<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/NCT02261142</url>
  </required_header>
  <id_info>
    <org_study_id>LIU-ED2013</org_study_id>
    <nct_id>NCT02261142</nct_id>
  </id_info>
  <brief_title>Efficacy and Cost-effectiveness of Spasticity Treatment With Multifocal TENS</brief_title>
  <official_title>Evaluation of Efficacy and Cost-effectiveness of Spasticity Treatment With Multifocal Transcutaneous Electrical Stimulation, Through a Garment With built-in Electrodes in Combination With Training.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Linkoeping University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Borås</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Linkoeping</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sodra Alvsborgs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Linkoeping University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Spasticity is a common consequence of injury to the central nervous system and can be a major&#xD;
      problem in motor function and everyday activities. A method for treating spasticity that&#xD;
      applies low-amplitude electrical stimulation through a garment with built-in electrodes,&#xD;
      Mollii® (Elektrodress), has been developed. The garment is to be used in combination with&#xD;
      individualized training and the stimulation is mainly given to antagonists of spastic&#xD;
      muscles.&#xD;
&#xD;
      The general objective of this study is to evaluate the efficacy of and costs associated with&#xD;
      the Mollii® treatment of spasticity due to stroke or cerebral palsy.&#xD;
&#xD;
      Primary objectives are;&#xD;
&#xD;
        -  to study whether treatment with the Mollii® improves function and activity&#xD;
&#xD;
        -  to evaluate the cost-effectiveness of the treatment, from both a health-care perspective&#xD;
           and a societal perspective.&#xD;
&#xD;
      Secondary objectives are;&#xD;
&#xD;
        -  to study whether there are differences in treatment effect between the stroke and the&#xD;
           Cerebral Palsy groups in a subgroup-analysis&#xD;
&#xD;
        -  to assess compliance with treatment&#xD;
&#xD;
        -  to report any adverse effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed as a double-blinded, randomized, cross-over trial (RCT). This part of&#xD;
      the study takes 12 weeks (6 weeks of active treatment and 6 weeks of non-active treatment)&#xD;
      and is followed by a wash-out period of 6 weeks. An uncontrolled,open phase starts after week&#xD;
      18, where patients are followed one year after inclusion.&#xD;
&#xD;
      30 participants with spasticity due to Stroke and Cerebral Palsy will be included.&#xD;
&#xD;
      Two centers are recruiting participants and are collecting data.&#xD;
&#xD;
      Outcome measures are chosen to reflect the different dimensions in the International&#xD;
      Classification of Functioning, Disability and Health (ICF) and patient reported outcome&#xD;
      measures (PROM).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Goal attainment scaling (GAS)</measure>
    <time_frame>12 weeks</time_frame>
    <description>1 to 3 goals are defined and evaluated using the original GAS scale by Kiresuk</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arm-hand ability (ARAT + WMFT tasks 1&amp;2)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Action Research Arm Test (ARAT)measuring grasp, grip, pinch and gross movement and this is complemented by Wolf Motor Function Test (WMFT) tasks 1 and 2 measuring active shoulder abduction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mobility</measure>
    <time_frame>12 weeks</time_frame>
    <description>10 meter walking test, divided into comfortable gait test (CGT) and fast gait test (FGT). Outcome is velocity, cadence and stride length.&#xD;
Timed Up &amp; Go (TUG)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health related Quality of Life/QALY</measure>
    <time_frame>Baseline, week 6, 12, 18, 52</time_frame>
    <description>SF-36 and EQ-VAS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self reported pain and spasticity</measure>
    <time_frame>Baseline, week 6, 12, 18, 52</time_frame>
    <description>Numeric rating scale (NRS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle hypertonicity (Spasticity)</measure>
    <time_frame>Baseline, week 6, 12, 18, 52</time_frame>
    <description>Modified Ashworth scale (0-5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>Baseline, week 6, 12, 18, 52</time_frame>
    <description>Goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs</measure>
    <time_frame>Baseline, week 6, 12, 18, 52</time_frame>
    <description>Costs directly related to intervention Baseline, week 6, 12, 18 Costs from a societal perspective at baseline and week 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Goal Attainment Scaling (GAS)</measure>
    <time_frame>52 weeks</time_frame>
    <description>1 to 3 goals are defined and evaluated using the original GAS scale by Kiresuk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arm-hand ability (ARAT + WMFT tasks 1&amp;2)</measure>
    <time_frame>52 weeks</time_frame>
    <description>Action Research Arm Test (ARAT)measuring grasp, grip, pinch and gross movement and this is complemented by Wolf Motor Function Test (WMFT) tasks 1 and 2 measuring active shoulder abduction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobility</measure>
    <time_frame>52 weeks</time_frame>
    <description>10 meter walking test, divided into comfortable gait test (CGT) and fast gait test (FGT). Outcome is velocity, cadence and stride length.&#xD;
Timed Up &amp; Go (TUG)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Spasticity</condition>
  <condition>Stroke</condition>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Multifocal TENS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multifocal TENS given in the garment Mollii® (Elektrodress) 1 hour every second day together with individualized training exercises. The steering unit counts down 60 minutes visible for the patient</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham treatment</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Use of the garment Mollii® (Elektrodress) but without the electrical stimulation combined with the individualized training exercises. The steering unit counts down 60 minutes visible for the patient</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Multifocal TENS garment (Mollii®)</intervention_name>
    <description>Multifocal transcutaneous electrical stimulation incorporated into a whole-body garment in combination with training</description>
    <arm_group_label>Multifocal TENS</arm_group_label>
    <arm_group_label>Sham treatment</arm_group_label>
    <other_name>Mollii®</other_name>
    <other_name>Elektrodress</other_name>
    <other_name>Swedish patent:SE534365.C2</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Spasticity due to stroke or Cerebral Palsy&#xD;
&#xD;
          -  Have some preserved walking ability, with or without walking aids&#xD;
&#xD;
          -  Be able to understand the treatment and instruments/interviews used&#xD;
&#xD;
          -  For stroke participants, two years should have elapsed since their injury/insult&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Electronic devices&#xD;
&#xD;
          -  Ventriculoperitoneal shunt&#xD;
&#xD;
          -  Arrhythmia&#xD;
&#xD;
          -  Hearth infarction or unstable angina pectoris&#xD;
&#xD;
          -  Symptomatic hyper- or hypotonia&#xD;
&#xD;
          -  Cancer under treatment&#xD;
&#xD;
          -  Unstable psychiatric disease&#xD;
&#xD;
          -  Lung disease, affecting daily life&#xD;
&#xD;
          -  Unstable epileptic disease&#xD;
&#xD;
          -  Orthopedic surgery last year&#xD;
&#xD;
          -  Obesity with BMI &gt; 35&#xD;
&#xD;
          -  Infectious disease with longstanding treatment&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>July 10, 2015</last_update_submitted>
  <last_update_submitted_qc>July 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Linkoeping University</investigator_affiliation>
    <investigator_full_name>Per Ertzgaard</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
    <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/NCT02261142
org study id: LIU-ED2013
nct id: NCT02261142
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Spasticity is a common consequence of injury to the central nervous system and can be a major
      problem in motor function and everyday activities. A method for treating spasticity that
      applies low-amplitude electrical stimulation through a garment with built-in electrodes,
      Mollii® (Elektrodress), has been developed. The garment is to be used in combination with
      individualized training and the stimulation is mainly given to antagonists of spastic
      muscles.

