<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/NCT03271125</url>
  </required_header>
  <id_info>
    <org_study_id>Treadmill MS</org_study_id>
    <nct_id>NCT03271125</nct_id>
  </id_info>
  <brief_title>Intensive Multimodal Training for Persons With MS</brief_title>
  <acronym>Treadmill</acronym>
  <official_title>Intensive Multimodal Training for Persons With Multiple Sclerosis: Random Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione Don Carlo Gnocchi Onlus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondazione Don Carlo Gnocchi Onlus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to evaluate the safety, feasibility and preliminary effects of a&#xD;
      high-intensity rehabilitative multimodal training protocol carried out on treadmill on&#xD;
      walking efficacy, mobility, balance, executive function, fatigue and health-related quality&#xD;
      of life in a sample of persons with moderate to severe MS deficit of mobility compared to a&#xD;
      control group that received a strengthening program of similar intensity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Persons with multiple sclerosis can have various deficits, affecting many aspects of physical&#xD;
      and cognitive functioning often leading to low levels of physical activity in daily life.&#xD;
      These include poor endurance, muscle weakness, incoordination and poor balance and cognitive&#xD;
      deficits that can all lead to persistent mobility difficulties in daily life.&#xD;
&#xD;
      Given the importance of exercise and physical activity for persons with multiple sclerosis&#xD;
      that are already moderately to severely hampered by their locomotor ability and balance, the&#xD;
      setting up of intense functional mobility training that targets the main deficits, in&#xD;
      adjunction to a clinical rehabilitation usual care and under close supervision, may be a&#xD;
      viable way of increasing the level of physiological health and give a basis for the persons&#xD;
      to start their own activity pursuit outside of the rehabilitation clinic. Treadmill walking&#xD;
      has several benefits for mobility rehabilitation. First, it is a everyday task, walking.&#xD;
      Second it lends itself well to a dual task paradigm where other aspects of mobility, such as&#xD;
      equilibrium and cognitive factors can be addressed during walking. Third, even persons with&#xD;
      severe walking limitations can train walking at various speeds when on treadmill, holding&#xD;
      onto handrails and using safety harnesses that minimize the possibility of adverse events&#xD;
      during training. Further, the treadmill paradigm lends itself well to training with&#xD;
      progressive task difficulty, numerous rhythmic repetitions, and importantly it can include an&#xD;
      aerobic component to improve cardiorespiratory fitness. All of which should lead to improved&#xD;
      submaximal exercise tolerance and endurance, more functional mobility and consequently&#xD;
      increased ability to carry out activities of daily living.&#xD;
&#xD;
      Methods: A consecutive sample of 42 People with Multiple Sclerosis (PwMS) were recruited from&#xD;
      the outpatient/inpatient rehabilitation service of the Don Gnocchi Foundation. The study was&#xD;
      conducted in accordance with the Declaration of Helsinki and was approved by the ethics&#xD;
      committee of the Don Gnocchi Foundation. Subjects signed an informed consent form before the&#xD;
      beginning of the study.&#xD;
&#xD;
      The study design was a two arm randomized 2:1 controlled trial (see study flow chart in&#xD;
      Figure 1).&#xD;
&#xD;
      The participants were assessed before and after the rehabilitation period by researchers&#xD;
      blinded to group assignment.&#xD;
&#xD;
      Participants in both groups received 15- 20 treatments sessions lasting 30 minutes 5 times&#xD;
      per week by experienced physical therapists trained for the study. All participants also&#xD;
      followed their usual rehabilitation care protocols as planned.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2013</start_date>
  <primary_completion_date type="Actual">May 19, 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>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Two minute walking test</measure>
    <time_frame>Two minutes</time_frame>
    <description>The subjects were instructed to walk at their usual speed for 2 minutes while the distance they covered in 2 minutes was recorded in meters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed up and go test</measure>
    <time_frame>1 minute</time_frame>
    <description>The Timed Up &amp; Go test (TUG) is a simple functional test that requires a person to stand up, walk 3m, turn back, and sit down again while being timed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Frontal Assessment Battery</measure>
    <time_frame>10 minutes</time_frame>
    <description>The Frontal Assessment Battery (FAB) is a short cognitive and behavioral six-subtest battery for the bedside screening of a global executive dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ten meter walking test</measure>
