<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/NCT03307135</url>
  </required_header>
  <id_info>
    <org_study_id>RC17_0028</org_study_id>
    <nct_id>NCT03307135</nct_id>
  </id_info>
  <brief_title>Medical Spastic Patient Machine Interface MSPMI : Biomechanical and Electrophysiological Assessment of the Triceps Surae Spasticity</brief_title>
  <acronym>MSPMI</acronym>
  <official_title>Medical Spastic Patient Machine Interface MSPMI : Biomechanical and Electrophysiological Assessment of the Triceps Surae Spasticity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Compiègne University of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Spasticity is a disorder of the muscular tonus that occurs in disease including the upper&#xD;
      motor neuron (strokes, spinal cord injuries, multiple sclerosis, traumatic brain injuries or&#xD;
      cerebral palsies). It begins few hours after the neural aggression and last until the grave.&#xD;
&#xD;
      The most accepted definition refers to a velocity-dependent increase in stretch reflexes&#xD;
      elicited by passive stretch (Lance definition) but new approaches prefers to distinguish&#xD;
      neural (reflex) and non-neural (soft tissues alterations) components of the increase&#xD;
      resistance to a passive stretch. This deficiency is a major cause of complications as walking&#xD;
      impairment, pain or bone deformities and may require intensive therapies (intrathecal&#xD;
      baclofen infusion, intramuscular toxin botulinium injection, surgery, etc). Despite its high&#xD;
      frequency and the potential complications, only clinical scales (modified Ashworth scale and&#xD;
      modified Tardieu scale essentially) with criticized metrological properties are available for&#xD;
      daily assessment. The SPASM Consortium has published on 2005 recommendations for developing&#xD;
      devices using both mechanical and electrophysiological parameters. The principle challenge&#xD;
      was to ally parameters accuracy and utilization facility allowing quickly evaluation to the&#xD;
      patient's bed. Few research team works on this topic but mostly on specific population and&#xD;
      nowadays, no device has really crossed the door of laboratories.&#xD;
&#xD;
      This kind of tool would help us to improve the quality of the follow-up and to guide us&#xD;
      between the choices of specific therapies.&#xD;
&#xD;
      The MSPMI has been created following these recommendations in the University of Technology of&#xD;
      Compiègne, thanks to the collaboration between researchers of the UMR 7338 CNRS and a brain&#xD;
      surgeon of the Nantes University Hospital. The patent was obtained on 2012. This device&#xD;
      allows the assessment of the ankle plantar extensor (triceps surae) during a manually applied&#xD;
      stretch movement. This muscle was selected as it is frequently involved and treated for&#xD;
      spasticity.&#xD;
&#xD;
      This study aims to evaluate the metrological properties of the MSPMI (reliabilities,&#xD;
      responsiveness, known group validity, construct validity, measurement errors and internal&#xD;
      consistency) among a large cohort of patients with no restriction of etiologies recruited in&#xD;
      the Nantes University Hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluation will include medical histories and specific information about spasticity&#xD;
      management and consequences. The patient will be assessed by two evaluators with the MSPMI&#xD;
      installed on the foot and the shank. MSPMI allows the record of angular movement of the ankle&#xD;
      (position, speed and acceleration), of biomechanics (stiffness, torque, work and power) and&#xD;
      electromyography (root mean squared and integrated electromyography signals) of two chiefs of&#xD;
      the triceps surae (medial gastrocnemius and soleus). Electromyography data will be recorded&#xD;
      on a maximum voluntary contraction when the deficiency will permit it. After that, data will&#xD;
      be recorded at 3 velocities (with respect to the clinical scale recommendations) on two&#xD;
      different positions (knee flexed and extended), according to our clinical practice. The&#xD;
      evaluation on day 0 will allow the assessment of inter-rater intra-session reproductibility,&#xD;
      internal consistency, construct validity, measurement error and known group validity. If the&#xD;
      patient is hospitalized, he will be included on the &quot;hospitalization group&quot; and a second&#xD;
      evaluation following the same protocol will be done 7 days later (assessment of inter and&#xD;
      intra-rater inter-session reproductibility). If a specific therapy (selective tibial&#xD;
      neurotomy, anesthetic block or botulinum toxin intramuscular injection) is proposed, the&#xD;
      patient will be included on the &quot;treatment group&quot; and a new evaluation will be done after the&#xD;
      therapy (30 minutes - 2 hours after an anesthetic block, 2-3 months after neurotomy or&#xD;
      botulinium toxin injection) allowing assessment of the responsiveness of the MSPMI. If the&#xD;
      patient is not on these two situations, he will be included on the &quot;simple evaluation group&quot;&#xD;
      and his participation will end.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2017</start_date>
  <completion_date type="Actual">March 13, 2020</completion_date>
  <primary_completion_date type="Actual">September 10, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of the mobilization reproductibility coefficient</measure>
