<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/NCT03769636</url>
  </required_header>
  <id_info>
    <org_study_id>BASEC Nr. 2017-00728</org_study_id>
    <nct_id>NCT03769636</nct_id>
  </id_info>
  <brief_title>Changes in Physical Activity in All Day Life in People With MS Before and After Rehabilitation</brief_title>
  <official_title>Changes in Physical Activity in All Day Life (Steps, Distance, Periods, Max. Speed) in People With MS Before and After the Rehabilitation - A Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Klinik Valens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Klinik Valens</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 primary objective is to observe the impact of in-patient rehabilitation on physical&#xD;
      activity in daily life using miniature, wearable sensors, fixed on the shoes. These sensors&#xD;
      record data about various aspects of walking. The information on the therapy effect on daily&#xD;
      life can complement the clinical information and the patients' subjective report on therapy&#xD;
      induced improvements.&#xD;
&#xD;
      The secondary objective is the association of changes in physical activity, self-rated&#xD;
      walking capacity, self-rated fatigue and self-rated health-related quality of life, wich will&#xD;
      be analysed for disease severity of the participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gait disorders are common in patients with multiple sclerosis (PwMS). Multidisciplinary&#xD;
      in-patient rehabilitation conducted by specialized doctors, nurses and therapists can improve&#xD;
      the ability to walk by tackling the problem with various approaches: by increasing strength&#xD;
      in leg muscles, by improving balance, by increasing cardio- pulmonary fitness, by fitting&#xD;
      walking aids, by reducing fatigue and cognitive deficits, by working out strategies to&#xD;
      compensate for impairments, and by optimising medical treatment. The investigator's patients,&#xD;
      who spend a lot of time (usually 2- 4 weeks) and effort for in-patient rehabilitation in&#xD;
      Valens tell us, that this intensive therapy is usually effective and that their walking&#xD;
      ability improves to a degree that is relevant in daily life. The scientific evidence for the&#xD;
      effectiveness of in- patient rehabilitation is usually based on either clinical assessments&#xD;
      of function (e.g. the 6 minute walking test) or on reports from PwMS, by using questionnaires&#xD;
      e.g. about mobility or quality of life in daily life. Although clinical assessments provide&#xD;
      important information about improvements of the functional capacity, they do not provide&#xD;
      information about the impact of therapy on daily life. Patient reports, on the other hand,&#xD;
      provide important information about the perceived impact in daily life, but the information&#xD;
      is not objective. Objective information about the impact of rehabilitation on daily life is&#xD;
      usually not available.&#xD;
&#xD;
      The primary objective therefore is to observe the impact of in-patient rehabilitation on&#xD;
      physical activity in daily life using miniature, wearable sensors, fixed on the shoes. These&#xD;
      sensors record data about various aspects of walking. The information on the therapy effect&#xD;
      on daily life can complement the clinical information and the patients' subjective report on&#xD;
      therapy induced improvements.&#xD;
&#xD;
      The secondary objective is the association of changes in physical activity, self-rated&#xD;
      walking capacity, self-rated fatigue and self-rated health-related quality of life, wich will&#xD;
      be analysed for disease severity of the participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">October 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in physical activity: Locomotion</measure>
    <time_frame>Physical activity will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).</time_frame>
    <description>The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life in patients with MS (EDSS 2.0-6.5) using miniature, wearable sensors, fixed on the shoes. These sensors record data about various aspects of walking. The information on the therapy effect on daily life can complement the clinical information and the patients' subjective report on therapy induced improvements.&#xD;
The following parameter represents the walking in daily life:&#xD;
- Locomotion: Percentage of locomotion (walking) per day The maximum value is 100%, the minumum value is 0%.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in physical activity: Non-locomotion</measure>
    <time_frame>Physical activity will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).</time_frame>
