Trial document





This trial has been registered retrospectively.
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  DRKS00011639

Trial Description

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Title

Patients with Multiple Sclerosis and Severe Disabilities: Effects of Electrical Stimulation Cycling Training on Mobility an Power Performance

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Two of the main symptoms of multiple sclerosis (MS) are impaired gait and postural imbalance, both of which have a negative impact on activities of daily living. Since cycling is practiced in a sitting position, it is a safe and functionally effective exercise for these patients. Ergometry propelled by electrical stimulation (FES) has previously been proved to be an effective rehabilitation procedure for patients with leg paralysis due to spinal cord injury. The main goal of the proposed project is to prove therapeutic effects of ergometer training supported by stimulation on the mobility of patients with partial or complete pareses of the legs due to MS.
Current research has shown, that cycling supported by functional electrical stimulation in patients with multiple sclerosis is both feasible and safe. As aerobic training is cycling with FES more effective than normal cycling, regarding cardiovascular and muscular improvements. Moreover we expect, that effects also include better mobility while daily living activities.
Goal of the study is to prove the therapeutic benefits of intensive long term training with electrical stimulation cycling on muscle state and mobility in patients with mobility deficits due to multiple sclerosis.
Potential participants of the study are patient with multiple sclerosis with moderate to heavy gait disability.
The main hypothesis of the study is that FES cycling is more effective than normal cycling in patients with multiple sclerosis

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Brief Summary in Scientific Language

Former studies on FES cycling of patients with MS were performed at not relevant conditions using low training intensities and short durations and frequency of exercise.
However it can be supposed, that sufficient training intensity and duration are necessary to achieve effective training improvements. Moreover optimal intensities of stimulation and training frequency and duration are actually not known.
Our goal was to prove positive effects on mobility and strengh condition in patients with moderate to severe mobility impairments (EDSS >= 4) under condition of controlled high intensity and adequate duration of functional electrical cycling exercise.

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Organizational Data

  •   DRKS00011639
  •   2017/02/20
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  •   yes
  •   Approved
  •   453-14, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   G35.2 -  [generalization G35: Multiple sclerosis]
  •   R26.3 -  Immobility
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Interventions/Observational Groups

  •   Cycling with Functional Electrical Stimulation for 12 weeks, 5 times a week, 20 Minutes
  •   Cycling without stimulation (PLacebo stimulation) for 12 weeks, 5 times a week 20 minutes
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, assessor, data analyst
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   N/A
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Primary Outcome

if gait possible: Time Up and Go Test
if gait not possible: International Standards for neurological classification of spinal cord injury motor score
measuremenst performed before, after and follow up.

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Secondary Outcome

Walking speed (if gait possible), Isometrical Force, Modified Ashworth Scale, Functional Independence Measure, Tinetti Perfoemance Oriented Mobility Assessment, Quality of Life SF-36 measured before, after the training period and 1 month follow up.

Cycling power and work measured during each training session.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2016/03/13
  •   64
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

-Diagnosis: Multiple Sklerosis
-Age > 18 y
-Reduced lower extremity muscle function, Gait impairment

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Exclusion Criteria

-having power of attorney
-no pacemaker or higher-grade arrhythmias
-no metall parts in the stimulation area
-no skin allergia against electrodes
-no wound or other lesions in the stimulation area
-no osteoporosis, no muscle or ligament contractures, no reduced range of motion in the knee and hip joints.

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Addresses

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    • Zentrum für Sensomotorik der Neurologischen Klinik,Klinikum Großhadern
    • Mr.  PD Dr.  Johann  Szecsi 
    • Feodor Lynen Str. 19
    • 81377  München
    • Germany
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    • Zentrum für Sensomotorik
    • Mr.  PD Dr. med.  Johann  Szecsi 
    • Feodor Lynen Str. 19
    • 81377  München
    • Germany
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    • Zentrum für Sensomotorik
    • Mr.  PD Dr. med.  Johann  Szecsi 
    • Feodor Lynen Str. 19
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Else-Kröner-Fresenius Stiftung
    • Am Pilgerrain 15
    • 61352  Homburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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