Effectiveness of robotic-assisted walking (lokomat) on quality of life, gait, activity level, and balance in patients with multiple sclerosis
- Conditions
- Multiple sclerosisNervous System DiseasesDemyelinating diseases
- Registration Number
- ISRCTN69803702
- Lead Sponsor
- Berner Klinik Montana (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
1. Aged 18 or older
2. Diagnosed with multiple sclerosis confirmed by a specialist in neurology by the mean of the McDonald criteria
3. EDSS score equal or higher than 3 and lower or equal than 7.0
4. Able to walk 14 metres (with or without assistive devices)
5. Willingness to comply with any programme to which randomly assigned
1. Disorders preventing active rehabilitation (cardiovascular, respiratory, orthopaedic, psychiatric, or other medical conditions, including unhealed decubitus and orthostatic hypotension; pregnancy)
2. Rehabilitation period planned of less than three weeks
3. One or more exacerbations in the preceding three months
4. More than 135 kg
5. Strong asymmetry of musculoskeletal system
6. Length of femur less than 34 cm
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Quality of life will be measured at baseline, at discharge (three weeks) and at 3 and 12 months<br>2. Activity level will be measured during seven days before the rehabilitation, in the middle week of the rehabilitation, and 3 and 12 months after discharge of rehabilitation<br>3. Gait-parameters (symmetry, gait security, gait speed, gait capacity) will be measured only during rehabilitation setting (at baseline, before and after the third, sixth and ninth gait intervention)
- Secondary Outcome Measures
Name Time Method 1. Pain will be measured at baseline, before and after gait interventions (each time), each day in the evening, at three weeks (discharge rehabilitation), 3 and 12 months post rehabilitation<br>2. Fatique will be measured at baseline, before and after gait interventions (each time), each day in the evening, at three weeks (discharge rehabilitation), 3 and 12 months post rehabilitation<br>3. Spasticity will be measured at baseline and discharge (at the end of three weeks rehabilitation)