    <time_frame>2 minutes</time_frame>
    <description>The 10 meters walking test (10MWT) is a test in which the participant is timed while walking 10m at their comfortable speed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Berg Balance Scale</measure>
    <time_frame>15 minutes</time_frame>
    <description>The Berg Balance Scale (BBS) is a 14-item scale widely used to assess balance disorders in PwMS. BBS provides information about patient's balance-related abilities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamic Gait Index</measure>
    <time_frame>15 minutes</time_frame>
    <description>The Dynamic Gait Index (DGI) measures gait function and dynamic balance. The eight tasks of this scale include walking, walking with head turns, pivoting, walking over objects, walking around objects, and going upstairs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Short Form-12 questionnaire (SF-12)</measure>
    <time_frame>10 minutes</time_frame>
    <description>The SF12 is comprised of two domains, physical and mental and gives two composite scores that reflect the perceived health of the participant.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Rehabilitation</condition>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Treadmill group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the experimental group received supervised treadmill training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resistance group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in the control group were treated with Resistance exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treadmill</intervention_name>
    <description>Participants in the experimental group received supervised treadmill training, 4-5 sessions per week. The treatment protocol was aimed at improving participants' resistance, walking velocity, balance and cognitive functions during motor and cognitive (dual) tasks. The treadmill training was carried out without body weight support but if needed the participants were attached to a safety harness.</description>
    <arm_group_label>Treadmill group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Resistance</intervention_name>
    <description>Participants in the control group were treated with Resistance exercises, 4-5 sessions per week. The treatment protocol was aimed at improving strength in muscles involved in walking (hip abductors, quadriceps, plantar flexors, dorsal flexors) according to current guidelines from the American College of Sports Medicine (2009). Three sets of 10 repetitions were performed bilaterally with appropriate weights for each exercise</description>
    <arm_group_label>Resistance group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of multiple sclerosis according to McDonald's criteria (Polman et al. Ann&#xD;
             Neurology 2011)&#xD;
&#xD;
          -  EDSS score &lt;= 7&#xD;
&#xD;
          -  Free from relapses and steroid treatment for at least 1 month)&#xD;
&#xD;
          -  Able to stand 30 seconds,&#xD;
&#xD;
          -  Able to walk at least 10 meters independently or with a cane&#xD;
&#xD;
          -  Able to understand and follow instructions&#xD;
&#xD;
          -  Stable neurological conditions and willingness to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac pacemaker&#xD;
&#xD;
          -  Any pre-existing conditions that affected walking function&#xD;
&#xD;
          -  diagnosis of depression or psychotic disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fondazione Don Carlo Gnocchi IRCCS</name>
      <address>
        <city>Milan</city>
        <state>MI</state>
        <zip>20148</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intervention</keyword>
  <keyword>Multiple sclerosis</keyword>
  <keyword>Treadmill</keyword>
  <keyword>Mobility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Due to ethical restrictions set by the Ethics Committee of Fondazione Don Carlo Gnocchi and the presence of identifying patient information, researchers wishing to access raw data for use in future research studies should write to the Corresponding Author that will apply to the Ethics Committee of Fondazione Don Carlo Gnocchi for approval. Additional data</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03271125
org study id: Treadmill MS
nct id: NCT03271125
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to evaluate the safety, feasibility and preliminary effects of a
      high-intensity rehabilitative multimodal training protocol carried out on treadmill on
      walking efficacy, mobility, balance, executive function, fatigue and health-related quality
      of life in a sample of persons with moderate to severe MS deficit of mobility compared to a
      control group that received a strengthening program of similar intensity.
Persons with multiple sclerosis can have various deficits, affecting many aspects of physical
      and cognitive functioning often leading to low levels of physical activity in daily life.
      These include poor endurance, muscle weakness, incoordination and poor balance and cognitive
      deficits that can all lead to persistent mobility difficulties in daily life.

