xml: <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/NCT05970367</url>
    </required_header>
    <id_info>
      <org_study_id>S67164</org_study_id>
      <nct_id>NCT05970367</nct_id>
    </id_info>
    <brief_title>Intensive Motor Rehabilitation With Technology for Patients With Central Neurological Disease</brief_title>
    <acronym>INTeRAcT</acronym>
    <official_title>Impact of an Intensive Motor Rehabilitation Programme Integrating Technology for Adults With Central Neurological Disease: A Randomised Controlled Rehabilitation Study in the Chronic Phase</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>KU Leuven</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>AZ Herentals</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Vrije Universiteit Brussel</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>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>
        This project will consist of 1 large clinical trial with 2 core concepts: (1) Clinical&#xD;
        benefits of an intensive rehabilitation programme using advanced technology, compared to the&#xD;
        control group; (2) A full health economic evaluation combined with model-based estimation of&#xD;
        costs and benefits.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 10, 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
    <phase>Phase 2/Phase 3</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>Randomised controlled trial (RCT)</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Functional Independence Measure (FIM)</measure>
      <time_frame>Baseline - 3weeks - 9months</time_frame>
      <description>The Functional Independence Measure (FIM), which measures independence in daily functioning after stroke. The FIM consists of 18 items designed to assess to what extent a person needs assistance in performing activities of daily living safely and efficiently. The activities consist of a number of basic skills related to self-care, pelvic floor function, transfers, gait, communication and social abilities. The FIM has acceptable reliability and has been found valid in people with stroke.&#xD;
  Min: 13; Max: 91; Higher = better</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Spinal Cord Independence Measure (SCIM)</measure>
      <time_frame>Baseline - 3weeks - 9months</time_frame>
      <description>Spinal Cord Independence Measure (SCIM), an assessment of achievements of daily function of patients with spinal cord lesions. The scale consists of 19 tasks organized in 3 subscales: self-care, respiration and sphincter management, and mobility. The SCIM is valid and reliable.&#xD;
  Min: 0; Max: 100; Higher = better</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in The Canadian Occupational Performance Measure (COPM)</measure>
      <time_frame>Baseline - 3weeks - 9months</time_frame>
      <description>The Canadian Occupational Performance Measure (COPM), is an evidence-based outcome measure designed to capture a patient's self-perception of performance in everyday living, over time. This outcome can be used in both study populations.&#xD;
  Min: 1; Max: 10; Higher = better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in EQ-5D-5L</measure>
      <time_frame>Baseline - 3weeks - every month during follow-up - 9 months</time_frame>
      <description>EQ-5D-5L, measures quality of life at five levels of health (mobility, self-care, daily activities, pain/discomfort and anxiety/depression). From this, a weighted health index can be calculated for an individual or population. This scale can also be used for both populations.&#xD;
  Min: 1; Max: 100; Higher = better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Goal Attainment Scaling (GAS)</measure>
      <time_frame>Baseline - 3weeks - 9months</time_frame>
      <description>Goal Attainment Scaling (GAS), is an individualised evaluation method. It is scored on an ordinal 5-point scale, which captures a person's individual treatment goal and is scored afterwards on the achievement of that treatment goal. The GAS can and will be used for both stroke and spinal cord injury.&#xD;
  Min: -2; Max: +2; Higher = better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in The fatigue severity scale (FSS)</measure>
      <time_frame>Baseline - 3weeks - 9months</time_frame>
      <description>The fatigue severity scale (FSS) contains 9 questions assessing the perceived severity of fatigue symptoms in the past week in various daily situations. The patient indicates the extent to which fatigue determines functioning. Again, this will be used for both stroke and spinal cord injury.&#xD;
  Min: 9; Max: 63; Higher = worse</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Borg Rating of Perceived Exertion Scale</measure>
      <time_frame>During intervention (up to 9 months)</time_frame>
      <description>During the intervention the Borg Rating of Perceived Exertion Scale will be completed to after every therapy block to assess subjective experiences of the patients during physical load.&#xD;
  Min: 6; Max: 20; Higher = worse</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the 6-minute Walk-Test (6MWT)</measure>
      <time_frame>Baseline - 3weeks - 9months (stroke only)</time_frame>
