Robot-Assisted Gait Therapy in the Subacute Phase of First Ischemic Stroke
- Conditions
- Ischemic Stroke
- Interventions
- Procedure: Conventional rehabilitationProcedure: Lokomat interventionProcedure: Leg/lower body exerciser device intervention.
- Registration Number
- NCT04910217
- Lead Sponsor
- University Hospital Ostrava
- Brief Summary
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.
- Detailed 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional rehabilitation Conventional rehabilitation 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) Lokomat intervention Lokomat intervention 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. Lokomat intervention Conventional rehabilitation 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. Conventional rehabilitation Leg/lower body exerciser device intervention. 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)
- Primary Outcome Measures
Name Time Method Functional Ambulation Category (FAC) at 3 months 3 months Functional Ambulation Category (FAC) - the scale range is from 0 to 5. The value at 6-months will be observed.
- Secondary Outcome Measures
Name Time Method Functional Ambulation Category (FAC) (after 3 weeks) 3 weeks Functional Ambulation Category (FAC) - the scale range is from 0 to 5. The value after 3 weeks will be observed.
10-meter walk test (10-MWT) (after 3 weeks and 3 months) up to 3 months 10-meter walk test will be performed after 3 weeks and 3 months
Timed Up and Go Test (TUG) (after 3 weeks, after 3 months) up to 3 months Timed Up and Go Test (TUG) will be performed after 3 weeks, after 3 months
3-months modified Rankin Scale (mRS) up to 3 months 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).
Adverse effects up to 3 years The number and character of adverse effects will be observed during the study.
Early termination of the study up to 3 years The number of patients terminating the study early will be observed during the study.
Reason/s for the termination up to 3 years The reason/s for the termination will be observed during the study.
Berg Balance Scale (BBS, after 3 weeks, after 3 months) up to 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.
Study-related death or death unrelated to study up to 3 years The number of study-related deaths or deaths unrelated to study will be observed during the study.
Trial Locations
- Locations (1)
University Hospital Ostrava
🇨🇿Ostrava, Moravian-Silesian Region, Czechia