None listed
Conditions
Brief summary
The limitation of the possibility of efficient and independent movement is one of the major problems among people with MS. The optimal level of locomotion is also a balance, strength and endurance. They allow the safe and efficient movement. The robots are often used in rehabilitation of people with neurological diseases especially with severe symptoms and significantly limitation ability to walk. So far, only few studies were conducted using the Lokomat in gait rehabilitation among the patients with MS as well as there are a few studies evaluating the effects of gait rehabilitation using the walking robots. There are no studies comparing these two types of robots. The main objective of the study is to compare of effectiveness the gait rehabilitation in patients with MS with the use of two kind of robots: lower body exoskeleton EKSO GT and Assisted Treadmill Therapy (Lokomat). The survey will be conducted in a specialized rehabilitation center. The study will include patients with MS (EDSS 6 do 7). The study will include 36 patients who will be randomly divided into two groups. Study group (n=18) which will practice using Ekso GT and control group which will practice using Lokomat. Both groups will have 15 training sessions during 3 weeks. The time of each training session will last from 45 to 60 minutes. An assessment of the patients will be carried out before the start of the program and after its completion. The gait (speed, cadence), static and dynamic balance, muscle strength of upper and lower extremities and the level of fatigue will be evaluated.
Interventions
People with multiple sclerosis will participate in the study.
The main objective of the study is the comparison of effectiveness the gait rehabilitation with the use of a lower body exoskeleton EKSO GT with Variable Assist software extension (EKSO Bionics, Richmond, CA, USA) and Robot-Assisted Treadmill Therapy (Lokomat, Hocoma, Volketswil, Switzerland). The assessment will be undertaken before program and after 3 weeks of training with EKSO GT and Lokomat. All measurement procedures will be p
People with multiple sclerosis will participate in the study. The main objective of the study is the comparison of effectiveness the gait rehabilitation with the use of a lower body exoskeleton EKSO GT with Variable Assist software extension (EKSO Bionics, Richmond, CA, USA) and Robot-Assisted Treadmill Therapy (Lokomat, Hocoma, Volketswil, Switzerland). The assessment will be undertaken before program and after 3 weeks of training with EKSO GT and Lokomat. All measurement procedures will be performed by members of the research team. Participants who meet eligibility requirements will be randomly divided into group with EKSO (n=18) and group with Lokomat (n=18). Each patient will participate in 15 training sessions with using EKSO GT. Each patient's training will last 3 weeks, 5 times a week (form Monday to Friday). Time of each training session is - from 45 to 60 minutes. Robotic gait training in both groups will be conducted by a physiotherapist who is not participating neither in a basic survey nor in a control test. Training parameters for each patient will be individually tailored by the physiotherapist. The duration of each training session will depend on the patient walking capabilities. Participation in the training is confirmed in medical records. Participants from both groups will implement a standard rehabilitation program. Physiotherapists who conduct the trainings, are certified EKSO and Lokomat specialists. Each training session in Ekso GT and Lokomat will be stored in software and recorded in patient's medical documentation.
Sponsors
University of Rzeszow
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Participants with Multiple Sclerosis, Expanded Disability Status Scale (EDSS) 6,0-7,0
Exclusion criteria
Difference in lower limbs length bigger then 2 cm Weight above 100 kg Height lower then 150 cm or above 190 cm History of significant problems with skin breakdown or current skin breakdown that would prevent subject from wearing the device Joint contractures of the hip, knee, or ankle that might limit normal ROM during ambulation Medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe osteoporosis, or severe spasticity)
Outcome results
None listed