      <description>The 6-minute Walk-Test (6MWT) is used to measure functional capacity. The maximum distance the patient can cover within 6 minutes is measured.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the action research Arm Test (ARAT)</measure>
      <time_frame>Baseline - 3weeks - 9months (stroke only)</time_frame>
      <description>The action research Arm Test (ARAT) is an observational measure to assess upper extremity performance (coordination, dexterity and functioning), including 19 items. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally).&#xD;
  Min: 0; Max: 57; Higher = better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in rhe Fugl-Meyer Assessment (FMA)</measure>
      <time_frame>Baseline - 3weeks - 9months (stroke only)</time_frame>
      <description>The Fugl-Meyer Assessment (FMA) is designed to assess motor functioning in upper and lower limbs, in patients with post-stroke. Patients are assessed on 50 test items and on an ordinal 3-point scale.&#xD;
  Min: 0; Max: 100; Higher = better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the functional Ambulation Classification (FAC)</measure>
      <time_frame>Baseline - 3weeks - 9months (stroke only)</time_frame>
      <description>The functional Ambulation Classification (FAC): is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient needs when walking, whether or not they use a personal assistive device.&#xD;
  Min: 0; Max: 5; Higher = better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the 10 Meter Walk Test (10MWT)</measure>
      <time_frame>Baseline - 3weeks - 9months (stroke only)</time_frame>
      <description>The 10 Meter Walk Test (10MWT) measures the time needed for a person to walk 10 meters. It is used to determine functional mobility and gait.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the Stroke Self-efficacy Questionnaire</measure>
      <time_frame>Baseline - 3weeks - 9months (stroke only)</time_frame>
      <description>The Stroke Self-efficacy Questionnaire Evaluate individuals' confidence in carrying out activities of daily living.&#xD;
  Min: 0; Max: 60; Higher = better</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change in health economic evaluation</measure>
      <time_frame>Baseline - 3weeks - every month during follow-up - 9 months</time_frame>
      <description>Through this questionnaire, health economic data are surveyed to estimate direct and indirect costs that participants have due to their condition.&#xD;
  The following types of resource use will be collected: primary care, emergency visits, inpatient stays, outpatient services, medication, transport costs, the estimation of the amount of informal care, days away from work, and social benefits (e.g. sickness leave payments).</description>
    </other_outcome>
    <other_outcome>
      <measure>Therapy diary</measure>
      <time_frame>every month during follow-up (up to 9 months)</time_frame>
      <description>Using a therapy diary that the investigators ask patients to fill in every time they have been to the physical therapist/psychologist. On a monthly basis, these records are requested via mail.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Stroke</condition>
    <condition>Spinal Cord Injuries</condition>
    <condition>Chronic Disease</condition>
    <arm_group>
      <arm_group_label>Intensive rehabilitation program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>3 weeks of intensive rehabilitation --&gt; follow-up 9 months standard care</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Follow-up 9 months standard care --&gt; 3 weeks of intensive rehabilitation</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Intensive rehabilitation programme</intervention_name>
      <description>Intensive rehabilitation using advanced technology, based on the patient's goals.&#xD;
  Including cardiovascular fitness training, goal-oriented training, physiotherapy with and without advanced technology and self-management.</description>
      <arm_group_label>Intensive rehabilitation program</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Voluntary written informed consent of the participant or their legally authorized&#xD;
               representative has been obtained prior to any screening procedures;&#xD;
  &#xD;
            2. A diagnosis of central neurological disease, made by a specialist. Conditions may&#xD;
               include stroke or spinal cord injury:&#xD;
  &#xD;
                 1. Stroke: Participants must have received a diagnosis of stroke for the first time,&#xD;
                    have been diagnosed at least 3 months ago, and live at home.&#xD;
  &#xD;
                 2. SCI: Participants have a rating A, B, C or D on the American Spinal Injury&#xD;
                    Association (ASIA) measurement scale, which refers to patients with complete or&#xD;
                    incomplete impairment. All levels of SCI can be included, if there is a clear&#xD;
                    patient need linked to the upper and/or lower extremities.&#xD;
  &#xD;
            3. At least 3 months post discharge from hospital/rehabilitation centre, living at home;&#xD;
  &#xD;
            4. Having a maximum recovery of 85% of independence in daily functioning (FIM/SCIM);&#xD;
  &#xD;