    <time_frame>Day 0</time_frame>
    <description>inter-rater intra-session reproductibility coefficient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>range of motion (degree) reproductibility coefficient</measure>
    <time_frame>Day 0</time_frame>
    <description>inter-rater intra-session reproductibility coefficient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>maximal angular speed (degree.sec-1) reproductibility coefficient</measure>
    <time_frame>Day 0</time_frame>
    <description>inter-rater intra-session reproductibility coefficient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>torque peaque (N.m) reproductibility coefficient</measure>
    <time_frame>Day 0</time_frame>
    <description>inter-rater intra-session reproductibility coefficient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>work variability index (mJ.sec) reproductibility coefficient</measure>
    <time_frame>Day 0</time_frame>
    <description>inter-rater intra-session reproductibility coefficient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>area under the curve raw Work = f(time) reproductibility coefficient</measure>
    <time_frame>Day 0</time_frame>
    <description>inter-rater intra-session reproductibility coefficient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>area under the curve rectified Work = f(time) (J.sec) reproductibility coefficient</measure>
    <time_frame>Day 0</time_frame>
    <description>inter-rater intra-session reproductibility coefficient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>raw and averaged rectified EMG for Soleus and Gastrocnemius medialis (μV and μV.sec-1) reproductibility coefficient</measure>
    <time_frame>Day 0</time_frame>
    <description>inter-rater intra-session reproductibility coefficient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Raw rectified EMG for Soleus (μv) reproductibility coefficient</measure>
    <time_frame>Day 0</time_frame>
    <description>inter-rater intra-session reproductibility coefficient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1) reproductibility coefficient</measure>
    <time_frame>Day 0</time_frame>
    <description>inter-rater intra-session reproductibility coefficient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Averaged rectified EMG for Soleus (μv.sec-1) reproductibility coefficient</measure>
    <time_frame>Day 0</time_frame>
    <description>inter-rater intra-session reproductibility coefficient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximal value of EMG for Gastrocnemius medialis (μv) reproductibility coefficient</measure>
    <time_frame>Day 0</time_frame>
    <description>inter-rater intra-session reproductibility coefficient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximal value of EMG for Soleus (μv) reproductibility coefficient</measure>
    <time_frame>Day 0</time_frame>
    <description>inter-rater intra-session reproductibility coefficient</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>duration of the mobilization (sec)</measure>
    <time_frame>Day0</time_frame>
    <description>Patients of the 3 groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of the mobilization (sec),</measure>
    <time_frame>Day7</time_frame>
    <description>Patients included in the &quot;hospitalization group&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of the mobilization (sec),</measure>
    <time_frame>30minutes to 2 hours after an anesthesic block</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by anesthesic block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of the mobilization (sec),</measure>
    <time_frame>2 to 3 months after neurotomy or botulinium toxin injection</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by selective tibial neurotomy or toxin intramuscular injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>range of motion (degree),</measure>
    <time_frame>Day0</time_frame>
    <description>Patients of the 3 groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>range of motion (degree),</measure>
    <time_frame>Day7</time_frame>
    <description>Patients included in the &quot;hospitalization group&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>range of motion (degree),</measure>
    <time_frame>30minutes to 2 hours after an anesthesic block</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by anesthesic block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>range of motion (degree),</measure>
    <time_frame>2 to 3 months after neurotomy or botulinium toxin injection</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by selective tibial neurotomy or toxin intramuscular injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maximal angular speed (degree.sec-1)</measure>
    <time_frame>Day 0</time_frame>
    <description>Patients of the 3 groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maximal angular speed (degree.sec-1)</measure>
    <time_frame>Day 7</time_frame>
    <description>Patients included in the &quot;hospitalization group&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maximal angular speed (degree.sec-1)</measure>
    <time_frame>30minutes to 2 hours after an anesthesic block</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by anesthesic block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maximal angular speed (degree.sec-1)</measure>
