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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Procedure: Conventional rehabilitation
* Procedure: Leg/lower body exerciser device intervention.
* Procedure: Lokomat intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-centre randomized parallel group neurorehabilitation trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lokomat intervention<br>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. | Procedure: Conventional rehabilitation<br>* Patients will undergo conventional rehabilitation<br>Procedure: Lokomat intervention<br>* Patients will undergo therapy with Lokomat Pro FreeD device intervention.<br>|
| Experimental: Conventional rehabilitation<br>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) | Procedure: Conventional rehabilitation<br>* Patients will undergo conventional rehabilitation<br>Procedure: Leg/lower body exerciser device intervention.<br>* Patients will undergo leg/lower body exerciser device therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gait, stroke, robotic rehabilitation, exoskeleton, neurorehabilitation, Lokomat