G35.3 G35.9
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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)
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| MAS, EDSS, Spacticity Score, clinical markers Timepoints: at baseline, after 12 weeks and after 24 weeks | — |
Countries
Germany
Contacts
Uniklinik Köln Studienbüro Neurologie