    <description>The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life in patients with MS (EDSS 2.0-6.5) using miniature, wearable sensors, fixed on the shoes. These sensors record data about various aspects of walking. The information on the therapy effect on daily life can complement the clinical information and the patients' subjective report on therapy induced improvements.&#xD;
The following parameter represents the walking in daily life:&#xD;
- Non-locomotion: Percentage of non-locomotion (sitting, standing, lying) per day The maximum value is 100%, the minumum value is 0%.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in physical activity: Level walking</measure>
    <time_frame>Physical activity will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).</time_frame>
    <description>The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life in patients with MS (EDSS 2.0-6.5) using miniature, wearable sensors, fixed on the shoes. These sensors record data about various aspects of walking. The information on the therapy effect on daily life can complement the clinical information and the patients' subjective report on therapy induced improvements.&#xD;
The following parameter represents the walking in daily life:&#xD;
- Level walking: Percentage of level walking per day The maximum value is 100%, the minumum value is 0%.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in physical activity: Up walking</measure>
    <time_frame>Physical activity will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).</time_frame>
    <description>The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life in patients with MS (EDSS 2.0-6.5) using miniature, wearable sensors, fixed on the shoes. These sensors record data about various aspects of walking. The information on the therapy effect on daily life can complement the clinical information and the patients' subjective report on therapy induced improvements.&#xD;
The following parameter represents the walking in daily life:&#xD;
- Up walking: Percentage of up walking per day The maximum value is 100%, the minumum value is 0%.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in physical activity: Down walking</measure>
    <time_frame>Physical activity will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).</time_frame>
    <description>The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life in patients with MS (EDSS 2.0-6.5) using miniature, wearable sensors, fixed on the shoes. These sensors record data about various aspects of walking. The information on the therapy effect on daily life can complement the clinical information and the patients' subjective report on therapy induced improvements.&#xD;
The following parameter represents the walking in daily life:&#xD;
- Down walking: Percentage of down walking per day The maximum value is 100%, the minumum value is 0%.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in physical activity: Maximum steps</measure>
    <time_frame>Physical activity will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).</time_frame>
    <description>The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life in patients with MS (EDSS 2.0-6.5) using miniature, wearable sensors, fixed on the shoes. These sensors record data about various aspects of walking. The information on the therapy effect on daily life can complement the clinical information and the patients' subjective report on therapy induced improvements.&#xD;
The following parameter represents the walking in daily life:&#xD;
- Maximum steps: Maximal number of continuous steps in one walking bout (a walking bout is defined as walking more than two continuous steps).&#xD;
The maximum value is open, the minimum value is zero.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in physical activity: Steps per hour</measure>
    <time_frame>Physical activity will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).</time_frame>
    <description>The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life in patients with MS (EDSS 2.0-6.5) using miniature, wearable sensors, fixed on the shoes. These sensors record data about various aspects of walking. The information on the therapy effect on daily life can complement the clinical information and the patients' subjective report on therapy induced improvements.&#xD;
The following parameter represents the walking in daily life:&#xD;
- Steps per hour: Number of steps during all recorded walking bouts (the values are normalised per worn hours).&#xD;
The maximum value is open, the minimum value is zero.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in self-rated fatigue</measure>
    <time_frame>Fatigue will first be measured 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).</time_frame>
