G35
Conditions
Interventions
Group 1: Lokomat(R) Group: 16 therapy Units a 1 hour (active therapy 30 min). Therapy with the Lokomat(R). 2 Units per week for 8 weeks.
Group 2: Control Group: Physiotherapy Standard Treatment, 16x1
Sponsors
Klinik und Poliklinik für Orthopädie, Physikalische Medizin und Rehabilitation
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with Multiple Sclerosis (McDonald Kriterien, Polman 2011) age > 18 years
Exclusion criteria
Exclusion criteria: •Inability for informed consent (severe cognitive deficits) •Additional cause for gait disturbance (neurologic, orthopedic) •Uncontrolable severe cardiovascular diseases •Change in additional therapy within the last four weeks Exclusion criteria for Lokomat(R)-therapy (as according to manufacturer) •Orthesis not adjustable to Body (lower extremity); Body hight 200cm •Body weight >135 kg •Severe fixed contractures •Bone instability •Circulation instability •Cardiac Contraindications •Unkooperative or (auto)agressive behaviour (during Delirium) •Patients with continous infusions •Apparative Ventilation •Patienten with severe dysproportional growth of lower extremities and / or the spine •Severe vascular disease of the lower extremities •Hip-, Knee- foot ankle arthrodesis •instabile or stress instable fractures •severe osteoporosis •Skin Problems in the area of the securing sleeves
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome measurements: 6MWT 6-Minute Walk Test, Timed 10-Meter Walk Test TUG Timed Up and Go MSIS-29 Multiple Sclerosis Impact Scale MSQoL54 Multiple Sclerosis Quality of Life-54 Instrument Primary outcome Parameters are the clinical gait tests and the questionaires for Quality/satisfaction of life. Demographic and clinical variables as well as the measurements on function, pain and Quality of life are recorded at entry in the study (t0). The further investigations take place at the end of Treatment (t1), after 3 months (t2) and 6 months (t3). In the control group data registrations is equivalent to the intervention group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome is: -BMI Body Mass Index, WHR waist-hip ratio -SDMT Symbol Digit Modalities Test -cognitive functions and functions of upper and lower extremities (MSFC multiple sclerosis functional composite) -Fatigue (MFIS Modified Fatigue Impact Scale, FSS Fatigue Severity Scale) Demographic and clinical variables as well as the measurements on function, pain and Quality of life are recorded at entry in the study (t0). The further investigations take place at the end of treatment (t1), after 3 months (t2) and 6 months (t3). In the control group data registrations is equivalent to the intervention group. | — |
Countries
Germany
Contacts
Public ContactAndreas Lorenz
Klinik und Poliklinik für Orthopädie, Physikalische Medizin und Rehabilitation
Outcome results
None listed