Trial document




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  DRKS00022962

Trial Description

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Title

Whole Body Vibration in Progressive Multiple Sclerosis in Patients with Gait Disorder

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Trial Acronym

WBV in PMS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Aim of the pilot cross over study is the effect of oscillatory whole body vibration with regard to gait disorder and spasticity in patients with progressive multiple sclerosis.

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Brief Summary in Scientific Language

Mono-centric randomised trial to evaluate the effect of oscillatory whole body vibration (WBV) with regard to gait disorder and spasticity in patients with progressive multiple sclerosis. Primary outcome is the 6 minutes walking distance 12 weeks after WBV training. Patients must either be treated with no change of immunomodulatory therapy in the last six months or receive no treatment. We aim to include 30 patients in total as a cross over design where 15 patients start directly with WBV and the control group starts 12 weeks later while receiving standard of care.

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

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00022962
  •   2020/08/31
  •   [---]*
  •   yes
  •   Approved
  •   18-181, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   G35.3 -  [generalization G35: Multiple sclerosis]
  •   G35.9 -  [generalization G35: Multiple sclerosis]
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Interventions/Observational Groups

  •   Arm 1: Whole Body Vibration Group
    home training program with a standardised training protocol (10x/week, 4x2 minutes, week 1-12) followed by no training (week 13-24)

  •   Arm 2: Standard of Care
    no training (Week 1-12), followed by WBV home training standardised training protocol 10xweek, 4 x 2 minutes (week 13-24)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Control group receives no treatment
  •   Treatment
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

6 minute walking distance, measured at baseline (before start of training), end of week 12 (after 12 weeks of WBV training or standard) and end of week 24 (after another 12 weeks with no training or WBV training)

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Secondary Outcome

MAS, EDSS, Spacticity Score, clinical markers
Timepoints: at baseline, after 12 weeks and after 24 weeks

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2020/09/24
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Men and women capable of giving informed legal consent aged between 18-70 years, diagnosed with progressive multiple sclerosis who have either no immunomodulatory therapy or have been stable for 6 months at their therapy, who display a gait disorder (EDSS 4-6,5)

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Exclusion Criteria

1. pregnancy (secure and safe contraception must be used)
Safe conceptive are means with a Pearl-Index smaller than 1 %:
a. Oral contraceptives
b. Dermal hormonal contraceptives
c. Vaginal hormonal contraceptives (NuvaRing®)
d. contraceptive dermal patch
e. longterm contraceptive shots (injectable) ,
f. Progesteron releasing contraceptive implants (Implanon®),
g. tubal ligation, tying of the fallopian tubes (female sterilisation ),
h. hormone releasing contraceptive coil (IUD, contraceptive intrauterine device ),
i. double barrier methods

Not reliable and unsafe are condom and spermicide, single barrier methods (condom, copper intrauterine device, basal temperature method, coitus interrupts, cervical clap, female condom, contraceptive sponge)

2. acute thrombosis
3. Implants in trained limbs (artificial hip, knee replacement)
4. bone fractures
5. not being able to give legal informed consent
6. not being able to exercise (immobility, NYHA IV)

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Addresses

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Sources of Monetary or Material Support

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    • Novartis Pharma GmbH
    • Roonstraße 25
    • 90429  Nürnberg
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.