            5. Had a normal functional state prior to the pathology: a pre-pathology Barthel Index &gt;&#xD;
               85/100;&#xD;
  &#xD;
            6. Unilateral or bilateral weakness of the affected upper or lower limbs (No maximum&#xD;
               score in all affected limbs = motricity index: score 5 on 3/3 segments)&#xD;
  &#xD;
            7. Having the clinical opportunity to engage in exercise therapy with available&#xD;
               technology, assessed by a specialist;&#xD;
  &#xD;
            8. Age of &gt; 18 years;&#xD;
  &#xD;
            9. Sufficient cognitive ability to understand the games and give informed consent,&#xD;
               assessed by a specialist;.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Having other neurological or musculoskeletal conditions that may affect the protocol,&#xD;
               assessed by a specialist;&#xD;
  &#xD;
            2. No ability to initiate movements against gravity in the upper and lower limbs;&#xD;
  &#xD;
            3. Severe visual impairment, communication, cognitive and language formation problems&#xD;
               that would prevent the intervention and measurement process, assessed by a specialist;&#xD;
  &#xD;
            4. Any disorder, which in the investigator's opinion might the compromise participant's&#xD;
               safety or compliance with the CIP;&#xD;
  &#xD;
            5. Female who is pregnant, breast-feeding.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>AZ Herentals</name>
        <address>
          <city>Herentals</city>
          <zip>2200</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ingue Allewijn</last_name>
        <phone>014 24 61 60</phone>
        <email>ingue.allewijn@azherentals.be</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>KU Leuven</name>
        <address>
          <city>Leuven</city>
          <zip>3000</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marjan Coremans</last_name>
        <phone>+32 16 19 34 52</phone>
        <email>marjan.coremans@kuleuven.be</email>
      </contact>
      <contact_backup>
        <last_name>Geert Verheyden</last_name>
        <email>geert.verheyden@kuleuven.be</email>
      </contact_backup>
      <investigator>
        <last_name>Marjan Coremans</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Geert Verheyden</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>KU Leuven</investigator_affiliation>
      <investigator_full_name>Prof Geert Verheyden</investigator_full_name>
      <investigator_title>Prof.</investigator_title>
    </responsible_party>
    <keyword>rehabilitation</keyword>
    <keyword>intensive</keyword>
    <keyword>technology</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Cord Injuries</mesh_term>
      <mesh_term>Nervous System Diseases</mesh_term>
      <mesh_term>Chronic Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05970367
  org study id: S67164
  nct id: NCT05970367
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This project will consist of 1 large clinical trial with 2 core concepts: (1) Clinical
        benefits of an intensive rehabilitation programme using advanced technology, compared to the
        control group; (2) A full health economic evaluation combined with model-based estimation of
        costs and benefits.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomised controlled trial (RCT)
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Change in Functional Independence Measure (FIM)
  time frame: Baseline - 3weeks - 9months
  description: The Functional Independence Measure (FIM), which measures independence in daily functioning after stroke. The FIM consists of 18 items designed to assess to what extent a person needs assistance in performing activities of daily living safely and efficiently. The activities consist of a number of basic skills related to self-care, pelvic floor function, transfers, gait, communication and social abilities. The FIM has acceptable reliability and has been found valid in people with stroke.
  Min: 13; Max: 91; Higher = better
  measure: Change in Spinal Cord Independence Measure (SCIM)
  time frame: Baseline - 3weeks - 9months
  description: Spinal Cord Independence Measure (SCIM), an assessment of achievements of daily function of patients with spinal cord lesions. The scale consists of 19 tasks organized in 3 subscales: self-care, respiration and sphincter management, and mobility. The SCIM is valid and reliable.
  Min: 0; Max: 100; Higher = better
  measure: Change in The Canadian Occupational Performance Measure (COPM)
  time frame: Baseline - 3weeks - 9months
  description: The Canadian Occupational Performance Measure (COPM), is an evidence-based outcome measure designed to capture a patient's self-perception of performance in everyday living, over time. This outcome can be used in both study populations.
  Min: 1; Max: 10; Higher = better
  measure: Change in EQ-5D-5L
  time frame: Baseline - 3weeks - every month during follow-up - 9 months
  description: EQ-5D-5L, measures quality of life at five levels of health (mobility, self-care, daily activities, pain/discomfort and anxiety/depression). From this, a weighted health index can be calculated for an individual or population. This scale can also be used for both populations.
