<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/NCT01663454</url>
  </required_header>
  <id_info>
    <org_study_id>bhø_2011/2271</org_study_id>
    <nct_id>NCT01663454</nct_id>
  </id_info>
  <brief_title>Working Memory Training in Children With Cerebral Palsy, a Pilot Study</brief_title>
  <official_title>Computer Based Working Memory Training in Children With Cerebral Palsy, a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helse Stavanger HF</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Helse Stavanger HF</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this pilot study is to assist the preparation of a larger multi-center study.&#xD;
      The main aim is to determine the feasibility of conducting computerized working memory&#xD;
      training in a group of children with cerebral palsy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in training index</measure>
    <time_frame>Changes in training index is measured during 5 weeks of working memory training</time_frame>
    <description>The training index is based on the user's best results from selected exercises in the program. The Start Index is calculated with the results from days 2 and 3, and the Max Index is calculated with the results from the two best days during the training period. The Index Improvement is calculated by subtracting the Start Index from the Max Index.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological testing</measure>
    <time_frame>baseline and 2 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Cerebral Palsy</condition>
  <condition>Working Memory Training</condition>
  <arm_group>
    <arm_group_label>Cogmed Robomemo working memory training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will complete 25 sessions (5 weeks) of Cogmed Robomemo (Pearson assessment) working memory training</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cogmed Robomemo working memory training</intervention_name>
    <description>The Cogmed Robomemo program is designed as a computer game in which an animated robot gives different tasks to be solved by the child. The tasks have various degrees of difficulty adapted continuously throughout the intervention period to the performance of the individual child. The program is standardized in that each child receives the same set of tasks during the training period. The child will perform the training sessions at home using their own computer for about 35-40 minutes each day.</description>
    <arm_group_label>Cogmed Robomemo working memory training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Born at term with unilateral spastic CP&#xD;
&#xD;
          -  Born preterm with bilateral spastic CP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with Gross Motor Function Classification Scale (GMFCS) level V&#xD;
&#xD;
          -  Severe visual or hearing impairments&#xD;
&#xD;
          -  Photosensitive epilepsy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harald Beneventi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Helse Stavanger HF</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stavanger University Hospital</name>
      <address>
        <city>Stavanger</city>
        <zip>4011</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>October 7, 2014</last_update_submitted>
  <last_update_submitted_qc>October 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 8, 2014</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>Cerebral Palsy</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/NCT01663454
org study id: bhø_2011/2271
nct id: NCT01663454
lead sponsor: 
has dmc: No
The purpose of this pilot study is to assist the preparation of a larger multi-center study.
      The main aim is to determine the feasibility of conducting computerized working memory
      training in a group of children with cerebral palsy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in training index
time frame: Changes in training index is measured during 5 weeks of working memory training
description: The training index is based on the user's best results from selected exercises in the program. The Start Index is calculated with the results from days 2 and 3, and the Max Index is calculated with the results from the two best days during the training period. The Index Improvement is calculated by subtracting the Start Index from the Max Index.
measure: Neuropsychological testing
time frame: baseline and 2 months
arm group label: Cogmed Robomemo working memory training
arm group type: Experimental
description: Participants will complete 25 sessions (5 weeks) of Cogmed Robomemo (Pearson assessment) working memory training
intervention type: Behavioral
intervention name: Cogmed Robomemo working memory training
description: The Cogmed Robomemo program is designed as a computer game in which an animated robot gives different tasks to be solved by the child. The tasks have various degrees of difficulty adapted continuously throughout the intervention period to the performance of the individual child. The program is standardized in that each child receives the same set of tasks during the training period. The child will perform the training sessions at home using their own computer for about 35-40 minutes each day.
arm group label: Cogmed Robomemo working memory training
criteria: 
gender: All
minimum age: 7 Years
maximum age: 8 Years
healthy volunteers: No
last name: Harald Beneventi, PhD
role: Principal Investigator
affiliation: Helse Stavanger HF
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Cerebral Palsy