<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/NCT04404868</url>
  </required_header>
  <id_info>
    <org_study_id>BoNT-A early treatment</org_study_id>
    <nct_id>NCT04404868</nct_id>
  </id_info>
  <brief_title>Early Treatment of Post-stroke Spasticity With Botulinum Toxin</brief_title>
  <acronym>BTX_ST-ITA14</acronym>
  <official_title>Role of Early Treatment With Botulinum Toxin in Adult Patients With Post-stroke Spasticity: an Observational Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universita di Verona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universita di Verona</source>
  <brief_summary>
    <textblock>
      This was a multicentric observational study with the aim to evaluate the effect of early&#xD;
      treatment with botulinum toxin type A (BoNT-A) on post-stroke spasticity in adult patients.&#xD;
      All patients enrolled (86 patients) after a baseline clinical assessment (modified Ashworth&#xD;
      scale, motricity index, Fughl Meyer assessment and modified Rankin' scale) undergoes to a&#xD;
      BoNT-A injection following the evidence-based clinical practice. Subsequently, at 4, 12 and&#xD;
      24 weeks they underwent the same clinical evaluation as a follow-up. Results are under&#xD;
      statistical evaluation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a multicentric observational study with the aim to evaluate the effect of early&#xD;
      treatment with botulinum toxin type A (BoNT-A) on post-stroke spasticity in adult patients.&#xD;
      All centres involved are in Italy. The inclusion and exclusion criteria are described in&#xD;
      detail in the correspondent section. The main outcome measure was to assess how the time&#xD;
      elapsed from the acute event can influence the effectiveness of the focal treatment of&#xD;
      spasticity with BoNT-A in adult patients with cerebral stroke. Secondary outcomes were to&#xD;
      evaluate the spasticity' grade and the level of functioning using a clinical assessment&#xD;
      (modified Ashworth scale, motricity index, Fughl Meyer assessment, Modified Rankin' scale).&#xD;
&#xD;
      The patients were enrolled from 10 centres that agreed to participate in this study (Azienda&#xD;
      Ospedaliera Universitaria Integrata of Verona - coordinating centre; Azienda Ospedaliero&#xD;
      Universitaria Ospedali Riuniti of Foggia; Azienda Ospedaliero-Universitaria of Ferrara;&#xD;
      Azienda Ospedaliero-Universitaria Pisana; Azienda Ospedaliero Universitaria &quot;Maggiore della&#xD;
      Carità&quot; of Novara; Azienda Ospedaliera Universitaria - Ospedali Riuniti of Ancona; Azienda&#xD;
      Ospedaliera &quot;Cardinale G. Panico&quot; of Tricase; Fondazione Santa Lucia IRCCS of Rome; Azienda&#xD;
      Ospedaliero-Universitaria Sant'Andrea of Rome; Ospedale &quot;Ca' Foncello&quot; of Treviso). No&#xD;
      patients were enrolled from the last two centers that have expressed their waiver to&#xD;
      participate when the study was already started.&#xD;
&#xD;
      Each patient (whether hospitalized or outpatient) included in the study underwent to a&#xD;
      baseline evaluation in which near and remote pathological history were recorded (main&#xD;
      concomitant pathologies, drug therapy in progress, previous major surgery, date of the&#xD;
      stroke) and the following evaluation scales were administered: modified Ashworth scale (MAS),&#xD;
      MI (motricity index), FMA (Fughl Meyer assessment) and Modified Rankin' scale (MRS). After&#xD;
      that received a BoNT-A injection to treat the spasticity focally following the evidence-based&#xD;
      clinical practice.&#xD;
&#xD;
      Each patient subsequently performed a follow-up evaluation at 4, 12 and 24 weeks after the&#xD;
      date of inoculation through the execution of a specialist visit (physiatric/neurological) and&#xD;
      the administration of the following evaluation scales: MAS, MI, FMA and MRS. For the duration&#xD;
      of the study, each patient may undergo integrated rehabilitation treatment at the discretion&#xD;
      of each of the investigators of each centre involved in the study according to the guidelines&#xD;
      and common clinical practice.&#xD;
&#xD;
      The estimation of the sample size was hypothesized with the aim to observe a frequency of 75%&#xD;
      in the number of patients who will show a reduction of one point at the MAS. If there is a&#xD;
      correlation between the time elapsed since the acute event and the reduction in the degree of&#xD;
      spastic hypertonia after the first administration of BoNT-A, to obtain an OR = 0.5, assuming&#xD;
      DS = 1 and R2 = 0, with α = 0.05 and β = 0.20 (study power = 80%), 90 patients will be&#xD;
      needed. Assuming a drop-out rate of 10%, a total of 100 patients will need to be enrolled in&#xD;
      the study.&#xD;
&#xD;
      Descriptive statistics were produced (frequency histograms; position or central trend&#xD;
      indices: average, median; variability or sample dispersion indices: standard deviation,&#xD;
      interquartile range; sample distribution profile estimate: Shapiro-Wilk test; construction of&#xD;
      the intervals of confidence) as regards demographic (age, gender, the time elapsed from a&#xD;
      stroke) and clinical (MAS, MI, FMA and MRS score at baseline, 4, 12 and 24 weeks after BoNT-A&#xD;
      injection).&#xD;
&#xD;
      In order to evaluate the role of the time elapsed from the acute event on the therapeutic&#xD;
      efficacy of the first administration of BoNT-A 4 weeks after the inoculation (primary&#xD;
      endpoint), a logistic regression analysis was performed in order to evaluate the effects of&#xD;
      time since the acute event (independent variable) on the reduction of spastic hypertonia&#xD;
      defined in dichotomous terms (dependent variable): RESPONDER (patient who will have obtained&#xD;
      a reduction of at least 1 point in MAS of the degree of spastic hypertonia after 4 weeks from&#xD;
      the administration) and NON RESPONDER (patient who has not obtained a reduction of at least 1&#xD;
      point in MAS of the degree of spastic hypertonia 4 weeks after administration), considering&#xD;
      as possible any covariates the gender and age of the patient at the time of the acute event.&#xD;
&#xD;
      As regards the evaluation of secondary endpoints, the analysis of correlation (Pearson&#xD;
      correlation index; Spearman correlation coefficient) was carried out in order to evaluate the&#xD;
      association between the effects of the time elapsed from the acute event and the change in&#xD;
      the score at MAS 4, 12 and 24 weeks after BoNT inoculation, as well as on the variation of&#xD;
      the score at MI, FMA and MRS at 4, 12 and 24 weeks from the administration of BoNT-A.&#xD;
&#xD;
      The statistical analysis will be performed using the Statistical Package for Social Science&#xD;
      SPSS® version 20.0 software for Macintosh (SPSS Inc., Chicago, IL, USA). Statistical&#xD;
      significance will set at P &lt;0.05.&#xD;
&#xD;
      Results are under statistical evaluation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 27, 2015</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time elapsed</measure>
    <time_frame>T1 (4 weeks)</time_frame>
    <description>In order to evaluate the role of the time elapsed since the acute event on the therapeutic efficacy of the first administration of BoNT-A, the reduction of spastic hypertonia will be considered as the primary endpoint.&#xD;
Patients who gain a reduction of at least 1 point at the modified Ashworth scale (MAS) were defined as &quot;responder&quot;. Who did not achieve that amelioration was classified as &quot;non-responders&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modified Ashworth scale (MAS)</measure>
    <time_frame>T0 (baseline); T1 (4 weeks); T2 (12 weeks); T3 (24 weeks)</time_frame>
    <description>Evaluation of the spasticity grade's at 4 - 12 - 24 weeks from the BoNT-A injection.&#xD;
