Interventional Recruiting
NCT04910217 on ClinicalTrials.gov
Robot-Assisted Gait Therapy in the Subacute Phase of First Ischemic Stroke
- Sponsor: University Hospital Ostrava
- Collaborators: Masaryk University, VSB - Technical University of Ostrava
- Enrollment: 80 (Estimated)
- Study start: 2022-05-01 (Actual)
- Primary completion: 2025-12-01 (Estimated)
- Study completion: 2025-12-01 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- InterventionModelDescription: Single-centre randomized parallel group neurorehabilitation trial
- Masking: None
- PrimaryPurpose: Treatment
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.
Conditions
- Ischemic Stroke
Intervention / Treatment
- Procedure: Conventional rehabilitation
- Procedure: Leg/lower body exerciser device intervention.
- Procedure: Lokomat intervention
Primary Outcome Measures
-
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.
Countries
Czechia
Locations and Investigators
-
University Hospital Ostrava, Ostrava, Czechia (Recruiting)
- Jiří Hynčica
- Ondrej Volny, MD,PhD,FESO (Principal Investigator)
- Iva Fiedorova, MSc.
- Pavla Hanzlíkova, MD,PhD
- Michal Bar, Assoc.Prof.,MD,PhD
- Martin Roubec, MD,PhD
- Radim Licenik, MD,PhD
- Miloslav Klugar, Dr, PhD
- Jitka Klugarova, Dr, PhD
- Andrea Pokorna, prof.,Dr,PhD
- Dana Salounova, prof.,Ing.,PhD
- Pavel Elias, prof.,MD,PhD
- Irina Chmelova, MD,PhD,MBA
- Robert Mikulik, prof.,MD,PhD
- Petra Brodova
Study Officials
- Ondřej Volný, MD,PhD,FESO (Principal Investigator) — University Hospital Ostrava