<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/NCT03798340</url>
  </required_header>
  <id_info>
    <org_study_id>A-ER-104-206</org_study_id>
    <nct_id>NCT03798340</nct_id>
  </id_info>
  <brief_title>Vibratory Perturbation-based Pinch Task Training for Stroke Patients</brief_title>
  <official_title>Effects of Motor Task-Specific Therapy Synchronized With Vibrotactile Cueing on Sensorimotor Performance of Upper Extremity for the Chronic Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cheng-Kung University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigator assumed that perturbed-event-induced vibrotactile cueing enable more&#xD;
      precision arm movement adjustment, sensory function and dexterity improvement in the spastic&#xD;
      arm. Thus the specific aim of the study was to develop a vibrotactile therapy system that can&#xD;
      provide vibrotactile feedback through the pinch performance of the hand when countering&#xD;
      mechanically induced perturbations and also analyzed training effects of the&#xD;
      perturbation-based pinch task training system on the sensorimotor performance of the hands&#xD;
      for stroke patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 24, 2016</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">October 4, 2016</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 the result of Fugl-Meyer assessment for UE motor function</measure>
    <time_frame>baseline, endpoint (6 weeks) and follow up (18 weeks)</time_frame>
    <description>Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the result of Modified Ashworth scale (MAS)</measure>
    <time_frame>baseline, endpoint (6 weeks) and follow up (18 weeks)</time_frame>
    <description>Muscle tone is defined by the resistance of a muscle being stretched.The tester graded the resistance felt, with a single score. The higher values represent a worse outcome. 0 point for no increase in muscle tone; 1 point for slight increase in muscle tone, manifested by a catch or by minimal resistance at the end of the range of motion (ROM) when the affected part is moved in flexion or extension; 1 + for slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2 point for more marked increase in muscle tone through most of the ROM, but affected parteasily moved, 3 point for considerable increase in muscle tone and passive movement difficult; 4 point for affected part rigid in flexion or extension.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the result of Box and blocks test</measure>
    <time_frame>baseline, endpoint (6 weeks) and follow up (18 weeks)</time_frame>
    <description>The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the result of Semmes-Weinstein monofilament (SWM) test</measure>
    <time_frame>baseline, endpoint (6 weeks) and follow up (18 weeks)</time_frame>
    <description>The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the result of Motor Activity Log</measure>
    <time_frame>baseline, endpoint (6 weeks) and follow up (18 weeks)</time_frame>
    <description>MAL is a structured interview with testing sensitivity used to examine how much (amount of use, AOU) and how well (quality of movement, QOM) the subject uses their more-affected arm. For the 30 items MAL, each item is scored on a 0-5-ordinal scale.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Stroke Rehabilitation</condition>
  <arm_group>
    <arm_group_label>Vibratory perturbed task-specific movement training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: 10 minutes of traditional sensorimotor facilitation followed by 20 minutes of vibratory perturbed task-specific movement training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional task-oriented facilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention:10 minutes of traditional sensorimotor training followed by 20 minutes of reach-to-grasp and hand release training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vibratory perturbed task-specific movement training</intervention_name>
    <description>The perturbation-based pinch task training was conducted with the affected hand placed on the pinch device. The horizontal vibratory perturbation was generated for a total of 20 minutes by two recoil-type actuators with a frequency of 30 Hz and an amplitude of 2 mm, and intermittent exposure (10 s per 30 s). Each training session was divided into eight cycles with a training interval of 2 min per 2.5 min.</description>
    <arm_group_label>Vibratory perturbed task-specific movement training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traditional task-oriented facilitation</intervention_name>
    <description>Reach-to-grasp training and hand release training</description>
    <arm_group_label>Traditional task-oriented facilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sensorimotor training</intervention_name>
    <description>Targeted to goals that are relevant to the sensorimotor facilitation of the patient</description>
