Robot-Assisted Gait Therapy in the Subacute Phase of First Ischemic Stroke

Robot-Assisted Gait Therapy in the Subacute Phase of First Ischemic Stroke

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).

Inclusion Criteria:

• signed informed consent by the participant or legal representative
• interval between stroke and first rehabilitation session < 6 weeks (study target within 2 weeks)
• age > 18 years
• early modified Rankin scale (mRS) 2 to 4 (pre-stroke mRS 0 to 1)
• early FAC of 0 to 3 (pre-stroke FAC of 5)
• standing ability with support up to 3 minutes and vertical tolerance > 15 minutes

Exclusion Criteria:

• inability or refusal to sign an informed consent
• history of stroke or another brain disease (tumour, multiple sclerosis, brain or spinal cord injury)
• severe internal, oncological, or surgical comorbidity preventing long-term re-habilitation or causing chronic or progressive gait disorder
• limited collaboration of any reason, moderate or severe dementia assessed by using the Montreal Cognitive Assessment (MoCA) scale
• impaired skin integrity in the lower torso and limbs preventing the use of Lokomat device
• limitations given by the Lokomat exoskeleton device (weight > 135 kg, thigh-length 23-35 cm, shank length 35-47cm)
• limitations given by the leg/lower body exerciser (weight > 180 kg, height < 120 cm or > 200 cm, (sub)acute lower limb fractures, deep vein thrombosis, skin disintegration)
• any contraindication to perform brain MRI