<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/NCT02982811</url>
  </required_header>
  <id_info>
    <org_study_id>i-ACT2</org_study_id>
    <nct_id>NCT02982811</nct_id>
  </id_info>
  <brief_title>Intelligent Activity-based Client-centred Training</brief_title>
  <acronym>i-ACT</acronym>
  <official_title>Intelligent Activity-based Client-centred Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PXL University College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Revalidatie &amp; MS Centrum Overpelt</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ziekenhuis Oost-Limburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hasselt University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>PXL University College</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>
      The purpose of this study is to determine whether additional therapy with i-ACT system is&#xD;
      effective in the training of functional skills in persons with central neurological diseases&#xD;
      (e.g. multiple sclerosis, stroke, spinal cord injury, etc.).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">June 26, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 2020</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wolf Motor Function Test (WMFT)</measure>
    <time_frame>At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up</time_frame>
    <description>Evaluation of upper extremity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short Form 36 (SF-36)</measure>
    <time_frame>At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up</time_frame>
    <description>Evaluation of general health status and quality of life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intrinsic Motivation Inventory (IMI)</measure>
    <time_frame>After 6 weeks of training, only persons in experimental group</time_frame>
    <description>Evaluation of motivation towards using the system in neurorehabilitation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Manual Ability Measure (MAM-36)</measure>
    <time_frame>At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up</time_frame>
    <description>Evaluation of performance of manual tasks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Fatigue Impact Scale (MFIS)</measure>
    <time_frame>At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up</time_frame>
    <description>Evaluation of fatigue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trunk Impairment Scale (TIS)</measure>
    <time_frame>At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up</time_frame>
    <description>Evaluation of sitting, standing and core stability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Active Range of Motion (AROM)</measure>
    <time_frame>At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up</time_frame>
    <description>Evaluation of active range of motion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Canadian Occupational Performance Measure (COPM)</measure>
    <time_frame>At baseline, after 6 weeks of training, and 6 weeks follow-up</time_frame>
    <description>Evaluation of self-perception of performance of ADL tasks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Central Nervous System Diseases</condition>
  <condition>Aged</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Therapy as usual, i.e. occupational therapy, physiotherapy, etc.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Therapy as usual together with 3x45min training with i-ACT system during 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>i-ACT</intervention_name>
    <description>3x 45 min training with i-ACT system (analytical and functional training) during 6 weeks, additional to therapy as usual (i.e. occupational therapy, physiotherapy, etc.)</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medical diagnosis of central nervous system disease (e.g. multiple sclerosis, stroke,&#xD;
             spinal cord, etc.)&#xD;
&#xD;
          -  Be able to understand and respond to questions in Dutch&#xD;
&#xD;
          -  Actively involved in a rehabilitation programme in the participating rehabilitation&#xD;
             centres&#xD;
&#xD;
          -  Have a dysfunction in upper and/or lower limb and/or core stability&#xD;
&#xD;
          -  Specifically for multiple sclerosis: min. of one month without corticosteroids&#xD;
&#xD;
          -  Specifically for stroke and spinal cord: min. 3 months post injury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe spasticity which prevent performing basic functional exercises&#xD;
&#xD;
          -  Severe cognitive and communicative impairment which prevent the person to understand&#xD;
             and respond to Dutch instructions&#xD;
&#xD;
          -  Severe visual impairment, e.g. blindness, cataract, etc.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Persons who use an electrical wheelchair, who can not transfer safely into a normal&#xD;
             chair and perform the exercises&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Annemie Spooren, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Centre of Expertise - Innovation in Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jessa Hospital - rehabilitation campus St-Ursula</name>
      <address>
        <city>Herk-de-Stad</city>
        <state>Limburg</state>
        <zip>3540</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Oost Limburg</name>
      <address>
        <city>Lanaken</city>
        <state>Limburg</state>
        <zip>3620</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Revalidatie en MS centrum</name>
      <address>
        <city>Overpelt</city>
        <state>Limburg</state>
        <zip>3900</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St-Trudo hospital</name>
      <address>
        <city>Sint-Truiden</city>
        <state>Limburg</state>
        <zip>3800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>PXL University College</investigator_affiliation>
    <investigator_full_name>Els Knippenberg</investigator_full_name>
    <investigator_title>Researcher and PhD student</investigator_title>
  </responsible_party>
  <keyword>Activity-based</keyword>
  <keyword>Client-centred</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Central Nervous System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 16, 2021</submitted>
    <returned>July 7, 2021</returned>
  </pending_results>
  <!-- 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/NCT02982811
org study id: i-ACT2
nct id: NCT02982811
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether additional therapy with i-ACT system is
      effective in the training of functional skills in persons with central neurological diseases
      (e.g. multiple sclerosis, stroke, spinal cord injury, etc.).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Wolf Motor Function Test (WMFT)
time frame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
description: Evaluation of upper extremity
measure: Short Form 36 (SF-36)
time frame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
description: Evaluation of general health status and quality of life
measure: Intrinsic Motivation Inventory (IMI)
time frame: After 6 weeks of training, only persons in experimental group
description: Evaluation of motivation towards using the system in neurorehabilitation
measure: Manual Ability Measure (MAM-36)
time frame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
description: Evaluation of performance of manual tasks
measure: Modified Fatigue Impact Scale (MFIS)
time frame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
description: Evaluation of fatigue
measure: Trunk Impairment Scale (TIS)
time frame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
description: Evaluation of sitting, standing and core stability
measure: Active Range of Motion (AROM)
time frame: At baseline, after 3 and 6 weeks of training, and 6 weeks follow-up
description: Evaluation of active range of motion
measure: Canadian Occupational Performance Measure (COPM)
time frame: At baseline, after 6 weeks of training, and 6 weeks follow-up
description: Evaluation of self-perception of performance of ADL tasks
arm group label: Control group
arm group type: No Intervention
description: Therapy as usual, i.e. occupational therapy, physiotherapy, etc.
arm group label: Experimental group
arm group type: Experimental
description: Therapy as usual together with 3x45min training with i-ACT system during 6 weeks.
intervention type: Device
intervention name: i-ACT
description: 3x 45 min training with i-ACT system (analytical and functional training) during 6 weeks, additional to therapy as usual (i.e. occupational therapy, physiotherapy, etc.)
arm group label: Experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Annemie Spooren, Prof. Dr.
role: Study Director
affiliation: Centre of Expertise - Innovation in Care
facility: 
facility: 
facility: 
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: PXL University College
investigator full name: Els Knippenberg
investigator title: Researcher and PhD student
mesh term: Nervous System Diseases
mesh term: Central Nervous System Diseases
sharing ipd: No
submitted: June 16, 2021
returned: July 7, 2021