Status:
RECRUITING
Gait Recovery in Patients After Acute Ischemic Stroke
Lead Sponsor:
University Hospital Olomouc
Collaborating Sponsors:
Palacky University
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ga...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04824482
Start Date
September 1 2020
End Date
December 31 2026
Last Update
July 29 2022
Active Locations (1)
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1
University Hospital Olomouc
Olomouc, Czechia, 77520