Gait Recovery in Patients After Acute Ischemic Stroke

Recruiting now · Not applicable

Conditions studied: Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT04824482

Run by

University Hospital Olomouc

People needed

120

Starts

2020-09-01

Expected to finish

2026-12-31

Last updated by the study team

2022-07-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ischemic stroke detected on magnetic resonance imaging (MRI) with NIHSS score 1-12 points at the time of enrolment
• Lower limb movement impairment with a score of at least 1 point on the NIH Stroke Scale (NIHSS) at the time of enrolment
• Dependency in walking according to Functional Ambulatory Category (FAC) with score interval <1,3> (supervision or assistance, or both, must be given in performing walking)

You may not qualify if…

• Previous history of any stroke, either ischemic or hemorrhagic
• Other diseases modifying or limiting walking ability, currently receiving rehabilitation or participation in another study
• Significant/symptomatic ischemic heart disease or significant/symptomatic peripheral arterial disease
• Obesity (BMI ≥ 40), or weight higher than 110 kg (weight limit for the robot-assisted gait training)
• Sensory aphasia with the inability to understand having been verified by a certified speech therapist.
• Moderate or severe depression present at the time of enrolment assessed using the Beck scale, with a score above 10.
• Known cognitive impairment
• Previous disability or dependence in the daily activities assessed using the modified Rankin Scale with a score of 3 and more points
• Currently receiving dialysis
• Diagnosed and/or receiving treatment for cancer
• Presence of other orthopedic or neurological conditions affecting the lower extremities
• For fMRI: Pregnancy; electronic implants, including cochlear implant, pacemaker, neurostimulator; incompatible metallic implants, including aneurysm clip; metallic intraocular foreign body; large tattoos; unremovable piercing; body weight over 150 kg; known claustrophobia

Where it is running

• University Hospital Olomouc — Olomouc, Czechia (enrolling)

Full record on ClinicalTrials.gov

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