MAS is a scale graded in 5 points (0 no increase in muscle tone; 4 rigid in flexion or extension).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motricity index (MI)</measure>
    <time_frame>T0 (baseline); T1 (4 weeks); T2 (12 weeks); T3 (24 weeks)</time_frame>
    <description>Evaluation of the motricity using the MI at 4 - 12 - 24 weeks from the BoNT-A injection.&#xD;
Motricity Index is an ordinal scale that evaluates motor and functional capacity at the level of the limbs in patients with neurological pathologies. The movements evaluated are 6 in all (3 for each limb) and are:&#xD;
for the arm (pinch grip, elbow flexion, shoulder abduction)&#xD;
for the leg (ankle dorsiflexion, knee extension, hip flexion) To each movement assessed the points attributed may range from 0 &quot;no movement&quot; to 33 &quot;normal pinch grip&quot; or &quot;normal power&quot; for upper and lower extremities respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fughl Meyer assessment (FMA)</measure>
    <time_frame>T0 (baseline); T1 (4 weeks); T2 (12 weeks); T3 (24 weeks)</time_frame>
    <description>The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The scale is comprised of five domains (motor functioning in the upper and lower extremities; sensory functioning, evaluates light touch on two surfaces of the arm and leg, and position perception for 8 joints; balance, contains 7 tests, 3 seated and 4 standing; the joint range of motion, 8 joints; joint pain). Lowest is the total for each domain, worse is the correspondent function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified rankin scale (MRS)</measure>
    <time_frame>T0 (baseline); T1 (4 weeks); T2 (12 weeks); T3 (24 weeks)</time_frame>
    <description>The Modified Rankin Scale (MRS) defines the physical and mental capacity to adapt to neurological deficits. The scale is divided into 6 degrees, from 0 (no deficit) to 5 (severe disability).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">86</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Enrolled patients</arm_group_label>
    <description>Each patient (whether hospitalized or outpatient) included in the study underwent to a baseline evaluation in which near and remote pathological history were recorded (main concomitant pathologies, drug therapy in progress, previous major surgery) and the following evaluation scales were administered: modified Ashworth scale (MAS), MI (motricity index), FMA (Fughl Meyer assessment) and Modified Rankin' scale (MRS).&#xD;
Each patient will subsequently undergo to a follow-up evaluation at 4, 12 and 24 weeks after the date of inoculation through the execution of a specialist visit (physiatric/neurological) and the administration of the following evaluation scales: MAS, MI, FMA and MRS. For the duration of the study, each patient may undergo integrated rehabilitation treatment at the discretion of each of the investigators of each centre involved in the study according to the guidelines and common clinical practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal clinical practice</intervention_name>
    <description>There are no experimental interventions. The procedures are in line with normal clinical practice.</description>
    <arm_group_label>Enrolled patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with the occurrence of post-stroke spastic hypertonia involving the main&#xD;
        muscle groups of the affected side.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of spasticity as a consequence of cerebral stroke (ischemic or hemorrhagic)&#xD;
             documented radiologically by brain CT or MRI;&#xD;
&#xD;
          -  Presence of spastic hypertonia in the main muscle groups of the affected side with an&#xD;
             intensity equal to or greater than MAS 1+/4;&#xD;
&#xD;
          -  Presence of paresis in the affected side with weakness of the main muscle groups equal&#xD;
             to or less than 2 according to the MRC scale;&#xD;
&#xD;
          -  Time elapsed since cerebral stroke less than 12 months;&#xD;
&#xD;
          -  No prior focal treatment of spasticity with botulinum toxin.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in other ongoing clinical studies&#xD;
&#xD;
          -  Presence of joint limitation or muscle contractures to the main muscle groups of the&#xD;
             affected side quantifiable as a score of 4/4 at the MAS&#xD;
&#xD;
          -  Therapy with antispastic drugs (baclofen, dantrolene, tizanidine, benzodiazepines,&#xD;
             clonidine, phenothiazine)&#xD;
&#xD;
          -  Other neurological (previous cerebral strokes, Parkinson's disease, multiple&#xD;
             sclerosis, medullary pathologies, extrapyramidal syndromes) or orthopaedic (severe&#xD;
             osteoarthritis, previous arthroplasty with residual joint limitation or fracture&#xD;
             healed with angular defects) diseases involving the affected side and able to&#xD;
             influence the results of the study.&#xD;
&#xD;
        Particularly vulnerable populations&#xD;
&#xD;
        The following cannot be included in the study:&#xD;
&#xD;
          -  women of childbearing age who do not use contraceptives&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  women in the breastfeeding period&#xD;
&#xD;
          -  patients in an emergency situation&#xD;
&#xD;
        Criteria for anticipated exit from the study:&#xD;
&#xD;
          -  Relapse of disease during the study period&#xD;
&#xD;
          -  Withdrawal of informed consent to participate in the study&#xD;
&#xD;
          -  Inability to perform the first follow-up evaluation 4 weeks after BoNT-A&#xD;
             administration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicola Smania, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universita di Verona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Section of Clinical Neurology, Department Neurological, Neuropsychological, Morphological and Movement Sciences, University of Verona, Verona, Italy</name>
      <address>
        <city>Verona</city>
        <zip>37124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 21, 2020</last_update_submitted>
  <last_update_submitted_qc>May 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universita di Verona</investigator_affiliation>
    <investigator_full_name>Nicola Smania, MD, Clinical Professor</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Botulinum toxin</keyword>
  <keyword>Spasticity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
    <mesh_term>Stroke</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/NCT04404868
org study id: BoNT-A early treatment
nct id: NCT04404868
lead sponsor: 
This was a multicentric observational study with the aim to evaluate the effect of early
      treatment with botulinum toxin type A (BoNT-A) on post-stroke spasticity in adult patients.
      All patients enrolled (86 patients) after a baseline clinical assessment (modified Ashworth
      scale, motricity index, Fughl Meyer assessment and modified Rankin' scale) undergoes to a
      BoNT-A injection following the evidence-based clinical practice. Subsequently, at 4, 12 and
      24 weeks they underwent the same clinical evaluation as a follow-up. Results are under
      statistical evaluation.
This was a multicentric observational study with the aim to evaluate the effect of early
      treatment with botulinum toxin type A (BoNT-A) on post-stroke spasticity in adult patients.
      All centres involved are in Italy. The inclusion and exclusion criteria are described in
      detail in the correspondent section. The main outcome measure was to assess how the time
      elapsed from the acute event can influence the effectiveness of the focal treatment of
      spasticity with BoNT-A in adult patients with cerebral stroke. Secondary outcomes were to
      evaluate the spasticity' grade and the level of functioning using a clinical assessment
      (modified Ashworth scale, motricity index, Fughl Meyer assessment, Modified Rankin' scale).

