Trial document




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  DRKS00016156

Trial Description

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Title

Measuring Gait Variability in Multiple Sclerosis (MS): exploring new markers for clinical monitoring

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Gait variability (i.e. stride-to-stride fluctuations in gait parameters such as stride length or step width) offers a way of quantifying locomotion and its changes associated with varying pathology. It has been reported that gait variability increases in various neurological patient populations, including conditions such as Parkinson's disease or multiple sclerosis.
However, gait variability has not received strong attention in clinical research. This situation has changed due to the emergence of mobile sensors that can be attached to patients' limbs and yield the possibility to derive parameters of gait variability.
The purpose of the current study is to address the issue outlined above, by examining gait variability and its sensitivity to patients' clinical status, using wireless inertial sensors. Further, the compatibility of the use of wireless inertial sensors in routine clinical practice is to be examined.

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Brief Summary in Scientific Language

Gait variability (i.e. stride-to-stride fluctuations in gait parameters such as stride length or step width) offers a way of quantifying locomotion and its changes associated with varying pathology. It has been reported that gait variability increases in various neurological patient populations, including conditions such as Parkinson's disease or multiple sclerosis.
However, gait variability has not received strong attention in clinical research. This might be attributed to the fact that until recently, extensive testing in context of motion laboratories was necessary to determine parameters of gait variability. Nowadays, this situation has changed due to the emergence of mobile sensors that can be attached to patients' limbs and yield the possibility to derive parameters of gait variability. In contrast to assessments in context of motion laboratories, the latter methodology is relatively inexpensive and may, after some training, be administered by trained study personnel.
It should be noted that gait sensors have not been adopted as a common methodology in clinical trials. Therefore, clinical trials frequently involve relatively superficial examinations of walking ability, e.g. the 25-foot walk. However, parameters of gait variability cannot be quantified with the 25-foot walk. Due to these circumstances, it may be suggested that contemporary clinical studies involving MS patients neglect a wide array of parameters (gait variability), putatively informative of patients' disease progression and potential treatment effects of immune-modulating medication.
The purpose of the current study is to address the issue outlined above, by examining gait variability and its sensitivity to patients' clinical status, using wireless inertial sensors. Further, the compatibility of the use of wireless inertial sensors in routine clinical practice is to be examined.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

The anonymized sensor data are also made available to the University of Jena, if required.

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Organizational Data

  •   DRKS00016156
  •   2019/04/15
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  •   yes
  •   Approved
  •   2018-1221, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

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Health Condition or Problem studied

  •   Multiple Sclerosis
  •   G35 -  Multiple sclerosis
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Interventions/Observational Groups

  •   MS patients:
    Gait variability in MS patients with a range of disability levels is to be examined by means of wireless inertial sensors, with measurement occasions separated by an interval of 4-6 months.
    On both measurement occasion, MS patients of the Klinikum Bayreuth GmbH have to complete a walking test that requires them to cover a distance of 25 feet repeatedly throughout a maximal assessment period of six minutes as enduring and fast as possible (6-min 25-ft walk).
    To measure gait variability, i.e. foot, shank and thigh kinematics, patients wear wireless inertial sensors throughout the walking course (MTw2, Xsens Technologies B.V.). These are attached to the forefoot, the tibia (medial and distal to the tibia tuberositas) and the iliotibial tract at the middle of the thigh of the patient's dominant leg and the trunk.
    In addition to the walking test and gait variability measures, a battery of self-report measures addressing fatigue (WEIMuS; Flachenecker et al., 2003), depression (ADS-K; Hautzinger et al., 2012) and body awareness (FMI; Wallach et al., 2006) is administered and patients are asked to report the number of falls that occurred during the past 12 months.

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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Determine sensitivity of inertial sensors to anomalies in gait variability (e.g. MTC-variability) across MS patients with a varying level of disability (EDSS: 0-6).
The primary outcome is reached after the gait variability of all MS patients and healthy controls has been analyzed at one time (July 2020).

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Secondary Outcome

Determine sufficiency of test-retest reliability of gait variability parameters derived with inertial sensors across a period of 4-6 months.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/08/01
  •   128
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

MS diagnoses based on McDonald criteria; ability to walk for at least six minutes without a walking aid; age range 18-65 years

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Exclusion Criteria

Able to walk only with walking aid

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Addresses

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    • Klinikum Bayreuth GmbH, Klinik für Neurologie
    • Hohe Warte 8
    • 95445  Bayreuth
    • Germany
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    • Klinikum Bayreuth GmbH, Klinik für Neurologie
    • Mr.  PD Dr.  Roy  Müller 
    • Hohe Warte 8
    • 95445  Bayreuth
    • Germany
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    • Klinikum Bayreuth GmbH, Studienzentrum Klinik für Neurologie, organisatorische Leitung
    • Ms.  Juliane  Stöhr 
    • Hohe Warte 8
    • 95445  Bayreuth
    • Germany
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Sources of Monetary or Material Support

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    • Sanofi-Aventis Deutschland GmbH
    • Siemensstraße 5B
    • 63263  Neu-Isenburg
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.