<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/NCT01696864</url>
  </required_header>
  <id_info>
    <org_study_id>SHEBA-12-9471-GZ-CTIL</org_study_id>
    <nct_id>NCT01696864</nct_id>
  </id_info>
  <brief_title>Remote Rehabilitation Via the Internet in Patients After a Stroke - Physical Rehabilitation Using Biofeedback Systems to Improve Upper Extremity Function</brief_title>
  <official_title>Remote Rehabilitation Via the Internet in Patients After a Stroke - Physical Rehabilitation Using Biofeedback Systems to Improve Upper Extremity Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to examine monitored rehabilitation therapy over the internet&#xD;
      to improve upper limb function for stroke patients. Home rehabilitation for stroke patients&#xD;
      will avoid the burden of arrival to the health facilities, making it easier on them and&#xD;
      improve their quality of life and the lives of their caregivers. To achieve this goal the&#xD;
      investigators will examine the effectiveness and feasibility of home rehabilitation system of&#xD;
      upper limb, consisting of ergonomic accessories (hand and arm tutors).&#xD;
&#xD;
      The quantitative indices will be based on the quantitative clinical measures that are used in&#xD;
      regular evaluations of stroke patients and function and range of motion indices as received&#xD;
      from the system.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment upper extremity part (FMA)</measure>
    <time_frame>10 minutes</time_frame>
    <description>The FMA assesses the motor impairment of the upper extremity after stroke. Each movement is graded on a 3-point scale, and the total score for the upper extremity ranges from 0-60 points where a higher score represents more active movements. An additional part assesses the coordination of the affected upper extremity and the score ranges between 0-6 where a higher score represents poorer coordination ability. This test is one of the most commonly used instruments in rehabilitation and its validity and reliability have been well established</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arm and Hand Activity Inventory (CAHAI)</measure>
    <time_frame>10 minutes</time_frame>
    <description>The test assesses the functional ability of the affected arm and hand of people with stroke. The abbreviated version includes 7 functional activities (e.g. open a jar of coffee) that require bilateral use of the upper extremities as well various types of grip. The score range between1 and 7</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Motor Activity Log (MAL)</measure>
    <time_frame>10 minutes</time_frame>
    <description>The MAL consist of a semi structured interview for the patient to assess the use of the paretic arm and hand during daily activities. Two scores on a scale of 1 -5, are given for each activity;for the amount of use (AOU) and for the quality of movement (QOM). Usability of the system i.e. ease of use of the system</description>
  </primary_outcome>
  <primary_outcome>
    <measure>System Usability Scale (SUS)</measure>
    <time_frame>10 minutes</time_frame>
    <description>This questionnaire includes 10 items rated on a 5 points scale, which provide a global view of subjective assessment of a system's usability. The item scores were calculated to give an overall score ranging from 10 to 100 points. The SUS has been shown to be a robust and reliable evaluation tool</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Box&amp; Block Test of Manual Dexterity</measure>
    <time_frame>10 minutes</time_frame>
    <description>This is a valid and reliable test which is used to assess hand dexterity. In addition it is used to assess endurance of the upper extremity. The subject is asked to transfer cubes, above a partition, from one side of a box to the other for one minute with both hands. The score is the number of cubes that were transferred. In addition: Range of motion of fingers, wrist elbow and shoulder as measured by the devices</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Stroke Patients</condition>
  <arm_group>
    <arm_group_label>stroke patients - hand</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>stroke patients with the ability to move their hand</description>
  </arm_group>
  <arm_group>
    <arm_group_label>stroke patient - arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>stroke patients with the ability to move their arms</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hand tutor rehabilitation device</intervention_name>
    <description>A rehabilitation device for the hand</description>
    <arm_group_label>stroke patients - hand</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Arm tutor rehabilitation device</intervention_name>
    <description>A rehabilitation device for the arm</description>
    <arm_group_label>stroke patient - arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stroke patients who had at least eight conventional rehabilitation treatments lasted&#xD;
