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| Name | Class |
|---|---|
| Masaryk University | OTHER |
| VSB - Technical University of Ostrava | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lokomat intervention | Experimental | 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 | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional rehabilitation | Procedure | Patients will undergo conventional rehabilitation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 weeks |
| 10-meter walk test (10-MWT) (after 3 weeks and 3 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiří Hynčica | Contact | 0042059737 | 2587 | jiri.hyncica@fno.cz |
| Name | Affiliation | Role |
|---|---|---|
| Ondřej Volný, MD,PhD,FESO | University Hospital Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Recruiting | Ostrava | Moravian-Silesian Region | 70852 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17908575 | Background | Mehrholz J, Wagner K, Rutte K, Meissner D, Pohl M. Predictive validity and responsiveness of the functional ambulation category in hemiparetic patients after stroke. Arch Phys Med Rehabil. 2007 Oct;88(10):1314-9. doi: 10.1016/j.apmr.2007.06.764. | |
| 21964750 | Background | Albert SJ, Kesselring J. Neurorehabilitation of stroke. J Neurol. 2012 May;259(5):817-32. doi: 10.1007/s00415-011-6247-y. Epub 2011 Oct 1. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Single-centre randomized parallel group neurorehabilitation trial
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| Leg/lower body exerciser device intervention. | Procedure | Patients will undergo leg/lower body exerciser device therapy. |
|
| Lokomat intervention | Procedure | Patients will undergo therapy with Lokomat Pro FreeD device intervention. |
|
10-meter walk test will be performed after 3 weeks and 3 months
| 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 | 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). | 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. | up to 3 months |
| Adverse effects | The number and character of adverse effects will be observed during the study. | up to 3 years |
| Early termination of the study | The number of patients terminating the study early will be observed during the study. | up to 3 years |
| Reason/s for the termination | The reason/s for the termination will be observed during the study. | 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. | up to 3 years |
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| 41313041 | Derived | Fiedorova I, Banikova S, Adamec T, Konde A, Hanzlikova P, Ganesh A, Bar M, Volny O. Robot-Assisted Gait Therapy in the Subacute Phase of Ischemic Stroke: A Randomized Controlled Trial. Ann Indian Acad Neurol. 2026 Jan 1;29(1):52-58. doi: 10.4103/aian.aian_526_25. Epub 2025 Nov 28. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |