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

University Hospital Ostrava

Status: Enrolling

Conditions: Ischemic Stroke

Treatments: Procedure: Conventional rehabilitation; Procedure: Lokomat intervention; Procedure: Leg/lower body exerciser device intervention.

Study type: Interventional

Funder types: Other

Identifiers

NCT04910217

FNO-Lokowalkers-2021

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Lokomat intervention

Experimental group

Description:

Patients randomized into the Lokomat arm will undergo therapy with Lokomat Pro FreeD for 20-50 minutes 5-times a week, a total of 15-times during the in-hospital stay in a total time of 1,800 minutes.

Treatment:

Procedure: Lokomat intervention

Procedure: Conventional rehabilitation

Conventional rehabilitation

Experimental group

Description:

Patients in this arm will undergo conventional rehabilitation ((ergotherapy and physiotherapy) for 60 min 5 times a week, a total of 15 times within 3 weeks (a total of 1200 min)

Treatment:

Procedure: Conventional rehabilitation

Procedure: Leg/lower body exerciser device intervention.