Robot-assisted gait training (RAGT) represents a modern concept of neurorehabilitation in stroke patients. This single-center randomized parallel-group neurorehabilitation trial with blinded primary outcome assessment is aimed at patients after the first-ever ischaemic stroke in the anterior or posterior cerebral circulation.
The main aim is to determine, whether the RAGT by using the Lokomat exoskeleton device (Hoccoma, Switzerland) plus the protocol-defined conventional rehabilitation versus conventional rehabilitation improves the gait of post-stroke patients after 6 months. Both groups are treated with the protocol-defined rehabilitation (ergotherapy and physiotherapy) for 60 min 5 times a week, a total of 15 times within 3 weeks (a total of 1200 min). The Lokowalkers group undergoes the RAGT using the Lokomat Pro Freed device for 20-50 minutes 5 times a week for a total of 15 times for 3 weeks (a total of 1800 minutes). The primary endpoint is the Functional Ambulation Category (FAC) after 3 months. Secondary endpoints include FAC (after 15th therapy), 10-meter walk test (10MWT) (after 15th therapy, after 3 months), Timed Up and Go Test (TUG) (after 15th therapy and after 3 months, 3-months modified Rankin Scale (mRS), and Berg Balance Scale (BBS, after 15th therapy, after 3 months).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Patients will undergo conventional rehabilitation
Patients will undergo leg/lower body exerciser device therapy.
Patients will undergo therapy with Lokomat Pro FreeD device intervention.
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
RECRUITINGFunctional Ambulation Category (FAC) at 3 months
Functional Ambulation Category (FAC) - the scale range is from 0 to 5. The value at 6-months will be observed.
Time frame: 3 months
Functional Ambulation Category (FAC) (after 3 weeks)
Functional Ambulation Category (FAC) - the scale range is from 0 to 5. The value after 3 weeks will be observed.
Time frame: 3 weeks
10-meter walk test (10-MWT) (after 3 weeks and 3 months)
10-meter walk test will be performed after 3 weeks and 3 months
Time frame: up to 3 months
Timed Up and Go Test (TUG) (after 3 weeks, after 3 months)
Timed Up and Go Test (TUG) will be performed after 3 weeks, after 3 months
Time frame: up to 3 months
3-months modified Rankin Scale (mRS)
3-months modified Rankin Scale (mRS) assesses the functional independence and represents a standard outcome measure in post-stroke patients (range from 0 to 6).
Time frame: up to 3 months
Berg Balance Scale (BBS, after 3 weeks, after 3 months)
Berg Balance Scale (BBS) objectifies balance functions in 14 tasks. It assesses the risk of possible falls: 0-20 high, 21-40 medium, 41-56 low risk of falling.
Time frame: up to 3 months
Adverse effects
The number and character of adverse effects will be observed during the study.
Time frame: up to 3 years
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Early termination of the study
The number of patients terminating the study early will be observed during the study.
Time frame: up to 3 years
Reason/s for the termination
The reason/s for the termination will be observed during the study.
Time frame: up to 3 years
Study-related death or death unrelated to study
The number of study-related deaths or deaths unrelated to study will be observed during the study.
Time frame: up to 3 years