NCT04824482 Gait Recovery in Patients After Acute Ischemic Stroke
| NCT ID | NCT04824482 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Olomouc |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2020-09-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2020-09-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Contact & Investigator
Petr Hlustik, MD, PhD
STUDY CHAIR
Palacky University
Frequently Asked Questions
Who can join the NCT04824482 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04824482 currently recruiting?
Yes, NCT04824482 is actively recruiting participants. Contact the research team at barbora.kolarova@fnol.cz for enrollment information.
Where is the NCT04824482 trial being conducted?
This trial is being conducted at Olomouc, Czechia.
Who is sponsoring the NCT04824482 clinical trial?
NCT04824482 is sponsored by University Hospital Olomouc. The principal investigator is Petr Hlustik, MD, PhD at Palacky University. The trial plans to enroll 120 participants.
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