    <description>Fatigue will be measured by the Fatigue Scale for Motor and Cognitive Functions (FSMC). The FSMC is a 20-points-questionnaire with ten questions about cognitive fatigue and ten questions about motor fatigue. The questions are rated on a 5-point Likert-scale from 1 (does not apply at all) to 5 (applies completely). The total score ranges from a minimum of 20 points to a maximum of 100 points, sub-scores for cognitive and motor fatigue range from a minimum of 10 points to a maximum of 50 points. Higher scores indicate a higher perception of fatigue.&#xD;
The following comparisons are executed:&#xD;
Comparison between T1 and T2&#xD;
Comparison between T2 and T3&#xD;
Comparison between T2 and T4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in self-rated health-related quality of life: EQ-5D</measure>
    <time_frame>Self-rated health-related quality of life will first be measured 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).</time_frame>
    <description>Self-rated health will be measured by the questionnaire &quot;health- related quality of life&quot; (EQ-5D). The EQ-5D is a fife-points questionnaire about the topics &quot;mobility&quot;, &quot;self-care&quot;, &quot;usual-activities&quot;, &quot;pain/discomfort&quot; and &quot;anxiety/depression&quot;. The questions are rated with the following possibilities: &quot;no problems&quot;, &quot;some problems&quot; and &quot;extreme problems&quot;. On the basis of standardized calculations a index value is generated. The value ranges form zero to one. Higher values indicate a higher health-related quality of life.&#xD;
The following comparisons are executed:&#xD;
Comparison between T1 and T2&#xD;
Comparison between T2 and T3&#xD;
Comparison between T2 and T4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in self-rated walking capacity</measure>
    <time_frame>Self-rated waking capacity will first be measured 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).</time_frame>
    <description>Self-rated walking capacity will be measured by the 12-Item MS Walking Scale (MSWS-12). The MSWS-12 is a twelve-points questionnaire to represent the impact of MS on walking capacity. The questions are rated on a five-point Likert-scale from 1 (not at all) to 5 (extremely). The total score ranges from a minimum of 12 points to a maximum of 60 points. Higher scores indicate a higher impact of MS on walking capacity.&#xD;
The following comparisons are executed:&#xD;
Comparison between T1 and T2&#xD;
Comparison between T2 and T3&#xD;
Comparison between T2 and T4</description>
  </secondary_outcome>
  <other_outcome>
    <measure>10 meter walking test (10TW)</measure>
    <time_frame>10TW will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the first week of rehabilitation (T2) and the third week of rehabilitation (T3).</time_frame>
    <description>10TW will be assessed to see changes in walking speed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Timed up and go (TUG)</measure>
    <time_frame>TUG will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the first week of rehabilitation (T2) and the third week of rehabilitation (T4).</time_frame>
    <description>TUG will be assessed to see changes in equilibrium and walking abilities.</description>
  </other_outcome>
  <other_outcome>
    <measure>2 minutes walking test (2MWT)</measure>
    <time_frame>2MWT will be assessed in the first week of rehabilitation (T2) and in the third week of rehabilitation (T3).</time_frame>
    <description>2MWT will be assessed to see changes in walking speed and distance</description>
  </other_outcome>
  <other_outcome>
    <measure>Stair measure test (ST)</measure>
    <time_frame>ST will be assessed in the first week of rehabilitation (T2) and in the third week of rehabilitation (T3).</time_frame>
    <description>ST will be assessed to see changes in speed and walking abilities on stairs.</description>
  </other_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Rehabilitation</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GaitUp Physilog 5</intervention_name>
    <description>The primary outcomes are measured by the Physilog 5 (physical activity) at four different periods (T1-T4). Physilog 5 is worn for 4 weeks in total.&#xD;
The secondary outcomes are fatigue, measured by FSMC (fatigue scale for motor and cognitive functions questionnaire), self-rated health-related quality of life, measured by the EQ-5D (health-questionnaire) and self-rated walking capacity, measured by the MSWS-12 (Twelve Item MS Walking Scale).</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The investigator plans to include 30 patients with multiple sclerosis with an EDSS 2.0-6.5,&#xD;
        who come to Valens for rehabilitation between january 2018 and june 2019&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Planed rehabilitation in Valens between january 2018 and june 2019&#xD;
&#xD;
          -  EDSS 2.0-6.5 (an EDSS 6.5 means the ability to walk 20 meters without resting, using&#xD;
             constant bilateral assistance)&#xD;
&#xD;
          -  German speaking&#xD;
&#xD;
          -  Good function of upper limb, that the device can be fixed by participant himself&#xD;
&#xD;
