotor
      impairments are present in 67% of the stroke patients, resulting in problems with
      independency and performance of activities of daily life. In addition, the pattern of
      recovery in the brain is still a matter of ongoing debate. Although the importance of
      somatosensory function on motor performance is well described, evidence for somatosensory or
      sensorimotor therapy and brain-related changes is scares. Therefore, we aim to explore the
      effect of a sensorimotor therapy compared to pure motor therapy on motor function of the
      upper limb. A second objective is to investigate therapy-induced brain-behavior associations
      using resting state functional Magnetic Resonance Imaging of the brain.
Stroke survivors often encounter impairments in the upper limb after stroke. Sensorimotor
      impairments are present in 67% of the stroke patients, resulting in problems with
      independency and performance of activities of daily life. In addition, the pattern of
      recovery in the brain is still a matter of ongoing debate. Although the importance of
      somatosensory function on motor performance is well described, evidence for somatosensory or
      sensorimotor therapy and brain-related changes is scares. Therefore, will conduct a
      Randomized Controlled Trial with three main objectives.

      The first objective of this project is to investigate the effect of sensorimotor therapy on
      motor function of the upper limb. To achieve this objective, a sensorimotor program will be
      developed based on the SENSE therapy. Patients will be randomly allocated to either the
      sensorimotor therapy group or the pure motor therapy group; and will receive 16 hours of
      therapy. Motor and Somatosensory assessments will be performed at three time points:
      baseline(admission to rehabilitation center), immediately after the 16 hours of therapy and
      after 4 weeks of follow-up.

      The second objective is to investigate therapy-induced brain-behavior associations with
      resting state functional connectivity. In order to achieve insights in brain-behavior
      associations, we will perform resting-state functional Magnetic Resonance Imaging (fMRI)
      scans at the same time points as the clinical assessments: baseline, immediately after the 16
      hours of therapy, and four weeks after the end of the therapy. Both measurements,
      brain-imaging and clinical measurements will be combined to investigate the associations.

      This project will lead to new insights in brain-behavior associations of sensorimotor
      function of the upper limb after stroke and will provide evidence for a new therapy in upper
      limb stroke rehabilitation.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled Trial with two therapy groups ( experimental and control therapy) and one healthy control group
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The assessor will be masked for treatment group
measure: Action Research Arm Test
time frame: within 4 months post stroke
description: grasp, grip, pinch and gross movement of the affected arm and hand
measure: Fugl-Meyer motor Assessment-upper Extremity
time frame: within 4 months post stroke
description: overall motor impairment of the affected upper limb: shoulder, arm, wrist , hand and fingers
measure: composite standardized somatosensory deficit index
time frame: within 4 months post stroke
description: composite standardized score consisting of fabric matching test, wrist position sense test and functional tactile object recognition test
measure: Erasmus modified Nottingham Sensory Assessment
time frame: within 4 months post stroke
description: light touch, pressure, sharp, sharp-dull discrimination, position sense of the arm and hand
measure: Perceptual Threshold of Touch
time frame: within 4 months post stroke
description: threshold of light touch determined with Transcutaneous Electric Nerve Stimulation at the index finger.
measure: Nine Hole Peg test
time frame: within 4 months post stroke
description: manual dexterity
measure: Stroke Upper Limb Capacity Scale
time frame: within 4 months post stroke
description: upper limb capacity by the means of ten functional and meaningful tasks related to daily live activities
measure: functional connectivity
time frame: within 4 months post stroke
description: resting-state fMRI functional connectivity between Regions of Interest of the sensorimotor network
arm group label: sensorimotor therapy
arm group type: Experimental
description: sensorimotor therapy will consist of 30minutes of sensory discrimination training and 30 minutes of sensorimotor training per session. The sensory discrimination training is based on on the SENSe training of Carey et all. The sensorimotor training is the same individually tailored motor therapy as described below, but with integration of sensory discrimination training aspects.
arm group label: motor therapy
arm group type: Active Comparator
description: The motor therapy consists of 30 minutes of cognitive and attention-based table top games and 30 minutes of motor training per session. The cognitive-attention-based therapy consists of table top games such as chess, rush hour, or other smart games. Individually tailored motor therapy consists of a unilateral motor exercise program for the upper limb, while seated at a table, under supervision of a therapist to match the therapy and intensity provided in the other sensorimotor therapy group. This 30 minutes of motor arm training is based on a set of standardized exercises which comprise task-related practice for gross movements and dexterity including different grips and selective finger movements, and training in daily life activities, however without any attention to sensory discrimination training.
intervention type: Other
intervention name: additional sensorimotor therapy for the upper limb
description: The intervention will consist of additional physiotherapy for the upper limb after stroke consisting of sensory discrimination training and sensorimotor training.
arm group label: sensorimotor therapy
intervention type: Other
intervention name: additional motor therapy for the upper limb after stroke
description: The intervention will consist of additional physiotherapy for the upper limb after stroke consisting of cognitive-attention based training and motor training
arm group label: motor therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Geert Verheyden
role: Principal Investigator
affiliation: KU Leuven
facility: 
country: Belgium
citation: Carey L, Macdonell R, Matyas TA. SENSe: Study of the Effectiveness of Neurorehabilitation on Sensation: a randomized controlled trial. Neurorehabil Neural Repair. 2011 May;25(4):304-13. doi: 10.1177/1545968310397705. Epub 2011 Feb 24.
PMID: 21350049
responsible party type: Principal Investigator
investigator affiliation: Universitaire Ziekenhuizen KU Leuven
investigator full name: Geert Verheyden
investigator title: Professor
mesh term: Stroke
sharing ipd: Undecided