      The patients were enrolled from 10 centres that agreed to participate in this study (Azienda
      Ospedaliera Universitaria Integrata of Verona - coordinating centre; Azienda Ospedaliero
      Universitaria Ospedali Riuniti of Foggia; Azienda Ospedaliero-Universitaria of Ferrara;
      Azienda Ospedaliero-Universitaria Pisana; Azienda Ospedaliero Universitaria "Maggiore della
      Carità" of Novara; Azienda Ospedaliera Universitaria - Ospedali Riuniti of Ancona; Azienda
      Ospedaliera "Cardinale G. Panico" of Tricase; Fondazione Santa Lucia IRCCS of Rome; Azienda
      Ospedaliero-Universitaria Sant'Andrea of Rome; Ospedale "Ca' Foncello" of Treviso). No
      patients were enrolled from the last two centers that have expressed their waiver to
      participate when the study was already started.

      Each patient (whether hospitalized or outpatient) included in the study underwent to a
      baseline evaluation in which near and remote pathological history were recorded (main
      concomitant pathologies, drug therapy in progress, previous major surgery, date of the
      stroke) and the following evaluation scales were administered: modified Ashworth scale (MAS),
      MI (motricity index), FMA (Fughl Meyer assessment) and Modified Rankin' scale (MRS). After
      that received a BoNT-A injection to treat the spasticity focally following the evidence-based
      clinical practice.