    <time_frame>2 to 3 months after neurotomy or botulinium toxin injection</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by selective tibial neurotomy or toxin intramuscular injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>torque peaque (N.m)</measure>
    <time_frame>Day 0</time_frame>
    <description>Patients of the 3 groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>torque peaque (N.m)</measure>
    <time_frame>Day 7</time_frame>
    <description>Patients included in the &quot;hospitalization group&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>torque peaque (N.m)</measure>
    <time_frame>30minutes to 2 hours after an anesthesic block</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by anesthesic block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>torque peaque (N.m)</measure>
    <time_frame>2 to 3 months after neurotomy or botulinium toxin injection</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by selective tibial neurotomy or toxin intramuscular injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>work variability index (mJ.sec)</measure>
    <time_frame>Day0</time_frame>
    <description>Patients of the 3 groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>work variability index (mJ.sec)</measure>
    <time_frame>Day7</time_frame>
    <description>Patients included in the &quot;hospitalization group&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>work variability index (mJ.sec)</measure>
    <time_frame>30minutes to 2 hours after an anesthesic block</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by anesthesic block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>work variability index (mJ.sec)</measure>
    <time_frame>2 to 3 months after neurotomy or botulinium toxin injection</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>area under the curve raw Work = f(time)</measure>
    <time_frame>Day 0</time_frame>
    <description>Patients of the 3 groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>area under the curve raw Work = f(time)</measure>
    <time_frame>Day 7</time_frame>
    <description>Patients included in the &quot;hospitalization group&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>area under the curve raw Work = f(time)</measure>
    <time_frame>30minutes to 2 hours after an anesthesic block</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by anesthesic block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>area under the curve raw Work = f(time)</measure>
    <time_frame>2 to 3 months after neurotomy or botulinium toxin injection</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by selective tibial neurotomy or toxin intramuscular injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>area under the curve rectified Work = f(time) (J.sec)</measure>
    <time_frame>Day 0</time_frame>
    <description>Patients of the 3 groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>area under the curve rectified Work = f(time) (J.sec)</measure>
    <time_frame>Day 7</time_frame>
    <description>Patients included in the &quot;hospitalization group&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>area under the curve rectified Work = f(time) (J.sec)</measure>
    <time_frame>30minutes to 2 hours after an anesthesic block</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by anesthesic block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>area under the curve rectified Work = f(time) (J.sec)</measure>
    <time_frame>2 to 3 months after neurotomy or botulinium toxin injection</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by selective tibial neurotomy or toxin intramuscular injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)</measure>
    <time_frame>Day 0</time_frame>
    <description>Patients of the 3 groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)</measure>
    <time_frame>Day 7</time_frame>
    <description>Patients included in the &quot;hospitalization group&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)</measure>
    <time_frame>30minutes to 2 hours after an anesthesic block</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by anesthesic block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)</measure>
    <time_frame>2 to 3 months after neurotomy or botulinium toxin injection</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by selective tibial neurotomy or toxin intramuscular injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)</measure>
    <time_frame>Day0</time_frame>
    <description>Patients of the 3 groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)</measure>
    <time_frame>Day7</time_frame>
    <description>Patients included in the &quot;hospitalization group&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)</measure>
    <time_frame>30minutes to 2 hours after an anesthesic block</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by anesthesic block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)</measure>
    <time_frame>2 to 3 months after neurotomy or botulinium toxin injection</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by selective tibial neurotomy or toxin intramuscular injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Raw rectified EMG for Soleus (μv)</measure>
    <time_frame>Day 0</time_frame>
    <description>Patients of the 3 groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Raw rectified EMG for Soleus (μv)</measure>
    <time_frame>Day 7</time_frame>
    <description>Patients included in the &quot;hospitalization group&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Raw rectified EMG for Soleus (μv)</measure>
