<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/NCT03008486</url>
  </required_header>
  <id_info>
    <org_study_id>2016/292</org_study_id>
    <nct_id>NCT03008486</nct_id>
  </id_info>
  <brief_title>Long Term Effects of Soft Splints on Stroke Patients and Patients With Disorders of Consciousness</brief_title>
  <official_title>Long Term Effects of Soft Splints on Stroke Patients and Patients With Disorders of Consciousness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Géraldine Martens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre Hospitalier Universitaire UCLouvain Namur</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Liege</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effects on upper limb spasticity of soft splints&#xD;
      worn during three weeks three hours a day by patients with stroke or disorders of&#xD;
      consciousness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with stroke or disorders of consciousness (DOC) are likely to suffer from major&#xD;
      muscular troubles such as spasticity. This spasticity may induce pain, loss in range of&#xD;
      motion and permanent joint deformities. The aim of this study is to investigate the effects&#xD;
      of soft splinting on the hand spasticity in both patients with stroke and patients with&#xD;
      disorders of consciousness. The investigators plan to include 100 patients (50 stroke - 50&#xD;
      with DOC) and each subgroup will be divided in two arms: one wearing real soft splints (6 cm&#xD;
      diameter) three hours a day for 3 three weeks and the other one wearing 'placebo' splints (1&#xD;
      cm diameter).&#xD;
&#xD;
      Skin condition will be followed by the nursing team during the three weeks. Spasticity, pain&#xD;
      and consciousness assessments will be performed at baseline (week 0), after 1 week of&#xD;
      treatment (week 1) at the end of the treatment (week 3), 1 week later (week 4), 3 weeks later&#xD;
      (week 6) and three months later (week 12).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">June 2019</completion_date>
  <primary_completion_date type="Actual">January 2019</primary_completion_date>
  <phase>Phase 2</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 Modified Ashworth Scale</measure>
    <time_frame>Week 0, 1, 3, 4, 6, 12</time_frame>
    <description>Spasticity assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Modified Tardieu Scale</measure>
    <time_frame>Week 0, 1, 3, 4, 6, 12</time_frame>
    <description>Spasticity assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Nociception Coma Scale-Revised</measure>
    <time_frame>Week 0, 1, 3, 4, 6, 12</time_frame>
    <description>Pain assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Visual Analogue Scale</measure>
    <time_frame>Week 0, 1, 3, 4, 6, 12</time_frame>
    <description>Pain assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Palm-finger distance</measure>
    <time_frame>Week 0, 1, 3, 4, 6, 12</time_frame>
    <description>Range of motion assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the Coma Recovery Scale-Revised</measure>
    <time_frame>Week 0, 1, 3, 4, 6, 12</time_frame>
    <description>Consciousness assessment</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Brain Injuries</condition>
  <condition>Disorder of Consciousness</condition>
  <condition>Stroke</condition>
  <condition>Spasticity as Sequela of Stroke</condition>
  <condition>Contracture</condition>
  <condition>Hypertonic Disorder</condition>
  <condition>Central Nervous System Diseases</condition>
  <condition>Pathologic Processes</condition>
  <condition>Craniocerebral Trauma</condition>
  <condition>Trauma, Nervous System</condition>
  <condition>Neurocognitive Disorders</condition>
  <arm_group>
    <arm_group_label>DOC - real</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Spastic patients with disorders of consciousness receiving the real soft splint</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DOC - placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Spastic patients with disorders of consciousness receiving the placebo soft splint</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stroke - real</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Spastic patients stroke receiving the real soft splint</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stroke - placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Spastic patients stroke receiving the placebo soft splint</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Real soft splint (6 cm)</intervention_name>
    <arm_group_label>DOC - real</arm_group_label>
    <arm_group_label>Stroke - real</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo soft splint (1 cm)</intervention_name>
    <arm_group_label>DOC - placebo</arm_group_label>
    <arm_group_label>Stroke - placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (DOC):&#xD;
&#xD;
          -  Altered state of consciousness according to international criteria since more than&#xD;
             three months&#xD;
&#xD;
          -  Stable condition&#xD;
&#xD;
          -  Ashworth score &gt; 1 for at least one upper limb joint&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bone fracture/lesion at the upper limbs&#xD;
&#xD;
          -  Serious neurological disorder (MMSE &gt; 24) prior to the accident&#xD;
&#xD;
          -  Botox injection on the upper limbs in the 6 months preceding the inclusion&#xD;
&#xD;
        Inclusion Criteria (stroke):&#xD;
&#xD;
          -  Central nervous system injury responsible for the spasticity&#xD;
&#xD;
          -  Ashworth score &gt; 1 for at least one upper limb joint&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bone fracture/lesion at the upper limbs&#xD;
&#xD;
          -  Serious neurological disorder (MMSE &gt; 24)&#xD;
&#xD;
          -  Botox injection on the upper limbs in the 6 months preceding the inclusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicolas Lejeune</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Neurologique William Lennox</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Neurologique William Lennox</name>
      <address>
        <city>Ottignies</city>
        <state>Brabant Wallon</state>
        <zip>1340</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>September 24, 2019</last_update_submitted>
  <last_update_submitted_qc>September 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Liege</investigator_affiliation>
    <investigator_full_name>Géraldine Martens</investigator_full_name>
    <investigator_title>PhD student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Contracture</mesh_term>
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Central Nervous System Diseases</mesh_term>
    <mesh_term>Consciousness Disorders</mesh_term>
    <mesh_term>Craniocerebral Trauma</mesh_term>
    <mesh_term>Trauma, Nervous System</mesh_term>
    <mesh_term>Pathologic Processes</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Neurocognitive Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03008486
org study id: 2016/292
nct id: NCT03008486
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to assess the effects on upper limb spasticity of soft splints
      worn during three weeks three hours a day by patients with stroke or disorders of
      consciousness.