      Given the importance of exercise and physical activity for persons with multiple sclerosis
      that are already moderately to severely hampered by their locomotor ability and balance, the
      setting up of intense functional mobility training that targets the main deficits, in
      adjunction to a clinical rehabilitation usual care and under close supervision, may be a
      viable way of increasing the level of physiological health and give a basis for the persons
      to start their own activity pursuit outside of the rehabilitation clinic. Treadmill walking
      has several benefits for mobility rehabilitation. First, it is a everyday task, walking.
      Second it lends itself well to a dual task paradigm where other aspects of mobility, such as
      equilibrium and cognitive factors can be addressed during walking. Third, even persons with
      severe walking limitations can train walking at various speeds when on treadmill, holding
      onto handrails and using safety harnesses that minimize the possibility of adverse events
      during training. Further, the treadmill paradigm lends itself well to training with
      progressive task difficulty, numerous rhythmic repetitions, and importantly it can include an
      aerobic component to improve cardiorespiratory fitness. All of which should lead to improved
      submaximal exercise tolerance and endurance, more functional mobility and consequently
      increased ability to carry out activities of daily living.

      Methods: A consecutive sample of 42 People with Multiple Sclerosis (PwMS) were recruited from
      the outpatient/inpatient rehabilitation service of the Don Gnocchi Foundation. The study was
      conducted in accordance with the Declaration of Helsinki and was approved by the ethics
      committee of the Don Gnocchi Foundation. Subjects signed an informed consent form before the
      beginning of the study.

      The study design was a two arm randomized 2:1 controlled trial (see study flow chart in
      Figure 1).

      The participants were assessed before and after the rehabilitation period by researchers
      blinded to group assignment.

      Participants in both groups received 15- 20 treatments sessions lasting 30 minutes 5 times
      per week by experienced physical therapists trained for the study. All participants also
      followed their usual rehabilitation care protocols as planned.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Two minute walking test
time frame: Two minutes
description: The subjects were instructed to walk at their usual speed for 2 minutes while the distance they covered in 2 minutes was recorded in meters.
measure: Timed up and go test
time frame: 1 minute
description: The Timed Up & Go test (TUG) is a simple functional test that requires a person to stand up, walk 3m, turn back, and sit down again while being timed.
measure: The Frontal Assessment Battery
time frame: 10 minutes
description: The Frontal Assessment Battery (FAB) is a short cognitive and behavioral six-subtest battery for the bedside screening of a global executive dysfunction.
measure: Ten meter walking test
time frame: 2 minutes
description: The 10 meters walking test (10MWT) is a test in which the participant is timed while walking 10m at their comfortable speed.
measure: The Berg Balance Scale
time frame: 15 minutes
description: The Berg Balance Scale (BBS) is a 14-item scale widely used to assess balance disorders in PwMS. BBS provides information about patient's balance-related abilities.
measure: Dynamic Gait Index
time frame: 15 minutes
description: The Dynamic Gait Index (DGI) measures gait function and dynamic balance. The eight tasks of this scale include walking, walking with head turns, pivoting, walking over objects, walking around objects, and going upstairs.
measure: The Short Form-12 questionnaire (SF-12)
time frame: 10 minutes
description: The SF12 is comprised of two domains, physical and mental and gives two composite scores that reflect the perceived health of the participant.
arm group label: Treadmill group
arm group type: Experimental
description: Participants in the experimental group received supervised treadmill training
arm group label: Resistance group
arm group type: Active Comparator
description: Participants in the control group were treated with Resistance exercises.
intervention type: Behavioral
intervention name: Treadmill
description: Participants in the experimental group received supervised treadmill training, 4-5 sessions per week. The treatment protocol was aimed at improving participants' resistance, walking velocity, balance and cognitive functions during motor and cognitive (dual) tasks. The treadmill training was carried out without body weight support but if needed the participants were attached to a safety harness.
arm group label: Treadmill group
intervention type: Behavioral
intervention name: Resistance
description: Participants in the control group were treated with Resistance exercises, 4-5 sessions per week. The treatment protocol was aimed at improving strength in muscles involved in walking (hip abductors, quadriceps, plantar flexors, dorsal flexors) according to current guidelines from the American College of Sports Medicine (2009). Three sets of 10 repetitions were performed bilaterally with appropriate weights for each exercise
arm group label: Resistance group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: Undecided
ipd description: Due to ethical restrictions set by the Ethics Committee of Fondazione Don Carlo Gnocchi and the presence of identifying patient information, researchers wishing to access raw data for use in future research studies should write to the Corresponding Author that will apply to the Ethics Committee of Fondazione Don Carlo Gnocchi for approval. Additional data