    <time_frame>30minutes to 2 hours after an anesthesic block</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by anesthesic block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Raw rectified EMG for Soleus (μv)</measure>
    <time_frame>2 to 3 months after neurotomy or botulinium toxin injection</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by selective tibial neurotomy or toxin intramuscular injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Averaged rectified EMG for Soleus (μv.sec-1)</measure>
    <time_frame>Day 0</time_frame>
    <description>Patients of the 3 groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Averaged rectified EMG for Soleus (μv.sec-1)</measure>
    <time_frame>Day 7</time_frame>
    <description>Patients included in the &quot;hospitalization group&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Averaged rectified EMG for Soleus (μv.sec-1)</measure>
    <time_frame>30minutes to 2 hours after an anesthesic block</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by anesthesic block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Averaged rectified EMG for Soleus (μv.sec-1)</measure>
    <time_frame>2 to 3 months after neurotomy or botulinium toxin injection</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by selective tibial neurotomy or toxin intramuscular injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maximal value of EMG for Gastrocnemius medialis (μV)</measure>
    <time_frame>Day0</time_frame>
    <description>Patients of the 3 groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maximal value of EMG for Gastrocnemius medialis (μV)</measure>
    <time_frame>Day7</time_frame>
    <description>Patients included in the &quot;hospitalization group&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maximal value of EMG for Gastrocnemius medialis (μV)</measure>
    <time_frame>30minutes to 2 hours after an anesthesic block</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by anesthesic block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maximal value of EMG for Gastrocnemius medialis (μV)</measure>
    <time_frame>2 to 3 months after neurotomy or botulinium toxin injection</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by selective tibial neurotomy or toxin intramuscular injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal value of EMG for Soleus (μv)</measure>
    <time_frame>Day 0</time_frame>
    <description>Patients of the 3 groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal value of EMG for Soleus (μv)</measure>
    <time_frame>Day 7</time_frame>
    <description>Patients included in the &quot;hospitalization group&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal value of EMG for Soleus (μv)</measure>
    <time_frame>30minutes to 2 hours after an anesthesic block</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by anesthesic block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal value of EMG for Soleus (μv)</measure>
    <time_frame>2 to 3 months after neurotomy or botulinium toxin injection</time_frame>
    <description>Patients included in the &quot;treatment group&quot; and treated by selective tibial neurotomy or toxin intramuscular injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>score on the modified Asworth scale</measure>
    <time_frame>Day 0</time_frame>
    <description>Patients of the 3 groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>modified Tardieu scale assigned by the evaluator</measure>
    <time_frame>Day 0</time_frame>
    <description>Patients of the 3 groups</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Spasticity, Muscle</condition>
  <arm_group>
    <arm_group_label>Simple Assessment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention is a single evaluation with the MSPMI by two evaluators.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hospitalization group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evaluation with the MSPMI by two evaluators on two consultations separate by a 7 days interval.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evaluation with the MSPMI by two evaluators before and after specific therapies proposed on our usual practices (Selective tibial neurotomy, anesthetic block or botulinum toxin intramuscular injection).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>single assessment with the MSPMI</intervention_name>
    <description>Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)</description>
    <arm_group_label>Simple Assessment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>double assessment with the MSPMI with 7 days of interval</intervention_name>
    <description>Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)</description>
    <arm_group_label>Hospitalization group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>double assessment with the MSPMI before and after treatment</intervention_name>
    <description>Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)</description>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Spasticity with respect to the Lance defintion (minimal score of 1 on the modified&#xD;
             Ashworth scale)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication of ankle manipulation : fracture, phlebitis, bedsore&#xD;
&#xD;
          -  amyotrophic lateral sclerosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brigitte Perrouin-Verbe, PU-PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nantes CHU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Médecine Physique et Réadaptation Neurologique</name>