          -  Informed consent&#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_contact>
    <last_name>Roger April, PT</last_name>
    <phone>0041786141712</phone>
    <email>roger.april@kliniken-valens.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jan Kool, PhD</last_name>
    <phone>0041813031403</phone>
    <email>jan.kool@kliniken-valens.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Klinik Valens</name>
      <address>
        <city>Valens</city>
        <state>St.Gallen</state>
        <zip>7313</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roger April, PT</last_name>
      <phone>0041786141712</phone>
      <email>roger.april@kliniken-valens.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Heesen C, Bohm J, Reich C, Kasper J, Goebel M, Gold SM. Patient perception of bodily functions in multiple sclerosis: gait and visual function are the most valuable. Mult Scler. 2008 Aug;14(7):988-91. doi: 10.1177/1352458508088916. Epub 2008 May 27.</citation>
    <PMID>18505775</PMID>
  </reference>
  <reference>
    <citation>Campbell E, Coulter EH, Mattison PG, Miller L, McFadyen A, Paul L. Physiotherapy Rehabilitation for People With Progressive Multiple Sclerosis: A Systematic Review. Arch Phys Med Rehabil. 2016 Jan;97(1):141-51.e3. doi: 10.1016/j.apmr.2015.07.022. Epub 2015 Aug 14.</citation>
    <PMID>26281954</PMID>
  </reference>
  <reference>
    <citation>Khan F, Amatya B. Rehabilitation in Multiple Sclerosis: A Systematic Review of Systematic Reviews. Arch Phys Med Rehabil. 2017 Feb;98(2):353-367. doi: 10.1016/j.apmr.2016.04.016. Epub 2016 May 20.</citation>
    <PMID>27216225</PMID>
  </reference>
  <reference>
    <citation>Beer S, Khan F, Kesselring J. Rehabilitation interventions in multiple sclerosis: an overview. J Neurol. 2012 Sep;259(9):1994-2008. doi: 10.1007/s00415-012-6577-4. Epub 2012 Jul 8.</citation>
    <PMID>22772357</PMID>
  </reference>
  <reference>
    <citation>Gunn H, Markevics S, Haas B, Marsden J, Freeman J. Systematic Review: The Effectiveness of Interventions to Reduce Falls and Improve Balance in Adults With Multiple Sclerosis. Arch Phys Med Rehabil. 2015 Oct;96(10):1898-912. doi: 10.1016/j.apmr.2015.05.018. Epub 2015 Jun 10.</citation>
    <PMID>26070975</PMID>
  </reference>
  <reference>
    <citation>Stevens V, Goodman K, Rough K, Kraft GH. Gait impairment and optimizing mobility in multiple sclerosis. Phys Med Rehabil Clin N Am. 2013 Nov;24(4):573-92. doi: 10.1016/j.pmr.2013.07.002. Epub 2013 Sep 7.</citation>
    <PMID>24314677</PMID>
  </reference>
  <reference>
    <citation>Schwartz CE, Ayandeh A, Motl RW. Investigating the minimal important difference in ambulation in multiple sclerosis: a disconnect between performance-based and patient-reported outcomes? J Neurol Sci. 2014 Dec 15;347(1-2):268-74. doi: 10.1016/j.jns.2014.10.021. Epub 2014 Oct 18.</citation>
    <PMID>25455299</PMID>
  </reference>
  <reference>
    <citation>Fjeldstad C, Fjeldstad AS, Pardo G. Use of Accelerometers to Measure Real-Life Physical Activity in Ambulatory Individuals with Multiple Sclerosis: A Pilot Study. Int J MS Care. 2015 Sep-Oct;17(5):215-20. doi: 10.7224/1537-2073.2014-037.</citation>
    <PMID>26472942</PMID>
  </reference>
  <reference>
    <citation>Casey B, Coote S, Donnelly A. Objective physical activity measurement in people with multiple sclerosis: a review of the literature. Disabil Rehabil Assist Technol. 2018 Feb;13(2):124-131. doi: 10.1080/17483107.2017.1297859. Epub 2017 Mar 13.</citation>
    <PMID>28285547</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 6, 2018</last_update_submitted>
  <last_update_submitted_qc>December 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Klinik Valens</investigator_affiliation>
    <investigator_full_name>April Roger</investigator_full_name>
    <investigator_title>Pricipal Investigator</investigator_title>
  </responsible_party>
  <keyword>Multiple Sclerosis</keyword>
  <keyword>In-patient rehabilitation</keyword>
  <keyword>All day life activities</keyword>
  <keyword>Walking capacity</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Quality of life</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03769636
org study id: BASEC Nr. 2017-00728
nct id: NCT03769636
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective is to observe the impact of in-patient rehabilitation on physical
      activity in daily life using miniature, wearable sensors, fixed on the shoes. These sensors
      record data about various aspects of walking. The information on the therapy effect on daily
      life can complement the clinical information and the patients' subjective report on therapy
      induced improvements.

      The secondary objective is the association of changes in physical activity, self-rated
      walking capacity, self-rated fatigue and self-rated health-related quality of life, wich will
      be analysed for disease severity of the participants.
