Improving walking ability in patients after ischemic stroke
GAIT Recovery in Patients aFter Acute Ischemic STroke: A Randomized Comparison of Robot-assisted and Therapist-assisted Gait Training on a Treadmill.
NA · University Hospital Olomouc · NCT04824482
This study is testing whether robot-assisted treadmill training or therapist-assisted treadmill training can help people recover their walking ability after having an ischemic stroke.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital Olomouc (other) |
| Locations | 1 site (Olomouc) |
| Trial ID | NCT04824482 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on enhancing gait recovery in patients who have experienced an ischemic stroke. It involves a two-week intensive inpatient rehabilitation program where participants are randomly assigned to either robot-assisted treadmill gait training (RTGT) or therapist-assisted treadmill gait training (TTGT). The study will assess various factors, including gait quality, neurological impairment, quality of life, cognition, and depression, to determine their impact on recovery. Additionally, a subset of patients will undergo advanced MRI imaging to explore brain structures related to gait recovery.
Who should consider this trial
Good fit: Ideal candidates are individuals who have suffered a first-ever ischemic stroke and have some level of walking dependency.
Not a fit: Patients with a history of previous strokes, significant heart disease, or severe depression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve walking ability and independence for patients recovering from ischemic stroke.
How similar studies have performed: Previous studies have shown promise in using robotic assistance for gait training, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Olomouc
- University Hospital Olomouc — Olomouc, Czechia (RECRUITING)
Study contacts
- Study coordinator: Barbora Kolarova, PhD
- Email: barbora.kolarova@fnol.cz
- Phone: +420 588 442 301
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ischemic Stroke, Stroke rehabilitation, Physical Therapy, Gait, Exoskeleton Device, Walking speed, Gait Analysis, Functional Magnetic Resonance Imaging