      <address>
        <city>Nantes</city>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>https://worldwide.espacenet.com/publicationDetails/originalDocument?FT=D&amp;date=20120726&amp;DB=EPODOC&amp;locale=fr_EP&amp;CC=WO&amp;NR=2012098121A1&amp;KC=A1&amp;ND=6#</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Bar-On L, Aertbelien E, Molenaers G, Van Campenhout A, Vandendoorent B, Nieuwenhuys A, Jaspers E, Hunaerts C, Desloovere K. Instrumented assessment of the effect of Botulinum Toxin-A in the medial hamstrings in children with cerebral palsy. Gait Posture. 2014 Jan;39(1):17-22. doi: 10.1016/j.gaitpost.2013.05.018. Epub 2013 Jun 20.</citation>
    <PMID>23791154</PMID>
  </reference>
  <reference>
    <citation>Bar-On L, Van Campenhout A, Desloovere K, Aertbelien E, Huenaerts C, Vandendoorent B, Nieuwenhuys A, Molenaers G. Is an instrumented spasticity assessment an improvement over clinical spasticity scales in assessing and predicting the response to integrated botulinum toxin type a treatment in children with cerebral palsy? Arch Phys Med Rehabil. 2014 Mar;95(3):515-23. doi: 10.1016/j.apmr.2013.08.010. Epub 2013 Aug 27.</citation>
    <PMID>23994052</PMID>
  </reference>
  <reference>
    <citation>de Vlugt E, de Groot JH, Schenkeveld KE, Arendzen JH, van der Helm FC, Meskers CG. The relation between neuromechanical parameters and Ashworth score in stroke patients. J Neuroeng Rehabil. 2010 Jul 27;7:35. doi: 10.1186/1743-0003-7-35.</citation>
    <PMID>20663189</PMID>
  </reference>
  <reference>
    <citation>Schless SH, Desloovere K, Aertbelien E, Molenaers G, Huenaerts C, Bar-On L. The Intra- and Inter-Rater Reliability of an Instrumented Spasticity Assessment in Children with Cerebral Palsy. PLoS One. 2015 Jul 2;10(7):e0131011. doi: 10.1371/journal.pone.0131011. eCollection 2015.</citation>
    <PMID>26134673</PMID>
  </reference>
  <reference>
    <citation>Gaverth J, Sandgren M, Lindberg PG, Forssberg H, Eliasson AC. Test-retest and inter-rater reliability of a method to measure wrist and finger spasticity. J Rehabil Med. 2013 Jul;45(7):630-6. doi: 10.2340/16501977-1160.</citation>
    <PMID>23695917</PMID>
  </reference>
  <reference>
    <citation>Turk R, Notley SV, Pickering RM, Simpson DM, Wright PA, Burridge JH. Reliability and sensitivity of a wrist rig to measure motor control and spasticity in poststroke hemiplegia. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):684-96. doi: 10.1177/1545968308315599. Epub 2008 Sep 5.</citation>
    <PMID>18776066</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>November 26, 2020</last_update_submitted>
  <last_update_submitted_qc>November 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Spasticity</keyword>
  <keyword>electrophysiology</keyword>
  <keyword>biomechanics</keyword>
  <keyword>objective assessment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</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/NCT03307135
org study id: RC17_0028
nct id: NCT03307135
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Spasticity is a disorder of the muscular tonus that occurs in disease including the upper
      motor neuron (strokes, spinal cord injuries, multiple sclerosis, traumatic brain injuries or
      cerebral palsies). It begins few hours after the neural aggression and last until the grave.

      The most accepted definition refers to a velocity-dependent increase in stretch reflexes
      elicited by passive stretch (Lance definition) but new approaches prefers to distinguish
      neural (reflex) and non-neural (soft tissues alterations) components of the increase
      resistance to a passive stretch. This deficiency is a major cause of complications as walking
      impairment, pain or bone deformities and may require intensive therapies (intrathecal
      baclofen infusion, intramuscular toxin botulinium injection, surgery, etc). Despite its high
      frequency and the potential complications, only clinical scales (modified Ashworth scale and
      modified Tardieu scale essentially) with criticized metrological properties are available for
      daily assessment. The SPASM Consortium has published on 2005 recommendations for developing
      devices using both mechanical and electrophysiological parameters. The principle challenge
      was to ally parameters accuracy and utilization facility allowing quickly evaluation to the
      patient's bed. Few research team works on this topic but mostly on specific population and
      nowadays, no device has really crossed the door of laboratories.

      This kind of tool would help us to improve the quality of the follow-up and to guide us
      between the choices of specific therapies.

      The MSPMI has been created following these recommendations in the University of Technology of
      Compiègne, thanks to the collaboration between researchers of the UMR 7338 CNRS and a brain
      surgeon of the Nantes University Hospital. The patent was obtained on 2012. This device
      allows the assessment of the ankle plantar extensor (triceps surae) during a manually applied
      stretch movement. This muscle was selected as it is frequently involved and treated for
      spasticity.

      This study aims to evaluate the metrological properties of the MSPMI (reliabilities,
      responsiveness, known group validity, construct validity, measurement errors and internal
      consistency) among a large cohort of patients with no restriction of etiologies recruited in
      the Nantes University Hospital.
Evaluation will include medical histories and specific information about spasticity
      management and consequences. The patient will be assessed by two evaluators with the MSPMI
      installed on the foot and the shank. MSPMI allows the record of angular movement of the ankle
      (position, speed and acceleration), of biomechanics (stiffness, torque, work and power) and
      electromyography (root mean squared and integrated electromyography signals) of two chiefs of
      the triceps surae (medial gastrocnemius and soleus). Electromyography data will be recorded
      on a maximum voluntary contraction when the deficiency will permit it. After that, data will
      be recorded at 3 velocities (with respect to the clinical scale recommendations) on two
      different positions (knee flexed and extended), according to our clinical practice. The
      evaluation on day 0 will allow the assessment of inter-rater intra-session reproductibility,
      internal consistency, construct validity, measurement error and known group validity. If the
      patient is hospitalized, he will be included on the "hospitalization group" and a second
      evaluation following the same protocol will be done 7 days later (assessment of inter and
      intra-rater inter-session reproductibility). If a specific therapy (selective tibial
      neurotomy, anesthetic block or botulinum toxin intramuscular injection) is proposed, the
      patient will be included on the "treatment group" and a new evaluation will be done after the
      therapy (30 minutes - 2 hours after an anesthetic block, 2-3 months after neurotomy or
      botulinium toxin injection) allowing assessment of the responsiveness of the MSPMI. If the
      patient is not on these two situations, he will be included on the "simple evaluation group"
      and his participation will end.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Duration of the mobilization reproductibility coefficient
time frame: Day 0
description: inter-rater intra-session reproductibility coefficient
measure: range of motion (degree) reproductibility coefficient
time frame: Day 0
description: inter-rater intra-session reproductibility coefficient
measure: maximal angular speed (degree.sec-1) reproductibility coefficient
time frame: Day 0
description: inter-rater intra-session reproductibility coefficient
measure: torque peaque (N.m) reproductibility coefficient
time frame: Day 0
description: inter-rater intra-session reproductibility coefficient
measure: work variability index (mJ.sec) reproductibility coefficient
time frame: Day 0
description: inter-rater intra-session reproductibility coefficient
measure: area under the curve raw Work = f(time) reproductibility coefficient
time frame: Day 0
description: inter-rater intra-session reproductibility coefficient
measure: area under the curve rectified Work = f(time) (J.sec) reproductibility coefficient
time frame: Day 0
description: inter-rater intra-session reproductibility coefficient
measure: raw and averaged rectified EMG for Soleus and Gastrocnemius medialis (μV and μV.sec-1) reproductibility coefficient
time frame: Day 0
description: inter-rater intra-session reproductibility coefficient
measure: Raw rectified EMG for Soleus (μv) reproductibility coefficient
time frame: Day 0
description: inter-rater intra-session reproductibility coefficient
measure: Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1) reproductibility coefficient
time frame: Day 0
description: inter-rater intra-session reproductibility coefficient
measure: Averaged rectified EMG for Soleus (μv.sec-1) reproductibility coefficient
time frame: Day 0
description: inter-rater intra-session reproductibility coefficient
measure: Maximal value of EMG for Gastrocnemius medialis (μv) reproductibility coefficient
time frame: Day 0
description: inter-rater intra-session reproductibility coefficient
measure: Maximal value of EMG for Soleus (μv) reproductibility coefficient
time frame: Day 0
description: inter-rater intra-session reproductibility coefficient
measure: duration of the mobilization (sec)
time frame: Day0
description: Patients of the 3 groups
measure: duration of the mobilization (sec),
time frame: Day7
description: Patients included in the "hospitalization group"
measure: duration of the mobilization (sec),
time frame: 30minutes to 2 hours after an anesthesic block
description: Patients included in the "treatment group" and treated by anesthesic block
measure: duration of the mobilization (sec),
time frame: 2 to 3 months after neurotomy or botulinium toxin injection
description: Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
measure: range of motion (degree),
time frame: Day0
description: Patients of the 3 groups
measure: range of motion (degree),
time frame: Day7
description: Patients included in the "hospitalization group"
measure: range of motion (degree),
time frame: 30minutes to 2 hours after an anesthesic block
description: Patients included in the "treatment group" and treated by anesthesic block
measure: range of motion (degree),
time frame: 2 to 3 months after neurotomy or botulinium toxin injection
description: Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
measure: maximal angular speed (degree.sec-1)
time frame: Day 0
description: Patients of the 3 groups
measure: maximal angular speed (degree.sec-1)
time frame: Day 7
description: Patients included in the "hospitalization group"
measure: maximal angular speed (degree.sec-1)
time frame: 30minutes to 2 hours after an anesthesic block
description: Patients included in the "treatment group" and treated by anesthesic block
measure: maximal angular speed (degree.sec-1)
time frame: 2 to 3 months after neurotomy or botulinium toxin injection
description: Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
measure: torque peaque (N.m)
time frame: Day 0
description: Patients of the 3 groups
measure: torque peaque (N.m)
time frame: Day 7
description: Patients included in the "hospitalization group"
measure: torque peaque (N.m)
time frame: 30minutes to 2 hours after an anesthesic block
description: Patients included in the "treatment group" and treated by anesthesic block
measure: torque peaque (N.m)
time frame: 2 to 3 months after neurotomy or botulinium toxin injection
description: Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
measure: work variability index (mJ.sec)
time frame: Day0
description: Patients of the 3 groups
measure: work variability index (mJ.sec)
time frame: Day7
description: Patients included in the "hospitalization group"
measure: work variability index (mJ.sec)
time frame: 30minutes to 2 hours after an anesthesic block
description: Patients included in the "treatment group" and treated by anesthesic block
measure: work variability index (mJ.sec)
time frame: 2 to 3 months after neurotomy or botulinium toxin injection
measure: area under the curve raw Work = f(time)
time frame: Day 0
description: Patients of the 3 groups
measure: area under the curve raw Work = f(time)
time frame: Day 7
description: Patients included in the "hospitalization group"
measure: area under the curve raw Work = f(time)
time frame: 30minutes to 2 hours after an anesthesic block
description: Patients included in the "treatment group" and treated by anesthesic block
measure: area under the curve raw Work = f(time)
time frame: 2 to 3 months after neurotomy or botulinium toxin injection
description: Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
measure: area under the curve rectified Work = f(time) (J.sec)
time frame: Day 0
description: Patients of the 3 groups
measure: area under the curve rectified Work = f(time) (J.sec)
time frame: Day 7
description: Patients included in the "hospitalization group"
measure: area under the curve rectified Work = f(time) (J.sec)
time frame: 30minutes to 2 hours after an anesthesic block
description: Patients included in the "treatment group" and treated by anesthesic block
measure: area under the curve rectified Work = f(time) (J.sec)
time frame: 2 to 3 months after neurotomy or botulinium toxin injection
description: Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
measure: raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
time frame: Day 0
description: Patients of the 3 groups
measure: raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
time frame: Day 7
description: Patients included in the "hospitalization group"
measure: raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
time frame: 30minutes to 2 hours after an anesthesic block
description: Patients included in the "treatment group" and treated by anesthesic block
measure: raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
time frame: 2 to 3 months after neurotomy or botulinium toxin injection
description: Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
measure: Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
time frame: Day0
description: Patients of the 3 groups
measure: Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
time frame: Day7
description: Patients included in the "hospitalization group"
measure: Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
time frame: 30minutes to 2 hours after an anesthesic block
description: Patients included in the "treatment group" and treated by anesthesic block
measure: Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
time frame: 2 to 3 months after neurotomy or botulinium toxin injection
description: Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
measure: Raw rectified EMG for Soleus (μv)
time frame: Day 0
description: Patients of the 3 groups
measure: Raw rectified EMG for Soleus (μv)
time frame: Day 7
description: Patients included in the "hospitalization group"
measure: Raw rectified EMG for Soleus (μv)
time frame: 30minutes to 2 hours after an anesthesic block
description: Patients included in the "treatment group" and treated by anesthesic block
measure: Raw rectified EMG for Soleus (μv)
time frame: 2 to 3 months after neurotomy or botulinium toxin injection
description: Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
measure: Averaged rectified EMG for Soleus (μv.sec-1)
time frame: Day 0
description: Patients of the 3 groups
measure: Averaged rectified EMG for Soleus (μv.sec-1)
time frame: Day 7
description: Patients included in the "hospitalization group"
measure: Averaged rectified EMG for Soleus (μv.sec-1)
time frame: 30minutes to 2 hours after an anesthesic block
description: Patients included in the "treatment group" and treated by anesthesic block
measure: Averaged rectified EMG for Soleus (μv.sec-1)
time frame: 2 to 3 months after neurotomy or botulinium toxin injection
description: Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
measure: maximal value of EMG for Gastrocnemius medialis (μV)
time frame: Day0
description: Patients of the 3 groups
measure: maximal value of EMG for Gastrocnemius medialis (μV)
time frame: Day7
description: Patients included in the "hospitalization group"
measure: maximal value of EMG for Gastrocnemius medialis (μV)
time frame: 30minutes to 2 hours after an anesthesic block
description: Patients included in the "treatment group" and treated by anesthesic block
measure: maximal value of EMG for Gastrocnemius medialis (μV)
time frame: 2 to 3 months after neurotomy or botulinium toxin injection
description: Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
measure: Maximal value of EMG for Soleus (μv)
time frame: Day 0
description: Patients of the 3 groups
measure: Maximal value of EMG for Soleus (μv)
time frame: Day 7
description: Patients included in the "hospitalization group"
measure: Maximal value of EMG for Soleus (μv)
time frame: 30minutes to 2 hours after an anesthesic block
description: Patients included in the "treatment group" and treated by anesthesic block
measure: Maximal value of EMG for Soleus (μv)
time frame: 2 to 3 months after neurotomy or botulinium toxin injection
description: Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
measure: score on the modified Asworth scale
time frame: Day 0
description: Patients of the 3 groups
measure: modified Tardieu scale assigned by the evaluator
time frame: Day 0
description: Patients of the 3 groups
arm group label: Simple Assessment group
arm group type: Experimental
description: Intervention is a single evaluation with the MSPMI by two evaluators.