             at least until a month before the start of the experiment,&#xD;
&#xD;
          -  not affected cognitively (to be determined by the score on the mini mental exam&#xD;
             greater than 23).&#xD;
&#xD;
          -  patients have daily access to a computer and the Internet, and use a personal&#xD;
             caregiver or family member can supervise the use of the system.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Global or sensory aphasia, unilateral spatial neglect, apraxia and other acute&#xD;
             neurological or orthopedic conditions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gabi Zeilig, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheba Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sheba Medical Center rehabilitation facility</name>
      <address>
        <city>Ramat Gan</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>January 2, 2017</last_update_submitted>
  <last_update_submitted_qc>January 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT01696864
org study id: SHEBA-12-9471-GZ-CTIL
nct id: NCT01696864
lead sponsor: 
has dmc: No
The objective of this study is to examine monitored rehabilitation therapy over the internet
      to improve upper limb function for stroke patients. Home rehabilitation for stroke patients
      will avoid the burden of arrival to the health facilities, making it easier on them and
      improve their quality of life and the lives of their caregivers. To achieve this goal the
      investigators will examine the effectiveness and feasibility of home rehabilitation system of
      upper limb, consisting of ergonomic accessories (hand and arm tutors).

      The quantitative indices will be based on the quantitative clinical measures that are used in
      regular evaluations of stroke patients and function and range of motion indices as received
      from the system.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Fugl-Meyer Assessment upper extremity part (FMA)
time frame: 10 minutes
description: The FMA assesses the motor impairment of the upper extremity after stroke. Each movement is graded on a 3-point scale, and the total score for the upper extremity ranges from 0-60 points where a higher score represents more active movements. An additional part assesses the coordination of the affected upper extremity and the score ranges between 0-6 where a higher score represents poorer coordination ability. This test is one of the most commonly used instruments in rehabilitation and its validity and reliability have been well established
measure: Arm and Hand Activity Inventory (CAHAI)
time frame: 10 minutes
description: The test assesses the functional ability of the affected arm and hand of people with stroke. The abbreviated version includes 7 functional activities (e.g. open a jar of coffee) that require bilateral use of the upper extremities as well various types of grip. The score range between1 and 7
measure: Motor Activity Log (MAL)
time frame: 10 minutes
description: The MAL consist of a semi structured interview for the patient to assess the use of the paretic arm and hand during daily activities. Two scores on a scale of 1 -5, are given for each activity;for the amount of use (AOU) and for the quality of movement (QOM). Usability of the system i.e. ease of use of the system
measure: System Usability Scale (SUS)
time frame: 10 minutes
description: This questionnaire includes 10 items rated on a 5 points scale, which provide a global view of subjective assessment of a system's usability. The item scores were calculated to give an overall score ranging from 10 to 100 points. The SUS has been shown to be a robust and reliable evaluation tool
measure: Box& Block Test of Manual Dexterity
time frame: 10 minutes
description: This is a valid and reliable test which is used to assess hand dexterity. In addition it is used to assess endurance of the upper extremity. The subject is asked to transfer cubes, above a partition, from one side of a box to the other for one minute with both hands. The score is the number of cubes that were transferred. In addition: Range of motion of fingers, wrist elbow and shoulder as measured by the devices
arm group label: stroke patients - hand
arm group type: Experimental
description: stroke patients with the ability to move their hand
arm group label: stroke patient - arm
arm group type: Experimental
description: stroke patients with the ability to move their arms
intervention type: Device
intervention name: Hand tutor rehabilitation device
description: A rehabilitation device for the hand
arm group label: stroke patients - hand
intervention type: Device
intervention name: Arm tutor rehabilitation device
description: A rehabilitation device for the arm
arm group label: stroke patient - arm
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Gabi Zeilig, Dr.
role: Principal Investigator
affiliation: Sheba Medical Center
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Stroke