Study protocol – robot-assisted gait therapy using Lokomat Pro FreeD in patients in the subacute phase of ischemic stroke

摘要

Aim: Robot-assisted gait training represents a modern concept of neurorehabilitation in stroke patients. Our randomized interventional study aims to assess the additive effect of robot-assisted gait rehabilitation in subacute ischemic stroke patients and to compare its effect with patients undergoing standard institutional protocol-defined rehabilitation. The primary endpoint is the functional ambulation category. The secondary endpoints include gait time parameters (10 Meter Walk Test, Timed Up and Go), changes in body composition, modified Rankin scale, Barthel index, Berg balance scale, and a questionnaire Falls Efficacy Scale – International. Radiological sub-study evaluates the dynamics of brain structural changes and atrophy using MRI. Methods: This is a prospective randomized open monocentric study enrolling patients within 6 weeks from the onset of the firs ischemic stroke. Both groups are treated with conventional rehabilitation (physiotherapy, occupational therapy and mechanotherapy) for 60 min 5 times a week, a total of 15 times for 3 to 4 weeks (a total of 1,200 min). The Lokomat group undergoes robot-assisted gait training using the interventional exoskeleton for 20-50 minutes 5 times a week for a total of 15 times for 3 to 4 weeks (a total of 1,800 min). Data collection takes place over four time periods: pre-intervention (T0), mid-intervention (T1; day 8), post-rehabilitation assessment (T2; day 15), and 3 months post-intervention (T3).