Status:
UNKNOWN
Robot-Assisted Gait Therapy in the Subacute Phase of First Ischemic Stroke
Lead Sponsor:
University Hospital Ostrava
Collaborating Sponsors:
Masaryk University
VSB - Technical University of Ostrava
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
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 o...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04910217
Start Date
May 1 2022
End Date
December 1 2025
Last Update
September 21 2023
Active Locations (1)
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1
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 70852