arm group label: Hospitalization group
arm group type: Experimental
description: Evaluation with the MSPMI by two evaluators on two consultations separate by a 7 days interval.
arm group label: Treatment group
arm group type: Experimental
description: Evaluation with the MSPMI by two evaluators before and after specific therapies proposed on our usual practices (Selective tibial neurotomy, anesthetic block or botulinum toxin intramuscular injection).
intervention type: Device
intervention name: single assessment with the MSPMI
description: Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)
arm group label: Simple Assessment group
intervention type: Device
intervention name: double assessment with the MSPMI with 7 days of interval
description: Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)
arm group label: Hospitalization group
intervention type: Device
intervention name: double assessment with the MSPMI before and after treatment
description: Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)
arm group label: Treatment group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Brigitte Perrouin-Verbe, PU-PH
role: Principal Investigator
affiliation: Nantes CHU
facility: 
country: France
url: https://worldwide.espacenet.com/publicationDetails/originalDocument?FT=D&date=20120726&DB=EPODOC&locale=fr_EP&CC=WO&NR=2012098121A1&KC=A1&ND=6#
description: Related Info
citation: Bar-On L, Aertbelien E, Molenaers G, Van Campenhout A, Vandendoorent B, Nieuwenhuys A, Jaspers E, Hunaerts C, Desloovere K. Instrumented assessment of the effect of Botulinum Toxin-A in the medial hamstrings in children with cerebral palsy. Gait Posture. 2014 Jan;39(1):17-22. doi: 10.1016/j.gaitpost.2013.05.018. Epub 2013 Jun 20.
PMID: 23791154
citation: Bar-On L, Van Campenhout A, Desloovere K, Aertbelien E, Huenaerts C, Vandendoorent B, Nieuwenhuys A, Molenaers G. Is an instrumented spasticity assessment an improvement over clinical spasticity scales in assessing and predicting the response to integrated botulinum toxin type a treatment in children with cerebral palsy? Arch Phys Med Rehabil. 2014 Mar;95(3):515-23. doi: 10.1016/j.apmr.2013.08.010. Epub 2013 Aug 27.
PMID: 23994052
citation: de Vlugt E, de Groot JH, Schenkeveld KE, Arendzen JH, van der Helm FC, Meskers CG. The relation between neuromechanical parameters and Ashworth score in stroke patients. J Neuroeng Rehabil. 2010 Jul 27;7:35. doi: 10.1186/1743-0003-7-35.
PMID: 20663189
citation: Schless SH, Desloovere K, Aertbelien E, Molenaers G, Huenaerts C, Bar-On L. The Intra- and Inter-Rater Reliability of an Instrumented Spasticity Assessment in Children with Cerebral Palsy. PLoS One. 2015 Jul 2;10(7):e0131011. doi: 10.1371/journal.pone.0131011. eCollection 2015.
PMID: 26134673
citation: Gaverth J, Sandgren M, Lindberg PG, Forssberg H, Eliasson AC. Test-retest and inter-rater reliability of a method to measure wrist and finger spasticity. J Rehabil Med. 2013 Jul;45(7):630-6. doi: 10.2340/16501977-1160.
PMID: 23695917
citation: Turk R, Notley SV, Pickering RM, Simpson DM, Wright PA, Burridge JH. Reliability and sensitivity of a wrist rig to measure motor control and spasticity in poststroke hemiplegia. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):684-96. doi: 10.1177/1545968308315599. Epub 2008 Sep 5.
PMID: 18776066
responsible party type: Sponsor
mesh term: Muscle Spasticity