Gait disorders are common in patients with multiple sclerosis (PwMS). Multidisciplinary
      in-patient rehabilitation conducted by specialized doctors, nurses and therapists can improve
      the ability to walk by tackling the problem with various approaches: by increasing strength
      in leg muscles, by improving balance, by increasing cardio- pulmonary fitness, by fitting
      walking aids, by reducing fatigue and cognitive deficits, by working out strategies to
      compensate for impairments, and by optimising medical treatment. The investigator's patients,
      who spend a lot of time (usually 2- 4 weeks) and effort for in-patient rehabilitation in
      Valens tell us, that this intensive therapy is usually effective and that their walking
      ability improves to a degree that is relevant in daily life. The scientific evidence for the
      effectiveness of in- patient rehabilitation is usually based on either clinical assessments
      of function (e.g. the 6 minute walking test) or on reports from PwMS, by using questionnaires
      e.g. about mobility or quality of life in daily life. Although clinical assessments provide
      important information about improvements of the functional capacity, they do not provide
      information about the impact of therapy on daily life. Patient reports, on the other hand,
      provide important information about the perceived impact in daily life, but the information
      is not objective. Objective information about the impact of rehabilitation on daily life is
      usually not available.

      The primary objective therefore is to observe the impact of in-patient rehabilitation on
      physical activity in daily life using miniature, wearable sensors, fixed on the shoes. These
      sensors record data about various aspects of walking. The information on the therapy effect
      on daily life can complement the clinical information and the patients' subjective report on
      therapy induced improvements.

      The secondary objective is the association of changes in physical activity, self-rated
      walking capacity, self-rated fatigue and self-rated health-related quality of life, wich will
      be analysed for disease severity of the participants.
observational model: Cohort
time perspective: Prospective
measure: Changes in physical activity: Locomotion
time frame: Physical activity will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).
description: The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life in patients with MS (EDSS 2.0-6.5) using miniature, wearable sensors, fixed on the shoes. These sensors record data about various aspects of walking. The information on the therapy effect on daily life can complement the clinical information and the patients' subjective report on therapy induced improvements.
The following parameter represents the walking in daily life:
- Locomotion: Percentage of locomotion (walking) per day The maximum value is 100%, the minumum value is 0%.
measure: Changes in physical activity: Non-locomotion
time frame: Physical activity will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).
description: The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life in patients with MS (EDSS 2.0-6.5) using miniature, wearable sensors, fixed on the shoes. These sensors record data about various aspects of walking. The information on the therapy effect on daily life can complement the clinical information and the patients' subjective report on therapy induced improvements.
The following parameter represents the walking in daily life:
- Non-locomotion: Percentage of non-locomotion (sitting, standing, lying) per day The maximum value is 100%, the minumum value is 0%.
measure: Changes in physical activity: Level walking
time frame: Physical activity will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).
description: The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life in patients with MS (EDSS 2.0-6.5) using miniature, wearable sensors, fixed on the shoes. These sensors record data about various aspects of walking. The information on the therapy effect on daily life can complement the clinical information and the patients' subjective report on therapy induced improvements.
The following parameter represents the walking in daily life:
- Level walking: Percentage of level walking per day The maximum value is 100%, the minumum value is 0%.
measure: Changes in physical activity: Up walking
time frame: Physical activity will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).
description: The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life in patients with MS (EDSS 2.0-6.5) using miniature, wearable sensors, fixed on the shoes. These sensors record data about various aspects of walking. The information on the therapy effect on daily life can complement the clinical information and the patients' subjective report on therapy induced improvements.
The following parameter represents the walking in daily life:
- Up walking: Percentage of up walking per day The maximum value is 100%, the minumum value is 0%.
measure: Changes in physical activity: Down walking
time frame: Physical activity will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).
description: The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life in patients with MS (EDSS 2.0-6.5) using miniature, wearable sensors, fixed on the shoes. These sensors record data about various aspects of walking. The information on the therapy effect on daily life can complement the clinical information and the patients' subjective report on therapy induced improvements.
The following parameter represents the walking in daily life:
- Down walking: Percentage of down walking per day The maximum value is 100%, the minumum value is 0%.
measure: Changes in physical activity: Maximum steps
time frame: Physical activity will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).
description: The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life in patients with MS (EDSS 2.0-6.5) using miniature, wearable sensors, fixed on the shoes. These sensors record data about various aspects of walking. The information on the therapy effect on daily life can complement the clinical information and the patients' subjective report on therapy induced improvements.
The following parameter represents the walking in daily life:
- Maximum steps: Maximal number of continuous steps in one walking bout (a walking bout is defined as walking more than two continuous steps).