      Each patient subsequently performed a follow-up evaluation at 4, 12 and 24 weeks after the
      date of inoculation through the execution of a specialist visit (physiatric/neurological) and
      the administration of the following evaluation scales: MAS, MI, FMA and MRS. For the duration
      of the study, each patient may undergo integrated rehabilitation treatment at the discretion
      of each of the investigators of each centre involved in the study according to the guidelines
      and common clinical practice.

      The estimation of the sample size was hypothesized with the aim to observe a frequency of 75%
      in the number of patients who will show a reduction of one point at the MAS. If there is a
      correlation between the time elapsed since the acute event and the reduction in the degree of
      spastic hypertonia after the first administration of BoNT-A, to obtain an OR = 0.5, assuming
      DS = 1 and R2 = 0, with α = 0.05 and β = 0.20 (study power = 80%), 90 patients will be
      needed. Assuming a drop-out rate of 10%, a total of 100 patients will need to be enrolled in
      the study.

      Descriptive statistics were produced (frequency histograms; position or central trend
      indices: average, median; variability or sample dispersion indices: standard deviation,
      interquartile range; sample distribution profile estimate: Shapiro-Wilk test; construction of
      the intervals of confidence) as regards demographic (age, gender, the time elapsed from a
      stroke) and clinical (MAS, MI, FMA and MRS score at baseline, 4, 12 and 24 weeks after BoNT-A
      injection).

      In order to evaluate the role of the time elapsed from the acute event on the therapeutic
      efficacy of the first administration of BoNT-A 4 weeks after the inoculation (primary
      endpoint), a logistic regression analysis was performed in order to evaluate the effects of
      time since the acute event (independent variable) on the reduction of spastic hypertonia
      defined in dichotomous terms (dependent variable): RESPONDER (patient who will have obtained
      a reduction of at least 1 point in MAS of the degree of spastic hypertonia after 4 weeks from
      the administration) and NON RESPONDER (patient who has not obtained a reduction of at least 1
      point in MAS of the degree of spastic hypertonia 4 weeks after administration), considering
      as possible any covariates the gender and age of the patient at the time of the acute event.

