None listed
Conditions
Brief summary
The study assesses the effects of the three-weeks gait training among people with MS using a exoskeleton EKSO GT. The study is a clinical trial with follow-up evaluation after 4 weeks. Study will qualify MS patients with an EDSS score of 5.5–6.0. Parameters to be tested are: Static balance - performed on barography platform, strength of the knee muscels ( extensors and flexors) and rotator cuff muscles, gait speed tested by T25-FW and fatigue level measured in the Fatigue Severity Scale. The expected result of the program is to increase muscle strength of the upper and lower extremities, improve static balance, increase walking speed and reduce fatigue level. The hypothesis of this study is to prove that, rehabilitation using exoskeleton EKSO GT significantly improves muscle strength, balance and walking speed in MS patients. The gait training program using Ekso GT lasted 45 to 60 minutes per day, 5 days per week for 3 weeks. The test was performed four times, the initial test, control examination after 3 weeks (control period without training with EKSO), third study after the completion of training with EKSO GT and the final examination after 4 weeks after completion of training. Throughout the test the participants will not use any other gait devices as treadmills, treadmills with partial body weight support (PBWS) such as Lokomat, Ekso GT or the like.
Interventions
People with multiple sclerosis will participate in the study.
The main objective of the study is to assess the efficacy of physiotherapy with the use of a lower body exoskeleton EKSO GT with Variable Assist software extension (EKSO Bionics, Richmond, CA, USA).
The assessment will be performed before program, after 3 weeks (a
period without training with EKSO GT), after 6 weeks (after training
with EKSO GT), after 12 weeks (6 weeks follow up from the end of
training). All measurement procedur
People with multiple sclerosis will participate in the study. The main objective of the study is to assess the efficacy of physiotherapy with the use of a lower body exoskeleton EKSO GT with Variable Assist software extension (EKSO Bionics, Richmond, CA, USA). The assessment will be performed before program, after 3 weeks (a period without training with EKSO GT), after 6 weeks (after training with EKSO GT), after 12 weeks (6 weeks follow up from the end of training). All measurement procedures will be performed by members of the research team. Each patient will participate in 15 training sessions with using EKSO GT. Each patient's training will last 3 weeks, 5 times a week. Standing and walking in EKSO GT exosceleton will be a part of the training session. Time of each training session is - from 45 to 60 minutes. The duration of each training session will depend on the patient walking capabilities. During the 3-week rehabilitation program using exoskeleton EKSO, patients will not use of any form of rehabilitation except exercises at home. Physiotherapists who conduct the trainings, are certified EKSO specialists. Each training session in Ekso GT will be stored in exoskeleton software and recorded in patient's medical documentation.
Sponsors
University of Rzeszow
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Participants with Multiple Sclerosis, Expanded Disability Status Scale (EDSS) 5,5-6,0
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