    <arm_group_label>Traditional task-oriented facilitation</arm_group_label>
    <arm_group_label>Vibratory perturbed task-specific movement training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical diagnosis of unilateral cerebral infarction or hemorrhage&#xD;
&#xD;
          2. Be able to perform a pinch task with the thumb and index finger&#xD;
&#xD;
          3. With premorbid right-handedness&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has a uncontrolled hypertension&#xD;
&#xD;
          2. Subject has major cognitive-perceptual deficits&#xD;
&#xD;
          3. Subject has other brain disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Cheng-Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>perturbation-based training</keyword>
  <keyword>task-specific motor training</keyword>
  <keyword>recovery of function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03798340
org study id: A-ER-104-206
nct id: NCT03798340
lead sponsor: 
is fda regulated drug: No
The investigator assumed that perturbed-event-induced vibrotactile cueing enable more
      precision arm movement adjustment, sensory function and dexterity improvement in the spastic
      arm. Thus the specific aim of the study was to develop a vibrotactile therapy system that can
      provide vibrotactile feedback through the pinch performance of the hand when countering
      mechanically induced perturbations and also analyzed training effects of the
      perturbation-based pinch task training system on the sensorimotor performance of the hands
      for stroke patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in the result of Fugl-Meyer assessment for UE motor function
time frame: baseline, endpoint (6 weeks) and follow up (18 weeks)
description: Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.
measure: Change in the result of Modified Ashworth scale (MAS)
time frame: baseline, endpoint (6 weeks) and follow up (18 weeks)
description: Muscle tone is defined by the resistance of a muscle being stretched.The tester graded the resistance felt, with a single score. The higher values represent a worse outcome. 0 point for no increase in muscle tone; 1 point for slight increase in muscle tone, manifested by a catch or by minimal resistance at the end of the range of motion (ROM) when the affected part is moved in flexion or extension; 1 + for slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2 point for more marked increase in muscle tone through most of the ROM, but affected parteasily moved, 3 point for considerable increase in muscle tone and passive movement difficult; 4 point for affected part rigid in flexion or extension.
measure: Change in the result of Box and blocks test
time frame: baseline, endpoint (6 weeks) and follow up (18 weeks)
description: The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.
measure: Change in the result of Semmes-Weinstein monofilament (SWM) test
time frame: baseline, endpoint (6 weeks) and follow up (18 weeks)
description: The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.
measure: Change in the result of Motor Activity Log
time frame: baseline, endpoint (6 weeks) and follow up (18 weeks)
description: MAL is a structured interview with testing sensitivity used to examine how much (amount of use, AOU) and how well (quality of movement, QOM) the subject uses their more-affected arm. For the 30 items MAL, each item is scored on a 0-5-ordinal scale.
arm group label: Vibratory perturbed task-specific movement training
arm group type: Experimental
description: Intervention: 10 minutes of traditional sensorimotor facilitation followed by 20 minutes of vibratory perturbed task-specific movement training
arm group label: Traditional task-oriented facilitation
arm group type: Active Comparator
description: Intervention:10 minutes of traditional sensorimotor training followed by 20 minutes of reach-to-grasp and hand release training.
intervention type: Other
intervention name: Vibratory perturbed task-specific movement training
description: The perturbation-based pinch task training was conducted with the affected hand placed on the pinch device. The horizontal vibratory perturbation was generated for a total of 20 minutes by two recoil-type actuators with a frequency of 30 Hz and an amplitude of 2 mm, and intermittent exposure (10 s per 30 s). Each training session was divided into eight cycles with a training interval of 2 min per 2.5 min.
arm group label: Vibratory perturbed task-specific movement training
intervention type: Other
intervention name: Traditional task-oriented facilitation
description: Reach-to-grasp training and hand release training
arm group label: Traditional task-oriented facilitation
intervention type: Other
intervention name: Sensorimotor training
description: Targeted to goals that are relevant to the sensorimotor facilitation of the patient
arm group label: Traditional task-oriented facilitation
arm group label: Vibratory perturbed task-specific movement training
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Stroke