Patients with stroke or disorders of consciousness (DOC) are likely to suffer from major
      muscular troubles such as spasticity. This spasticity may induce pain, loss in range of
      motion and permanent joint deformities. The aim of this study is to investigate the effects
      of soft splinting on the hand spasticity in both patients with stroke and patients with
      disorders of consciousness. The investigators plan to include 100 patients (50 stroke - 50
      with DOC) and each subgroup will be divided in two arms: one wearing real soft splints (6 cm
      diameter) three hours a day for 3 three weeks and the other one wearing 'placebo' splints (1
      cm diameter).

      Skin condition will be followed by the nursing team during the three weeks. Spasticity, pain
      and consciousness assessments will be performed at baseline (week 0), after 1 week of
      treatment (week 1) at the end of the treatment (week 3), 1 week later (week 4), 3 weeks later
      (week 6) and three months later (week 12).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in the Modified Ashworth Scale
time frame: Week 0, 1, 3, 4, 6, 12
description: Spasticity assessment
measure: Change in the Modified Tardieu Scale
time frame: Week 0, 1, 3, 4, 6, 12
description: Spasticity assessment
measure: Change in the Nociception Coma Scale-Revised
time frame: Week 0, 1, 3, 4, 6, 12
description: Pain assessment
measure: Change in the Visual Analogue Scale
time frame: Week 0, 1, 3, 4, 6, 12
description: Pain assessment
measure: Change in the Palm-finger distance
time frame: Week 0, 1, 3, 4, 6, 12
description: Range of motion assessment
measure: Change in the Coma Recovery Scale-Revised
time frame: Week 0, 1, 3, 4, 6, 12
description: Consciousness assessment
arm group label: DOC - real
arm group type: Active Comparator
description: Spastic patients with disorders of consciousness receiving the real soft splint
arm group label: DOC - placebo
arm group type: Placebo Comparator
description: Spastic patients with disorders of consciousness receiving the placebo soft splint
arm group label: Stroke - real
arm group type: Active Comparator
description: Spastic patients stroke receiving the real soft splint
arm group label: Stroke - placebo
arm group type: Placebo Comparator
description: Spastic patients stroke receiving the placebo soft splint
intervention type: Device
intervention name: Real soft splint (6 cm)
arm group label: DOC - real
arm group label: Stroke - real
intervention type: Device
intervention name: Placebo soft splint (1 cm)
arm group label: DOC - placebo
arm group label: Stroke - placebo
criteria: 
gender: All
minimum age: 14 Years
maximum age: 75 Years
healthy volunteers: No
last name: Nicolas Lejeune
role: Principal Investigator
affiliation: Centre Hospitalier Neurologique William Lennox
facility: 
country: Belgium
responsible party type: Sponsor-Investigator
investigator affiliation: University of Liege
investigator full name: Géraldine Martens
investigator title: PhD student
mesh term: Contracture
mesh term: Stroke
mesh term: Brain Injuries
mesh term: Nervous System Diseases
mesh term: Central Nervous System Diseases
mesh term: Consciousness Disorders
mesh term: Craniocerebral Trauma
mesh term: Trauma, Nervous System
mesh term: Pathologic Processes
mesh term: Wounds and Injuries
mesh term: Neurocognitive Disorders
sharing ipd: No