The maximum value is open, the minimum value is zero.
measure: Changes in physical activity: Steps per hour
time frame: Physical activity will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).
description: The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life in patients with MS (EDSS 2.0-6.5) using miniature, wearable sensors, fixed on the shoes. These sensors record data about various aspects of walking. The information on the therapy effect on daily life can complement the clinical information and the patients' subjective report on therapy induced improvements.
The following parameter represents the walking in daily life:
- Steps per hour: Number of steps during all recorded walking bouts (the values are normalised per worn hours).
The maximum value is open, the minimum value is zero.
measure: Changes in self-rated fatigue
time frame: Fatigue will first be measured 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).
description: Fatigue will be measured by the Fatigue Scale for Motor and Cognitive Functions (FSMC). The FSMC is a 20-points-questionnaire with ten questions about cognitive fatigue and ten questions about motor fatigue. The questions are rated on a 5-point Likert-scale from 1 (does not apply at all) to 5 (applies completely). The total score ranges from a minimum of 20 points to a maximum of 100 points, sub-scores for cognitive and motor fatigue range from a minimum of 10 points to a maximum of 50 points. Higher scores indicate a higher perception of fatigue.
The following comparisons are executed:
Comparison between T1 and T2
Comparison between T2 and T3
Comparison between T2 and T4
measure: Changes in self-rated health-related quality of life: EQ-5D
time frame: Self-rated health-related quality of life will first be measured 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).
description: Self-rated health will be measured by the questionnaire "health- related quality of life" (EQ-5D). The EQ-5D is a fife-points questionnaire about the topics "mobility", "self-care", "usual-activities", "pain/discomfort" and "anxiety/depression". The questions are rated with the following possibilities: "no problems", "some problems" and "extreme problems". On the basis of standardized calculations a index value is generated. The value ranges form zero to one. Higher values indicate a higher health-related quality of life.
The following comparisons are executed:
Comparison between T1 and T2
Comparison between T2 and T3
Comparison between T2 and T4
measure: Changes in self-rated walking capacity
time frame: Self-rated waking capacity will first be measured 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).
description: Self-rated walking capacity will be measured by the 12-Item MS Walking Scale (MSWS-12). The MSWS-12 is a twelve-points questionnaire to represent the impact of MS on walking capacity. The questions are rated on a five-point Likert-scale from 1 (not at all) to 5 (extremely). The total score ranges from a minimum of 12 points to a maximum of 60 points. Higher scores indicate a higher impact of MS on walking capacity.
The following comparisons are executed:
Comparison between T1 and T2
Comparison between T2 and T3
Comparison between T2 and T4
measure: 10 meter walking test (10TW)
time frame: 10TW will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the first week of rehabilitation (T2) and the third week of rehabilitation (T3).
description: 10TW will be assessed to see changes in walking speed.
measure: Timed up and go (TUG)
time frame: TUG will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the first week of rehabilitation (T2) and the third week of rehabilitation (T4).
description: TUG will be assessed to see changes in equilibrium and walking abilities.
measure: 2 minutes walking test (2MWT)
time frame: 2MWT will be assessed in the first week of rehabilitation (T2) and in the third week of rehabilitation (T3).
description: 2MWT will be assessed to see changes in walking speed and distance
measure: Stair measure test (ST)
time frame: ST will be assessed in the first week of rehabilitation (T2) and in the third week of rehabilitation (T3).
description: ST will be assessed to see changes in speed and walking abilities on stairs.
intervention type: Device
intervention name: GaitUp Physilog 5
description: The primary outcomes are measured by the Physilog 5 (physical activity) at four different periods (T1-T4). Physilog 5 is worn for 4 weeks in total.
The secondary outcomes are fatigue, measured by FSMC (fatigue scale for motor and cognitive functions questionnaire), self-rated health-related quality of life, measured by the EQ-5D (health-questionnaire) and self-rated walking capacity, measured by the MSWS-12 (Twelve Item MS Walking Scale).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roger April, PT
phone: 0041786141712
email: roger.april@kliniken-valens.ch
last name: Jan Kool, PhD
phone: 0041813031403
email: jan.kool@kliniken-valens.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
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PMID: 28285547
responsible party type: Principal Investigator
investigator affiliation: Klinik Valens
investigator full name: April Roger
investigator title: Pricipal Investigator
sharing ipd: No