Gait Recovery in Patients After Acute Ischemic Stroke

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital Olomouc

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Robot-assisted treadmill gait training (RTGT)
  • Therapist-assisted treadmill gait training (TTGT)

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital Olomouc

Lead sponsor

Palacky University

Collaborator