Ischemic Stroke
Conditions
Keywords
gait, stroke, robotic rehabilitation, exoskeleton, neurorehabilitation, Lokomat
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).
Interventions
PROCEDUREConventional rehabilitation
Patients will undergo conventional rehabilitation
PROCEDURELeg/lower body exerciser device intervention.
Patients will undergo leg/lower body exerciser device therapy.
PROCEDURELokomat intervention
Patients will undergo therapy with Lokomat Pro FreeD device intervention.
Sponsors
Masaryk University
VSB - Technical University of Ostrava
University Hospital Ostrava
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-centre randomized parallel group neurorehabilitation trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
| Adverse effects | up to 3 years | The number and character of adverse effects will be observed during the study. |
Countries
Czechia
Contacts
Primary ContactJiří Hynčica
Outcome results
None listed