      As regards the evaluation of secondary endpoints, the analysis of correlation (Pearson
      correlation index; Spearman correlation coefficient) was carried out in order to evaluate the
      association between the effects of the time elapsed from the acute event and the change in
      the score at MAS 4, 12 and 24 weeks after BoNT inoculation, as well as on the variation of
      the score at MI, FMA and MRS at 4, 12 and 24 weeks from the administration of BoNT-A.

      The statistical analysis will be performed using the Statistical Package for Social Science
      SPSS® version 20.0 software for Macintosh (SPSS Inc., Chicago, IL, USA). Statistical
      significance will set at P <0.05.

      Results are under statistical evaluation.
observational model: Cohort
time perspective: Cross-Sectional
measure: Time elapsed
time frame: T1 (4 weeks)
description: In order to evaluate the role of the time elapsed since the acute event on the therapeutic efficacy of the first administration of BoNT-A, the reduction of spastic hypertonia will be considered as the primary endpoint.
Patients who gain a reduction of at least 1 point at the modified Ashworth scale (MAS) were defined as "responder". Who did not achieve that amelioration was classified as "non-responders".
measure: Modified Ashworth scale (MAS)
time frame: T0 (baseline); T1 (4 weeks); T2 (12 weeks); T3 (24 weeks)
description: Evaluation of the spasticity grade's at 4 - 12 - 24 weeks from the BoNT-A injection.
MAS is a scale graded in 5 points (0 no increase in muscle tone; 4 rigid in flexion or extension).
measure: Motricity index (MI)
time frame: T0 (baseline); T1 (4 weeks); T2 (12 weeks); T3 (24 weeks)
description: Evaluation of the motricity using the MI at 4 - 12 - 24 weeks from the BoNT-A injection.
Motricity Index is an ordinal scale that evaluates motor and functional capacity at the level of the limbs in patients with neurological pathologies. The movements evaluated are 6 in all (3 for each limb) and are:
for the arm (pinch grip, elbow flexion, shoulder abduction)
for the leg (ankle dorsiflexion, knee extension, hip flexion) To each movement assessed the points attributed may range from 0 "no movement" to 33 "normal pinch grip" or "normal power" for upper and lower extremities respectively.
measure: Fughl Meyer assessment (FMA)
time frame: T0 (baseline); T1 (4 weeks); T2 (12 weeks); T3 (24 weeks)
description: The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The scale is comprised of five domains (motor functioning in the upper and lower extremities; sensory functioning, evaluates light touch on two surfaces of the arm and leg, and position perception for 8 joints; balance, contains 7 tests, 3 seated and 4 standing; the joint range of motion, 8 joints; joint pain). Lowest is the total for each domain, worse is the correspondent function.
measure: Modified rankin scale (MRS)
time frame: T0 (baseline); T1 (4 weeks); T2 (12 weeks); T3 (24 weeks)
description: The Modified Rankin Scale (MRS) defines the physical and mental capacity to adapt to neurological deficits. The scale is divided into 6 degrees, from 0 (no deficit) to 5 (severe disability).
arm group label: Enrolled patients
description: Each patient (whether hospitalized or outpatient) included in the study underwent to a baseline evaluation in which near and remote pathological history were recorded (main concomitant pathologies, drug therapy in progress, previous major surgery) and the following evaluation scales were administered: modified Ashworth scale (MAS), MI (motricity index), FMA (Fughl Meyer assessment) and Modified Rankin' scale (MRS).
Each patient will subsequently undergo to a follow-up evaluation at 4, 12 and 24 weeks after the date of inoculation through the execution of a specialist visit (physiatric/neurological) and the administration of the following evaluation scales: MAS, MI, FMA and MRS. For the duration of the study, each patient may undergo integrated rehabilitation treatment at the discretion of each of the investigators of each centre involved in the study according to the guidelines and common clinical practice.
intervention type: Other
intervention name: Normal clinical practice
description: There are no experimental interventions. The procedures are in line with normal clinical practice.
arm group label: Enrolled patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicola Smania, MD
role: Principal Investigator
affiliation: Universita di Verona
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Universita di Verona
investigator full name: Nicola Smania, MD, Clinical Professor
investigator title: Professor
mesh term: Muscle Spasticity
mesh term: Stroke