      The general objective of this study is to evaluate the efficacy of and costs associated with
      the Mollii® treatment of spasticity due to stroke or cerebral palsy.

      Primary objectives are;

        -  to study whether treatment with the Mollii® improves function and activity

        -  to evaluate the cost-effectiveness of the treatment, from both a health-care perspective
           and a societal perspective.

      Secondary objectives are;

        -  to study whether there are differences in treatment effect between the stroke and the
           Cerebral Palsy groups in a subgroup-analysis

        -  to assess compliance with treatment

        -  to report any adverse effects.
This study is designed as a double-blinded, randomized, cross-over trial (RCT). This part of
      the study takes 12 weeks (6 weeks of active treatment and 6 weeks of non-active treatment)
      and is followed by a wash-out period of 6 weeks. An uncontrolled,open phase starts after week
      18, where patients are followed one year after inclusion.

      30 participants with spasticity due to Stroke and Cerebral Palsy will be included.

      Two centers are recruiting participants and are collecting data.

      Outcome measures are chosen to reflect the different dimensions in the International
      Classification of Functioning, Disability and Health (ICF) and patient reported outcome
      measures (PROM).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Goal attainment scaling (GAS)
time frame: 12 weeks
description: 1 to 3 goals are defined and evaluated using the original GAS scale by Kiresuk
measure: Arm-hand ability (ARAT + WMFT tasks 1&2)
time frame: 12 weeks
description: Action Research Arm Test (ARAT)measuring grasp, grip, pinch and gross movement and this is complemented by Wolf Motor Function Test (WMFT) tasks 1 and 2 measuring active shoulder abduction
measure: Mobility
time frame: 12 weeks
description: 10 meter walking test, divided into comfortable gait test (CGT) and fast gait test (FGT). Outcome is velocity, cadence and stride length.
Timed Up & Go (TUG)
measure: Health related Quality of Life/QALY
time frame: Baseline, week 6, 12, 18, 52
description: SF-36 and EQ-VAS
measure: Self reported pain and spasticity
time frame: Baseline, week 6, 12, 18, 52
description: Numeric rating scale (NRS)
measure: Muscle hypertonicity (Spasticity)
time frame: Baseline, week 6, 12, 18, 52
description: Modified Ashworth scale (0-5)
measure: Range of Motion
time frame: Baseline, week 6, 12, 18, 52
description: Goniometer
measure: Costs
time frame: Baseline, week 6, 12, 18, 52
description: Costs directly related to intervention Baseline, week 6, 12, 18 Costs from a societal perspective at baseline and week 52
measure: Goal Attainment Scaling (GAS)
time frame: 52 weeks
description: 1 to 3 goals are defined and evaluated using the original GAS scale by Kiresuk
measure: Arm-hand ability (ARAT + WMFT tasks 1&2)
time frame: 52 weeks
description: Action Research Arm Test (ARAT)measuring grasp, grip, pinch and gross movement and this is complemented by Wolf Motor Function Test (WMFT) tasks 1 and 2 measuring active shoulder abduction
measure: Mobility
time frame: 52 weeks
description: 10 meter walking test, divided into comfortable gait test (CGT) and fast gait test (FGT). Outcome is velocity, cadence and stride length.
Timed Up & Go (TUG)
arm group label: Multifocal TENS
arm group type: Experimental
description: Multifocal TENS given in the garment Mollii® (Elektrodress) 1 hour every second day together with individualized training exercises. The steering unit counts down 60 minutes visible for the patient
arm group label: Sham treatment
arm group type: Sham Comparator
description: Use of the garment Mollii® (Elektrodress) but without the electrical stimulation combined with the individualized training exercises. The steering unit counts down 60 minutes visible for the patient
intervention type: Device
intervention name: Multifocal TENS garment (Mollii®)
description: Multifocal transcutaneous electrical stimulation incorporated into a whole-body garment in combination with training
arm group label: Multifocal TENS
arm group label: Sham treatment
other name: Mollii®
other name: Elektrodress
other name: Swedish patent:SE534365.C2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Linkoeping University
investigator full name: Per Ertzgaard
investigator title: M.D.
mesh term: Muscle Spasticity
mesh term: Cerebral Palsy