NCT04824482

Gait Recovery in Patients After Acute Ischemic Stroke

GAIT Recovery in Patients aFter Acute Ischemic STroke: A Randomized Comparison of Robot-assisted and Therapist-assisted Gait Training on a Treadmill.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University Hospital Olomouc · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
OTHER	Robot-assisted treadmill gait training (RTGT)	Locomotor training guided by the robotic device (Lokomat Hocoma) according to a pre-programmed gait pattern with the help of robot-driven exoskeleton orthoses. The process of gait training is automated and controlled by a computer under supervision of a physiotherapist.
OTHER	Therapist-assisted treadmill gait training (TTGT)	Locomotor training via a repetitive execution of walking movements manually guided by a physiotherapist during treadmill gait training.

Timeline

• Start date: 2020-09-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2021-04-01
• Last updated: 2022-07-29

Locations

1 site across 1 country: Czechia