<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/NCT02209467</url>
  </required_header>
  <id_info>
    <org_study_id>Researchweb 153691</org_study_id>
    <nct_id>NCT02209467</nct_id>
  </id_info>
  <brief_title>Balance and Falls in Multiple Sclerosis</brief_title>
  <official_title>Balance and Falls in Multiple Sclerosis: Intervention and Perceptions From Patients and Next of Kins</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Örebro County Council</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Örebro County Council</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study hypothesis is that for people with moderate to severe multiple sclerosis postural&#xD;
      balance and walking improve and the risk of accidental falls are reduced after participating&#xD;
      in a specific training intervention of 7 weeks. The hypothesis is also the the effect remain&#xD;
      a further 7 weeks post training.&#xD;
&#xD;
      Multiple Sclerosis (MS) is disease affecting the central nervous system. Walking and postural&#xD;
      balance are often affected early in the course of the disease. The risk of falls is large.&#xD;
      Many persons with MS have decreased trunk stability compared to healthy persons . In an&#xD;
      earlier study including people with mild to moderate MS we found that a period of core&#xD;
      stability exercises reduced the risk of falls. In this study the training concept will be&#xD;
      applied for persons with more severe walking limitations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Berg Balance Scale at 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in 10 repetitions Sit to stand test at 15 weeks</measure>
    <time_frame>baseline, 15 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Trunk Impairment scale at 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the Trunk Impairment Scale at 15 weeks</measure>
    <time_frame>baseline, 15 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the 10 repetition Si to stand test at 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the Berg Balance scale at 15 weeks</measure>
    <time_frame>baseline, 15 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on the Timed Up and Go test at 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on the Timed Up and Go test at 15 weeks</measure>
    <time_frame>baseline, 15 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on the10 meter walking test at 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on the 10 meter walking test at 15 weks</measure>
    <time_frame>baseline, 15 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on the 2 minutes walking test at 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on the 2 minutes walking test at 15 weeks</measure>
    <time_frame>baseline, 15 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in postural sway at 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in postural sway at 15 weeks</measure>
    <time_frame>baseline, 15 weeks</time_frame>
    <description>postural sway in standing on the floor is assessed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on the Falls-Efficacy scale at 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on the Falls Efficacy scale at 15 weeks</measure>
    <time_frame>baseline, 15 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 15 weeks</measure>
    <time_frame>baseline, 15 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on the MS Walking Scale-12 at 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on the MS Walking scale-12 at 15 weeks</measure>
    <time_frame>baseline, 15 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of falls and accidental falls</measure>
    <time_frame>from baseline to 15 weeks</time_frame>
    <description>the number of falls and accidental falls are noted by the participant in a study-specific falls diary.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Group balance training late start</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomized to late start act as No intervention group during the study period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group balance training early start</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group balance training focusing on core stability exercises 2 times per week for 7 weeks and 2 home training sessions per weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group balance training</intervention_name>
    <description>Group balance training 60 minutes 2 times per week plus 3-5 home exercises 2 times/week. Exercises focus om core stability in sitting, standing and lying.</description>
    <arm_group_label>Group balance training early start</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed multiple sclerosis&#xD;
&#xD;
          -  Expanded Disability Scale Score of 5-6.5&#xD;
&#xD;
          -  walking speed of less than 0.8 m/s as tested on a 10 meter walking test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ongoing relapse&#xD;
&#xD;
          -  Cognitive or language difficulties that prohibit participating in the intervention or&#xD;
             performing the outcome measures&#xD;
&#xD;
          -  Change in specific MS medication during the last 30 days&#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>Anna Carling, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for Health Care Sciences, Örebro County Council</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anette Forsberg, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Family Medicine Research Centre, Örebro County Council</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ylva Nilsagård, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Centre for Health Care Sciences, Örebro County Council</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Neurorehab Mälarsjukhuset</name>
      <address>
        <city>Eskilstuna</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physiotherapy department Gävle hospital</name>
      <address>
        <city>Gävle</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rehab unit Karlskoga hospital</name>
      <address>
        <city>Karlskoga</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Health Care</name>
      <address>
        <city>Linköping</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nyköping hospital</name>
      <address>
        <city>Nyköping</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rehab unit Västerås hospital</name>
      <address>
        <city>Västerås</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physiotherapy department University hospital</name>
      <address>
        <city>Örebro</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Nilsagard YE, von Koch LK, Nilsson M, Forsberg AS. Balance exercise program reduced falls in people with multiple sclerosis: a single-group, pretest-posttest trial. Arch Phys Med Rehabil. 2014 Dec;95(12):2428-34. doi: 10.1016/j.apmr.2014.06.016. Epub 2014 Jul 6.</citation>
    <PMID>25004466</PMID>
  </reference>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>October 28, 2015</last_update_submitted>
  <last_update_submitted_qc>October 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Örebro County Council</investigator_affiliation>
    <investigator_full_name>Anette Forsberg, PhD</investigator_full_name>
    <investigator_title>PhD, lecturer</investigator_title>
  </responsible_party>
  <keyword>walking</keyword>
  <keyword>postural balance</keyword>
  <keyword>falls</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>
  <!-- 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/NCT02209467
org study id: Researchweb 153691
nct id: NCT02209467
lead sponsor: 
has dmc: No
The study hypothesis is that for people with moderate to severe multiple sclerosis postural
      balance and walking improve and the risk of accidental falls are reduced after participating
      in a specific training intervention of 7 weeks. The hypothesis is also the the effect remain
      a further 7 weeks post training.

      Multiple Sclerosis (MS) is disease affecting the central nervous system. Walking and postural
      balance are often affected early in the course of the disease. The risk of falls is large.
      Many persons with MS have decreased trunk stability compared to healthy persons . In an
      earlier study including people with mild to moderate MS we found that a period of core
      stability exercises reduced the risk of falls. In this study the training concept will be
      applied for persons with more severe walking limitations.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Change from baseline in Berg Balance Scale at 8 weeks
time frame: baseline, 8 weeks
measure: Change from baseline in 10 repetitions Sit to stand test at 15 weeks
time frame: baseline, 15 weeks
measure: Change from baseline in Trunk Impairment scale at 8 weeks
time frame: baseline, 8 weeks
measure: Change from baseline in the Trunk Impairment Scale at 15 weeks
time frame: baseline, 15 weeks
measure: Change from baseline in the 10 repetition Si to stand test at 8 weeks
time frame: baseline, 8 weeks
measure: Change from baseline in the Berg Balance scale at 15 weeks
time frame: baseline, 15 weeks
measure: Change from baseline on the Timed Up and Go test at 8 weeks
time frame: baseline, 8 weeks
measure: Change from baseline on the Timed Up and Go test at 15 weeks
time frame: baseline, 15 weeks
measure: Change from baseline on the10 meter walking test at 8 weeks
time frame: baseline, 8 weeks
measure: Change from baseline on the 10 meter walking test at 15 weks
time frame: baseline, 15 weeks
measure: Change from baseline on the 2 minutes walking test at 8 weeks
time frame: baseline, 8 weeks
measure: Change from baseline on the 2 minutes walking test at 15 weeks
time frame: baseline, 15 weeks
measure: Change from baseline in postural sway at 8 weeks
time frame: baseline, 8 weeks
measure: Change from baseline in postural sway at 15 weeks
time frame: baseline, 15 weeks
description: postural sway in standing on the floor is assessed
measure: Change from baseline on the Falls-Efficacy scale at 8 weeks
time frame: baseline, 8 weeks
measure: Change from baseline on the Falls Efficacy scale at 15 weeks
time frame: baseline, 15 weeks
measure: Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 8 weeks
time frame: baseline, 8 weeks
measure: Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 15 weeks
time frame: baseline, 15 weeks
measure: Change from baseline on the MS Walking Scale-12 at 8 weeks
time frame: baseline, 8 weeks
measure: Change from baseline on the MS Walking scale-12 at 15 weeks
time frame: baseline, 15 weeks
measure: The number of falls and accidental falls
time frame: from baseline to 15 weeks
description: the number of falls and accidental falls are noted by the participant in a study-specific falls diary.
arm group label: Group balance training late start
arm group type: No Intervention
description: Participants randomized to late start act as No intervention group during the study period.
arm group label: Group balance training early start
arm group type: Experimental
description: Group balance training focusing on core stability exercises 2 times per week for 7 weeks and 2 home training sessions per weeks.
intervention type: Other
intervention name: Group balance training
description: Group balance training 60 minutes 2 times per week plus 3-5 home exercises 2 times/week. Exercises focus om core stability in sitting, standing and lying.
arm group label: Group balance training early start
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anna Carling, MSc
role: Principal Investigator
affiliation: Centre for Health Care Sciences, Örebro County Council
last name: Anette Forsberg, PhD
role: Study Chair
affiliation: Family Medicine Research Centre, Örebro County Council
last name: Ylva Nilsagård, PhD
role: Study Director
affiliation: Centre for Health Care Sciences, Örebro County Council
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Sweden
citation: Nilsagard YE, von Koch LK, Nilsson M, Forsberg AS. Balance exercise program reduced falls in people with multiple sclerosis: a single-group, pretest-posttest trial. Arch Phys Med Rehabil. 2014 Dec;95(12):2428-34. doi: 10.1016/j.apmr.2014.06.016. Epub 2014 Jul 6.
PMID: 25004466
responsible party type: Principal Investigator
investigator affiliation: Örebro County Council
investigator full name: Anette Forsberg, PhD
investigator title: PhD, lecturer
mesh term: Multiple Sclerosis
mesh term: Sclerosis