  Min: 1; Max: 100; Higher = better
  measure: Change in Goal Attainment Scaling (GAS)
  time frame: Baseline - 3weeks - 9months
  description: Goal Attainment Scaling (GAS), is an individualised evaluation method. It is scored on an ordinal 5-point scale, which captures a person's individual treatment goal and is scored afterwards on the achievement of that treatment goal. The GAS can and will be used for both stroke and spinal cord injury.
  Min: -2; Max: +2; Higher = better
  measure: Change in The fatigue severity scale (FSS)
  time frame: Baseline - 3weeks - 9months
  description: The fatigue severity scale (FSS) contains 9 questions assessing the perceived severity of fatigue symptoms in the past week in various daily situations. The patient indicates the extent to which fatigue determines functioning. Again, this will be used for both stroke and spinal cord injury.
  Min: 9; Max: 63; Higher = worse
  measure: Borg Rating of Perceived Exertion Scale
  time frame: During intervention (up to 9 months)
  description: During the intervention the Borg Rating of Perceived Exertion Scale will be completed to after every therapy block to assess subjective experiences of the patients during physical load.
  Min: 6; Max: 20; Higher = worse
  measure: Change in the 6-minute Walk-Test (6MWT)
  time frame: Baseline - 3weeks - 9months (stroke only)
  description: The 6-minute Walk-Test (6MWT) is used to measure functional capacity. The maximum distance the patient can cover within 6 minutes is measured.
  measure: Change in the action research Arm Test (ARAT)
  time frame: Baseline - 3weeks - 9months (stroke only)
  description: The action research Arm Test (ARAT) is an observational measure to assess upper extremity performance (coordination, dexterity and functioning), including 19 items. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally).
  Min: 0; Max: 57; Higher = better
  measure: Change in rhe Fugl-Meyer Assessment (FMA)
  time frame: Baseline - 3weeks - 9months (stroke only)
  description: The Fugl-Meyer Assessment (FMA) is designed to assess motor functioning in upper and lower limbs, in patients with post-stroke. Patients are assessed on 50 test items and on an ordinal 3-point scale.
  Min: 0; Max: 100; Higher = better
  measure: Change in the functional Ambulation Classification (FAC)
  time frame: Baseline - 3weeks - 9months (stroke only)
  description: The functional Ambulation Classification (FAC): is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient needs when walking, whether or not they use a personal assistive device.
  Min: 0; Max: 5; Higher = better
  measure: Change in the 10 Meter Walk Test (10MWT)
  time frame: Baseline - 3weeks - 9months (stroke only)
  description: The 10 Meter Walk Test (10MWT) measures the time needed for a person to walk 10 meters. It is used to determine functional mobility and gait.
  measure: Change in the Stroke Self-efficacy Questionnaire
  time frame: Baseline - 3weeks - 9months (stroke only)
  description: The Stroke Self-efficacy Questionnaire Evaluate individuals' confidence in carrying out activities of daily living.
  Min: 0; Max: 60; Higher = better
  measure: Change in health economic evaluation
  time frame: Baseline - 3weeks - every month during follow-up - 9 months
  description: Through this questionnaire, health economic data are surveyed to estimate direct and indirect costs that participants have due to their condition.
  The following types of resource use will be collected: primary care, emergency visits, inpatient stays, outpatient services, medication, transport costs, the estimation of the amount of informal care, days away from work, and social benefits (e.g. sickness leave payments).
  measure: Therapy diary
  time frame: every month during follow-up (up to 9 months)
  description: Using a therapy diary that the investigators ask patients to fill in every time they have been to the physical therapist/psychologist. On a monthly basis, these records are requested via mail.
  arm group label: Intensive rehabilitation program
  arm group type: Experimental
  description: 3 weeks of intensive rehabilitation --> follow-up 9 months standard care
  arm group label: Standard care
  arm group type: No Intervention
  description: Follow-up 9 months standard care --> 3 weeks of intensive rehabilitation
  intervention type: Other
  intervention name: Intensive rehabilitation programme
  description: Intensive rehabilitation using advanced technology, based on the patient's goals.
  Including cardiovascular fitness training, goal-oriented training, physiotherapy with and without advanced technology and self-management.
  arm group label: Intensive rehabilitation program
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Belgium
  responsible party type: Principal Investigator
  investigator affiliation: KU Leuven
  investigator full name: Prof Geert Verheyden
  investigator title: Prof.
  mesh term: Spinal Cord Injuries
  mesh term: Nervous System Diseases
  mesh term: Chronic Disease
  sharing ipd: No