Gait Recovery in Patients After Acute Ischemic Stroke

Status Recruiting

Clinical Trial Summary

More than 80% of ischemic stroke (IS) patients have some walking disability, which restricts their independence in the activities of daily living. Physical therapy (PT) significantly contributes to gait recovery in patients after IS. However, it remains unclear, what type of gait training is more effective and which factors may have impact on gait recovery. Two hundred fifty IS patients will be enrolled to undergo a 2-week intensive inpatient rehabilitation including randomly assigned robot-assisted treadmill gait training (RTGT) or therapist-assisted treadmill gait training (TTGT). A detailed clinical and laboratory assessment of gait quality, as well as the degree of neurological impairment, quality of life, cognition and depression will be performed in all patients during the study. We hypothesize that these variables may also affect gait recovery in patients after IS. In a randomly selected 60 enrolled patients, a multi-modal magnetic resonance imaging (MRI), including functional MRI, will be performed to assess neural correlates and additional predictors of gait recovery.

Clinical Trial Description

One hundred twenty consecutive first ever ischemic stroke patients classified as dependent walkers (Functional Ambulatory Category interval <1,3>) will be enrolled in the randomized blinded single center prospective clinical trial GAITFAST with a randomization either for robot-assisted treadmill gait training (RGT) or therapist-assisted treadmill gait training (TTGT) after acute phase (5-10 days after stroke onset). All enrolled patients will undergo a 2-week intensive inpatient rehabilitation including randomly assigned TTGT or RTGT followed with clinical visits (at the beginning of inpatient rehabilitation, at discharge, and three and six months after enrollment in the study). Each clinical visit will include detailed clinical functional assessments, assessment of spatiotemporal and kinetic gait parameters, assessment of neurological impairment, assessment of quality of life, cognition and depression. In 60 randomly selected enrolled IS patients, a repeated multi-modal magnetic resonance imaging (MRI) including functional MRI (fMRI) will be performed during the study follow-up to identify brain structures with possible impact on gait recovery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04824482
Study type	Interventional
Source	University Hospital Olomouc
Contact	Barbora Kolarova, PhD
Phone	+420 588 442 301
Email	barbora.kolarova@fnol.cz
Status	Recruiting
Phase	N/A
Start date	September 1, 2020
Completion date	December 31, 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Gait Recovery in Patients After Acute Ischemic Stroke — GAITFAST

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms