Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT04824482

Gait Recovery in Patients After Acute Ischemic Stroke

Led by University Hospital Olomouc · Updated on 2022-07-29

120

Participants Needed

1

Research Sites

330 weeks

Total Duration

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Sponsors

U

University Hospital Olomouc

Lead Sponsor

P

Palacky University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Gait Recovery in Patients After Acute Ischemic Stroke

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ischemic stroke confirmed by magnetic resonance imaging (MRI) with NIHSS score between 1 and 12 at enrollment
  • Lower limb movement impairment with at least 1 point on the NIH Stroke Scale at enrollment
  • Dependent walking status with Functional Ambulatory Category score less than 3, requiring supervision or assistance for walking
Not Eligible

You will not qualify if you...

  • Previous stroke, ischemic or hemorrhagic
  • Other diseases affecting walking ability or current participation in another rehabilitation or study
  • Significant ischemic heart disease or peripheral arterial disease
  • Obesity with BMI 40 or higher, or weight above 110 kg
  • Sensory aphasia preventing understanding as verified by a speech therapist
  • Moderate or severe depression with Beck scale score above 10
  • Known cognitive impairment
  • Previous disability with modified Rankin Scale score 3 or higher
  • Currently receiving dialysis
  • Diagnosed or treated for cancer
  • Other orthopedic or neurological conditions affecting lower limbs
  • For fMRI subgroup: pregnancy, electronic implants (pacemaker, cochlear implant, neurostimulator), incompatible metallic implants, metallic intraocular foreign body, large tattoos, unremovable piercings, body weight over 150 kg, known claustrophobia

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Hospital Olomouc

Olomouc, Czechia, 77520

Actively Recruiting

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Research Team

B

Barbora Kolarova, PhD

CONTACT

D

Daniel Sanak, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Gait Recovery in Patients After Acute Ischemic Stroke | DecenTrialz